Data management {19}
Medical data will be entered by means of an online data collection system and transmitted directly to the central data management (center for clinical studies [ZKS] Jena). Transfer of patient-related medical data will be carried out pseudonymized. No features will be transferred that enable immediate identification of specific participants by the data management. Data entry, processing, and evaluation will comply with the provisions of the German Federal Data Protection Act (BDSG) and the EU General Data Protection Regulation (EU-GPDR) Records and documents related to the clinical trial must be kept for at least 15 years.