Serious adverse events
SAEs
All AEs and SAEs reported spontaneously by participants or observed by researchers will be recorded and reported to the trail manager (TM) and chief investigator (CI). Urgent actions concerning participant and staff safety, communication with others and clinical care will be immediately addressed by the CI and reported to the TMG. A summary of (S)AEs will be presented at each TMG and TSC meeting. AEs will be categorised for severity and seriousness by the TM and CI. SAEs will be further reviewed for relatedness to trial procedures and unexpectedness by the CI initially, and additionally by the chair of the TSC.