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Article History

Received: 14 June 2021

Accepted: 26 December 2021

First Online: 26 January 2022

Declarations

:

: Written informed consent in the local vernacular to participate in the trial will be obtained from guardians of all participants with written assent from participants aged below 18 years before enrolment. Participants aged 18 years or older and emancipated minors (those aged below 16 years who are married or have children) will be able to provide independent consent. The trial was approved by the Biomedical Research and Training Institute Institutional Review Board (reference AP158/2020) on 10 May 2020, by the Harare Central Hospital Ethics committee on 18 May 2020 (reference HCHEC 030320/12), by the London School of Hygiene and Tropical Medicine Ethics Committee (reference 22030) on 17 August 2020, by the Medical Research Council of Zimbabwe (reference A/2626) on 17 December 2020 and by the University of Zambia Biomedical Research Ethics Committee (reference 1116-2020) on 17 August 2020. Approval for conducting the clinical trial and for importation of the study investigational products was obtained from the Medicines Control Authority of Zimbabwe (reference CT203/2020) on 17 November 2020 and from the Zambia Medicines Regulatory Authority (reference CT103/20) on 11 December 2020.

: Not applicable.

: The authors declare that they have no competing interests.