Analysis principles
SECONDARY, RECRUITMENT
All analyses will be conducted using R software (version 4.2.2 or above) or STATA (version 17.0 or above). Analyses of the primary and secondary outcomes will be conducted by a statistician (member of the trial team), taking no part in participant recruitment or data collection. Analyses will follow intention-to-treat principles, with all participants analysed according to their randomised allocation. A masked sample of the data will first be used to trial and confirm statistical procedures. Next, the fully masked dataset will be used, with data interpretation occurring prior to unblinding of group allocation. There is no intention to conduct interim analyses.Categorical variables will be summarised by frequencies and percentages. Continuous variables will be reported using standard measures of central tendency and dispersion, either mean and standard deviation (SD) or median and interquartile range, depending on the shape or skewness of the data. A 