Recruitment {15}
HOLIDAY, RECRUITMENT
Our target sample is 1320 participants (i.e. 220 per group/site) which also accounts for an anticipated 10% lost to follow-up. Originally, the recruitment phase was to be completed in about 3.5 years, dependent upon seasonal fluctuations, hospital bed closures, and holiday periods. However, the COVID-19 pandemic has delayed the trial considerably, hence its extension to December 2023.A screening tool reflecting inclusion and exclusion criteria to identify potential participants was specifically developed based on our previous research in this area [