Recruitment {15}
RECRUITMENT, RECRUITMENT
Based on a feasibility study using a questionnaire and personal contact with the PIs, the potential participant recruitment rate was assessed for each centre. These rates were then reduced by 50%. Applying these re-calculated rates, a recruitment period of 12 months was calculated. We expect a high adherence to the anticipated recruitment rates in this investigator-driven study. All PIs were included in the trial design at an early stage and intensive training on the trial protocol has been performed. Recruitment rates will be continuously monitored by the Data and Safety Monitoring Board (DSMB). The funding allows for 12 additional months of recruitment. Moreover, potential alternative recruiting sites have been identified.