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" |
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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" |
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"Treatment and placebo capsules appeared identical…" |
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Comment: Most likely done |
Blinding of participants and personnel (performance bias) |
Unclear risk |
Quote: "Treatment and placebo capsules appeared identical…" |
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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" |
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Comment: Most likely done |
Incomplete outcome data (attrition bias) |
Unclear risk |
Total number of loss to follow up: n (%) |
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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 |