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. 2021 Mar 5;17(1):e1141. doi: 10.1002/cl2.1141
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A separate team at Johns Hopkins University prepared the study capsule packets. Study identification numbers were randomly allocated to the treatment groups by computer in blocks of 12"
Comment: Most likely done
Allocation concealment (selection bias) Low risk Quote: "Lists linking the study number to the treatment were kept in sealed envelopes and encrypted computer files"
"Treatment and placebo capsules appeared identical…"
Comment: Most likely done
Blinding of participants and personnel (performance bias) Unclear risk Quote: "Treatment and placebo capsules appeared identical…"
Comment: Most likely done
Blinding of outcome assessment (detection bias) Low risk Quote: "Cause of death was determined from medical records for infants who died in a hospital or from a review of verbal autopsy information by a study pediatrician, who was masked to treatment group, for infants dying at home"
Comment: Most likely done
Incomplete outcome data (attrition bias) Unclear risk Total number of loss to follow up: n (%)
The loss to follow up was not balanced
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