Statistical analysis
intermediate-stage disease
Based on the maximum feasible enrolment in a reasonable timeframe of 2 years, the sample size was fixed to 162 patients with late-stage gambiense HAT, including an expectation of seven dropouts (5%), but we did not predetermine the number of patients with early-stage or intermediate-stage gambiense HAT. A first cohort of patients with late-stage gambiense HAT was recruited and after futility analyses and study data review by the data safety monitoring board for safety and tolerability, a second cohort of patients with early-stage and intermediate-stage disease was recruited after 8 months.The modified intention-to-treat (mITT; defined as all patients who received treatment, excluding those who fled the region due to armed conflict, a natural disaster, or force majeure and for whom no treatment failure was detected early and no data were available at 12 and 18 months) and per protocol populations (defined as all mITT patients with no major protocol deviations) were identical (