Study approval
The TOL-1 study was reviewed and approved by the ethics committee of the University of Heidelberg, Heidelberg, Germany, and the Paul-Ehrlich Institute, Langen, Germany (ethics number: AFmo-549/2014; Paul-Ehrlich Institute, Vorlagen-Nr. 2252/01; EudraCT number: 2014-002086-30; Clinicaltrials.gov identifier: NCT02560220). The study was performed in compliance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from participants before inclusion in the study. During follow-up, patient data and biomaterials were collected and analyzed retrospectively according to protocols approved by the ethics committee of the University of Heidelberg (ethics numbers: 082/2005, 083/2005, S-395/2011, and S-225/2014).