Statistical analysis
REGRESSION, EARLY PREGNANCY
Data were analysed using intention to treat principles, according to the treatment group to which the woman was randomised in pregnancy. Missing data were imputed using the fully conditional specification (chained equations) method to create 100 complete datasets under the assumption that the data were missing at random (MAR) [Continuous outcomes were analysed using linear regression models, with estimates reported as differences in means with 95% confidence interval (CI). Binary outcomes were analysed using log binomial or log Poisson regression models with estimates reported as relative risks (RR) with 95% CI. Both adjusted and unadjusted analyses were performed. Adjusted analyses included stratification variables (maternal early pregnancy BMI category (25.0-29.9 kg/m