Safety and adverse events
ADVERSE EVENT, ADVERSE EVENT, LONG COVID
Collection of Adverse events (AE) and Serious Adverse Events (SAE) data was started directly after inclusion and recorded until Visit 3. Only SAE was collected outside the treatment period (after Visit 2). Ongoing AE and SAE at the end of Visit 3 will be followed up during long-term follow-up until the subject’s last visit. The definition, handling, follow-up, and reporting of AEs are defined in the original protocol (pp. 34–38). The safety endpoints were evaluated by an independent Data Safety Monitoring Board (DSMB) in the context of the trial design and currently existing information about Long COVID and HBOT. The DSMB is composed of three experts in their respective disciplines of medicine, clinical trial methodology and conduct. The DSMB reviewed the data at the predetermined interim analysis of 20 subjects with safety data available. A charter delineating their guidelines for operating and rules for terminating individual subjects, a portion of or the full trial prematurely was drawn up and agreed upon before the trial started. The members of the DSMB, meeting plan and responsibilities are specified in the original protocol (pp. 6 and 44). The DSMB meeting consists of two parts: An open part where the principal investigator and monitor summarised current status and experience form the trial. During the second, closed part, only the DSMB members discussed safety data (Additional file 