Data monitoring
For quality control of the study conduct and data retrieval, monitoring will be performed according to a monitoring plan determined by the Clinical Trial Unit from the University of Bern. Any findings and comments will be documented in site visit reports and communicated to the Sponsor-Investigator as applicable. Site staff will support the Monitor in his/ her activities. All source data and relevant documents will be accessible to Monitors and questions of Monitors are answered during site visits. All involved parties will keep participant data strictly confidential.