Funding for this research was provided by:
Novartis Pharma (NA)
Received: 18 October 2019
Accepted: 12 March 2020
First Online: 6 April 2020
Ethics approval and consent to participate
: The study protocol was approved by all relevant bodies (BfArM, Bonn, Germany). The study received positive opinions from the consulting Ethics Committee of the State Chamber of Physicians at the Federal States of Berlin, Bremen, Dessau-Roßlau, Dresden, Düsseldorf, Frankfurt a.M., Hamburg, Hannover, Mainz, München, Münster, Saarbrücken and Stuttgart as well as from the Ethics Committees at the Medical Faculty of the Universities of Bochum, Essen, Greifswald, Heidelberg, Mannheim and Würzburg, Germany. The study was conducted in accordance with Good Clinical Practice and all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study adheres to CONSORT guidelines. Written informed consent was obtained from all individual participants included in the study.
: Thomas Decker: CONSULTANT OR ADVISORY ROLE: Novartis.Ulrike Söling: No conflict of interest.Antje Hahn: No conflict of interest.Christoph Maintz: No conflict of interest.Christian Martin Kurbacher: HONORARIA: Amgen, Eli Lilly, Mundipharma, Novartis, Pfizer, Roche, Tesaro; CONSULTANT OR ADVISORY ROLE: Amgen, Eli Lilly, Mundipharma, Novartis, Pfizer, Riemser, Roche, Tesaro; RESERACH FUNDING: Astra Zeneca, MSD Sharp & Dohme (Merck), Novartis, Pfizer, Seattle Genetics; TRAVEL, ACCOMODATIONS: Amgen, Hexal, PharmaMar, Pfizer, Tesaro.Ursula Vehling-Kaiser: No conflict of interest.Dagmar Sent: No conflict of interest.Peter Klare: No conflict of interest.Volker Hagen: HONORARIA: Amgen, BMS, Celgene, FomF, Gilead, Janssen Cilag, iOMEDICO, Pfizer, Roche; SHAREHOLDINGS: Bristol-Myers Squibb, Johnson & Johnson.Marco Chiabudini: No conflict of interest.Julia Falkenstein: No conflict of interest.Martin Indorf: No conflict of interest.Eva Runkel: No conflict of interest.Karin Potthoff: No conflict of interest.