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Article History

Received: 4 March 2022

Accepted: 11 April 2022

First Online: 10 June 2022

Declarations

:

: The PROTID trial protocol, ICF, eCRFs and other relevant trial documents were reviewed and approved by all respective ethical committees at each of the trial sites (including the Makere University, Rubaga Hospital, KCMC and NIMR-MMRC). Nationally, the trial has been approved by the Uganda National Council for Science and Technology (reference number HS1112ES) and the Medical Research Coordinating Committee (MRCC) in Tanzania (reference number NIMR/HQ/R.a/Vol.IX/3703). Regulatory approval has been given by the National Drug Authority (NDA) via certificate number NDA/SCI01/55871/2021 and Tanzania Medicines and Medical Devices Authority (TMDA) with a reference number TMDA-WEB0021/CTR/0005/4 in Uganda and Tanzania, respectively. Any further amendments will be submitted for review and approval by the relevant ethics committee and regulatory authorities.The rights of the participants to refuse to participate in the trial without giving a reason will be respected. The participants will remain free to change their minds at any time about the protocol treatment and trial follow-up without giving a reason and without prejudicing their further treatment. No any trial procedure will be conducted prior to a written informed consenting by an individual participant or legal representative in their preferred language [Kiswahili (for Tanzania) Luganda (for Uganda) or English (for Uganda and Tanzania)].

: Not applicable as there are no any details, images or videos relating to an individual person

: The authors declare that they have no competing interests.