Oversight
The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. It was approved by the research ethics committee of the Faculté de Médecine, de Pharmacie et d’Odonto-Stomatologie, Mali; the Institutional Review Board of the University of Maryland School of Medicine, USA; the Gambia Government/MRC Joint Ethics Committee, The Gambia; and the Western Institutional Review Board. Regulatory approval was obtained from Directorate of Pharmacy and Medicine, Mali and the Medicines Control Agency, The Gambia. A data safety monitoring board oversaw the trial.