Adverse event reporting and harms {22}
SD
ADVERSE EVENTS
The sleep interventions (SD and SR) mimic common real-world scenarios. The trial was thus categorized as a low-risk trial by the independent ethics review board. Therefore, we do not expect adverse events to happen. Collection, assessment, reporting, and management of adverse events and other unintended effects of trial interventions or trial conduct will be realized according to local ethics regulations, however. Furthermore, providing a yearly safety report is mandatory.