Ethics
The present study was conducted in accordance with the Declaration of Helsinki and the ADVANCE protocol WRHI 060 (NCT03122262) received ethics and regulatory approvals from the Wits Human Research Ethics Committee (REF 160606B) and the South African Health Products Regulatory Authority (REF 20160620), respectively. Ethics approval for the pharmacogenetics sub-study was also granted by the University of Cape Town Health Sciences Human Research Ethics (REF 571/2019). Written informed consent for genetic research was obtained from study participants.