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Article History

Received: 7 April 2020

Accepted: 30 November 2020

First Online: 4 January 2021

Ethics approval and consent to participate

: The trial was submitted for approval by the Health Research Authority (ID: 179128), University of Witwatersrand Human Research Ethics Committee (ID:150601B), Medicine Control Council (ID: 20150527), Stellenbosch University Ethics Committee (ID:M15/07/022), Pharma-Ethics (ID:160914534), Joint Clinical Research Centre Institutional Review Board/Research Ethics Committee, Joint Research Ethics Committee for the University of Zimbabwe (ID:JREC/202/15), Institutional Review Board of the Faculty of Medicine Chulalongkorn University (ID:331/58), Ministry of Public Health Thailand (ID:27/2558), Goethe University Ethics Commission (ID:417/16), National Ethics Committee for Clinical Research (ID: 20170366), and Hospital Universitario 12 de Octubre Ethics Committee for Investigation of Medicinal Products (ID:16/003). Parents/carers and children, where applicable, gave informed written consent to participate in the trial.

: Not applicable.

: MFC is a member of an advisory board for ViiV Healthcare and reports grants from ViiV Healthcare and Gilead, outside the submitted work. DMB is a member of an advisory board for Merck and ViiV Healthcare and reports grants from Merck, BMS, Janssen/Tibotec, Gilead and ViiV Healthcare outside the submitted work. All other authors declare that they have no competing interests.