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A continuum of socioeconomic status ranging from the least to the most privileged persons is evidenced in population studies, with profound implications for health and care.1 Individuals in the most disadvantaged social group suffer from extreme poverty and face several specific challenges to their health and healthcare.2 They frequently cannot meet their most basic needs (including their physiological needs, most acutely exemplified by homelessness) and are at a higher risk of health problems and accelerated ageing due to unhealthy habits (eg, unhealthy diet and drug consumption), harmful environmental and biological factors and social isolation.1–4 As a result, the most socially disadvantaged persons have higher rates of premature mortality, especially caused by suicide and violence, and higher prevalence of all types of diseases, particularly infectious diseases and mental disorders.2 5 Besides, care for chronic conditions is compromised for this population group, which relies to a substantial degree in emergency care, particularly in health systems that do not guarantee universal health coverage.5Even considering the relative size of the most deprived extreme of the social continuum (eg, about 0.5% of the UK adult population in 2018 was considered homeless),6 the scale of …Anyone who has been tracking the public health literature on the greater risks experienced by minority ethnic groups in the erectile dysfunction viagra will have been struck by female viagra for sale the almost ubiquitous use of the acronym ‘BAME’. Government public health female viagra for sale agencies use BAME as a modifying adjective for ‘… communities’, ‘… groups’, ‘… households’, ‘… people’, ‘… populations’, ‘… staff’ and as a noun. A 2020 report by Public Health England1 on the impact of erectile dysfunction treatment on minority ethnic groups mentioned BAME 217 times without defining the term other than spelling out the acronym.

Such usage is redolent of Ian female viagra for sale Hacking’s ‘kinds of person’,2 a social group brought into being by the creation of labels for them and whose life narratives are dependent on social practices associated with such labelling.While ‘BME’ (black and minority ethnic) entered the lexicon in the early 1980s and was first used in Parliamentary proceedings in 1987,3 BAME made a later debut in this source in 2004 but had exceeded BME in frequency by 2020.4 A search of the GOV.UK portal—the website for the UK Government launched in 2012—reveals that results for the use of BAME substantially outpace BME (428 vs 242), a progressively widening gap that now makes it the government’s collective term of choice for minority ethnic groups. Astonishingly, all five petitions submitted in June 2020 to the UK Government and Parliament5 requesting the banning or review of BAME were rejected on the grounds that ‘the Government’s guidance on writing about ethnicity already states that it does not use BAME or BME for a number of reasons’. The disingenuousness and obvious falsity of the statement derives from the fact that this guidance relates only to the work of the Race Disparity Audit, a small unit in female viagra for sale the Cabinet Office, and not to Government as a whole.

The growing usage of these acronyms has also been apparent in the work of the media and the third and private sectors. Indeed, BAME was added to the female viagra for sale Oxford English Dictionary’s ‘new words list’ in 2014, confirming its arrival in the authoritative lexicon of contemporary English and further sustaining its use.The use of BAME is problematic for a number of reasons. A survey by the Race Disparity Audit, the best female viagra for sale available evidence, found that among nearly 300 people across the UK, <1% either recognised the acronym or knew what it stood for,6 against a required government standard of 80% of the UK population.

The term is generally used to refer to all minority ethnic groups except those that are white, thus excluding such groups as Gypsies, Roma and Travellers, some of the most disadvantaged and marginalised in Britain. It is female viagra for sale illogically constructed, the use of ‘minority ethnic’ following ‘black’ and ‘Asian’ suggesting that these pan-ethnicities are not minority ethnic groups. Moreover, the acronym implies that the individuals captured by it are a homogeneous group and it singles out and highlights specific pan-ethnicities (‘black’ and ‘Asian’), raising issues of exclusion and divisiveness.

Black British Academics argue that BME and BAME ‘reproduce unequal power relations where white is not a visible marker of identity and is therefore a privileged identity’.7 Both the Office for National Statistics and Cabinet Office advise against the use of these acronyms.In policy work on racial/ethnic disparities and inequities and structural or systematic racism, the language of female viagra for sale BME and BAME offers a convenient shorthand for those who are discriminated against by virtue of their physical appearance, but at the cost of confusion, ambiguity and a lack of understanding. Unfortunately, these acronyms are gaining in reality with respect to usage by government and the media. A wider female viagra for sale public debate is invited on appropriate collective terminology for minority ethnic groups.

There is evidence that terms like ‘minority ethnic’ and ‘ethnic minority’ are widely accepted and understood and a case for the use of accurate description to delineate the population groups encompassed by collective terms..

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This year http://grangebaptistchurch.org/reflections/ is looking to be very similar to last year for health mexican viagra insurance companies. Older patients continue to defer care, erectile dysfunction treatment mexican viagra costs are a burden and record profits are the end result.Reality isn't matching expectations. Health insurance companies predicted a flood of patients who'd gotten sicker as they put off care during the first year of the viagra would rush back. The assumption mexican viagra that medical expenses would rise was built into higher premiums for this year. But insurance companies guessed wrong and utilization remains depressed.On net, this has worked out fine for insurers.

Lower-than-expected costs tend to translate into higher profits, although the Affordable Care Act's medical-loss ratio rebates limit how much insurance companies can benefit financially when they overshoot on premiums.Health insurers have eyed their surprise boon as a means to spend on new initiatives, said Adam Block, a public health professor at New York Medical College and founder of Charm Economics."Health plans are looking at these [claims] reductions and switches to telehealth—a less expensive mexican viagra platform—and thinking about ways that they can invest the savings into improving the health of their population," Block said.Insurers are particularly focused on caring for the lucrative and growing Medicare Advantage population. Older people forgoing care makes it harder for insurers to anticipate their current and future medical needs. Incomplete information can lead to mexican viagra inaccurate risk scores, which can cut into Medicare reimbursements under the risk-adjustment program.While patients are not deferring care at the levels reported this time last year, erectile dysfunction treatment surges and treatment hesitancy have led to a deluge of patients taking up costly hospital beds. Staffing shortages also have made it hard for individuals to schedule visits, leading older people to continue to forgo medical care, said Rick Kes, a healthcare senior policy analyst at RSM.Appropriately modeling for these members' health and utilization poses the largest business risk faced by UnitedHealth Group's UnitedHealthcare, Humana and CVS Health's Aetna, the three largest Medicare Advantage carriers, Kes said. This risk is driving their investments for mexican viagra 2022 and beyond, he said."In 2020, a lot of health plans saw pretty favorable results, and I think there were some concerns that, 'We'll see this incredible return on claims and we'll see this big utilization in '21,'" Kes said.

"I don't think we saw a watershed moment where everybody came back to the medical office."Humana, UnitedHealthcare and Aetna declined to make executives available for interviews. Humana and UnitedHealthcare referred Modern Healthcare to their most recent earnings calls and Aetna mexican viagra declined to comment.During Humana's third quarter, which ended Sept. 30, the company reported that Medicare Advantage utilization not related to erectile dysfunction treatment dropped 7.7% compared to pre-viagra levels. At the same time, in-patient care for mexican viagra older adults with erectile dysfunction were higher than expected. The net result was a 1% decline in utilization among its Medicare Advantage enrollees.Humana has focused on collecting risk scores and has gathered information on 92% of policyholders with diagnoses the company believes could affect revenue next year.

Unlike competitors that rely on virtual-first visits to collect these data, Humana is counting on home visits and patient mexican viagra visits to its senior care centers to capture members' diagnoses. "I don't know if [telehealth] would be a replacement or if we would want to motivate highly chronic members to have a virtual-first interaction for a whole host of reasons from a care point of view, and from the ability for us to establish the proper care plan," Humana CEO Bruce Broussard told analysts during the company's earnings call. Over the past quarter, Humana has made seven acquisitions that gave it ownership mexican viagra of 21 more senior clinics. By the end of the year, the company expects to operate 200 CenterWell and Conviva offices nationwide. The insurer intends to mexican viagra open another 30 senior-focused clinics next year.

Humana also recently paid an undisclosed sum to acquire onehome and announced plans buy Kindred At Home in bids to beef up its home care business.At a high level, Humana's savings from fewer elective visit claims are offset by erectile dysfunction treatment expenses, said Brad Ellis, senior director of North American Insurance Ratings at Fitch Ratings. But because this difference was not as mexican viagra large as Humana anticipated, the insurer lowered its profit expectations for this year but maintained its forecast for 2022."We've been kind of amazed by how the deferral of care has governed the medical loss ratios for these companies," Ellis said. "When you see a large surge in acute erectile dysfunction treatment cases in the news, people start to defer care and stop going to a doctor or the hospital."UnitedHealth Group has seen commercial policyholders continue to schedule elective visits, while Medicare and Medicaid enrollees have been slightly more likely to defer care, Chief Financial Officer John Rex said during the company's earnings call in October. The outcome of the push and pull between these two factors led the company to raise its earnings outlook for the third time this year.After a spike in erectile dysfunction visits in mexican viagra September, UnitedHealthcare believes the worst of erectile dysfunction treatment is over. Meanwhile, the insurer has focused on capturing patient risk scores through in-person and virtual visits.UnitedHealthcare enrolls its highest risk Medicare Advantage and Medicaid members in an intervention program in which care teams monitor patients' daily vitals at home to reduce inpatient admissions and mortality rates, Rex said.

"During these house calls, our registered nurses do an environmental scan of the home, a medication review and mexican viagra administer preventative tests," Rex said. "Last year, we made more than 1.7 million visits, including to more than 200,000 people living in rural areas, and will complete more than 2 million in 2021."UnitedHealth Group's healthcare services arm, Optum, is conducting virtual visits with its primary care physicians and behavioral clinicians for all its patients, an approach that combines traditional and digital care.This strategy mirrors Aetna's focus on blending CVS Pharmacy's 10,000-store footprint with digital sites of care as a way to enable patient access while cutting costs."They're bracing themselves like, 'What can happen to 2022 risk scores?. ' Because we still have a mexican viagra viagra in 2021," said Deana Bell, principal actuary at Milliman. "The same issues could be in place—especially with different localized hotspots—and how do you manage that if people are too freaked out to go get their normal health care services and get those diagnosis codes recorded on their claims?. It's hard to manage that for your revenue for the next year."More than 12 million people have enrolled in Medicaid and the Children's Health Insurance Program since erectile dysfunction treatment outbreaks mexican viagra began in the U.S., largely due to shifting eligibility requirements and increases in federal funding to make care more accessible.

Now, community health centers are worried these flexibilities might not last once the public health emergency ends, leaving many without insurance. Ninety percent of health centers believe the termination of viagra-related Medicaid policies will lead to patients losing their benefits, forgoing vital healthcare services and relying on emergency and urgent care mexican viagra departments for treatment, according to a 2021 survey of federally-qualified health centers by the National Association of Community Health Centers.A lack of Medicaid flexibilities may mean health centers will not be able to continue their current services and methods of care delivery, said Jeremy Crandall, director of federal and state policy at NACHC."When children and adults have more access to preventive care, it prevents worsening conditions down the line," Crandall said. States began receiving a 6.2% hike in their Federal Medicaid Assistance Percentage as part of the Families First erectile dysfunction Response Act which passed in March 2020, and they were prohibited from disenrolling members from Medicaid during the public health emergency.This ultimately contributed to Medicaid and CHIP enrollment increasing by 17.1%, according to data from the Center for Medicare and Medicaid Services. Prior to the viagra, 48% of health center mexican viagra patients were Medicaid and CHIP beneficiaries, Crandall said, and most health centers reported up to a 25% increase in Medicaid patients over the course of the viagra.Nationwide, a total of 1,400 community-directed provider clinics serve nearly 29 million people, including one in five Medicaid beneficiaries and one in three people living in poverty. Enrollment protections have allowed more working families, vulnerable populations and patients with chronic conditions to experience primary and preventive care at lower costs, said Sarah Baizer, director of research policy at NACHC.In selecting the viagra-era Medicaid policies that would impact patients the most if they ended, 96% of NACHC survey respondents chose telehealth flexibilities, 72% listed allowing federally qualified health centers to bill Prospective Payment Systems for additional services provided, and 52% said continued interest in the federal Medicaid matching rate.To protect underserved patients after the viagra ends, NACHC is recommending that Congress extend key Affordable Care Act marketplace subsidies and enrollment periods to limit cost-sharing, reduce premiums, and provide pathways to coverage for low income people, while also mexican viagra investing in outreach, enrollment, and navigators for people in the Medicaid coverage gap, Baizer said.

Other areas currently under consideration by Congress include http://www.snackoverflow.uk/2015/08/the-start/. Providing more information to mexican viagra states about the planned phase-down of their Federal Medicaid Assistance Percentage increase. Extending the timeframe for states to complete pending eligibility and enrollment actions. Requiring states to complete an mexican viagra additional redetermination for those deemed ineligible for Medicaid. And ensuring state-authorized Medicaid audio-only telehealth services for the elderly, homebound and rural residents can continue beyond the public health emergency.If any of these protections are eliminated, health centers said it could lead to more uninsured patients, life-threatening situations for those unable to access treatment, a sliding fee scale for care, and a decrease in erectile dysfunction treatment testing and vaccination."Almost all health centers through the Medicaid flexibilities were able to provide more services to patients who would otherwise go without care," Baizer said.

"Patients who, in absence of these flexibilities, would likely seek care in an emergency department."Ten states sued the federal government Wednesday challenging its mandate for employees at Medicare and Medicaid-participating healthcare facilities to receive erectile dysfunction treatments, saying the requirement will exacerbate mexican viagra workforce shortages. The lawsuit, filed in the U.S. District Court for the Eastern District of Missouri, asks the court to permanently stop the Centers for Medicare and Medicaid Services interim final rule that mexican viagra created the mandate. Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire predict in their complaint that the mandate will devastate healthcare systems, especially in rural areas. "Vaccination requirements are mexican viagra matters that depend on local factors and conditions.

Whatever might make sense in New York City, St. Louis, or Omaha could be decidedly counterproductive and harmful in rural communities like Memphis, mexican viagra Missouri or McCook, Nebraska," the complaint said. While CMS acknowledged workforce concerns in its interim final rule, it said unvaccinated employees could get jobs in healthcare fields not covered under the mandate, like physician and dental offices, according to the lawsuit. "It does not suggest that the healthcare worker shortage will disappear but only that shortages will be further concentrated among the mexican viagra healthcare facilities covered by the CMS mandate," the complaint said. The lawsuit also took issue with CMS' decision not to let employees choose regular erectile dysfunction treatment testing instead of vaccination or opt out if they've previously had the viagra, saying this ignores personal liberty considerations as well as workforce concerns.

That decision also creates a conflict with the Occupational Safety and Health Administration's related requirement.The states claim the rule directly harms them because it requires state-run healthcare facilities and surveyors to enforce the mandate, leading to increased enforcement costs mexican viagra. "Yet again, this lawsuit is not about whether people should get vaccinated. Instead, it is about federal overreach and the federal government using an unconstitutional mandate to force front-line healthcare workers to choose between a vaccination or unemployment," North mexican viagra Dakota Attorney General Wayne Stenehjem said in a statement. The states argue public health matters, including treatment mandates, should be regulated by the states. They claim CMS' rulemaking authority doesn't allow it to impose such a broad mandate not authorized by Congress, and the provisions CMS laid out in its own justification of the rule mexican viagra aren't sufficient.

The states further argue CMS is violating laws that prevent federal agencies from controlling the selection or tenure of people providing health services. Prior to mexican viagra the lawsuit's filing, legal scholars said CMS' authority to impose the mandate was pretty concrete. James Hodge, director of the Center for Public Health Law and Policy at Arizona State University, told Modern Healthcare last week CMS has the broad ability to tie policy to the receipt of federal funds. Several states, including those suing CMS, have also filed lawsuits against the OSHA mandate.Employers increased access to telemedicine during the erectile dysfunction treatment viagra this year, according to survey results published Wednesday.Ninety-five percent of businesses with 50 or more workers offered at least some telemedicine coverage, up from 85% last year, according to the Kaiser mexican viagra Family Foundation's annual survey on employer benefits. Nearly half of employers surveyed expect telemedicine will continue to be an important access point.The new data highlight the telemedicine's rapid, viagra-driven growth.

Just one-third of companies with at least 50 mexican viagra employees covered this benefit three years ago. A modest share of companies also enhanced mental health benefits this year."The expansions of telemedicine and mental health benefits were important in meeting the needs of employees and their families in difficult times," Kaiser Family Foundation executives Gary Claxton and Matthew Rae said in a news release. "These types of changes made sense not because employers want to spend more, but because employers want their mexican viagra employees to see their health benefit programs as 'benefits' and to value them as such."Nearly six in 10 U.S. Residents get their health insurance from a job, which amounts to 155 million people, making employer-based health benefits the most common form of health coverage in the country, according to data compiled by the Kaiser Family Foundation.Among firms with at least 200 employees, 35% expanded the services and providers available via telehealth, as did 19% of companies with 50 to 199 workers. Twenty-seven percent of employers with 200 or more workers and 15% of those with 50 to 199 employees reduced or eliminated cost sharing for telemedicine.Although 31% of mexican viagra employers reported some form of improved mental health benefits, such as covering telehealth visits, few took concrete steps to increase access or reduce costs for workers.

For instance, 6% of companies added more mental health and substance abuse providers to their provider networks, 3% improved coverage of out-of-network providers and 4% waived or reduced cost sharing.The survey also found that the cost of employer-sponsored health insurance continue to rise. Premiums for a family plan rose 4% to $22,221 in 2021 mexican viagra. Since 2011, family policy premiums have grown 47%. Employees are responsible mexican viagra for an average of 28% of the premiums for family plans, a share that has remained fairly steady for decades. In 2021, that amounted to an average of almost $6,000 for the year..

This year is looking to female viagra for sale be very similar to last year for health insurance companies. Older patients continue to defer female viagra for sale care, erectile dysfunction treatment costs are a burden and record profits are the end result.Reality isn't matching expectations. Health insurance companies predicted a flood of patients who'd gotten sicker as they put off care during the first year of the viagra would rush back.

The assumption that female viagra for sale medical expenses would rise was built into higher premiums for this year. But insurance companies guessed wrong and utilization remains depressed.On net, this has worked out fine for insurers. Lower-than-expected costs tend to translate into higher profits, although the Affordable Care Act's medical-loss ratio rebates limit how much insurance companies can benefit financially when they overshoot on premiums.Health insurers have eyed their surprise boon as a means to spend on new initiatives, said Adam Block, a public health professor at New York Medical College and founder of Charm Economics."Health plans are looking at these [claims] reductions and switches to telehealth—a less expensive platform—and thinking about ways that they can invest the savings into improving the health of their population," Block said.Insurers are particularly focused on caring for the lucrative female viagra for sale and growing Medicare Advantage population.

Older people forgoing care makes it harder for insurers to anticipate their current and future medical needs. Incomplete information can lead to inaccurate risk scores, which can cut into Medicare reimbursements under the risk-adjustment program.While patients are not deferring care at the levels reported this time last year, erectile dysfunction treatment surges and treatment hesitancy have led female viagra for sale to a deluge of patients taking up costly hospital beds. Staffing shortages also have made it hard for individuals to schedule visits, leading older people to continue to forgo medical care, said Rick Kes, a healthcare senior policy analyst at RSM.Appropriately modeling for these members' health and utilization poses the largest business risk faced by UnitedHealth Group's UnitedHealthcare, Humana and CVS Health's Aetna, the three largest Medicare Advantage carriers, Kes said.

This risk is driving their investments for 2022 and beyond, he said."In 2020, a female viagra for sale lot of health plans saw pretty favorable results, and I think there were some concerns that, 'We'll see this incredible return on claims and we'll see this big utilization in '21,'" Kes said. "I don't think we saw a watershed moment where everybody came back to the medical office."Humana, UnitedHealthcare and Aetna declined to make executives available for interviews. Humana and UnitedHealthcare referred Modern female viagra for sale Healthcare to their most recent earnings calls and Aetna declined to comment.During Humana's third quarter, which ended Sept.

30, the company reported that Medicare Advantage utilization not related to erectile dysfunction treatment dropped 7.7% compared to pre-viagra levels. At the same time, in-patient care for older adults female viagra for sale with erectile dysfunction were higher than expected. The net result was a 1% decline in utilization among its Medicare Advantage enrollees.Humana has focused on collecting risk scores and has gathered information on 92% of policyholders with diagnoses the company believes could affect revenue next year.

Unlike competitors that rely on virtual-first visits to collect these data, Humana is counting on home visits and patient visits to its senior care female viagra for sale centers to capture members' diagnoses. "I don't know if [telehealth] would be a replacement or if we would want to motivate highly chronic members to have a virtual-first interaction for a whole host of reasons from a care point of view, and from the ability for us to establish the proper care plan," Humana CEO Bruce Broussard told analysts during the company's earnings call. Over the female viagra for sale past quarter, Humana has made seven acquisitions that gave it ownership of 21 more senior clinics.

By the end of the year, the company expects to operate 200 CenterWell and Conviva offices nationwide. The insurer intends to open female viagra for sale another 30 senior-focused clinics next year. Humana also recently paid an undisclosed sum to acquire onehome and announced plans buy Kindred At Home in bids to beef up its home care business.At a high level, Humana's savings from fewer elective visit claims are offset by erectile dysfunction treatment expenses, said Brad Ellis, senior director of North American Insurance Ratings at Fitch Ratings.

But because this difference was not as large as Humana anticipated, the insurer lowered female viagra for sale its profit expectations for this year but maintained its forecast for 2022."We've been kind of amazed by how the deferral of care has governed the medical loss ratios for these companies," Ellis said. "When you see a large surge in acute erectile dysfunction treatment cases in the news, people start to defer care and stop going to a doctor or the hospital."UnitedHealth Group has seen commercial policyholders continue to schedule elective visits, while Medicare and Medicaid enrollees have been slightly more likely to defer care, Chief Financial Officer John Rex said during the company's earnings call in October. The outcome of female viagra for sale the push and pull between these two factors led the company to raise its earnings outlook for the third time this year.After a spike in erectile dysfunction visits in September, UnitedHealthcare believes the worst of erectile dysfunction treatment is over.

Meanwhile, the insurer has focused on capturing patient risk scores through in-person and virtual visits.UnitedHealthcare enrolls its highest risk Medicare Advantage and Medicaid members in an intervention program in which care teams monitor patients' daily vitals at home to reduce inpatient admissions and mortality rates, Rex said. "During these female viagra for sale house calls, our registered nurses do an environmental scan of the home, a medication review and administer preventative tests," Rex said. "Last year, we made more than 1.7 million visits, including to more than 200,000 people living in rural areas, and will complete more than 2 million in 2021."UnitedHealth Group's healthcare services arm, Optum, is conducting virtual visits with its primary care physicians and behavioral clinicians for all its patients, an approach that combines traditional and digital care.This strategy mirrors Aetna's focus on blending CVS Pharmacy's 10,000-store footprint with digital sites of care as a way to enable patient access while cutting costs."They're bracing themselves like, 'What can happen to 2022 risk scores?.

' Because female viagra for sale we still have a viagra in 2021," said Deana Bell, principal actuary at Milliman. "The same issues could be in place—especially with different localized hotspots—and how do you manage that if people are too freaked out to go get their normal health care services and get those diagnosis codes recorded on their claims?. It's hard to manage that for your revenue for the next year."More than 12 million people have enrolled in Medicaid and the Children's Health Insurance Program since erectile dysfunction treatment outbreaks began in the U.S., largely due to shifting eligibility requirements and female viagra for sale increases in federal funding to make care more accessible.

Now, community health centers are worried these flexibilities might not last once the public health emergency ends, leaving many without insurance. Ninety percent of health centers believe the termination of viagra-related Medicaid policies will lead to patients losing their benefits, forgoing vital healthcare services and relying on emergency and urgent care departments for treatment, according to a 2021 survey of federally-qualified health centers by the National Association of Community Health Centers.A lack of Medicaid flexibilities may female viagra for sale mean health centers will not be able to continue their current services and methods of care delivery, said Jeremy Crandall, director of federal and state policy at NACHC."When children and adults have more access to preventive care, it prevents worsening conditions down the line," Crandall said. States began receiving a 6.2% hike in their Federal Medicaid Assistance Percentage as part of the Families First erectile dysfunction Response Act which passed in March 2020, and they were prohibited from disenrolling members from Medicaid during the public health emergency.This ultimately contributed to Medicaid and CHIP enrollment increasing by 17.1%, according to data from the Center for Medicare and Medicaid Services.

Prior to the viagra, 48% of health center patients were Medicaid and CHIP beneficiaries, Crandall female viagra for sale said, and most health centers reported up to a 25% increase in Medicaid patients over the course of the viagra.Nationwide, a total of 1,400 community-directed provider clinics serve nearly 29 million people, including one in five Medicaid beneficiaries and one in three people living in poverty. Enrollment protections have allowed more working families, vulnerable populations and patients with chronic conditions to experience primary and preventive care at lower costs, said Sarah Baizer, director of research policy at female viagra for sale NACHC.In selecting the viagra-era Medicaid policies that would impact patients the most if they ended, 96% of NACHC survey respondents chose telehealth flexibilities, 72% listed allowing federally qualified health centers to bill Prospective Payment Systems for additional services provided, and 52% said continued interest in the federal Medicaid matching rate.To protect underserved patients after the viagra ends, NACHC is recommending that Congress extend key Affordable Care Act marketplace subsidies and enrollment periods to limit cost-sharing, reduce premiums, and provide pathways to coverage for low income people, while also investing in outreach, enrollment, and navigators for people in the Medicaid coverage gap, Baizer said. Other areas currently under consideration by Congress include.

Providing more information to states about the planned phase-down of their Federal Medicaid Assistance Percentage increase female viagra for sale. Extending the timeframe for states to complete pending eligibility and enrollment actions. Requiring states to female viagra for sale complete an additional redetermination for those deemed ineligible for Medicaid.

And ensuring state-authorized Medicaid audio-only telehealth services for the elderly, homebound and rural residents can continue beyond the public health emergency.If any of these protections are eliminated, health centers said it could lead to more uninsured patients, life-threatening situations for those unable to access treatment, a sliding fee scale for care, and a decrease in erectile dysfunction treatment testing and vaccination."Almost all health centers through the Medicaid flexibilities were able to provide more services to patients who would otherwise go without care," Baizer said. "Patients who, female viagra for sale in absence of these flexibilities, would likely seek care in an emergency department."Ten states sued the federal government Wednesday challenging its mandate for employees at Medicare and Medicaid-participating healthcare facilities to receive erectile dysfunction treatments, saying the requirement will exacerbate workforce shortages. The lawsuit, filed in the U.S.

District Court for the Eastern District of Missouri, asks the court female viagra for sale to permanently stop the Centers for Medicare and Medicaid Services interim final rule that created the mandate. Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire predict in their complaint that the mandate will devastate healthcare systems, especially in rural areas. "Vaccination requirements are female viagra for sale matters that depend on local factors and conditions.

Whatever might make sense in New York City, St. Louis, or Omaha could be decidedly counterproductive female viagra for sale and harmful in rural communities like Memphis, Missouri or McCook, Nebraska," the complaint said. While CMS acknowledged workforce concerns in its interim final rule, it said unvaccinated employees could get jobs in healthcare fields not covered under the mandate, like physician and dental offices, according to the lawsuit.

"It does not suggest that the healthcare worker shortage will disappear but only that shortages will be further concentrated female viagra for sale among the healthcare facilities covered by the CMS mandate," the complaint said. The lawsuit also took issue with CMS' decision not to let employees choose regular erectile dysfunction treatment testing instead of vaccination or opt out if they've previously had the viagra, saying this ignores personal liberty considerations as well as workforce concerns. That decision female viagra for sale also creates a conflict with the Occupational Safety and Health Administration's related requirement.The states claim the rule directly harms them because it requires state-run healthcare facilities and surveyors to enforce the mandate, leading to increased enforcement costs.

"Yet again, this lawsuit is not about whether people should get vaccinated. Instead, it is about federal overreach and the federal government using an unconstitutional mandate to force front-line female viagra for sale healthcare workers to choose between a vaccination or unemployment," North Dakota Attorney General Wayne Stenehjem said in a statement. The states argue public health matters, including treatment mandates, should be regulated by the states.

They claim CMS' rulemaking authority doesn't female viagra for sale allow it to impose such a broad mandate not authorized by Congress, and the provisions CMS laid out in its own justification of the rule aren't sufficient. The states further argue CMS is violating laws that prevent federal agencies from controlling the selection or tenure of people providing health services. Prior to the lawsuit's filing, legal scholars said CMS' authority to impose the mandate was pretty concrete female viagra for sale.

James Hodge, director of the Center for Public Health Law and Policy at Arizona State University, told Modern Healthcare last week CMS has the broad ability to tie policy to the receipt of federal funds. Several states, including those suing CMS, have also filed lawsuits against the OSHA mandate.Employers increased access to telemedicine during the erectile dysfunction treatment viagra this year, according to survey results published Wednesday.Ninety-five percent of businesses with 50 female viagra for sale or more workers offered at least some telemedicine coverage, up from 85% last year, according to the Kaiser Family Foundation's annual survey on employer benefits. Nearly half of employers surveyed expect telemedicine will continue to be an important access point.The new data highlight the telemedicine's rapid, viagra-driven growth.

Just one-third of companies with at least 50 employees covered this benefit three years ago female viagra for sale. A modest share of companies also enhanced mental health benefits this year."The expansions of telemedicine and mental health benefits were important in meeting the needs of employees and their families in difficult times," Kaiser Family Foundation executives Gary Claxton and Matthew Rae said in a news release. "These types of changes made sense not because female viagra for sale employers want to spend more, but because employers want their employees to see their health benefit programs as 'benefits' and to value them as such."Nearly six in 10 U.S.

Residents get their health insurance from a job, which amounts to 155 million people, making employer-based health benefits the most common form of health coverage in the country, according to data compiled by the Kaiser Family Foundation.Among firms with at least 200 employees, 35% expanded the services and providers available via telehealth, as did 19% of companies with 50 to 199 workers. Twenty-seven percent of employers with 200 or more workers and 15% of those with 50 to 199 employees reduced or eliminated cost sharing for telemedicine.Although 31% of employers reported some form of improved mental health benefits, such as covering telehealth visits, few took concrete steps to increase access or reduce costs for female viagra for sale workers. For instance, 6% of companies added more mental health and substance abuse providers to their provider networks, 3% improved coverage of out-of-network providers and 4% waived or reduced cost sharing.The survey also found that the cost of employer-sponsored health insurance continue to rise.

Premiums for female viagra for sale a family plan rose 4% to $22,221 in 2021. Since 2011, family policy premiums have grown 47%. Employees are responsible for an average of 28% of the premiums for family plans, a female viagra for sale share that has remained fairly steady for decades.

In 2021, that amounted to an average of almost $6,000 for the year..

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How long before sex should you take viagra

Objectives, Participants, and Oversight how long before sex should you take viagra We conducted a randomized, placebo-controlled, observer-blinded, click here for more phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 how long before sex should you take viagra to 25 years of age and an evaluation of the noninferiority of immunogenicity in the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort. Data were collected through the cutoff date of March 13, 2021.

Eligible participants were healthy or had stable preexisting disease (including hepatitis B, hepatitis C, or how long before sex should you take viagra human immunodeficiency viagra ). Persons with a previous clinical or virologic erectile dysfunction treatment diagnosis or erectile dysfunction , previous erectile dysfunction vaccination, diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded. The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the how long before sex should you take viagra full text of this article at NEJM.org.

Additional details of the trial are provided in the protocol, available at NEJM.org. Pfizer was responsible for the trial design and conduct, data how long before sex should you take viagra collection, data analysis, data interpretation, and writing of the manuscript that was submitted. Both Pfizer and BioNTech manufactured the treatment and placebo.

BioNTech was the regulatory sponsor of how long before sex should you take viagra the trial and contributed to data interpretation and writing of the manuscript. All data were available to the authors, who vouch for their accuracy and completeness and for the adherence of the trial to the protocol. Procedures Randomization was conducted with the use of an interactive Web-based how long before sex should you take viagra response system.

Participants were assigned in a 1:1 ratio to receive two intramuscular injections of 30 μg of BNT162b2 or placebo (saline) 21 days apart. For evaluation of how long before sex should you take viagra immediate treatment-associated reactions, participants were observed in the clinic for 30 minutes after vaccination. Safety Safety objectives included the assessment of local or systemic reactogenicity events, which were recorded by the participants in an electronic diary (e-diary) for 7 days after each dose.

Unsolicited adverse events (i.e., those how long before sex should you take viagra reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose 2, respectively. Immunogenicity Immunogenicity assessments (erectile dysfunction serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as how long before sex should you take viagra compared with that in 16-to-25-year-old participants. Noninferiority was assessed among participants who had no evidence of previous erectile dysfunction with the use of the two-sided 95% confidence interval for the geometric mean ratio of erectile dysfunction 50% neutralizing titers in 12-to-15-year-old participants as compared with 16-to-25-year-old participants 1 month after dose 2.

BNT162b2 immunogenicity was how long before sex should you take viagra evaluated in participants with and those without serologic or virologic evidence of previous erectile dysfunction . Corresponding end points were the geometric mean erectile dysfunction neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2. Efficacy The efficacy of BNT162b2 against confirmed erectile dysfunction treatment with how long before sex should you take viagra an onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous erectile dysfunction , as well as in all vaccinated participants.

Surveillance for potential erectile dysfunction treatment cases was undertaken throughout the trial. If acute how long before sex should you take viagra respiratory illness developed in a participant, the participant was tested for erectile dysfunction. Methods for identifying erectile dysfunction s and erectile dysfunction treatment diagnoses are summarized in the Supplementary Appendix.

Statistical Analysis The safety how long before sex should you take viagra population included all participants who received at least one dose of BNT162b2 or placebo. The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events). Safety end points are presented descriptively as counts, percentages, and how long before sex should you take viagra associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described according to terms in the Medical Dictionary for Regulatory Activities, version 23.1, for each group.

Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure. For immunogenicity how long before sex should you take viagra assessments, all participants in both age cohorts were from U.S. Sites.

The dose 2 immunogenicity population that could be evaluated included participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at how long before sex should you take viagra least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of erectile dysfunction 50% neutralizing titers how long before sex should you take viagra. A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67).

A testing laboratory supply how long before sex should you take viagra limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix. Although the formal evaluation of efficacy was to be based on the overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the how long before sex should you take viagra stratification factor).

The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population that could how long before sex should you take viagra be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations. The all-available efficacy population included all participants who received one or two doses.

treatment efficacy was defined as 100×(1−IRR), where IRR is the ratio of the how long before sex should you take viagra rate of a first confirmed erectile dysfunction treatment illness in the BNT162b2 group to the corresponding rate in the placebo group. Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons). Because the number of participants who reported how long before sex should you take viagra symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not imputed in the analysis.Participants Figure 1.

Figure 1. Enrollment and how long before sex should you take viagra Randomization. The diagram represents all enrolled participants through November 14, 2020.

The safety subset (those how long before sex should you take viagra with a median of 2 months of follow-up, in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1 how long before sex should you take viagra.

Demographic Characteristics of the Participants how long before sex should you take viagra in the Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1 how long before sex should you take viagra.

Brazil, 2. South Africa, how long before sex should you take viagra 4. Germany, 6.

And Turkey, 9) in the phase 2/3 portion of the trial how long before sex should you take viagra. A total of 43,448 participants received injections. 21,720 received how long before sex should you take viagra BNT162b2 and 21,728 received placebo (Figure 1).

At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, how long before sex should you take viagra 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2).

Safety Local how long before sex should you take viagra Reactogenicity Figure 2. Figure 2. Local and Systemic Reactions Reported within 7 Days after Injection how long before sex should you take viagra of BNT162b2 or Placebo, According to Age Group.

Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days after how long before sex should you take viagra each vaccination. Solicited injection-site (local) reactions are shown in Panel A. Pain at the how long before sex should you take viagra injection site was assessed according to the following scale.

Mild, does not interfere with activity. Moderate, interferes how long before sex should you take viagra with activity. Severe, prevents daily activity.

And grade 4, emergency how long before sex should you take viagra department visit or hospitalization. Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in how long before sex should you take viagra diameter.

Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 how long before sex should you take viagra cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling).

Systemic events how long before sex should you take viagra and medication use are shown in Panel B. Fever categories are designated in the key. Medication use was not how long before sex should you take viagra graded.

Additional scales were as how long before sex should you take viagra follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild. Does not interfere with activity how long before sex should you take viagra.

Moderate. Some interference how long before sex should you take viagra with activity. Or severe.

Prevents daily how long before sex should you take viagra activity), vomiting (mild. 1 to 2 times in 24 hours. Moderate.

>2 times in 24 hours. Or severe. Requires intravenous hydration), and diarrhea (mild.

2 to 3 loose stools in 24 hours. Moderate. 4 to 5 loose stools in 24 hours.

Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2).

Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose. 66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose).

A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction. In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days.

Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients.

17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose.

Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients. Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C.

Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1. 38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose.

Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group.

Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients.

Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy. Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia).

Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo. No erectile dysfunction treatment–associated deaths were observed.

No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2.

Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3.

Table 3. treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3.

Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose. Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population).

Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates.

The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period.

The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients. This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2).

Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4). treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%.

95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Placebo, 44 cases). Figure 3 shows cases of erectile dysfunction treatment or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.V-safe Surveillance.

Local and Systemic Reactogenicity in Pregnant Persons Table 1. Table 1. Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment.

Table 2. Table 2. Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons.

From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1).

Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1.

Figure 1. Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA erectile dysfunction treatment Vaccination. Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) erectile dysfunction disease 2019 (erectile dysfunction treatment) treatment — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021.

The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1). Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar. Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3).

V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3.

Characteristics of V-safe Pregnancy Registry Participants. As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility).

The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel. Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3).

Among 1040 participants (91.9%) who received a treatment in the first trimester and 1700 (99.2%) who received a treatment in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart. Limited follow-up calls had been made at the time of this analysis. Table 4.

Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%).

A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview.

Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed. Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons.

155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases. 37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each.

No congenital anomalies were reported to the VAERS, a requirement under the EUAs.Trial Oversight This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. Sites. Participants received the first trial injection between July 27 and October 23, 2020.

The trial is being conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice guidelines, and applicable government regulations. The central institutional review board approved the protocol and the consent forms. All participants provided written informed consent before enrollment.

Safety is reviewed by a protocol safety review team weekly and by an independent data and safety monitoring board on a continual basis. The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design (with input from the Biomedical Advanced Research and Development Authority, the NIAID, the erectile dysfunction treatment Prevention Network, and the trial cochairs), site selection and monitoring, and data analysis. Investigators are responsible for data collection.

A medical writer funded by Moderna assisted in drafting the manuscript for submission. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. The trial is ongoing, and the investigators remain unaware of participant-level data.

Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board. All other trial staff and participants remain unaware of the treatment assignments. Participants, Randomization, and Data Blinding Eligible participants were persons 18 years of age or older with no known history of erectile dysfunction and with locations or circumstances that put them at an appreciable risk of erectile dysfunction , a high risk of severe erectile dysfunction treatment, or both.

Inclusion and exclusion criteria are provided in the protocol (available with the full text of this article at NEJM.org). To enhance the diversity of the trial population in accordance with Food and Drug Administration Draft Guidance, site-selection and enrollment processes were adjusted to increase the number of persons from racial and ethnic minorities in the trial, in addition to the persons at risk for erectile dysfunction in the local population. The upper limit for stratification of enrolled participants considered to be “at risk for severe illness” at screening was increased from 40% to 50%.17 Participants were randomly assigned in a 1:1 ratio, through the use of a centralized interactive response technology system, to receive treatment or placebo.

Assignment was stratified, on the basis of age and erectile dysfunction treatment complications risk criteria, into the following risk groups. Persons 65 years of age or older, persons younger than 65 years of age who were at heightened risk (at risk) for severe erectile dysfunction treatment, and persons younger than 65 years of age without heightened risk (not at risk). Participants younger than 65 years of age were categorized as having risk for severe erectile dysfunction treatment if they had at least one of the following risk factors, based on the Centers for Disease Control and Prevention (CDC) criteria available at the time of trial design.

Chronic lung disease (e.g., emphysema, chronic bronchitis, idiopathic pulmonary fibrosis, cystic fibrosis, or moderate-to-severe asthma). Cardiac disease (e.g., heart failure, congenital coronary artery disease, cardiomyopathies, or pulmonary hypertension). Severe obesity (body mass index [the weight in kilograms divided by the square of the height in meters] ≥40).

Diabetes (type 1, type 2, or gestational). Liver disease. Or with the human immunodeficiency viagra.18 treatment dose preparation and administration were performed by pharmacists and treatment administrators who were aware of treatment assignments but had no other role in the conduct of the trial.

Once the injection was completed, only trial staff who were unaware of treatment assignments performed assessments and interacted with the participants. Access to the randomization code was strictly controlled at the pharmacy. The data and safety monitoring board reviewed efficacy data at the group level and unblinded safety data at the participant level.

Trial treatment The mRNA-1273 treatment, provided as a sterile liquid at a concentration of 0.2 mg per milliliter, was administered by injection into the deltoid muscle according to a two-dose regimen. Injections were given 28 days apart, in the same arm, in a volume of 0.5 ml containing 100 μg of mRNA-1273 or saline placebo.1 treatment mRNA-1273 was stored at 2° to 8°C (35.6° to 46.4°F) at clinical sites before preparation and vaccination. No dilution was required.

Doses could be held in syringes for up to 8 hours at room temperature before administration. Safety Assessments Safety assessments included monitoring of solicited local and systemic adverse events for 7 days after each injection. Unsolicited adverse reactions for 28 days after each injection.

Adverse events leading to discontinuation from a dose, from participation in the trial, or both. And medically attended adverse events and serious adverse events from day 1 through day 759. Adverse event grading criteria and toxicity tables are described in the protocol.

Cases of erectile dysfunction treatment and severe erectile dysfunction treatment were continuously monitored by the data and safety monitoring board from randomization onward. Efficacy Assessments The primary end point was the efficacy of the mRNA-1273 treatment in preventing a first occurrence of symptomatic erectile dysfunction treatment with onset at least 14 days after the second injection in the per-protocol population, among participants who were seronegative at baseline. End points were judged by an independent adjudication committee that was unaware of group assignment.

erectile dysfunction treatment cases were defined as occurring in participants who had at least two of the following symptoms. Fever (temperature ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder, or as occurring in those who had at least one respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia) and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if the participant was hospitalized) that was positive for erectile dysfunction by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test. Participants were assessed for the presence of erectile dysfunction–binding antibodies specific to the erectile dysfunction nucleocapsid protein (Roche Elecsys, Roche Diagnostics International) and had a nasopharyngeal swab for erectile dysfunction RT-PCR testing (Viracor, Eurofins Clinical Diagnostics) before each injection.

erectile dysfunction–infected volunteers were followed daily, to assess symptom severity, for 14 days or until symptoms resolved, whichever was longer. A nasopharyngeal swab for RT-PCR testing and a blood sample for identifying serologic evidence of erectile dysfunction were collected from participants with symptoms of erectile dysfunction treatment. The consistency of treatment efficacy at the primary end point was evaluated across various subgroups, including age groups (18 to <65 years of age and ≥65 years), age and health risk for severe disease (18 to <65 years and not at risk.

18 to <65 years and at risk. And ≥65 years), sex (female or male), race and ethnic group, and risk for severe erectile dysfunction treatment illness. If the number of participants in a subgroup was too small, it was combined with other subgroups for the subgroup analyses.

A secondary end point was the efficacy of mRNA-1273 in the prevention of severe erectile dysfunction treatment as defined by one of the following criteria. Respiratory rate of 30 or more breaths per minute. Heart rate at or exceeding 125 beats per minute.

Oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg. Respiratory failure. Acute respiratory distress syndrome.

Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or a need for vasopressors). Clinically significant acute renal, hepatic, or neurologic dysfunction. Admission to an intensive care unit.

Or death. Additional secondary end points included the efficacy of the treatment at preventing erectile dysfunction treatment after a single dose or at preventing erectile dysfunction treatment according to a secondary (CDC), less restrictive case definition. Having any symptom of erectile dysfunction treatment and a positive erectile dysfunction test by RT-PCR (see Table S1 in the Supplementary Appendix, available at NEJM.org).

Statistical Analysis For analysis of the primary end point, the trial was designed for the null hypothesis that the efficacy of the mRNA-1273 treatment is 30% or less. A total of 151 cases of erectile dysfunction treatment would provide 90% power to detect a 60% reduction in the hazard rate (i.e., 60% treatment efficacy), with two planned interim analyses at approximately 35% and 70% of the target total number of cases (151) and with a one-sided O’Brien–Fleming boundary for efficacy and an overall one-sided error rate of 0.025. The efficacy of the mRNA-1273 treatment could be demonstrated at either the interim or the primary analysis, performed when the target total number of cases had been observed.

The Lan–DeMets alpha-spending function was used for calculating efficacy boundaries at each analysis. At the first interim analysis on November 15, 2020, treatment efficacy had been demonstrated in accordance with the prespecified statistical criteria. The treatment efficacy estimate, based on a total of 95 adjudicated cases (63% of the target total), was 94.5%, with a one-sided P value of less than 0.001 to reject the null hypothesis that treatment efficacy would be 30% or less.

The data and safety monitoring board recommendation to the oversight group and the trial sponsor was that the efficacy findings should be shared with the participants and the community (full details are available in the protocol and statistical analysis plan). treatment efficacy was assessed in the full analysis population (randomized participants who received at least one dose of mRNA-1273 or placebo), the modified intention-to-treat population (participants in the full analysis population who had no immunologic or virologic evidence of erectile dysfunction treatment on day 1, before the first dose), and the per-protocol population (participants in the modified intention-to-treat population who received two doses, with no major protocol deviations). The primary efficacy end point in the interim and primary analyses was assessed in the per-protocol population.

Participants were evaluated in the treatment groups to which they were assigned. treatment efficacy was defined as the percentage reduction in the hazard ratio for the primary end point (mRNA-1273 vs. Placebo).

A stratified Cox proportional hazards model was used to assess the treatment efficacy of mRNA-1273 as compared with placebo in terms of the percentage hazard reduction. (Details regarding the analysis of treatment efficacy are provided in the Methods section of the Supplementary Appendix.) Safety was assessed in all participants in the solicited safety population (i.e., those who received at least one injection and reported a solicited adverse event). Descriptive summary data (numbers and percentages) for participants with any solicited adverse events, unsolicited adverse events, unsolicited severe adverse events, serious adverse events, medically attended adverse events, and adverse events leading to discontinuation of the injections or withdrawal from the trial are provided by group.

Two-sided 95% exact confidence intervals (Clopper–Pearson method) are provided for the percentages of participants with solicited adverse events. Unsolicited adverse events are presented according to the Medical Dictionary for Regulatory Activities (MedDRA), version 23.0, preferred terms and system organ class categories. To meet the regulatory agencies’ requirement of a median follow-up duration of at least 2 months after completion of the two-dose regimen, a second analysis was performed, with an efficacy data cutoff date of November 21, 2020.

This second analysis is considered the primary analysis of efficacy, with a total of 196 adjudicated erectile dysfunction treatment cases in the per-protocol population, which exceeds the target total number of cases (151) specified in the protocol. This was an increase from the 95 cases observed at the first interim analysis data cutoff on November 11, 2020. Results from the primary analysis are presented in this report.

Subsequent analyses are considered supplementary.Supported by the Bill and Melinda Gates Foundation through a grant to the World Health Organization (grant number OPP1151718). Disclosure forms provided by the authors are with the full text of this article at NEJM.org. No potential conflict of interest relevant to this article was reported.

The members of the writing committee are as follows. Sugandha Arya, M.D., Helga Naburi, M.D., M.P.H., Ph.D., Kondwani Kawaza, M.B., B.S., Sam Newton, M.B., Ch.B., M.P.H., Ph.D., Chineme H. Anyabolu, M.B., B.S., Nils Bergman, M.B., Ch.B., M.P.H., Ph.D., Suman P.N.

Rao, M.D., D.M., Pratima Mittal, M.S., Evelyne Assenga, M.D., M.P.H., Luis Gadama, F.C.O.G., Roderick Larsen-Reindorf, M.B., Ch.B., Oluwafemi Kuti, M.D., Agnes Linnér, M.D., Sachiyo Yoshida, Ph.D., Nidhi Chopra, M.D., Matilda Ngarina, M.D., Ph.D., Ausbert T. Msusa, M.B., B.S., Adwoa Boakye-Yiadom, M.B., Ch.B., Bankole P. Kuti, M.B., Ch.B., F.M.C.Paed., Barak Morgan, M.B., B.Ch., Ph.D., Nicole Minckas, M.Sc., Jyotsna Suri, M.S., Robert Moshiro, M.D., Ph.D., Vincent Samuel, M.Sc., Naana Wireko-Brobby, M.B., Ch.B., Siren Rettedal, M.D., Ph.D., Harsh V.

Jaiswal, B.Tech., M. Jeeva Sankar, M.D., D.M., Isaac Nyanor, M.P.H., Hiresh Tiwary, M.C.A., Pratima Anand, M.D., D.M., Alexander A. Manu, M.B., Ch.B., Ph.D., Kashika Nagpal, M.S., Daniel Ansong, M.B., Ch.B., Isha Saini, M.D., Kailash C.

Aggarwal, M.D., Nitya Wadhwa, M.D., Rajiv Bahl, M.D., Ph.D., Bjorn Westrup, M.D., Ph.D., Ebunoluwa A. Adejuyigbe, M.B., Ch.B., M.D., Gyikua Plange-Rhule, M.B., Ch.B., Queen Dube, Ph.D., Harish Chellani, M.D., and Augustine Massawe, M.D.This study was reviewed and approved by the World Health Organization Ethics Review Committee and the institutional review boards at the five study sites. The School of Medical Science–Komfo Anokye Teaching Hospital, Ghana.

Vardhman Mahavir Medical College and Safdarjung Hospital, India. The Malawi College of Medicine, Malawi. The Obafemi Awolowo University Teaching Hospitals Complex, Nigeria.

And the National Institute for Medical Research, Tanzania.This is the New England Journal of Medicine version of record, which includes all Journal editing and enhancements. The Author Final Manuscript, which is the author’s version after external peer review and before publication in the Journal, is registered under a CC BY license at PMC8108485.A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.We thank the women, infants, and families that have participated in the trial. All staff members in all participating sites for their dedication.

And the members of the data and safety monitoring board, including Prof. Betty Kirkwood (Chair), Prof. Elizabeth Molyneux, Prof.

Ravindra Mohan Pandey (statistician), Prof. Siddarth Ramji, Prof. Esther Mwaikambo, Prof.

Olugbenga Mokuolu, and Ms. Charlotte Tawiah, for providing independent oversight..

Objectives, Participants, and Oversight We conducted a randomized, female viagra for sale placebo-controlled, observer-blinded, phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age buy generic viagra or older. This report presents findings from 12-to-15-year-old participants enrolled in the United States, including descriptive comparisons of safety between participants in that age cohort and those who were 16 to 25 years of age and an evaluation of the noninferiority of immunogenicity in female viagra for sale the 12-to-15-year-old cohort to that in the 16-to-25-year-old cohort. Data were collected through the cutoff date of March 13, 2021. Eligible participants were healthy or had stable preexisting disease (including hepatitis female viagra for sale B, hepatitis C, or human immunodeficiency viagra ).

Persons with a previous clinical or virologic erectile dysfunction treatment diagnosis or erectile dysfunction , previous erectile dysfunction vaccination, diagnosis of an immunocompromising or immunodeficiency disorder, or treatment with immunosuppressive therapy (including cytotoxic agents and systemic glucocorticoids) were excluded. The ethical conduct of the trial is summarized in the Supplementary Appendix, available with the full text of this article female viagra for sale at NEJM.org. Additional details of the trial are provided in the protocol, available at NEJM.org. Pfizer was responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the manuscript that was female viagra for sale submitted.

Both Pfizer and BioNTech manufactured the treatment and placebo. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and female viagra for sale writing of the manuscript. All data were available to the authors, who vouch for their accuracy and completeness and for the adherence of the trial to the protocol. Procedures Randomization was conducted with the use of an female viagra for sale interactive Web-based response system.

Participants were assigned in a 1:1 ratio to receive two intramuscular injections of 30 μg of BNT162b2 or placebo (saline) 21 days apart. For evaluation of immediate treatment-associated reactions, participants were observed in the female viagra for sale clinic for 30 minutes after vaccination. Safety Safety objectives included the assessment of local or systemic reactogenicity events, which were recorded by the participants in an electronic diary (e-diary) for 7 days after each dose. Unsolicited adverse events (i.e., those female viagra for sale reported by the participant without e-diary prompting) and serious adverse events were also recorded from receipt of the first dose through 1 month and 6 months after dose 2, respectively.

Immunogenicity Immunogenicity assessments (erectile dysfunction serum neutralization assay and receptor-binding domain [RBD]–binding or S1-binding IgG direct Luminex immunoassays) were performed before vaccination and 1 month after dose 2, as described previously.3 The immunogenicity objective was to show noninferiority of the immune response to BNT162b2 female viagra for sale in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants. Noninferiority was assessed among participants who had no evidence of previous erectile dysfunction with the use of the two-sided 95% confidence interval for the geometric mean ratio of erectile dysfunction 50% neutralizing titers in 12-to-15-year-old participants as compared with 16-to-25-year-old participants 1 month after dose 2. BNT162b2 immunogenicity was evaluated in participants with and those without serologic or virologic evidence of previous erectile dysfunction female viagra for sale. Corresponding end points were the geometric mean erectile dysfunction neutralizing titers at baseline (i.e., immediately before receipt of the first injection) and 1 month after dose 2 and geometric mean fold rises (GMFRs) in titers from baseline to 1 month after dose 2.

Efficacy The efficacy of BNT162b2 against confirmed erectile dysfunction treatment female viagra for sale with an onset 7 or more days after dose 2 was summarized in participants who did not have evidence of previous erectile dysfunction , as well as in all vaccinated participants. Surveillance for potential erectile dysfunction treatment cases was undertaken throughout the trial. If acute female viagra for sale respiratory illness developed in a participant, the participant was tested for erectile dysfunction. Methods for identifying erectile dysfunction s and erectile dysfunction treatment diagnoses are summarized in the Supplementary Appendix.

Statistical Analysis The safety population included all participants who received at least one dose of BNT162b2 female viagra for sale or placebo. The reactogenicity subset included all 12-to-15-year-old participants and a subset of 16-to-25-year-old participants (those who received an e-diary to record reactogenicity events). Safety end points are presented descriptively as counts, percentages, and associated Clopper–Pearson two-sided 95% confidence intervals, with adverse events and serious adverse events described according to terms in the Medical Dictionary for Regulatory Activities, version 23.1, for each female viagra for sale group. Immunogenicity was assessed in a random subset of participants in each age cohort with the use of a simple random-sample selection procedure.

For immunogenicity assessments, all female viagra for sale participants in both age cohorts were from U.S. Sites. The dose 2 immunogenicity population that could be evaluated included female viagra for sale participants who underwent randomization and received two BNT162b2 doses in accordance with the protocol, received dose 2 within the prespecified window (19 to 42 days after dose 1), had at least one valid and determinate immunogenicity result from a blood sample obtained within 28 to 42 days after dose 2, and had no major protocol deviations. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old female viagra for sale participants as compared with that in 16-to-25-year-old participants was assessed on the basis of the geometric mean ratio of erectile dysfunction 50% neutralizing titers.

A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67). A testing laboratory female viagra for sale supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses. Calculations of the geometric mean ratios, geometric mean titers, and GMFRs are described in the Supplementary Appendix. Although the formal evaluation of efficacy was to be based on the female viagra for sale overall results obtained across all age cohorts, the statistical analysis plan specified that descriptive efficacy summaries would be provided for each age cohort (the stratification factor).

The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown. The efficacy population female viagra for sale that could be evaluated included all eligible 12-to-15-year-old participants who underwent randomization and received two doses of BNT162b2 or placebo, received dose 2 within the prespecified window (19 to 42 days after dose 1), and had no major protocol deviations. The all-available efficacy population included all participants who received one or two doses. treatment efficacy female viagra for sale was defined as 100×(1−IRR), where IRR is the ratio of the rate of a first confirmed erectile dysfunction treatment illness in the BNT162b2 group to the corresponding rate in the placebo group.

Two-sided Clopper–Pearson 95% confidence intervals were calculated (not adjusted for multiple comparisons). Because the number of participants who reported symptoms but were missing a valid polymerase-chain-reaction test result was small, data for these participants were not female viagra for sale imputed in the analysis.Participants Figure 1. Figure 1. Enrollment and Randomization female viagra for sale.

The diagram represents all enrolled participants through November 14, 2020. The safety subset (those with a median of 2 months of follow-up, female viagra for sale in accordance with application requirements for Emergency Use Authorization) is based on an October 9, 2020, data cut-off date. The further procedures that one participant in the placebo group declined after dose 2 (lower right corner of the diagram) were those involving collection of blood and nasal swab samples.Table 1. Table 1 female viagra for sale.

Demographic Characteristics of the Participants in the female viagra for sale Main Safety Population. Between July 27, 2020, and November 14, 2020, a total of 44,820 persons were screened, and 43,548 persons 16 years of age or older underwent randomization at 152 sites worldwide (United States, 130 sites. Argentina, 1 female viagra for sale. Brazil, 2.

South Africa, 4 female viagra for sale. Germany, 6. And Turkey, 9) female viagra for sale in the phase 2/3 portion of the trial. A total of 43,448 participants received injections.

21,720 received BNT162b2 and 21,728 received placebo female viagra for sale (Figure 1). At the data cut-off date of October 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set. Among these 37,706 participants, 49% were female, 83% were White, 9% were Black or African American, 28% were Hispanic or Latinx, 35% were obese female viagra for sale (body mass index [the weight in kilograms divided by the square of the height in meters] of at least 30.0), and 21% had at least one coexisting condition. The median age was 52 years, and 42% of participants were older than 55 years of age (Table 1 and Table S2).

Safety Local female viagra for sale Reactogenicity Figure 2. Figure 2. Local and Systemic Reactions Reported within 7 Days female viagra for sale after Injection of BNT162b2 or Placebo, According to Age Group. Data on local and systemic reactions and use of medication were collected with electronic diaries from participants in the reactogenicity subset (8,183 participants) for 7 days female viagra for sale after each vaccination.

Solicited injection-site (local) reactions are shown in Panel A. Pain at the injection site was female viagra for sale assessed according to the following scale. Mild, does not interfere with activity. Moderate, interferes female viagra for sale with activity.

Severe, prevents daily activity. And grade 4, female viagra for sale emergency department visit or hospitalization. Redness and swelling were measured according to the following scale. Mild, 2.0 to 5.0 cm in diameter female viagra for sale.

Moderate, >5.0 to 10.0 cm in diameter. Severe, >10.0 female viagra for sale cm in diameter. And grade 4, necrosis or exfoliative dermatitis (for redness) and necrosis (for swelling). Systemic events and medication use are shown female viagra for sale in Panel B.

Fever categories are designated in the key. Medication use was not graded female viagra for sale. Additional scales were as female viagra for sale follows. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain (mild.

Does not female viagra for sale interfere with activity. Moderate. Some interference with female viagra for sale activity. Or severe.

Prevents daily activity), vomiting (mild female viagra for sale. 1 to 2 times in 24 hours. Moderate. >2 times in 24 hours.

Or severe. Requires intravenous hydration), and diarrhea (mild. 2 to 3 loose stools in 24 hours. Moderate.

4 to 5 loose stools in 24 hours. Or severe. 6 or more loose stools in 24 hours). Grade 4 for all events indicated an emergency department visit or hospitalization.

Н™¸ bars represent 95% confidence intervals, and numbers above the 𝙸 bars are the percentage of participants who reported the specified reaction.The reactogenicity subset included 8183 participants. Overall, BNT162b2 recipients reported more local reactions than placebo recipients. Among BNT162b2 recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most commonly reported local reaction, with less than 1% of participants across all age groups reporting severe pain (Figure 2). Pain was reported less frequently among participants older than 55 years of age (71% reported pain after the first dose.

66% after the second dose) than among younger participants (83% after the first dose. 78% after the second dose). A noticeably lower percentage of participants reported injection-site redness or swelling. The proportion of participants reporting local reactions did not increase after the second dose (Figure 2A), and no participant reported a grade 4 local reaction.

In general, local reactions were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Systemic Reactogenicity Systemic events were reported more often by younger treatment recipients (16 to 55 years of age) than by older treatment recipients (more than 55 years of age) in the reactogenicity subset and more often after dose 2 than dose 1 (Figure 2B). The most commonly reported systemic events were fatigue and headache (59% and 52%, respectively, after the second dose, among younger treatment recipients. 51% and 39% among older recipients), although fatigue and headache were also reported by many placebo recipients (23% and 24%, respectively, after the second dose, among younger treatment recipients.

17% and 14% among older recipients). The frequency of any severe systemic event after the first dose was 0.9% or less. Severe systemic events were reported in less than 2% of treatment recipients after either dose, except for fatigue (in 3.8%) and headache (in 2.0%) after the second dose. Fever (temperature, ≥38°C) was reported after the second dose by 16% of younger treatment recipients and by 11% of older recipients.

Only 0.2% of treatment recipients and 0.1% of placebo recipients reported fever (temperature, 38.9 to 40°C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose. Two participants each in the treatment and placebo groups reported temperatures above 40.0°C. Younger treatment recipients were more likely to use antipyretic or pain medication (28% after dose 1. 45% after dose 2) than older treatment recipients (20% after dose 1.

38% after dose 2), and placebo recipients were less likely (10 to 14%) than treatment recipients to use the medications, regardless of age or dose. Systemic events including fever and chills were observed within the first 1 to 2 days after vaccination and resolved shortly thereafter. Daily use of the electronic diary ranged from 90 to 93% for each day after the first dose and from 75 to 83% for each day after the second dose. No difference was noted between the BNT162b2 group and the placebo group.

Adverse Events Adverse event analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1 (Table S3). More BNT162b2 recipients than placebo recipients reported any adverse event (27% and 12%, respectively) or a related adverse event (21% and 5%). This distribution largely reflects the inclusion of transient reactogenicity events, which were reported as adverse events more commonly by treatment recipients than by placebo recipients. Sixty-four treatment recipients (0.3%) and 6 placebo recipients (<0.1%) reported lymphadenopathy.

Few participants in either group had severe adverse events, serious adverse events, or adverse events leading to withdrawal from the trial. Four related serious adverse events were reported among BNT162b2 recipients (shoulder injury related to treatment administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the treatment or placebo.

No erectile dysfunction treatment–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of treatment. Efficacy Table 2.

Table 2. treatment Efficacy against erectile dysfunction treatment at Least 7 days after the Second Dose. Table 3. Table 3.

treatment Efficacy Overall and by Subgroup in Participants without Evidence of before 7 Days after Dose 2. Figure 3. Figure 3. Efficacy of BNT162b2 against erectile dysfunction treatment after the First Dose.

Shown is the cumulative incidence of erectile dysfunction treatment after the first dose (modified intention-to-treat population). Each symbol represents erectile dysfunction treatment cases starting on a given day. Filled symbols represent severe erectile dysfunction treatment cases. Some symbols represent more than one case, owing to overlapping dates.

The inset shows the same data on an enlarged y axis, through 21 days. Surveillance time is the total time in 1000 person-years for the given end point across all participants within each group at risk for the end point. The time period for erectile dysfunction treatment case accrual is from the first dose to the end of the surveillance period. The confidence interval (CI) for treatment efficacy (VE) is derived according to the Clopper–Pearson method.Among 36,523 participants who had no evidence of existing or prior erectile dysfunction , 8 cases of erectile dysfunction treatment with onset at least 7 days after the second dose were observed among treatment recipients and 162 among placebo recipients.

This case split corresponds to 95.0% treatment efficacy (95% confidence interval [CI], 90.3 to 97.6. Table 2). Among participants with and those without evidence of prior SARS CoV-2 , 9 cases of erectile dysfunction treatment at least 7 days after the second dose were observed among treatment recipients and 169 among placebo recipients, corresponding to 94.6% treatment efficacy (95% CI, 89.9 to 97.3). Supplemental analyses indicated that treatment efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population (Table 3 and Table S4).

treatment efficacy among participants with hypertension was analyzed separately but was consistent with the other subgroup analyses (treatment efficacy, 94.6%. 95% CI, 68.7 to 99.9. Case split. BNT162b2, 2 cases.

Placebo, 44 cases). Figure 3 shows cases of erectile dysfunction treatment http://sidecountrytheatre.org/donate/ or severe erectile dysfunction treatment with onset at any time after the first dose (mITT population) (additional data on severe erectile dysfunction treatment are available in Table S5). Between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a treatment efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the treatment, starting as soon as 12 days after the first dose.V-safe Surveillance. Local and Systemic Reactogenicity in Pregnant Persons Table 1.

Table 1. Characteristics of Persons Who Identified as Pregnant in the V-safe Surveillance System and Received an mRNA erectile dysfunction treatment. Table 2. Table 2.

Frequency of Local and Systemic Reactions Reported on the Day after mRNA erectile dysfunction treatment Vaccination in Pregnant Persons. From December 14, 2020, to February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Age distributions were similar among the participants who received the Pfizer–BioNTech treatment and those who received the Moderna treatment, with the majority of the participants being 25 to 34 years of age (61.9% and 60.6% for each treatment, respectively) and non-Hispanic White (76.2% and 75.4%, respectively). Most participants (85.8% and 87.4%, respectively) reported being pregnant at the time of vaccination (Table 1).

Solicited reports of injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both treatments (Table 2) and were reported more frequently after dose 2 for both treatments. Participant-measured temperature at or above 38°C was reported by less than 1% of the participants on day 1 after dose 1 and by 8.0% after dose 2 for both treatments. Figure 1. Figure 1.

Most Frequent Local and Systemic Reactions Reported in the V-safe Surveillance System on the Day after mRNA erectile dysfunction treatment Vaccination. Shown are solicited reactions in pregnant persons and nonpregnant women 16 to 54 years of age who received a messenger RNA (mRNA) erectile dysfunction disease 2019 (erectile dysfunction treatment) treatment — BNT162b2 (Pfizer–BioNTech) or mRNA-1273 (Moderna) — from December 14, 2020, to February 28, 2021. The percentage of respondents was calculated among those who completed a day 1 survey, with the top events shown of injection-site pain (pain), fatigue or tiredness (fatigue), headache, muscle or body aches (myalgia), chills, and fever or felt feverish (fever).These patterns of reporting, with respect to both most frequently reported solicited reactions and the higher reporting of reactogenicity after dose 2, were similar to patterns observed among nonpregnant women (Figure 1). Small differences in reporting frequency between pregnant persons and nonpregnant women were observed for specific reactions (injection-site pain was reported more frequently among pregnant persons, and other systemic reactions were reported more frequently among nonpregnant women), but the overall reactogenicity profile was similar.

Pregnant persons did not report having severe reactions more frequently than nonpregnant women, except for nausea and vomiting, which were reported slightly more frequently only after dose 2 (Table S3). V-safe Pregnancy Registry. Pregnancy Outcomes and Neonatal Outcomes Table 3. Table 3.

Characteristics of V-safe Pregnancy Registry Participants. As of March 30, 2021, the v-safe pregnancy registry call center attempted to contact 5230 persons who were vaccinated through February 28, 2021, and who identified during a v-safe survey as pregnant at or shortly after erectile dysfunction treatment vaccination. Of these, 912 were unreachable, 86 declined to participate, and 274 did not meet inclusion criteria (e.g., were never pregnant, were pregnant but received vaccination more than 30 days before the last menstrual period, or did not provide enough information to determine eligibility). The registry enrolled 3958 participants with vaccination from December 14, 2020, to February 28, 2021, of whom 3719 (94.0%) identified as health care personnel.

Among enrolled participants, most were 25 to 44 years of age (98.8%), non-Hispanic White (79.0%), and, at the time of interview, did not report a erectile dysfunction treatment diagnosis during pregnancy (97.6%) (Table 3). Receipt of a first dose of treatment meeting registry-eligibility criteria was reported by 92 participants (2.3%) during the periconception period, by 1132 (28.6%) in the first trimester of pregnancy, by 1714 (43.3%) in the second trimester, and by 1019 (25.7%) in the third trimester (1 participant was missing information to determine the timing of vaccination) (Table 3). Among 1040 participants (91.9%) who received a treatment in the first trimester and 1700 (99.2%) who received a treatment in the second trimester, initial data had been collected and follow-up scheduled at designated time points approximately 10 to 12 weeks apart. Limited follow-up calls had been made at the time of this analysis.

Table 4. Table 4. Pregnancy Loss and Neonatal Outcomes in Published Studies and V-safe Pregnancy Registry Participants. Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%).

A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible treatment dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]). No neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received erectile dysfunction treatment in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed.

Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature (Table 4). Adverse-Event Findings on the VAERS During the analysis period, the VAERS received and processed 221 reports involving erectile dysfunction treatment vaccination among pregnant persons. 155 (70.1%) involved nonpregnancy-specific adverse events, and 66 (29.9%) involved pregnancy- or neonatal-specific adverse events (Table S4). The most frequently reported pregnancy-related adverse events were spontaneous abortion (46 cases.

37 in the first trimester, 2 in the second trimester, and 7 in which the trimester was unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each. No congenital anomalies were reported to the VAERS, a requirement under the EUAs.Trial Oversight This phase 3 randomized, stratified, observer-blinded, placebo-controlled trial enrolled adults in medically stable condition at 99 U.S. Sites. Participants received the first trial injection between July 27 and October 23, 2020.

The trial is being conducted in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practice guidelines, and applicable government regulations. The central institutional review board approved the protocol and the consent forms. All participants provided written informed consent before enrollment. Safety is reviewed by a protocol safety review team weekly and by an independent data and safety monitoring board on a continual basis.

The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design (with input from the Biomedical Advanced Research and Development Authority, the NIAID, the erectile dysfunction treatment Prevention Network, and the trial cochairs), site selection and monitoring, and data analysis. Investigators are responsible for data collection. A medical writer funded by Moderna assisted in drafting the manuscript for submission. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

The trial is ongoing, and the investigators remain unaware of participant-level data. Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board. All other trial staff and participants remain unaware of the treatment assignments. Participants, Randomization, and Data Blinding Eligible participants were persons 18 years of age or older with no known history of erectile dysfunction and with locations or circumstances that put them at an appreciable risk of erectile dysfunction , a high risk of severe erectile dysfunction treatment, or both.

Inclusion and exclusion criteria are provided in the protocol (available with the full text of this article at NEJM.org). To enhance the diversity of the trial population in accordance with Food and Drug Administration Draft Guidance, site-selection and enrollment processes were adjusted to increase the number of persons from racial and ethnic minorities in the trial, in addition to the persons at risk for erectile dysfunction in the local population. The upper limit for stratification of enrolled participants considered to be “at risk for severe illness” at screening was increased from 40% to 50%.17 Participants were randomly assigned in a 1:1 ratio, through the use of a centralized interactive response technology system, to receive treatment or placebo. Assignment was stratified, on the basis of age and erectile dysfunction treatment complications risk criteria, into the following risk groups.

Persons 65 years of age or older, persons younger than 65 years of age who were at heightened risk (at risk) for severe erectile dysfunction treatment, and persons younger than 65 years of age without heightened risk (not at risk). Participants younger than 65 years of age were categorized as having risk for severe erectile dysfunction treatment if they had at least one of the following risk factors, based on the Centers for Disease Control and Prevention (CDC) criteria available at the time of trial design. Chronic lung disease (e.g., emphysema, chronic bronchitis, idiopathic pulmonary fibrosis, cystic fibrosis, or moderate-to-severe asthma). Cardiac disease (e.g., heart failure, congenital coronary artery disease, cardiomyopathies, or pulmonary hypertension).

Severe obesity (body mass index [the weight in kilograms divided by the square of the height in meters] ≥40). Diabetes (type 1, type 2, or gestational). Liver disease. Or with the human immunodeficiency viagra.18 treatment dose preparation and administration were performed by pharmacists and treatment administrators who were aware of treatment assignments but had no other role in the conduct of the trial.

Once the injection was completed, only trial staff who were unaware of treatment assignments performed assessments and interacted with the participants. Access to the randomization code was strictly controlled at the pharmacy. The data and safety monitoring board reviewed efficacy data at the group level and unblinded safety data at the participant level. Trial treatment The mRNA-1273 treatment, provided as a sterile liquid at a concentration of 0.2 mg per milliliter, was administered by injection into the deltoid muscle according to a two-dose regimen.

Injections were given 28 days apart, in the same arm, in a volume of 0.5 ml containing 100 μg of mRNA-1273 or saline placebo.1 treatment mRNA-1273 was stored at 2° to 8°C (35.6° to 46.4°F) at clinical sites before preparation and vaccination. No dilution was required. Doses could be held in syringes for up to 8 hours at room temperature before administration. Safety Assessments Safety assessments included monitoring of solicited local and systemic adverse events for 7 days after each injection.

Unsolicited adverse reactions for 28 days after each injection. Adverse events leading to discontinuation from a dose, from participation in the trial, or both. And medically attended adverse events and serious adverse events from day 1 through day 759. Adverse event grading criteria and toxicity tables are described in the protocol.

Cases of erectile dysfunction treatment and severe erectile dysfunction treatment were continuously monitored by the data and safety monitoring board from randomization onward. Efficacy Assessments The primary end point was the efficacy of the mRNA-1273 treatment in preventing a first occurrence of symptomatic erectile dysfunction treatment with onset at least 14 days after the second injection in the per-protocol population, among participants who were seronegative at baseline. End points were judged by an independent adjudication committee that was unaware of group assignment. erectile dysfunction treatment cases were defined as occurring in participants who had at least two of the following symptoms.

Fever (temperature ≥38°C), chills, myalgia, headache, sore throat, or new olfactory or taste disorder, or as occurring in those who had at least one respiratory sign or symptom (including cough, shortness of breath, or clinical or radiographic evidence of pneumonia) and at least one nasopharyngeal swab, nasal swab, or saliva sample (or respiratory sample, if the participant was hospitalized) that was positive for erectile dysfunction by reverse-transcriptase–polymerase-chain-reaction (RT-PCR) test. Participants were assessed for the presence of erectile dysfunction–binding antibodies specific to the erectile dysfunction nucleocapsid protein (Roche Elecsys, Roche Diagnostics International) and had a nasopharyngeal swab for erectile dysfunction RT-PCR testing (Viracor, Eurofins Clinical Diagnostics) before each injection. erectile dysfunction–infected volunteers were followed daily, to assess symptom severity, for 14 days or until symptoms resolved, whichever was longer. A nasopharyngeal swab for RT-PCR testing and a blood sample for identifying serologic evidence of erectile dysfunction were collected from participants with symptoms of erectile dysfunction treatment.

The consistency of treatment efficacy at the primary end point was evaluated across various subgroups, including age groups (18 to <65 years of age and ≥65 years), age and health risk for severe disease (18 to <65 years and not at risk. 18 to <65 years and at risk. And ≥65 years), sex (female or male), race and ethnic group, and risk for severe erectile dysfunction treatment illness. If the number of participants in a subgroup was too small, it was combined with other subgroups for the subgroup analyses.

A secondary end point was the efficacy of mRNA-1273 in the prevention of severe erectile dysfunction treatment as defined by one of the following criteria. Respiratory rate of 30 or more breaths per minute. Heart rate at or exceeding 125 beats per minute. Oxygen saturation at 93% or less while the participant was breathing ambient air at sea level or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen below 300 mm Hg.

Respiratory failure. Acute respiratory distress syndrome. Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg, or a need for vasopressors). Clinically significant acute renal, hepatic, or neurologic dysfunction.

Admission to an intensive care unit. Or death. Additional secondary end points included the efficacy of the treatment at preventing erectile dysfunction treatment after a single dose or at preventing erectile dysfunction treatment according to a secondary (CDC), less restrictive case definition. Having any symptom of erectile dysfunction treatment and a positive erectile dysfunction test by RT-PCR (see Table S1 in the Supplementary Appendix, available at NEJM.org).

Statistical Analysis For analysis of the primary end point, the trial was designed for the null hypothesis that the efficacy of the mRNA-1273 treatment is 30% or less. A total of 151 cases of erectile dysfunction treatment would provide 90% power to detect a 60% reduction in the hazard rate (i.e., 60% treatment efficacy), with two planned interim analyses at approximately 35% and 70% of the target total number of cases (151) and with a one-sided O’Brien–Fleming boundary for efficacy and an overall one-sided error rate of 0.025. The efficacy of the mRNA-1273 treatment could be demonstrated at either the interim or the primary analysis, performed when the target total number of cases had been observed. The Lan–DeMets alpha-spending function was used for calculating efficacy boundaries at each analysis.

At the first interim analysis on November 15, 2020, treatment efficacy had been demonstrated in accordance with the prespecified statistical criteria. The treatment efficacy estimate, based on a total of 95 adjudicated cases (63% of the target total), was 94.5%, with a one-sided P value of less than 0.001 to reject the null hypothesis that treatment efficacy would be 30% or less. The data and safety monitoring board recommendation to the oversight group and the trial sponsor was that the efficacy findings should be shared with the participants and the community (full details are available in the protocol and statistical analysis plan). treatment efficacy was assessed in the full analysis population (randomized participants who received at least one dose of mRNA-1273 or placebo), the modified intention-to-treat population (participants in the full analysis population who had no immunologic or virologic evidence of erectile dysfunction treatment on day 1, before the first dose), and the per-protocol population (participants in the modified intention-to-treat population who received two doses, with no major protocol deviations).

The primary efficacy end point in the interim and primary analyses was assessed in the per-protocol population. Participants were evaluated in the treatment groups to which they were assigned. treatment efficacy was defined as the percentage reduction in the hazard ratio for the primary end point (mRNA-1273 vs. Placebo).

A stratified Cox proportional hazards model was used to assess the treatment efficacy of mRNA-1273 as compared with placebo in terms of the percentage hazard reduction. (Details regarding the analysis of treatment efficacy are provided in the Methods section of the Supplementary Appendix.) Safety was assessed in all participants in the solicited safety population (i.e., those who received at least one injection and reported a solicited adverse event). Descriptive summary data (numbers and percentages) for participants with any solicited adverse events, unsolicited adverse events, unsolicited severe adverse events, serious adverse events, medically attended adverse events, and adverse events leading to discontinuation of the injections or withdrawal from the trial are provided by group. Two-sided 95% exact confidence intervals (Clopper–Pearson method) are provided for the percentages of participants with solicited adverse events.

Unsolicited adverse events are presented according to the Medical Dictionary for Regulatory Activities (MedDRA), version 23.0, preferred terms and system organ class categories. To meet the regulatory agencies’ requirement of a median follow-up duration of at least 2 months after completion of the two-dose regimen, a second analysis was performed, with an efficacy data cutoff date of November 21, 2020. This second analysis is considered the primary analysis of efficacy, with a total of 196 adjudicated erectile dysfunction treatment cases in the per-protocol population, which exceeds the target total number of cases (151) specified in the protocol. This was an increase from the 95 cases observed at the first interim analysis data cutoff on November 11, 2020.

Results from the primary analysis are presented in this report. Subsequent analyses are considered supplementary.Supported by the Bill and Melinda Gates Foundation through a grant to the World Health Organization (grant number OPP1151718). Disclosure forms provided by the authors are with the full text of this article at NEJM.org. No potential conflict of interest relevant to this article was reported.

The members of the writing committee are as follows. Sugandha Arya, M.D., Helga Naburi, M.D., M.P.H., Ph.D., Kondwani Kawaza, M.B., B.S., Sam Newton, M.B., Ch.B., M.P.H., Ph.D., Chineme H. Anyabolu, M.B., B.S., Nils Bergman, M.B., Ch.B., M.P.H., Ph.D., Suman P.N. Rao, M.D., D.M., Pratima Mittal, M.S., Evelyne Assenga, M.D., M.P.H., Luis Gadama, F.C.O.G., Roderick Larsen-Reindorf, M.B., Ch.B., Oluwafemi Kuti, M.D., Agnes Linnér, M.D., Sachiyo Yoshida, Ph.D., Nidhi Chopra, M.D., Matilda Ngarina, M.D., Ph.D., Ausbert T.

Msusa, M.B., B.S., Adwoa Boakye-Yiadom, M.B., Ch.B., Bankole P. Kuti, M.B., Ch.B., F.M.C.Paed., Barak Morgan, M.B., B.Ch., Ph.D., Nicole Minckas, M.Sc., Jyotsna Suri, M.S., Robert Moshiro, M.D., Ph.D., Vincent Samuel, M.Sc., Naana Wireko-Brobby, M.B., Ch.B., Siren Rettedal, M.D., Ph.D., Harsh V. Jaiswal, B.Tech., M. Jeeva Sankar, M.D., D.M., Isaac Nyanor, M.P.H., Hiresh Tiwary, M.C.A., Pratima Anand, M.D., D.M., Alexander A.

Manu, M.B., Ch.B., Ph.D., Kashika Nagpal, M.S., Daniel Ansong, M.B., Ch.B., Isha Saini, M.D., Kailash C. Aggarwal, M.D., Nitya Wadhwa, M.D., Rajiv Bahl, M.D., Ph.D., Bjorn Westrup, M.D., Ph.D., Ebunoluwa A. Adejuyigbe, M.B., Ch.B., M.D., Gyikua Plange-Rhule, M.B., Ch.B., Queen Dube, Ph.D., Harish Chellani, M.D., and Augustine Massawe, M.D.This study was reviewed and approved by the World Health Organization Ethics Review Committee and the institutional review boards at the five study sites. The School of Medical Science–Komfo Anokye Teaching Hospital, Ghana.

Vardhman Mahavir Medical College and Safdarjung Hospital, India. The Malawi College of Medicine, Malawi. The Obafemi Awolowo University Teaching Hospitals Complex, Nigeria. And the National Institute for Medical Research, Tanzania.This is the New England Journal of Medicine version of record, which includes all Journal editing and enhancements.

The Author Final Manuscript, which is the author’s version after external peer review and before publication in the Journal, is registered under a CC BY license at PMC8108485.A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.We thank the women, infants, and families that have participated in the trial. All staff members in all participating sites for their dedication. And the members of the data and safety monitoring board, including Prof. Betty Kirkwood (Chair), Prof.

Elizabeth Molyneux, Prof. Ravindra Mohan Pandey (statistician), Prof. Siddarth Ramji, Prof. Esther Mwaikambo, Prof.

Olugbenga Mokuolu, and Ms. Charlotte Tawiah, for providing independent oversight..

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Viagra pill

¿pañales, comida o viagra pill renta?. La pandemia de erectile dysfunction treatment ha agravado la situación, engrosando las listas de desempleados y causando interrupciones en la cadena de suministro que han generado precios más altos para una multitud de productos, incluidos los pañales. Los bancos de pañales, programas financiados por la comunidad que ofrecen pañales gratis a familias de bajos ingresos, distribuyeron un 86% más de pañales en promedio en 2020, comparado con 2019, según la red nacional. En algunos lugares, la viagra pill distribución aumentó hasta en un 800%. Sin embargo, ningún programa federal ayuda a los padres a pagar por este producto esencial de la niñez.

El programa de asistencia alimentaria del gobierno no cubre pañales, ni la mayoría de los programas de ayuda pública a nivel estatal. California es viagra pill el único estado que financia directamente los pañales para las familias, pero el apoyo es limitado. CalWORKS, un programa de asistencia financiera para familias con niños, proporciona $30 al mes para ayudar a las familias a pagar por los pañales para los menores de 3 años. También se pueden producir cambios en las políticas federales. Los legisladores demócratas están presionando para incluir $200 millones para la distribución de pañales en el paquete viagra pill masivo de reconciliación presupuestaria.

Sin los recursos adecuados, los padres de bajos ingresos luchan por encontrar formas de aprovechar al máximo cada pañal. Esta tarea estresante es el tema de un artículo reciente en American Sociological Review de Jennifer Randles, profesora de sociología en la Universidad Estatal de California en Fresno. En 2018, Randles realizó entrevistas telefónicas con 70 madres en California viagra pill durante nueve meses. También trató de reclutar padres, pero solo respondieron dos hombres. Randles habló con Jenny Gold de KHN sobre cómo el costo de los pañales pesa en las mamás de bajos ingresos y la “maternidad creativa” que muchas mujeres adoptan para proteger a sus hijos de los daños de la pobreza.

¿Qué rol viagra pill juegan los pañales en las ansiedades cotidianas de las madres de bajos ingresos?. Jennifer Randles, profesora de sociología en la Universidad Estatal de California en Fresno, ha realizado una investigación sobre el papel que juegan los pañales, y no tener suficientes, en las ansiedades de las mamás de bajos ingresos. €œEn mi muestra, la mitad de las madres me dijeron que se preocupaban más por los pañales que por la comida o la vivienda”, dice Randles.(Vickie Kirby) En mi muestra, la mitad de las madres me dijeron que se preocupaban más por los pañales que por la comida o la vivienda. Comencé a viagra pill preguntarles a las madres. €œÂ¿Pueden decirme cuántos pañales tienen a mano en este momento?.

€ Casi todas me dijeron con precisión exacta cuántos tenían. Cinco, siete viagra pill o 12. Y sabían exactamente cuánto duraría esa cantidad, según la frecuencia con la que sus hijos defecaban y orinaban, si su hijo estaba enfermo, o si tenía una dermatitis del pañal en ese momento. Llevar un registro tan cuidadoso de los suministros de pañales es todo un trabajo emocional y cognitivo. Estaban preocupadas y pensando viagra pill.

€œEstá bien, me he quedado casi con mi último pañal. ¿Qué hago ahora?. ¿Voy viagra pill a buscar algunas latas [para vender]?. ¿Voy a vender algunas cosas en mi casa?. ¿Quién en mi red social podría tener algo de dinero extra en este momento?.

€. Hablé con mamás que venden plasma sanguíneo solo para comprar pañales a sus bebés. ¿Qué estrategias para afrontar esto le llamaron la atención?. Los que estudiamos los pañales a menudo los llamamos estrategias para estirar los pañales. Una le dejaba puesto un pañal a su niño un poco más de lo habitual, hasta que se llenara por completo.

Algunas madres se dieron cuenta de que si compraban un pañal [más caro] que aguantaba más y goteaba menos, podían dejarlo puesto por más tiempo. También hacían cosas como dejar que el bebé se quedara sin pañal, especialmente cuando estaban en la casa y sentían que no serían juzgadas por esto. Y utilizaban todos los bienes domésticos que puedas imaginar para hacer pañales improvisados. Telas, sábanas y fundas de almohada. Están usando cosas que son desechables como toallas de papel con cinta adhesiva.

Están haciendo pañales con sus propios suministros para la menstruación o suministros para la incontinencia de adultos cuando pueden obtener una muestra gratis. Una de las preguntas que me hacen a menudo es. €œÂ¿Por qué no usan simplemente tela?. € Muchas de las madres con las que hablé habían probado los pañales de tela y descubrieron que eran muy costosos y la mano de obra, prohibitiva. Si pagas por un juego completo de pañales de tela para comenzar, estamos hablando de entre $500 y $1,000.

Y estas mamás nunca tuvieron tanto dinero. La mayoría no tenían lavadoras ni secadoras en casa. Algunas ni siquiera tenían casa o acceso consistente a agua, y es ilegal en muchas lavanderías comunitarias y públicas lavar pañales usados. Por lo tanto, las mismas condiciones que evitarían que las mamás puedan pagar fácilmente pañales desechables son las mismas condiciones que les impiden usar telas. Descubrió que el concepto de muchas mujeres de ser “una buena madre” está relacionado con el cambio de pañales.

¿Por qué es eso?. Los pañales y el manejo de los pañales eran fundamentales para su identidad como buenas mamás. La mayoría de las madres de mi muestra se privaban de su propia comida. No estaban pagando una factura de teléfono celular o comprando sus propios medicamentos o sus propios suministros menstruales, como una forma de ahorrar dinero para pañales. Hablé con muchas mamás que dijeron que cuando su bebé tiene hambre, eso es horrible.

Obviamente, haces todo lo posible para evitarlo. Pero hay algo en un pañal que cubre esta parte vulnerable del cuerpo de un bebé muy pequeño, esta piel tan delicada. Y poder hacer algo para satisfacer esta necesidad humana que todos tenemos, y mantener la dignidad y la limpieza. Muchas de las mamás habían pasado por el sistema de asistencia social, por lo que viven con este miedo constante [de perder a sus hijos]. Esto es especialmente cierto entre las madres de color, que son mucho más propensas a ser parte del sistema de bienestar infantil.

Las personas no necesariamente pueden ver cuándo un bebé tiene hambre. Pero la gente puede ver un pañal en mal estado. Esa será una de las cosas que la etiquetará como mala madre. ¿Su trabajo con los pañales se vio influenciado por su experiencia como madre?. Cuando estaba haciendo estas entrevistas, mi hija tenía alrededor de 2 o 3 años.

Así que todavía estaba en pañales. Cuando mi hija orinaba durante un cambio de pañal, pensaba. €œOh, puedo tirar ese. Déjame conseguir otro limpio”. Esa es una elección realmente fácil.

Para mi. Pero es una crisis para las madres que entrevisté. Muchas me dijeron que tienen un ataque de ansiedad con cada cambio de pañal. ¿Ve una solución política clara para el estrés relacionado con los pañales?. Lo que resulta un tanto irónico es la cantidad de trabajo físico, emocional y cognitivo que implica la gestión de algo que la sociedad y los legisladores ni siquiera reconocen.

Los pañales todavía no se reconocen realmente como una necesidad básica, como lo demuestra el hecho de que todavía están sujetos a impuestos en 35 estados. Creo que lo que está haciendo California es un excelente comienzo. Y creo que los bancos de pañales son un tipo de organización comunitaria fabulosa, que está satisfaciendo una gran necesidad que no está siendo cubierta por las políticas de la red de seguridad. Entonces, apoyo público a los bancos de pañales. La ayuda directa en efectivo que forma parte de la red de seguridad social prácticamente se ha desmantelado en los últimos 25 años.

California es bastante generosa. Pero hay algunos estados donde solo el costo de los pañales usaría casi la mitad del beneficio estatal promedio de TANF [Asistencia Temporal para Familias Necesitadas] para una familia de tres. Creo que realmente tenemos que abordar el hecho de que el valor de la ayuda en efectivo compra mucho menos de lo que solía hacerlo. Su trabajo sobre el matrimonio y la familia es fascinante e inusual. ¿Hay una pregunta central detrás de su investigación?.

El hilo conductor es. ¿Cómo apoyan nuestras políticas de red de seguridad los objetivos de crianza de los hijos de las familias de bajos ingresos?. ¿Son igualitarias las condiciones de la crianza de los hijos?. Lo considero un problema de justicia reproductiva. La capacidad de tener un hijo o no tener un hijo, y luego criar a ese hijo en condiciones en las que se satisfagan las necesidades básicas del niño.

Nos gusta decir que somos aptos para tener niños y familias. El tema de los pañales es solo uno de muchos, muchos problemas en los que realmente no ponemos nuestro dinero o nuestras políticas en lo que decimos que haremos, en términos de apoyo a las familias y apoyo a los niños. Creo que mi trabajo está tratando de hacer que la gente piense de manera más colectiva acerca de tener una responsabilidad social con todas las familias y con el otro. Ningún país, pero especialmente el país más rico del planeta, debería tener 1 de cada 3 niños muy pequeños sin satisfacer una de sus necesidades básicas. Entrevisté a un padre que estaba preso porque escribió un cheque sin fondos.

Y como me lo describió, tenía una cierta cantidad de dinero y necesitaban tanto pañales como leche para el bebé. Y nunca lo olvidaré, dijo, “No tomé una buena decisión, pero tomé la correcta”. Estos no son zapatos elegantes. No se trata de ropa de marca. Este era un padre que necesitaba leche y pañales.

No creo que haya nada más básico que eso. Jenny Gold. jgold@kff.org, @JennyAGold Related Topics Contact Us Submit a Story TipCan’t see the video player?. View the video here. What does ageism in health care look like?.

It can be a thoughtless quip that makes an older person feel diminished. Or an assumption that patients are unable to follow a conversation or make their own decisions.

Comencé a preguntarles female viagra for sale a las madres. €œÂ¿Pueden decirme cuántos pañales tienen a mano en este momento?. € Casi todas me dijeron con precisión exacta cuántos tenían.

Cinco, siete female viagra for sale o 12. Y sabían exactamente cuánto duraría esa cantidad, según la frecuencia con la que sus hijos defecaban y orinaban, si su hijo estaba enfermo, o si tenía una dermatitis del pañal en ese momento. Llevar un registro tan cuidadoso de los suministros de pañales es todo un trabajo emocional y cognitivo.

Estaban preocupadas female viagra for sale y pensando. €œEstá bien, me he quedado casi con mi último pañal. ¿Qué hago ahora?.

¿Voy a buscar algunas latas [para vender]? female viagra for sale. ¿Voy a vender algunas cosas en mi casa?. ¿Quién en mi red social podría tener algo de dinero extra en este momento?.

€. Hablé con mamás que venden plasma sanguíneo solo para comprar pañales a sus bebés. ¿Qué estrategias para afrontar esto le llamaron la atención?.

Los que estudiamos los pañales a menudo los llamamos estrategias para estirar los pañales. Una le dejaba puesto un pañal a su niño un poco más de lo habitual, hasta que se llenara por completo. Algunas madres se dieron cuenta de que si compraban un pañal [más caro] que aguantaba más y goteaba menos, podían dejarlo puesto por más tiempo.

También hacían cosas como dejar que el bebé se quedara sin pañal, especialmente cuando estaban en la casa y sentían que no serían juzgadas por esto. Y utilizaban todos los bienes domésticos que puedas imaginar para hacer pañales improvisados. Telas, sábanas y fundas de almohada.

Están usando cosas que son desechables como toallas de papel con cinta adhesiva. Están haciendo pañales con sus propios suministros para la menstruación o suministros para la incontinencia de adultos cuando pueden obtener una muestra gratis. Una de las preguntas que me hacen a menudo es.

€œÂ¿Por qué no usan simplemente tela?. € Muchas de las madres con las que hablé habían probado los pañales de tela y descubrieron que eran muy costosos y la mano de obra, prohibitiva. Si pagas por un juego completo de pañales de tela para comenzar, estamos hablando de entre $500 y $1,000.

Y estas mamás nunca tuvieron tanto dinero. La mayoría no tenían lavadoras ni secadoras en casa. Algunas ni siquiera tenían casa o acceso consistente a agua, y es ilegal en muchas lavanderías comunitarias y públicas lavar pañales usados.

Por lo tanto, las mismas condiciones que evitarían que las mamás puedan pagar fácilmente pañales desechables son las mismas condiciones que les impiden usar telas. Descubrió que el concepto de muchas mujeres de ser “una buena madre” está relacionado con el cambio de pañales. ¿Por qué es eso?.

Los pañales y el manejo de los pañales eran fundamentales para su identidad como buenas mamás. La mayoría de las madres de mi muestra se privaban de su propia comida. No estaban pagando una factura de teléfono celular o comprando sus propios medicamentos o sus propios suministros menstruales, como una forma de ahorrar dinero para pañales.

Hablé con muchas mamás que dijeron que cuando su bebé tiene hambre, eso es horrible. Obviamente, haces todo lo posible para evitarlo. Pero hay algo en un pañal que cubre esta parte vulnerable del cuerpo de un bebé muy pequeño, esta piel tan delicada.

Y poder hacer algo para satisfacer esta necesidad humana que todos tenemos, y mantener la dignidad y la limpieza. Muchas de las mamás habían pasado por el sistema de asistencia social, por lo que viven con este miedo constante [de perder a sus hijos]. Esto es especialmente cierto entre las madres de color, que son mucho más propensas a ser parte del sistema de bienestar infantil.

Las personas no necesariamente pueden ver cuándo un bebé tiene hambre. Pero la gente puede ver un pañal en mal estado. Esa será una de las cosas que la etiquetará como mala madre.

¿Su trabajo con los pañales se vio influenciado por su experiencia como madre?. Cuando estaba haciendo estas entrevistas, mi hija tenía alrededor de 2 o 3 años. Así que todavía estaba en pañales.

Cuando mi hija orinaba durante un cambio de pañal, pensaba. €œOh, puedo tirar ese. Déjame conseguir otro limpio”.

Esa es una elección realmente fácil. Para mi. Pero es una crisis para las madres que entrevisté.

Muchas me dijeron que tienen un ataque de ansiedad con cada cambio de pañal. ¿Ve una solución política clara para el estrés relacionado con los pañales?. Lo que resulta un tanto irónico es la cantidad de trabajo físico, emocional y cognitivo que implica la gestión de algo que la sociedad y los legisladores ni siquiera reconocen.

Los pañales todavía no se reconocen realmente como una necesidad básica, como lo demuestra el hecho de que todavía están sujetos a impuestos en 35 estados. Creo que lo que está haciendo California es un excelente comienzo. Y creo que los bancos de pañales son un tipo de organización comunitaria fabulosa, que está satisfaciendo una gran necesidad que no está siendo cubierta por las políticas de la red de seguridad.

Entonces, apoyo público a los bancos de pañales. La ayuda directa en efectivo que forma parte de la red de seguridad social prácticamente se ha desmantelado en los últimos 25 años. California es bastante generosa.

Pero hay algunos estados donde solo el costo de los pañales usaría casi la mitad del beneficio estatal promedio de TANF [Asistencia Temporal para Familias Necesitadas] para una familia de tres. Creo que realmente tenemos que abordar el hecho de que el valor de la ayuda en efectivo compra mucho menos de lo que solía hacerlo. Su trabajo sobre el matrimonio y la familia es fascinante e inusual.

¿Hay una pregunta central detrás de su investigación?. El hilo conductor es. ¿Cómo apoyan nuestras políticas de red de seguridad los objetivos de crianza de los hijos de las familias de bajos ingresos?.

¿Son igualitarias las condiciones de la crianza de los hijos?. Lo considero un problema de justicia reproductiva. La capacidad de tener un hijo o no tener un hijo, y luego criar a ese hijo en condiciones en las que se satisfagan las necesidades básicas del niño.

Nos gusta decir que somos aptos para tener niños y familias. El tema de los pañales es solo uno de muchos, muchos problemas en los que realmente no ponemos nuestro dinero o nuestras políticas en lo que decimos que haremos, en términos de apoyo a las familias y apoyo a los niños. Creo que mi trabajo está tratando de hacer que la gente piense de manera más colectiva acerca de tener una responsabilidad social con todas las familias y con el otro.

Ningún país, pero especialmente el país más rico del planeta, debería tener 1 de cada 3 niños muy pequeños sin satisfacer una de sus necesidades básicas. Entrevisté a un padre que estaba preso porque escribió un cheque sin fondos. Y como me lo describió, tenía una cierta cantidad de dinero y necesitaban tanto pañales como leche para el bebé.

Y nunca lo olvidaré, dijo, “No tomé una buena decisión, pero tomé la correcta”. Estos no son zapatos elegantes. No se trata de ropa de marca.

Este era un padre que necesitaba leche y pañales. No creo que haya nada más básico que eso. Jenny Gold.

jgold@kff.org, @JennyAGold Related Topics Contact Us Submit a Story TipCan’t see the video player?. View the video here. What does ageism in health care look like?.

It can be a thoughtless quip that makes an older person feel diminished. Or an assumption that patients are unable to follow a conversation or make their own decisions. Maybe it occurs when a concern is voiced, then discounted or dismissed.

Ageism is reflected in care strategies that ignore a patient’s values and ideas about what constitutes a productive life. Too often, attitudes such as “these patients are old and near the end anyway” or “there’s not much we can do to help them” prevail. Ageism is not new, but the erectile dysfunction treatment viagra brought it shockingly into view.

In its early days, the viagra was shrugged off as something of concern mostly to older people, with some arguing they were expendable if the alternative was shutting down the economy. In the grave months that followed, many who died in nursing care were dehumanized in news reports that showed body bags piled outside facilities. To date, about 80% of those who have died of erectile dysfunction treatment have been older adults, including nearly 140,000 nursing home residents — a population beset by understaffing, inadequate control and neglect.

KHN and The John A. Hartford Foundation held a web event Thursday. Judith Graham, KHN’s Navigating Aging columnist, hosted the discussion.

She was joined by. Dr. Louise Aronson, a geriatrician, professor of medicine at the University of California-San Francisco and author of “Elderhood.” Dr.

Michael Wasserman, a geriatrician, advocate for vulnerable older adults during the viagra and leader of the public policy committee of the California Association of Long Term Care Medicine. Dr. Javette Orgain, a family physician and medical director for Longevity Health Plan of Illinois, which serves nursing home residents.

Former president of the National Medical Association, which represents African American physicians and their patients. And former assistant dean of the University of Illinois-Chicago’s Urban Health Program.

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