Software
A study-specific internet-based secure data management system (MedSciNet™) is the repository for all trial data. Baseline and follow-up data will be entered on to the MedSciNet database contemporaneously, with the exception of pregnancy outcome follow-up which will be updated postnatally. The study statistician will extract data from the database as required. Statistical analyses will be performed using Stata Version 16 or later (StataCorp, College Station, TX, USA).