Frequency and plans for auditing trial conduct {23}
Monitoring is carried out in accordance with directives of the Swiss Association of Research Ethics Committees (swissethics) and Swiss laws and enactments on human research. An independent and experienced trial monitor has been appointed and approved by the local ethics commission. He will verify study conduct according to the protocol and have insight in all study documents and data under a confidentiality agreement. His monitoring report will be sent to the local ethics committee without prior insight of study stakeholders. Furthermore, the local ethics committee is authorized to audit at any time without prior notification.