Interim analysis
An interim analysis will be conducted when approximately 60% of the target PYR is available. This interim analysis will focus on mortality and SAEs. For this analysis, statistical significance is defined as two-sided If the interim analysis reveals statistically significant mortality difference between the quarterly azithromycin-MDA group and the placebo group and between the biannual azithromycin-MDA group and the placebo group but not between the two azithromycin groups, the placebo arm will be discontinued, and the trial will continue with two arms only. In this scenario, the villages with remaining MDA rounds in the placebo arm will be re-randomized to either of the treatment arms. If there is evidence of a mortality benefit in one or both azithromycin groups and also a statistically significant difference between the two azithromycin groups, the trial will be stopped, and the team will offer to work with Malian Ministry of Health to provide AZI MDA in the trial site and elsewhere in the regions of Mali, choosing the MDA regimen (quarterly or biannual) based on the trial data [