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Authors
Mundle, Shuchita
Bracken, Hillary
Khedikar, Vaishali
Mulik, Jayashree
Faragher, Brian
Easterling, Thomas
Leigh, Simon
Granby, Paul
Haycox, Alan
Turner, Mark A.
Lightly, Kate
Ebringer, Miroslava
Alfirevic, Zarko
Winikoff, Beverly
Weeks, Andrew D. http://orcid.org/0000-0002-1909-337X
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Funding
Funding for this research was provided by:
DFID/MRC/Wellcome Trust through the Joint Global Health Trials Scheme (G1100686/1)
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Article History
Received: 13 April 2021
Accepted: 1 September 2021
First Online: 10 September 2021
Declarations
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: The Research Ethics Committees at Government Medical College, Nagpur and the University of Liverpool both approved this study. Women provided written and video-recorded oral consent, as per the Drug Controller General of India recommendations, at that time. Study monitoring was undertaken by an independent trial steering committee and data monitoring committee. The trial was registered on ClinicalTrials.gov (NCT01801410).
: The INFORM consent form allowed women to tick an extra box confirming that they were agreeable for their data to be used for future research studies. All women recruited to the INFORM study consented to share their data.
: ADW is a Scientific Advisor to Norgine, a Dutch pharmaceutical company. The company pays the University of Liverpool for his time and he receives no personal payments. MAT has provided consultancy services to Chiesi, BMS, Novartis, Shire, Janssen & Grunenthal. The companies pay the University of Liverpool for his time and he receives no personal payments. There are no other conflicts of interest to declare.
