,
Funding for this research was provided by:
Bill and Melinda Gates Foundation (OPP1126331)
Article History
Received: 5 August 2019
Accepted: 22 October 2019
First Online: 13 January 2020
Ethics approval and consent to participate
: The trial has been approved by the WHO Ethics Review Committee and by the Ethics Committees of all participating sites in the seven countries – Bangladesh (Ethical Review Committee of the International Centre for Diarrhoeal Disease Research), India (Institutional Ethics Committee, Subharti Medical College & Hospital, Swami Vivekanand Subharti University), Kenya (Kenya Medical Research Institute Ethical Review Committee and the University of Washington Institutional Review Board), Malawi (University of Malawi College of Medicine Research Ethics Committee), Mali (Comite d’Ethique de la FMPOS (ERC at USTTB), University of Maryland, Baltimore Research Ethics Committee), Pakistan (Aga Khan University, Ethical Review Committee), Tanzania (Muhimbili University of Health and Allied Sciences Senate Research and Publications Committee; Tanzanian Food and Drug Administration; National Institute for Medical Research), and Boston (Boston Children’s Hospital Institutional Review Board). Each updated version of the approved protocol will be submitted to the ethical committees above.Written informed consent (from parents/caregivers) is obtained by study staff before any trial procedures are carried out and participant confidentiality is maintained throughout the trial in line with the standard ICH-GCP principles.
: Not applicable.
: The authors declare that they have no competing interests.