Authors’ contributions
A copy of the ethical approval and funding approval has already been submitted.
A copy of the funding letter has already been submitted.Study initiation on 17.07.2020, first patient enrolled 23.09.2020.Ruprecht-Karls-University of Heidelberg Medical Faculty represented in law by Universitätsklinikum Heidelberg and its acting Commercial Director Mrs. Katrin ErkProf. Dr. Richard F. SchlenkThe trial is co-financed by funds of Heidelberg University Hospital and Daiichi Sankyo Europe GmbH. The latter also provides study drug free of charge.Since study initiation there have been 4 amendments.RFS, LLC, MK, JK, and SJ designed the study. RFS, SJ, JK, LLC, and MK wrote the first draft of the manuscript. All authors read and contributed to the final version of the manuscript.