Adverse event reporting and harms {22}
ADVERSE EVENTS, ADVERSE EVENT
Although serious adverse events are not to be expected, the sponsor and the principal investigator will suspend the study if there is reasonable doubt that the continuation of the survey will compromise the safety and well-being of participants. In this case, the local ethics committee will be informed immediately, and the study will remain suspended pending a favorable decision from the local ethics committee.Adverse events will be noted, and serious adverse events will also be reported to the local ethics committee.