Funding for this research was provided by:
London School of Hygiene and Tropical Medicine
Wellcome Trust (WT094947)
Bill and Melinda Gates Foundation (OPP1095618)
Department of health (HICF-T2-0510-007)
Text and Data Mining valid from 2018-05-29
Received: 20 February 2018
Accepted: 15 May 2018
First Online: 29 May 2018
Ethics approval and consent to participate
: This is a secondary analysis of the WOMAN trial data. The need for ethics approval and consent was waived as per national guidelines. The relevant ethics committees and regulatory agencies approved the consent procedures at each trial site for the original study. We obtained informed consent from women if their physical and mental capacity allowed. If a woman could not give consent, we obtained proxy consent from a relative or representative. If no proxy was available, then if local regulation allowed, we deferred or waived the consent. In these cases, we told the woman about the trial as soon as possible and obtained consent for use of the data collected. The consent procedures are described in detail in the Woman trial protocol.
: The authors declare that they have no competing interests.
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