Ethical approvals
RECRUITMENT
Written informed consent was obtained from all participants aged ≥18 years and emancipated minors (in Uganda); for those <18 years and not emancipated minors, assent with parental consent was obtained. The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice and approved in the South African Health Products Regulatory Authority (20181004). Ethical approval was granted from University of Cape Town (290/2018), University of the Witwatersrand (180906 B, M1811148, 180108), Uganda Virus Research Institute research ethics committee (GC/127/18/12/680), Uganda National Council of Science and Technology (HS2534), Uganda National Drug Authority (618/NDA/DPS/09/2019), and London School of Hygiene and Tropical Medicine research ethics committee (17403). An independent Data Safety and Monitoring Board evaluated trial progress and safety data twice during recruitment; no interim analyses were done.