Random sequence generation (selection bias) |
Low risk |
Quote: “The computerised block randomisation scheme was done with a block size of 20, so that in each block ten infants received vitamin A and ten received placebo” |
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Comment: Most likely done |
Allocation concealment (selection bias) |
Low risk |
Quote: “An independent statistician who was not part of the trial prepared the randomisation code at the WHO offices in Geneva, Switzerland. The code was available only to the Data Safety and Monitoring Board (DSMB) and their statistician” |
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Comment: Most likely done |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: “The research team and parents were fully unaware of the content of the capsules, which were only labelled with the infant number. Amanufacturer (StridesArcolab Limited, Bangalore, India) supplied the capsules. Separate staff, who were not part of the trial, labelled all capsules” |
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Comment: Most likely done |
Blinding of outcome assessment (detection bias) |
Unclear risk |
Quote: "…" |
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Comment: Most likely done |
Incomplete outcome data (attrition bias) |
Low risk |
Quote: “Our loss to follow‐up was only 1.1% at the time of ascertainment of our primary outcome at 6 months and only 2.9% at 12 months” |
Selective reporting (reporting bias) |
Low risk |
Authors seem to report all the relevant outcomes |
Other bias |
Low risk |
No other risk of bias was noted |