Huque, Sumaya
Roberts, Ian http://orcid.org/0000-0003-1596-6054
Fawole, Bukola
Chaudhri, Rizwana
Arulkumaran, Sabaratnam
Shakur-Still, Haleema
Funding for this research was provided by:
London School of Hygiene and Tropical Medicine
Pfizer
Department of health (HICF-T2-0510-007)
Wellcome Trust (WT094947)
Bill and Melinda Gates Foundation (OPP1095618)
Article History
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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