HIGHLIGHTS
- What: Discontinuation/withdrawal of participants A participant may be withdrawn from the trial whenever continued participation is no longer in the participant`s best interests, but the reasons for doing so should be recorded. Their decisions regarding withdrawal from the intervention and withdrawal from follow-up will be recorded in their medical notes and in the trial electronic CRF, along with any reasons that they have shared.
- Who: Aimee Spector et al. from the Randomisation procedures and blinding Participant randomisation will be undertaken remotely via a secure online system using a dynamic adaptive randomisation algorithm . . .
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