Enrolment, randomization, and blinding
RECRUITMENT
During the first, multiple dose stage, eligible participants were consecutively enrolled in three groups of five participants each for the safety assessment of the study drug, no randomization or blinding was applied. Following the review of safety data at the end of each group by the safety review committee, recruitment into the subsequent group was opened. In the second stage of the study, participants were randomized to either ivermectin or placebo in an allocation ratio of 1:1 with 17 participants in each group. A study statistician independent of the clinical team and sponsor generated the random allocation sequence and randomization list prior to the study using a random number generator implemented in R Statistical Software (version 3.6.0; R Core Team 2019) with the package blockrand version 1.3 using random block sizes between 2 and 3. A pharmacy team, not involved in recruitment, patient care and outcome assessments, randomized patients according to the randomization list concealed in the pharmacy and oversaw study drug administration. Investigational team, participants, and microscopists were blinded to treatment administered to the participants and the randomization list was kept strictly confidential until final analysis.