Editorial support was provided by Karin Eichele, www.mediwiz.de.
Funding
This study was sponsored by Novartis Pharma GmbH. Editorial support by a medical writing expert was also funded by Novartis Pharma GmbH.
Availability of data and materials
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Authors’ contributions
VL: Design and conceptualization of the study, interpretation of the data; revising the manuscript for intellectual content; TZ, ML, SR, BW, JH, SS, KG, CL, LK, OH, CA: Revising the manuscript for intellectual content; KS: Design and conceptualization of the study, revising the manuscript for intellectual content; MB: Statistical Expert, interpretation of the data; revising the manuscript for intellectual content; GW, HS, SH, RD, WH: Interpretation of the data; revising the manuscript for intellectual content. All authors read and approved the final manuscript.
Competing interests
V. Limmroth has received speaker’s honoraria, financial research support or consultancy fees from Antisence, Allergan, Almirall, Bayer, Biogen, Bionorica, Genzyme, Novartis, Roche, Sanofi, and Teva.
T. Ziemssen has received compensation for consulting services from Almirall, Biogen Idec, Bayer, Genzyme, GSK, MSD, Merck Serono, Novartis, Sanofi, Teva and Synthon, and has received research support from Bayer, Biogen Idec, Hertie Foundation, Roland Ernst Foundation, German Diabetes Foundation, Merck Serono, Novartis, Teva, and Sanofi Aventis.
M. Lang has received travel grants, speaker’s honoraria, financial research support, consultancy fees from Teva, Merck Serono, Genzyme, Sanofi, Novartis, Bayer, and Biogen Idec.
S. Richter has received travel grants und compensation for scientific advisory boards from Novartis and travel grants from Biogen, Teva, Bayer, and Genzyme.
J. Haas has received compensation from Almirall, Biogen, Bayer, Octapharma, Teva, Allergan, and Novartis.
B. Wagner has received travel grants from Novartis, Biogen, Bayer, and Genzyme and speaker’s honoraria from Biogen and Novartis.
S. Schmidt has received speaking honoraria and travel expenses from Bayer Vital, Biogen, Genzyme, Merck Serono, Novartis, and Teva. He has also served on advisory boards for Bayer Vital, Biogen, Genzyme, Merck Serono, Novartis, and Teva.
K. Gerbershagen has received speaker’s honoraria, financial research support or consultancy fees from Bayer, Biogen, Genzyme, Novartis, Sanofi, and Teva.
C. Lassek has received travel grants, speaker’s honoraria, financial research support, consultancy fees from Teva, Merck Serono, Genzyme, Sanofi, Novartis, Bayer, and Biogen Idec.
L. Klotz has received compensation for serving on scientific advisory boards for Genzyme and Novartis. She has received speaker’s honoraria and travel support from Novartis, Merck Serono and CSL Behring. She receives research support from Novartis and Biogen Idec.
O. Hoffmann reports research grants from Biogen, Boehringer Ingelheim, Novartis, and Sanofi-Genzyme not pertaining to this study. He has received compensation for activities with Bayer Healthcare, Biogen, Daiichi-Sankyo, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, and TEVA.
C. Albert has received travel grants from Novartis, Biogen, Genzyme, and Teva, compensation for scientific advisory boards from Novartis and Merck Serono, as well as speaker’s honoraria from Biogen.
K. Schuh is employed by Novartis Pharma GmbH, Germany.
M. Baier-Ebert is employed by Novartis Pharma GmbH, Germany.
G. Wendt is employed by Novartis Pharma GmbH, Germany.
H. Schieb is employed by Novartis Pharma GmbH, Germany.
S. Hoyer is employed by Novartis Pharma GmbH, Germany.
R. Dechend has received speaker’s honoraria, financial research support or consultancy fees from Berlin Chemie, Novartis, Alnylam, Boehringer Ingelheim, Bayer, and MSD.
W. Haverkamp is working as consultant to Novartis.
Consent for publication
Not applicable.
Ethics approval and consent to participate
The study is performed in accordance with the Declaration of Helsinki. The study protocol has been approved by the respective state and institutional ethical standards committees at all participating sites (Competent ethics committee: Ethikkommission der Ärztekammer Nordrhein; EUDRACT No. 2012-000653-32-DE). Patients have to give written informed consent.