Statistical analysis
ADVERSE EVENT, ADVERSE EVENT, BEST
It was anticipated that there would be a 5% The primary outcome was analysed by intention-to-treat, followed by a per-protocol analysis. Efficacy of artemether–lumefantrine versus multivitamin, here defined as the proportion of participants who remained uninfected over the 28-day episode, was summarised using proportions and 95% CIs. Crude proportions were calculated using the exact binomial 95% CIs. The absolute risk differences, protective efficacies, and risk ratios between artemether–lumefantrine and multivitamin were reported along with the corresponding 95% CIs. The robust standard errors were used to adjust for intracluster correlation of months at risk from the same individual (clustering within individual) using the generalised estimating equation approach with exchangeable correlation structure. Tests of significance were at the 5% level.Best and worst case scenarios were initially planned to handle missing data.Adverse events were graded according to Common Terminology Criteria for Adverse Events version 5.0; November, 2017.Monitoring was coordinated by the Clinical Trials Support Group within the Mahidol Oxford Tropical Medicine Research Unit. The trial is registered with 