Ethics and consent
The University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC043/15) and the South African Medical Research Council Ethics Review Committee (EC006–2/2015) both gave their ethical approval for the primary trial. Written informed consent was gotten from each participant. The University of KwaZulu-Biomedical Natal’s Research Ethics Committee gave their approval for the use of the data in the current study (00002795/2021). ClinicalTrials.gov registered the trial (NCT03022370).