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Article History

Accepted: 27 August 2022

First Online: 6 September 2022

Declarations

:

: The authors have no relevant financial or non-financial interests to disclose.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the following Institutional Review Boards/Ethics Committees and Drug Regulatory Authorities: Prevention Sciences Research Committee of the US National Institute of Allergy and Infectious Diseases; US Food and Drug Administration; National Health Sciences Research Committee of Malawi; Johns Hopkins University Bloomberg School of Public Health Institutional Review Board; University of North Carolina at Chapel Hill Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; University of Cape Town: Human Research Ethics Committee; Biomedical Research Ethics Committee University of KwaZulu-Natal; South African Medical Research Council Ethics Committee; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; Medicines Control Council of South Africa; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins University School of Medicine Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Committee on Human Research, University of California - San Francisco; Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe.

: Informed consent was obtained from all individual participants included in the study.

: Not applicable.