Roberts, Ian http://orcid.org/0000-0003-1596-6054
Shakur, Haleema
Fawole, Bukola
Kuti, Modupe
Olayemi, Oladapo
Bello, Adenike
Ogunbode, Olayinka
Kotila, Taiwo
Aimakhu, Chris O.
Olutogun, Tolulase
Hunt, Beverley J.
Huque, Sumaya
Funding for this research was provided by:
LSHTM
Wellcome Trust
Bill and Melinda Gates Foundation
Article History
Received: 31 January 2018
Accepted: 30 April 2018
First Online: 9 May 2018
Ethics approval and consent to participate
: Approvals to conduct this study were obtained from the Ethics Committees of London School of Hygiene and Tropical Medicine and the University of Ibadan & University College Hospital Ethics Committee. Regulatory approval was obtained from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). The study was undertaken according to ICH-GCP guidelines. The consent procedures is detailed in the WOMAN Trial protocol [CitationRef removed]. Briefly, we obtained written consent from a patient if their physical and mental capacity allowed. If a patient could not give written consent, we obtained proxy consent from a relative or representative. If a proxy was unavailable, then if local regulation allows, we deferred or waived consent. In this situation, we informed the patient about the trial as soon as possible, and obtained written consent to use the data. The London School of Hygiene & Tropical Medicine is the sponsor.
: The authors declare that they have no competing interests.
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