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Authors
Marchese, Valentina
Brito, André
Rakotozandrindrainy, Raphäel
Schwarz, Norbert Georg
Rakotozandrindrainy, Njary
Rasamoelina, Tahinamandranto
Andrianarivelo, Mala Rakoto
Solonirina, Jeannine
Ratiaharison, Elveric Fesia
Radomanana, Mickael
Randrianarisoa, Tiana
Klein, Philipp
Hameister, Jule
Gunga, Leonard
Kislaya, Irina
Jaeger, Anna
Dam, Govert van
May, Jürgen
Rakotoarivelo, Rivo Andry
Fusco, Daniela
,
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Funding
Funding for this research was provided by:
Bernhard-Nocht-Institut für Tropenmedizin
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Article History
Received: 22 September 2025
Accepted: 4 June 2026
First Online: 12 June 2026
Declarations
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: The freeBILy trial (Pan-African Clinical Trial Register PACTR201905784271304, registered on 04.04.2019) was conducted in accordance with the Declaration of Helsinki and the ICH (International Conference on Harmonisation)-GCP (Good Clinical Practice) guidelines. The trial protocol was approved by the National Ethics Committee of Madagascar (ref. no. 022-SANP/CERBM, 05.03.2018) and the Ethics Committee of the State Medical Chamber of Hamburg, Germany (ref. no. PV5966, 18.03.2019). Written informed consent was obtained from all participants or their legal guardians (for the mothers under 18 years of age or not legally emancipated). Participation was voluntary, and participants could withdraw from the study at any time. In compliance with the recommendations provided by the founder and upon evaluation of the local social context by the Malagasy Principal Investigators, a financial incentive for participation was proposed for the patients and approved by the two Ethics Committees. This consisted of a reimbursement of travel costs from home to the PHCCs.
: N/A.
: The authors declare no competing interests.
