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Article History

Received: 22 September 2024

Accepted: 21 December 2024

First Online: 20 January 2025

Declarations

:

: Stellenbosch University Human Research Ethics committee (reference M21/03/010) approved the study. Western Cape Department of Health approved access to Khayelitsha District Hospital for study recruitment (reference WC_202107_007). Mothers signed a written informed consent form for their and their child’s participation in this study.

: Not applicable. Study results are presented in aggregate format in technical reports and journal publications. A model consent form is provided on request.

: The authors declare no competing interests.

: List of study investigators: Prof Mark Cotton, Stellenbosch University; Dr Christine Els, Khayelitsha District Hospital; Prof Louise Kuhn, Columbia University; Prof Lehana Thabane, McMaster University; Prof Taryn Young, Stellenbosch University; Dr Moleen Zunza, Stellenbosch University. Independent data analyst: Dr Carl Lombard, Stellenbosch University. List of voting DSMB (Data Safety Monitoring Board) members: Prof Jonathan Levin (Chair), University of Witwatersrand, South Africa. Email: Jonathan.Levin@wits.ac.za; Prof Hassan Mahomed, Stellenbosch University, South Africa. Email: hmahomed@sun.ac.za; Prof Lawrence Mbuagbaw, McMaster University, Canada. Email: mbuagblc@mcmaster.ca; Prof Kennedy Otwombe, University of Witwatersrand, South Africa. Email: otwombek@phru.co.za; Dr Vundli Ramokolo, Medical Research Council, South Africa. Email: Vundli.Ramokolo@mrc.ac.za; Dr Elizabeth Spooner, Medical Research Council, South Africa. Email: Elizabeth.Spooner@mrc.ac.za.