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Article History

Received: 25 March 2024

Accepted: 5 March 2025

First Online: 18 March 2025

Competing interests

: The authors declare no competing interests.

: The study was approved by the Commissie voor Medische Ethiek (CME) of Ghent University Hospital (protocol code: B670201734334 and date of 10/08/2020) and the Comité d’Éthique Institutionnel de la Recherche En Sciences de la Santé (CEIRES) of the Institut de Recherche en Sciences de la Santé (IRSS) (protocol code: 50-2020/CEIRES and date of 22/10/2020). An independent Data and Safety Monitoring Board (DSMB), which included an endocrinologist, two pediatricians, a gynecologist, and an ethicist from Belgium and Burkina Faso, was established prior to the trial. The DSMB managed remote safety reviews for adverse and serious events at nine and 20 months after the start of enrollment. The MISAME-III trial was registered on ClinicalTrials.gov (identifier: NCT03533712). The research was conducted in collaboration with local partners, including Agence de Formation de Recherche et d’Expertise en Santé pour l’Afrique (AFRICSanté) and IRSS. Researchers from AFRICSanté and IRSS who contributed to the research and fulfilled the authorship criteria were included as co-authors, while other team members, such as physicians and midwives who contributed to data collection, were acknowledged in the Acknowledgements section. Roles and responsibilities were agreed upon among collaborators ahead of the research initiation. A clear delineation of tasks and contributions was outlined in collaborative meetings and documented in written agreements to ensure effective coordination and execution of the study objectives. Additionally, capacity-building plans for local researchers were discussed and integrated into the research framework, including training sessions, knowledge-sharing initiatives, and authorship opportunities. The research does not lead to stigmatization, incrimination, discrimination, or personal risk for participants. Thorough risk assessments were conducted prior to the commencement of the research to identify and evaluate potential hazards and risks associated with various aspects of the study. These assessments considered factors such as environmental conditions, exposure to hazardous materials, and travel risks. Benefit-sharing measures have been discussed in the event that biological materials, cultural artifacts, or associated traditional knowledge are transferred outside the country. Local and regional research relevant to our study has been taken into account in our citations.