Ethical considerations
PIS
ADVERSE EVENT
Ethical approvals for the trial were obtained from the Research Ethics Committees of the London School of Hygiene & Tropical Medicine and the Comité National d’Ethique pour la Recherche en Santé (CNERS) in Senegal. The Participant Information Sheet (PIS) was translated into French and trained field assistants who were native speakers interpreted the consent information in a Senegalese language preferred by the parents/carer-givers. If the parent/carer-giver was not able to read and write in French, a literate adult witness was present throughout the whole consent process and signed and dated the consent form. For children aged ≥ 12 years, positive assent was obtained in addition to the parental consent. All study children were assigned a unique number, which was used as an identifier throughout the study. Participants’ data were securely stored in the dedicated study’s computer devices which were encrypted and password protected. All laboratory results and adverse event data were encoded in an electronic database and stored securely. Only authorized study personnel had access to the study data.