Statistical analysis
Parasitaemia, parasitaemia
REGRESSION, ADVERSE EVENT, EVENT
Data were transcribed from paper case report forms to the REDCap electronic data capture system version 8.3.1. hosted at CERMEL. Analyses were done using Stata IC version 17.0 (StataCorp LLC, College Station, Texas, USA) with the package Baseline characteristics of the intention-to-treat population (n = 49).Data are median (interquartile range) and n (%), IVM: ivermectin.All participants who received at least one dose of study treatment were considered the intention-to-treat population (ITT) and the safety population was made of everyone enrolled in the study. The per-protocol population (PP population) consisted of all participants who received all doses designated to the allocated group, had a mono-infection with The seven days follow-up parasitaemia in the ivermectin and placebo groups was compared using the Kaplan–Meier method for survival analysis. Time to event was defined as the time of 90% parasite reduction, otherwise, participants were censored at the day last seen. Median survival time was given with 95% confidence intervals, wherever the variability of the sample allowed. Groups were compared using log-rank test and Cox regression for point estimate and 95% confidence intervals. A post-hoc Wilcoxon Breslow test was performed on advice by the reviewer. The same analysis was done in both ITT and PP populations.For the qPCR parasite reduction and parasite clearance time (asexual parasite load <100 P/μl), the same analyses as with the primary outcome were performed.AUC of log-10 transformed parasitaemia until day 7 has been calculated by trapezoidal rule and compared between ivermectin and placebo group by Student's t-test. Parasitaemia values have been augmented by a constant of half the limit of detection before log-transformation.A two-sided α < 5% was used as a statistical significance threshold and statistics are presented with a p value as well as a confidence interval where appropriate. All statistical test results are tabulated.Adverse events were recorded from the first drug administration until the end of active follow-up at day 7. Verbatim-recorded AEs have been coded using MedDRA version 3.0, The proportion of participants with AEs, and the proportion of AEs, classified by preferred term level, were tabulated. Time until onset of dermatological AEs has been analysed post-hoc.