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The authors report no conflict of interest.
This study was funded by the Coombe Women and Infants University Hospital and Friends of the Coombe charity. The funders had no role in any aspect of the study.
Randomized controlled trial registered on January 29, 2018, with first patient recruited on February 12, 2018 (ISRCTN 11214785. https://doi.org/10.1186/ISRCTN112147855).
Data sharing statements:
a. Will individual participant data be available (including data dictionaries)?
b. What data in particular will be shared?
c. What other documents will be available (eg, study protocol, statistical analysis plan, etc.)?
Study Protocol, Statistical Analysis Plan, Informed Consent Form, Patient Information Leaflets.
d. When will data be available (start and end dates)?
e. How will data be shared (including with whom, for what types of analyses, and by what mechanism)?