Confidentiality {27}
All data will be handled in accordance to the European General Data Protection Regulation and the applicable local data protection regulations as well as the applicable regulations for the clinical trial. Subjects will be informed about data safety in the trial and have to give written consent to collect and process their data as well as to the transfer of their data in a pseudonymous way. The privacy policy has been reviewed by the responsible ethics committee. Data capture records, trial reports and communications and drug accountability records identifies the patient by an assigned identity number to maintain privacy. It must be determined by the principle investigators who is authorized to view personal data. The Patient Identification Log can be accessed only by the authorized study personnel. To prevent unauthorized access (electronically and physically) restricted access rights to pseudonymized data are implemented. All data will be stored either paper-based or electronically in a pseudonymous manner and handled strictly confidential. Data will be processed at the investigation site in accordance to the safety concept of the institution. Extensive back‐up procedures are implemented to strictly avoid loss of data. All legal requirements that concern data protection and data confidentiality will be respected thoroughly. Every authorized person is sworn to secrecy. Data of withdrawn patients will be stored and further used subjected to the patient’s consent. Data that is no longer used will be deleted immediately.. After the end of the archiving period, all data will be deleted according to data protection law.