PASSReviewer 1· 85% conf
The manuscript is well-structured, methods are detailed, the trial is registered, and null results are reported. However, a conflicts-of-interest statement is absent and the use of CONSORT is not explicitly acknowledged.
Evidence
paraphrase[Abstract, Methods]
“ClinicalTrials.gov Identifier NCT04152161”direct quote[Results, Efficacy]
“The VE point estimate for the primary endpoint was −0.038 (95% CI, −0.483 to 0.274)”absence[End of manuscript]
No conflicts-of-interest statementPASSReviewer 2· 80% conf
The trial is registered, the null primary result is transparently reported, limitations are discussed, and conclusions are proportional; the main gaps are no explicit CONSORT checklist statement and no explicit conflicts-of-interest declaration.
Evidence
direct quote[Abstract, Conclusions]
“ClinicalTrials.gov (http://clinicaltrials.gov/) Identifier NCT04152161”direct quote[Discussion]
“Other limitations include that enrollment was paused for four months due to COVID-19 pandemic restrictions, and schools were closed for several additional months , which may have contributed to a lower incidence rate.”absence[Manuscript (full text)]
No explicit conflicts-of-interest statement is present.WARNReviewer 3· 80% conf
Trial registration, transparent null-result reporting, limitations, and proportional conclusions are present, but methods are incomplete in the text, no reporting guideline is mentioned, and a conflicts-of-interest statement is missing.
Evidence
direct quote[Abstract]
“ClinicalTrials.gov (http://clinicaltrials.gov/) Identifier NCT04152161”direct quote[Discussion]
“Other limitations include that enrollment was paused for four months due to COVID-19 pandemic restrictions, and schools were closed for several additional months , which may have contributed to a lower incidence rate.”direct quote[Methods, Participants]
“Detailed eligibility criteria are described in the and protocol at nejm.org (http://nejm.org/) .”