Document is current

Article History

Received: 16 March 2022

Accepted: 22 July 2022

First Online: 2 August 2022

Declarations

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: All participants will sign an informed consent obtained by the research team. In Brazil, index TB patients will also sign an informed consent. The current version of the study was approved by the Research Ethic Board of the Research Institute of the McGill University Health Centre on August 16, 2019 (Study 2020–5634 Form F1-59915), by the Brazilian National Ethical Board CONEP on May 7, 2020 (#4.014.402), and by the “Comité Local d’Éthique Pour la Recherche Biomédicale (CLERB) de l’Université de Parakou,” Benin, on December 30, 2019 (#0293). In Brazil, an amendment to include children under 5 and index TB patients who were clinically diagnosed (not microbiologically confirmed) was approved on July 30, 2021 (#4.133.939).All protocol amendments were approved by the ethical review boards and notified to the funders and subsequently to the centers. A copy of the revised protocol is available in each site’s Master Binder. Any deviations or violations from the protocol are fully documented using a report form (Note to File). All adverse events and deviation are informed to the Coordinating Centre in Montreal. Any serious adverse event is also reported to the ethical review boards.Findings will be submitted for publication in major medical journals and presented in conferences, to WHO and National and municipal TB Programs of the involved countries as reports and in planned workshops. All data is safely stored at . Results will be submitted for publication in major medical journals.

: The authors declare no competing interests.