Conclusion
LAKANA will provide valuable information on effect of different MDA strategies on 1–11-month-old mortality and health outcomes in Mali. This article provides details of the statistical analysis strategies planned for the trial data, aiming to reduce the risk of data driven results, as well as reporting bias. Large cluster randomized study design aims to evaluate the effect of azithromycin treatment on infant mortality by adding in dimensions that have not been addressed in previous studies. Cluster randomized design also simulates how the potential intervention rollout could be applied, should there be a nationwide implementation program.