Frequency and plans for auditing trial conduct {23}
The DSMB will meet when the first 25% of the patients have been included and followed until the 3-month follow-up. The DSMB will receive data on the primary outcome. The DSMB will also meet following the inclusion of 50% and 75% of the patients. The DSMB will receive data on the primary outcome. The plan for DSMB meetings in terms of auditing and safety is described in the “Monitoring of the study will be done by the GCP unit in Copenhagen. The monitoring will both be on-site and off-site. The first monitoring meeting will be held after the inclusion of 2 patients. The following meetings will be held as needed. The principal investigator will be responsible for all data entered in the eCRF.