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Authors
Iannucci, Ilaria
Di Marco, Federico
Moghaddasi, Kiarash
Miotto, Paolo
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Borges, Álvaro H.
Churchyard, Gavin
Dawson, Rodney
Diacon, Andreas H.
Haterill, Mark
Mortensen, Rasmus
Nemes, Elisa
Russell, Marisa
Sabi, Issa
Scriba, Thomas
Skallerup, Per
Van Brakel, Elana
Cabibbe, Andrea Maurizio
Cirillo, Daniela Maria
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Funding
Funding for this research was provided by:
The European and Developing Countries Clinical Trials Partnership (RIA2016V-1631)
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Article History
Received: 15 January 2026
Accepted: 13 July 2026
First Online: 21 July 2026
Declarations
Ethics approval and consent to participate: The trial was done in accordance with the Declaration of Helsinki, the International Council for Harmonisation Guideline for Good Clinical Practice (version E6, revision 2), and national Good Clinical Practice guidelines, and is registered with ClinicalTrials.gov, NCT03512249 (23). The study protocol was approved by the South Africa Health Products Regulatory Authority (Pretoria, South Africa; approval number 20180624), by the Tanzania Medicines and Medical Devices Authority (Dar es Salaam, Tanzania; approval number TFDA0019/CTR/00147/18), and by all relevant institutional ethics committees in South Africa and Tanzania (23).All participants consented to participate in the trial and to the sample storage for biobank and TB research (23).
Consent for publication: Not applicable.
Competing interests: The authors declare no competing interests.
