Concealment mechanism {16b}
The centrally managed, blinded randomisation model will ensure allocation concealment and prevent selection bias. The allocation sequence will be stored within the REDCap database and inaccessible to all but the statistician, ensuring concealment. Following randomisation, the allocation details will be displayed on the web-based system for each participant, and an automated email will be sent to members of the research team to ensure appropriate documentation in the medical record.