Protocol deviations and non-adherence
Protocol deviations will be recorded, and frequencies will be presented overall and by trial arm. Where deviations occur, further details will be provided (e.g., reasons for non-eligibility). Potential protocol deviations will include:Participants who are randomised but do not meet eligibility criteriaParticipants randomised with incorrect date of birthMissed/late follow-up assessmentsSamples stored at incorrect temperatureReasons for non-adherence will be broken down into the steps described above (Table 