Confidentiality {27}
Investigators and study staff will keep all information on participants in strict confidence. Appropriate local data legislation will be applied in full. A confidential log of the names of all study patients with the identification code assigned to each patient at the time of enrolment in the clinical study will be filed at each site. With this list, the identity of each patient can be revealed (key list for pseudonymization). The list must be kept confidential and must be maintained and stored exclusively at the study site in the investigator site file (ISF). The personal data collected and generated in the course of the study are processed and stored at the sponsor site (Jena University Hospital) solely based on the patient identification number in order to maintain the pseudonymization. The data managers of the ZKS Jena will have access to all clinical trial data. These persons are sworn to secrecy. The data will be protected against unauthorized access. The monitor, safety manager, and trial statistician will also have access to several clinical trial data as well as study leaders and statisticians for any substudies including future meta-analyses.