Metz, Michael
Semsek, Dieter
Rogmans, Gunther
Hutzschenreuter, Ulrich
Fietz, Thomas
Harde, Johanna
Zacharias, Stefan
Hielscher, Carsten
Lorenz, Andreas
Zahn, Mark-Oliver
Guth, Dagmar
Liebers, Steffen
Berghorn, Michael
Grebhardt, Sina
Matillon, Christiane D.
Egerer, Gerlinde
Potthoff, Karin http://orcid.org/0000-0003-1015-9624
Funding for this research was provided by:
Amgen GmbH
Article History
Received: 21 December 2020
Accepted: 15 April 2021
First Online: 6 May 2021
Declarations
:
: The initial clinical study protocol and its amendment as well as patient information and informed consent form and patient questionnaires were reviewed and approved by the ethics committees (ECs) of the State Medical Association at Baden Württemberg and local ECs. Approval of the clinical study protocol by competent authority was not required. This prospective, interventional study was planned, conducted and analyzed in accordance with Good Clinical Practice and according to the clinical study protocol, which was in compliance with the German Medical Devices Act § 23b (“Medizinproduktegesetz”, MPG), and the principles of the Declaration of Helsinki.Written informed consent was obtained from all individual participants included in the study.
: Not applicable.
: D. Semsek, G. Rogmans, U. Hutzschenreuter, T. Fietz, J. Harde, S. Zacharias, A. Lorenz, M.-O. Zahn, D. Guth, S. Liebers, M. Berghorn, S. Grebhardt, C. Matillon, G. Egerer, and K. Potthoff have nothing to disclose.M. Metz reports personal fees from iOMEDICO, during the conduct of the study; and personal fees from Novartis, BMS, MSD, Amgen, Roche, Biotest, Medac, AbbVie, Celgene, Hexal, Pfizer, Astra Zeneca, Octapharma, Lilly, Sanofi Genzyme, Novartis, Bristol Myers Squibb, and Boehringer Ingelheim, outside the submitted work.C. Hielscher reports personal fees from Roche, Amgen, Pfizer, and Astra Zeneca and non-financial support from Oncovis, outside the submitted work.