Study design and participants
RT1 is an investigator-initiated, prospective, open-label, multicenter phase 2 study (This study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization guidelines for Good Clinical Practice. All patients provided written informed consent. The study protocol and relevant documents were approved by an independent institutional review board or ethics committee at each investigative center. The study was reviewed and approved by all responsible ethics committees (Ethics Committee of the Medical Faculty of the Christian Albrechts University in Kiel; Ethics Committee of the Medical Faculty of the University of Duisburg-Essen; Ethics Committee of the University of Cologne (Central Ethics Committee in Germany); OVGU Ethics Committee at the Medical Faculty; Ethics Committee of the Medical Faculty of the University of Rostock; Ethics Committee of the Medical Faculty of the TU Dresden; Ethics Committee of the University of Ulm; Ethics Committee of the Medical Faculty of the LMU Munich; Ethics committee of the Westfalen-Lippe Medical Association and the Medical Faculty of the Westphalian Wilhelms University of Münster; Ethics Committee of the Bavarian State Medical Association; Ethics Committee of the Medical University of Vienna; and the National Videnskabsetisk Komité, Copenhagen). No data safety monitoring board was implemented in the RT1 protocol. The study protocol and statistical analysis plan are provided in the 