Ethics
The study will be carried out according to the principles stated in the Declaration of Helsinki, Good Clinical Practice (GCP), General Data Protection Regulation (GDPR), and all applicable regulations and according to established international scientific standards. A yearly update on the status of the study will be provided as required.In Comoros, 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 ‘Direction Générale de la Santé’ (Réf.N°23/33/MSSPSPG/DGS). 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.The study protocol has been included in the Clinicaltrials.gov public registry (on 28 October 2022, 