Study Oversight
RECRUITMENT
An independent DSMB oversaw the safety of the trial and advised to continue recruitment without change after review of primary end point data for each 15 participants enrolled.Approval for the trial was granted by the University of Cape Town Human Research Ethics Committee, Walter Sisulu University Human Research Committee, and the South African Health Products Regulatory Authority. The trial was registered on the South African National Clinical Trials Register, Pan African National Clinical Trials Register, and clinicaltrials.gov.