Authors’ contributions
IHH
HJS acts as the chief investigator of the study. EKG acts as the sponsor representative (University Hospital Regensburg). HJS initiated the study and invented the cooperation with the funding company. DSW, BJ, IHH and IM wrote the study protocol and the corresponding manuscript. HJS, EKG and SMB critically corrected the manuscript. BJ designed the eCRF which was programmed by Excelya Germany GmbH (Freiburg, Germany) and is responsible for safety reporting. DSW, MG and FB also act as investigators. IM and SB are responsible for monitoring. The authors read and approved the final manuscript.