Ethical Approval
Ethics approval for the ITREMA trial was obtained from the University of Pretoria Human Research Ethics Committee (Ref Number: 69/2015) and the Department of Health, Limpopo province (Ref No 4/2/2). Ethical clearance for this sub-study was obtained from the University of the Witwatersrand Human Research Ethics Committee (M190641), and approval was provided by the Johannesburg Health District (DRC Ref: 2019-10-005, National Health Research Database Reference Number: GP_201910_031).