Adverse event reporting and harms {22}
ADVERSE EVENTS, EVENT, ADVERSE EVENT
Any event that has a reasonable, causal relationship to the study intervention will be deemed an adverse event (AE). All patients are evaluated with regard to potential AEs or serious adverse events (SAE) by one of the investigators. Potential AEs and SAEs are recorded in the eCRF and should be hastily reported to the chief investigators for decisions on any change in the protocol. Furthermore, the DMC will be notified whenever there is a serious adverse event.