General principles
SECONDARY
We will analyze the mortality outcome data by the intention-to-treat (ITT) principle, where the ITT population will include all infants of the eligible age at the time of the MDA visit from all the randomized villages according to the treatment the villages were randomized to receive. That is, if the household gives consent on participating to the study, the study team will offer to treat the child. Even if the child is not treated, their survival information will be analyzed. For the secondary outcome data from the subset of 59 villages, we will analyze the treated population, which only includes the infants who received at least one dose of the treatment drug.Unless otherwise specified, we will use mixed-effects modeling approach to account for clustering, all the hypothesis testing will be at 5% two-sided significance level, and all confidence intervals will be 95% and two-sided, calculated by using robust standard errors. For calculating robust standard errors, we will use sandwich estimator of variance for clustered data. For the primary aim of the estimation of the effect of azithromycin treatment on 1–11-month-old mortality and for the secondary aims, we will carry out adjustment for multiple comparisons between groups by closed-testing procedure [We conduct blind-review on the data during data collection and prior to any formal analysis. That is, we conduct exploratory analysis to check for errors and inconsistencies, without knowing the intervention group identities. Based on the blind-review of the data as well as previous literature, we will apply natural log transformation on the following biomarker variables: CRP, AAT, NEO, MPO, and parasite density [