Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
All principal analyses will be based on the intention-to-treat principle, analysing participants in the groups to which they are randomised. Missing data will be quantified and if possible multiple imputation will be used; otherwise, simple imputation will be used. Owing to the nature of enrolment and randomisation in this study, it is unlikely that a participant will be randomised and subsequently not receive the intervention, and thus adherence does not apply directly to the intervention arm.