Huntgeburth, Michael
Kießling, Johannes
Weimann, Gerrit
Wilberg, Verena
Saleh, Soundos
Hunzelmann, Nicolas
Rosenkranz, Stephan
Funding for this research was provided by:
Bayer
Article History
First Online: 20 September 2018
Compliance with Ethical Standards
:
: MH and JK report no conflicts. NH received a research grant and honoraria for lectures from Bayer AG. SR received honoraria for lectures and/or consultancy from Bayer AG and MSD, and his institution received research grants from Bayer AG. GW and SS are employees of Bayer AG. VW is an employee of ClinStat GmbH.
: Protocol and all protocol amendments were reviewed and approved by the Ethics Committee of the University Hospital of Cologne (Ethikkommission der Medizinischen Fakultaet, Kerpener Str. 62, 50937 Cologne) before the start of the study, ethics approval number 13-174. As applicable according to local regulations, the protocol was reviewed and approved by the BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany) on 29 July 2013. The study was conducted in accordance with the Declaration of Helsinki, and Good Clinical Practice.
: All patients gave written informed consent before entering the study.
: This study was supported by Bayer AG (Berlin, Germany). Verena Wilberg was assigned by Bayer AG (Berlin, Germany) to conduct the analyses. Medical writing assistance was provided by Adelphi Communications Limited (Bollington, UK), funded by Bayer AG (Berlin, Germany).