Outcomes
parasitaemia
ADVERSE EVENTS, SECONDARY
The primary efficacy endpoint was the time to 90% reduction of asexual parasitaemia, consistent for at least 8 h, assessed by microscopy. Secondary efficacy endpoints were the time to 90% reduction of asexual parasitaemia assessed by qPCR, the parasite clearance time, defined as time to parasitaemia <100P/μl by qPCR, and the difference in AUC of parasitaemia until day 7.The primary safety endpoint was the number of treatment-emergent serious adverse events (SAEs) and severe adverse events (AEs) from the time of first administration of study drugs until day 7. The secondary safety endpoint was the number of any AE from the time of first administration of study drugs up to day 7. AE relationship to the study medication was assessed by the investigators and classified as unrelated, unlikely, possibly, probably, and definitely related. AE intensity was categorized as mild, moderate, or severe.To address the potential issue of multiplicity of outcomes, the priorities of the endpoints were specified in advance in the study protocol and statistical analysis plan. No post-hoc outcomes were added and results from secondary outcomes served to support the confirmatory results from the primary outcome.