The Better Way Forward Begins in Malaysia

The aftermath of the Covid-19 pandemic has an ironic unintended outcome.

Written by Malaysian Council for Health member Capt Dr Wong Ang Peng, a researcher in cardiovascular disease with Dr Rath Research Institute who serves as the president of Naturopathic Medical Association Malaysia. He is also a member of the Editorial Board for Journal of Cellular Medicine & Natural Health.

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The aftermath of the Covid-19 pandemic has an ironic unintended outcome - eroding trust towards governments, world health establishments, and the media - all of which the public previously had unquestionable trust pertaining to public health.

Willingly sacrificing personal liberties to mandates on face masks, social distancing, lockdowns, passports, movement restriction, and vaccination is epitome of such public trust. In less than two years after the so-called Covid-19 vaccines rollout, the once public trust held on high pedestal had eroded and severely dented.

Purpose of This Paper

It has often been said that tragedies will repeat if historical lessons are not learnt. This paper takes a hindsight view of some of the key events of the Covid-19 pandemic, a vintage point informed by post event scientific publications. It strives for a courageous discourse without fear or favour looking at incongruous mainstream narratives of Covid-19 pandemic that science and world data in the end proved ridiculous.

The purpose here is not to ridicule but to draw lessons so that tragedies may not repeat. It is also to explore better ways going forward to ensure peace, fairness and social justice for the betterment of society.

Emergency Use Authorisation

The so-called Covid vaccines are not real vaccines, rather they are gene-modification therapies fast-tracked via emergency use authorisation (EUA) during phase III clinical trials, as such, still experimental. Many were forced to choose between lockdowns and prolonged economic hardship or submit to the experimental vaccines they did not want, while the vast majority was lured somewhat like a collective hypnosis that bewitched them.

From the outset, the Covid vaccines were positioned as the only pandemic saviour. Any other medication that challenges this position would incur the wrath of the vaccine cartel that was hellbent to get EUA for their vaccines. Such was the fate of hydroxychloroquine and ivermectin that were potential alternatives against Covid-19 but bastardised through bad science and synchronised media campaigns. The US FDA’s condition for vaccine EUA is that there must be “no adequate, approved, and available alternative”.

Herd Immunity

‘Herd immunity’, also known as ‘population immunity’, is the indirect protection from an infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection (1). This theoretical definition by WHO is crystal clear. It became blurred and even contradictory in the implementation of health policy to achieve herd immunity. Vaccination programme was bulldozed through, coerced or made mandatory. Only mainstream narratives from the establishments were allowed. The one-track mind of health officials could not entertain alternative views arguing for infection-induced immunity. Life was made very difficult for those who refused the shots even having acquired immunity through previous Covid infection.

It would have been triumphant for the vaccine’s proponents if the claimed herd immunity through vaccination was actually superior over natural immunity. Science has now shown the opposite. A recent study published in The Lancet has confirmed that natural immunity acquired from a previous Covid-19 infection is as high, if not higher, than that provided by two doses of an mRNA vaccine (2). This publication discredits the policy of enforcing draconian vaccine mandates.

By August 2022, more than 84% of Malaysians were fully vaccinated and about 50% had the booster (3). Herd immunity was deemed achieved and coercion to take the shots appeared to have toned down and began talks of transition into the endemic phase. Meanwhile, the manufacturers of the vaccines were happy for the over 44 million shots administered. However, reports of adverse effects linked to the Covid vaccines started to gain prominence.

Serious Adverse Effects

The safety of the Covid-19 vaccines has been a contentious issue from the beginning of the pandemic. Official narratives have been that they are safe and serious adverse effects, if any, are minimal. Yet, actuarial records have given a different view. Insurance claims for deaths, serious illnesses, injury and incapacity have sky-rocketed over the past year. A random pick on anyone will most likely show that person knows of someone seriously harmed after receiving the inoculations.

Two and half years have gone by since the global Covid-19 vaccination programme started in December 2020. Serious adverse effects are now being reported in scientific publications in connection with the mRNA vaccines, such as liver damage (4), myocarditis (5,6,7), thrombocytopenia (8), thrombosis (9), anaphylaxis (10), and death (11).

Officials in health authorities maintain an eerie silence of these emerging scientific reports. The same goes for those individuals who once recklessly championed vaccination speaking like marketing agents even though the vaccines were experimental and safety unascertained. Their silence symbolises a reverberation of guilt manifested from a new societal normal of high cancer rate, sudden adult death syndrome, myocarditis among teenagers, lowered fertility rate, and many other ailments.

Mythology of Vaccines

The early stage promise of the Covid-19 vaccines as transmission prevention has now fallen into the realm of myth. Official narratives were constantly changing pitch. From the beginning it was announced that just two shots would stop the transmission, and those getting the shots were privileged. No booster was mentioned. Then a booster shot was necessary, and later followed by perhaps a few boosters in a year. Official narratives at first were about stopping transmission, but later changed to reducing risk of severe disease, hospitalisation, and death. Science has now debunked several of these narratives.

As early as 2021 and barely six months after the vaccine rollout, studies in Israel (12), Japan (13), and Vietnam (14) have confirmed the vaccine escape hypothesis. Delta variant, the highly infectious and virulent strain was able to by-pass the vaccines. Those vaccinated were more susceptible and carried higher viral loads than the unvaccinated. At around the same time in 2021, two prominent papers published in distinguished journals had suggested that countries with a higher percentage of population fully vaccinated had higher Covid-19 cases (15,16).

A more damning revelation to the vaccine myth is shown in the recent large-scale study conducted by the prestigious Cleveland Clinic (17) regarding Covid-19 infection among those who took the shots and those who didn’t. The study result shows, “the higher the number of vaccines previously received, the higher the risk of contracting Covid-19”.

Perhaps the most damning revelation of all is the scientific confirmation through an in-vitro study that shows the Covid-19 mRNA vaccine could enter human liver cells and reverse transcribed intracellularly into DNA in six hours (18). Shedding of mRNA is also of serious concern. Spike protein induced in those who have taken the mRNA shots is able to transmit from one person to another via inhalation and skin contact. This has been confirmed by Pfizer’s own internal document regarding ‘environmental exposure’ (19). Due to its ability to replicate, the toxicity associated with spike protein shedding is not a one-time exposure, but perhaps indefinite.

While the scientific publications continue unravelling of the Covid vaccine myth and officials of world health establishments and governments remain tight lipped, world data about all-cause deaths in relation to Covid-19 vaccines has spoken with a vengeance. All 34 countries in the OECD have reported vast increases in excess deaths in the first 38 weeks of 2022 following the vaccines rollout compared to the first 38 weeks of 2020 during the ferocious wave of Delta variant and before the vaccines rollout (20).

Despite all the emerging scientific reports in 2021 and early 2022 that contradicted the official narratives on the Covid pandemic and vaccines, why did our then health minister and our health officials continue to push for the booster shot? The day of reckoning has yet to confront these officials.

Eroding Trust

Initially under the impression that two Covid shots were sufficient to achieve permanent immunity like any other vaccine, the people enthusiastically rolled up their sleeves. When it was soon made known that the induced immunity was short-lived necessitating a booster, the public again relented. Subsequently a second booster shot was required when the contagious but much less virulent Omicron variant reigned during the time when the majority had already completed two or three shots, making mockery of the claim that vaccines could prevent infection.

Two key issues had caused the people’s trust in government to waver. First, it was the changed narrative from stopping infection with two shots to the need of periodic boosters. Second, it was the establishment's insistence that herd immunity could only be achieved through the Covid shots and nothing else matters that led the people to perceive health officials working on the behest of the for-profits multinational corporations, especially the vaccine cartel.

We have heard of SIDS (sudden infant death syndrome). Now, we also hear of SADS (sudden adult death syndrome) adding to the jigsaw puzzle. Both these infant and adult sudden death syndromes have no culpable cause, at least officially, The surge of unexplained sudden deaths, heart attacks and strokes after the Covid vaccines rollout that was met with pin-drop silence from those in authorities has resulted in a contemptuous outlook towards the health authorities.

Bad Science

The Covid-19 pandemic is a showcase of many tragedies of superlative scale. Bad science is one of those. There is now too much junk masquerading as science both in cyberspace and so-called scientific journals - studies that are highly biased, flawed in design, reviews based on unreliable data, data falsification, studies sponsored and funded by vested interest groups to cast aspersion on a rival medication, and non-disclosure of financial links to study sponsors.  

Ethics, principles and norms governing research that have been jealously guarded because the outcome of clinical studies informed clinical practices involving life and death matters, have now been thrashed. Research governance appears non-existence to check the conduct of scientific enquiries. Evidence-based medicine is now a bane of a once pride for clinicians guiding their practice. Never before has science and the scientific method been so corrupted. The following are some examples.

1. Pfizer-BioNTech’s primary trial of its Covid vaccine, BNT162-b2 conducted by Polack et al (21), had overstated its evidence of efficacy based on statistical bias. It claimed 95% efficacy in preventing infection based on the relative risk reduction (RRR) measure. Calculated based on absolute risk reduction (ARR), the efficacy rate was a mere 0.71%, but it was intentionally not reported. The CONSORT standard for reporting clinical trials is that the efficacy results must be reported in both RRR and ARR. Using only the RRR measure to claim 95% efficacy is misleading and insincere.

2. At the beginning of the Covid-19 pandemic and prior to the EUA approval for the Covid vaccines, hydroxychloroquine was a potential medication to treat the disease. Two short-duration and badly designed studies had used flawed data from analytics company Surgispher to show negative results of hydroxychloroquine. One study showed Covid-19 patients treated with the drug did not have lower risk of death compared to patients receiving other treatments. The other study showed cancer patients with Covid-19 receiving hydroxychloroquine and azithromycin had a risk of death 2.89 times greater within 30 days than those who did not receive the drug. A global media campaign casting aspersion on hydroxychloroquine had then helped pave the way for the EUA approval for the Covid vaccines.
   
   The data used by the authors could not be verified and therefore deemed flawed. Based on this, the New England Journal of Medicine and The Lancet retracted the papers (22).

3. After bringing hydroxychloroquine to disrepute, an apparent orchestrated smear campaign and disinformation started against ivermectin, a drug proclaimed essential and safe by the WHO. The orchestration started mildly calling the repurposed drug a ‘horse dewormer’. It then advanced to sponsoring poorly designed and badly conducted clinical trials showing negative results on ivermectin. Finally, a vicious orchestrated assault was launched against a clinical trial with ivermectin positive outcome aiming to get its publication retracted and therefore crumble all the systematic reviews and meta-analyses (23, 24) that supported the use of ivermectin. All the points made in the vicious attack on Prof Dr Ahmed Elgazzar of Benha University have been debunked in a published blog discussion (25).

4. The Lopez-Medina trial (26) is often cited by the health authorities to denounce ivermectin use. But the study is flawed in many aspects - poor design, underpowered (n = 400), low-risk and unsuitable age group, poor execution and conduct of trial. The most critical flaw of the study is that the authors had changed the primary endpoint midway of the trial to full symptom recovery by 21 days. Despite the study conclusion being statistically non-significant, the results show lower rates of disease progression, hospitalisation, ICU admission, and mortality in the ivermectin arm compared to control. This is clinically significant. Omission to mention the clinical significance shows the authors’ bias. The study should not have been published and doing so has blemished the sanctity of science.

5. The Together Trial (27) is the worst example of a clinical trial that has run foul in all the key aspects of conducting a randomised control trial (RCT). Its publication has demeaned the sanctity of science and the scientific method. Describing the trial with shortcomings is an understatement because of its many fundamental flaws, even fraudulent. The followings are some of the very serious flaws:
   (1) Ethical issue. The Together Trial investigating hydroxychloroquine and lopinavir had a total of 685 subjects recruited from 2 June to 30 September 2020 (28). This was highly unethical because the WHO had already halted clinical trials of hydroxychloroquine in June 2020 and lopinavir the following month based on recommendation from the Solidarity Trial’s International Steering Committee. This was before the two studies on hydroxychloroquine were discovered to have used data that could not be substantiated and therefore deemed fake. Submitting the subjects in the Together Trial to take an investigational agent that was at that time already found possible of causing adverse effects, is highly unethical. The research ethics committee should have prevented the conduct of the hydroxychloroquine and lopinavir trial.  
   
   (2) Protocol change. The Together ivermectin trial has several mid-trial protocol changes - dosage change from a single dose to three doses of ivermectin for three days; change of having Covid vaccine shot from inclusion to exclusion criteria; and the all-cause, cardiovascular, and respiratory mortality outcomes were removed. This has clearly indicated that the trial was poorly conceptualised, designed, and conducted.    
   
   (3) Impossible confounders control. The ivermectin trial had its subjects for both the placebo and the 3-dose ivermectin arms allocated at different times. The ivermectin arm was allocated during the peak of the gamma variant, which would influence higher case fatality rate and hospitalisation outcome. This is an unacceptable conflict with the principle of RCTs.  
   
   (4) Ivermectin use not officially excluded. The Together Trial has no mention of Ivermectin use in the exclusion criteria, nor in any of the protocols, pre-registrations or any discussion prior to the paper publication. Furthermore, ivermectin was easily available in Brazil as an over-the-counter drug and trial participants were easily exposed to outside influence to take the drug and thereby compromising the trial.
   
   (5) Potential conflict of interest. The five members Data and Safety Monitoring Committee had deep connection with the trial co-principal investigator, Dr Edward Mills, and the key funder of the study, the Bill and Melinda Gates Foundation. Some of the researchers involved in the trial had previously received grants from Pfizer, Merck, AstraZeneca and Regeneron, companies that are developing Covid-19 therapeutics. As such, conflict of interest has every potential to run afoul.
   
   (6) Conclusion inconsistent with results. The conclusion of the trial stated, “the administration of ivermectin did not result in a lower incidence of medical admission to a hospital or prolonged emergency department observation for Covid-19 among outpatients at high risk for serious illness”. Yet, the results as reported in New England Journal of Medicine found the ivermectin arm had 12.5% lower risk of death, 16.8% lower risk of hospitalisation, 24% lower risk of mechanical ventilation, and a 9.9% lower risk of extended ER observation or hospitalisation compared to the placebo arm. This type of trial reporting is typical among those towing the establishment narratives that have nothing good to say about ivermectin.

Three other flaws of a lesser nature are worth mentioning. First, the potential unblinding due to the different arms having different schedules in taking the ‘medication’. Second, randomisation took place only around seven days after tested positive of Covid-19 and therefore the treatment started only around the 8th day. Third, the content of the placebo used in the Together Trial was not mentioned.

Flaws are abundant and many are serious in the Together Trial. Questions arise as to how and why the Institutional Review Board could have allowed such a poorly designed and badly conducted trial, and how a prestigious journal and their reviewers could have approved publication of such a paper. Students in research methodology and researchers will from now see the mark of shame of those involved in the trial, including those prestigious universities. The Together Trial is in many aspects a good example of what a good RCT should not be.  

The case put forward in the foregoing paragraphs in Bad Science is an answer to the establishment and government officials’ earlier disparaging call to dissenters to “follow the science”.

Media Capture

Another tragedy that happened during the Covid-19 pandemic is the failure of both the mainstream media and the alternative media (the portals) to give an all-round coverage reporting from all sides. Only narratives from the world health establishments and those of the government got reported. Views from prominent scientists including Nobel laureates and medical expert’s contradictory to the establishments’ narratives were ignored.

The establishments were quick to censure and censor alternative Covid views as quackery, fake news, and not following the science. The media acted hands-in-gloves as propagandists reporting one-sided news and views, and critical against ‘anti-vaxxers’ of very caustic nature giving no regard for the many scientists and medical experts who have numerous scientific publications along with thousands of citations to their credit.

Editors of the media could have redeemed themselves by reporting the truth towards the latter part of the pandemic from 2022 onwards when it was revealed that Pfizer-BioNTech had overstated their primary clinical trial claims. Furthermore, world data has surfaced showing excess deaths in 2022 compared to 2020 and 2021. Scientific reports had shown that the more Covid shot one received, the higher the risk of infection compared to those unvaccinated, and that the mRNA vaccine could alter human DNA. There was also the mercurial rise of unexplained sudden deaths, cancer; teenagers having myocarditis that prior to the pandemic was almost unheard of. What a pity that the media editors heard and saw no evil during the pandemic. The failings of the media during the Covid-19 pandemic have revealed a media capture of a colossal scale with no parallel in history.

Pandemic of the Vaccinated

All the above points make the argument that the Covid-19 pandemic can also be referred to as the pandemic of the vaccinated. Higher death rates are one aspect of the negative impact now apparent after two and half years of the vaccines’ rollout. Antibodies dependent enhancement, cascading immune dysfunction including vaccine-induced acquired immune deficiency syndrome, cancer, and infertility; all of which have been forewarned, have now become real.

The establishment, in particular the WHO, has failed miserably.

WHO Pandemic Treaty

As the scientific publications and world data stack up one on another, the people are waking up realising that they have been misled about Covid-19 pandemic and its vaccines. However, the WHO is moving in the opposite direction. The Covid-19 pandemic has exposed severe limitations and the failure of the WHO to bring a swift end to it. The WHO now uses its failure as an excuse to amend the International Health Regulations (IHR) 2005 and institute a legally binding pandemic treaty that would dictate how nations should respond to future outbreaks.

Accepting the WHO Pandemic Treaty would mean surrendering our rights to make independent decisions for what is good for our nation. It also means surrendering our national sovereignty to a world government. As of now Malaysia has already acceded to the IHR (2005) amendments and the WHO Pandemic Treaty. All nations are allowed until November 2023 to ratify the treaty.

The Malaysian Council for Health (MCH) takes the strong stand that we must not ratify the WHO Pandemic Treaty. Compelling arguments against the ratification of the treatment are made in the paper by the World Council of Health (WCH) - Rejecting Monopoly Power Over Public Health - on the proposed IHR (2005) amendments and WHO pandemic treaty.

A Better Way for Public Global Health

The MCH advocates for the six pillars essential actions that national, international leaders and organisations need to partake in.

These are:

1. Decentralisation of control and the rights of the individual.

2. The right to privacy in a digitalised world. A momentum is being built towards complete digitalisation (ID, certificates, health records, banking, etc) without adequate safeguards for privacy and abuse that can result from giving up such control.

3. Free speech and the right to dissent.

4. International sharing and integrity of regulatory processes.

5. Defunding and halting gain-of-function research.

6. Ideational framework and approaches to global health.

The detailed explanations of these six pillars can also be found in the WCH paper mentioned above.

The membership of MCH comprises experts in health, among whom are scientists, researchers, medical and pharmaceutical experts in practice and in academia; allied health experts from natural and complementary therapies; experts in other fields; and consumer advocates.  

Membership is open to all who aspire for health freedom and be part of a movement free from the for-profits corporate-industrial hegemony.

MCH advocates to empower and support members in health, knowledge, therapies; and for members to tap into the large pool of knowledge and experience from among our experts.

Besides the local experts, MCH has close connections to foreign health experts, scientists and researchers who are ever ready to provide assistance.

The MCH adopts an open policy of health for all and cordially invites all peace-loving, social justice and good health-seeking Malaysians to join our cause. Together we can help make our nation great.

For the sake of future generations, we must act now. This is The Better Way Forward.

MALAYSIAN COUNCIL FOR HEALTH

REFERENCES

1. WHO (2020). Coronavirus disease (Covid-19): herd immunity, lockdowns and Covid-19. https://www.who.int/news-room/questions-and-answers/item/herd-immunity-lockdowns-and-covid-19 (Accessed 18 June 2023).

2. Stein et.al. (2023). Past SARS-CoV-2 infection protection against reinfection: a systematic review and meta-analysis. The Lancet; 401-10397.

3. MOH COVIDNOW. Covidnow.moh.gov.my

2. Stein et.al. (2023). Past SARS-CoV-2 infection protection against reinfection: a systematic review and meta-analysis. The Lancet; 401-10397.

4. Shwe et al (2021). Immune-mediated hepatitis with the Moderna vaccine, no longer a coincidence but confirmed. Journal of Hepatology.

3. MOH COVIDNOW. Covidnow.moh.gov.my

5. Montgomery et al. (2021). Myocarditis following immunisation with mRNA Covid-19 vaccines in members of the US military. JAMA Cardiology; 6(10: 1-5.

6. Schwab et al. (2022). Autopsy-based histopathological characterisation of myocarditis after anti-SARS-CoV-2-vaccination. Clinical Research in Cardiology; 112: 431-440.

7. Mansanguan et al. (2022). Cardiovascular effects of the BNT162b2 mRNA Covid-19 vaccine in adolescents. Tropical Medicine and Infectious Disease; 7: 196.
8. Lee et al. (2021). Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. American Journal of Hematology; 96(5): 534-537.

9. Hafeez et al. (2021). Covid-19 vaccine-associated thrombosis with thrombocytopenia syndrome (TTS): a systematic review and post-hoc analysis. Clinical and Applied Thrombosis/Hemostasis; Jan-Dec: 27.

10. Risma et al. (2021). Potential mechanisms of anaphylaxis to Covid-19 mRNA vaccines. Journal of Allergy and Clinical Immunology; 147(6): 2075-2082.e2.

11. Choi et al. (2021). Myocarditis-induced sudden death after BNT162b2 mRNA Covid-19 vaccination in Korea: case report focussing on histopathological findings. Journal of Korean Medical Science; 36(40): e286.

12. Gazit et al. (2021). Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections. Clinical Infectious Diseases; 10.1093.

13. Liu et al. (2021). The SARS-CoV-2 Delta variant is poised to acquire complete resistance to wild-type spike vaccines. BioRxiv; preprint.

14. Chau et al. (2021). An observational study of breakthrough SARS-CoV-@ Delta variant infections among vaccinated healthcare workers in Vietnam. The Lancet; 4: 101143.

15. Subramaniam & Kumar. (2021). Increases in Covid-19 are unrelated to levels of vaccination across 68 countries and 2,947 counties in the United States. European Journal of Epidemiology; 36(12): 1237-1240.

16. Kampf (2021). The epidemiological relevance of the Covid-19-vaccinated population is increasing. The Lancet; Letter, 11:100272.
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17. Shrestha et al. (2022). Effectiveness of the coronavirus disease 2019 (Covid-19) bivalent vaccine. MedRxiv; 19 Dec 2022.

18. Alden et al. (2022). Intracellular reverse transcription of Pfizer-BioNTech Covid-19 mRNA BNT162.b2 in vitro in human liver cell line. Current Issues Molecular Biology; 44(3): 1115-1126.

19. Pfizer (2021). A phase 1/2/3 placebo-controlled, randomised, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-CoV-2 RNA vaccine candidates against Covid-19 in healthy individuals.

20. OECD. Excess deaths 2020 to 2023. https://stats.oecd.org/Index.aspx?QueryId=104676 Accessed, 2 July 2023.

21. Polack, Thomas, Kitchin et al. (2020). Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine; 383:2603-2615.

22. The Lancet - Retraction-Hydroxychloroquine or chloroquine with or without a macrolide for treatment of Covid-19: a multinational registry analysis. https://docs.google.com/document/d/1Y7HkOteBZhqhUvUNsrgduZ22LX4WP_YaYlZa1owMVaI/edit Accessed, 24 June 2023.

23. Bryant, Lawrie, Dowswell et al. (2021). Ivermectin for prevention and treatment of Covid-19 infection: a systematic review, meta-analysis, and trial sequential analysis to inform clinical guidelines. American Journal of Therapeutics; 28(4): e434-e460.

24. Kory, Meduri, Varon et al. (2021). Review of the emerging evidence demonstrating the efficacy of ivermectin in the prophylaxis and treatment of Covid-19. American Journal of Therapeutics; 28: e299-e318.

25. Wong (2021). Malaysia: doctor review of a withdrawn ivermectin study. https://louisaclary.wixsite.com/mysite-1/post/malaysia-doctor-review-of-elgazzar-withdrawn-ivermectin-study Accessed, 4 July 2023.

26. Lopez-Medina, Eduardo, et al (2021). Effect of ivermectin on time to resolution of symptoms among adults with mild Covid-19. JAMA.

27. Reis et al. (2021). A multi-center, adaptive, randomised, platform trial to eliminate the effect of repurposed medicines in outpatients with early coronavirus disease 2019 (Covid-19) and high-risk for complications: the TOGETHER master trial protocol. Gates Open Research; 5:117.

28. Reis et al. (2021). Effect of early treatment with hydroxychloroquine or lopinavir and ritonavir on risk of hospitalisation among patients with Covid-19 - The Together Randomised clinical trial. JAMA Network Open; 4(4):e216468.

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