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Article History

Received: 18 January 2023

Accepted: 4 August 2023

First Online: 4 October 2023

Declarations

:

: The study was conducted according to Good Clinical Practice, the Belmont Report, the Declaration of Helsinki, and South African law. Ethical approval was obtained from the South African Health Products Regulatory Agency and the Human Research Ethics Committee (Medical), University of the Witwatersrand, with additional approval required from the Gauteng Provincial Department of Health to allow recruitment from public clinics. The trial was overseen by an independent data monitoring committee. All patients provided written or electronic informed consent.

: Not applicable.

: NC declares grants and non-financial support from Shin Poong Pharm. Co. Ltd. during the conduct of the study and grants and non-financial support from ViiV Healthcare, Gilead Sciences, Merck, and Johnson & Johnson grants, personal fees and non-financial support from, personal fees from Cipla and Frontiers Biotech and Novo Nordisk outside the submitted work. NR reported personal fees from Medicines for Malaria Venture for the submitted work, and from Medicines for Malaria Venture, the World Health Organization, GlaxoSmithKline, and Artemida Pharma outside of the submitted work. ACM is an employee of Medicines for Malaria Venture. ACM holds share in Novartis, Alcon, and Idorsia. HJ was a consultant medical monitor for this study contracted by Medicines for Malaria Venture. JF was a consultant clinical trial manager for this study contracted by Medicines for Malaria Venture. WK and CJ are employees of Shin Poong Pharm. Co. Ltd. CJ has a patent pharmaceutical composition for COVID-19 treatment pending. SA-B is an employee of Artemida Pharma which received funding from Shin Poong Pharm. Co. Ltd. WDFV reports grants from Unitaid during the conduct of the study; grants from the Bill and Melinda Gates Foundation, the South African Medical Research Council, USAID, National Institutes of Health, FIND, Children’s Investment Fund Foundation; personal fees from Virology Education; grants, personal fees, and non-financial support from ViiV Healthcare; personal fees and non-financial support from Gilead Healthcare; grants, personal fees, and non-financial support from MSD; grants, personal fees, and non-financial support from Johnson & Johnson; and personal fees from Mylan/Viatris, Adcock-Ingram, Aspen, Abbott, Roche, and Sanofi outside the submitted work. CK, SN, NMa, YD, and NMu declare no competing interests.