Ethics approval and consent to participate
RECRUITMENT
The study was conducted according to Good Clinical Practice, the Belmont Report, the Declaration of Helsinki, and South African law. Ethical approval was obtained from the South African Health Products Regulatory Agency and the Human Research Ethics Committee (Medical), University of the Witwatersrand, with additional approval required from the Gauteng Provincial Department of Health to allow recruitment from public clinics. The trial was overseen by an independent data monitoring committee. All patients provided written or electronic informed consent.