Ethics approval and consent to participate
The BE-PEOPLE trial was approved by ‘Comité National d’Ethique pour les Sciences de la Vie et de la Santé’ (CNESS) (Réf.N°23/03/CNESS/PR) as well as by the as well as by the ‘Direction Générale de la Santé’ (Réf.N°23/33/MSSPSPG/DGS) in the Union of Comoros. Approval was also received from the Institutional Review Board (IRB) of the Institute of Tropical Medicine (ITM). In addition, the study has been approved by the Ethics Committee (EC) of the University of Antwerp Hospital in Antwerp. Written individual informed consent will be obtained from all participants included in the study. As the legal age of consent in Comoros is 18 years old, for participants between 2 and 18 years old informed consent of the parents or guardian will be sought. Consent information will be read to illiterate participants and written informed consent will be obtained from their respective legal authorized representative. Prior to the start, this study has been included in the Clinicaltrials.gov public registry (NCT05597280, on 28 October 2022, 