Adverse events
disability or incapacity, death, birth defect, congenital anomaly
ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT
Adverse events (AE) are defined as any undesirable experience occurring to a subject during the study, whether considered related to undergoing dietary treatment. All adverse events observed by the researchers or reported by the participants will be recorded and processed according to legislation in The Netherlands. A serious adverse event (SAE) is an event that 1) results in death, 2) is life-threatening (at the time of the event), 3) requires hospitalization or prolongation of existing inpatient hospitalization, 4) results in persistent or significant disability or incapacity, 5) is a congenital anomaly or birth defect, and 6) may jeopardize the participant or may require an intervention to prevent one of the outcomes listed previously. All SAEs will be communicated to the coordinating investigator (first author), who will be responsible for reporting this information through the web portal ToetsingOnline to the accredited MREC that approved the protocol. Reporting of SAEs that are life-threatening or result in death will be reported no later than seven days after the first knowledge of SAEs in a preliminary report. The final report will be completed no later than eight days after the preliminary report. All AEs will be monitored until they diminish or reach a stable state. Follow-up may require 1) medical procedures, 2) additional tests, or 3) referral to a general physician or medical specialist. SAEs need to be reported until the end of the study in the Netherlands, as defined in the protocol.