Funding for this research was provided by:
Boehringer Ingelheim (N/A)
Received: 25 January 2019
Accepted: 1 July 2019
First Online: 18 July 2019
Ethics approval and consent to participate
: All studies included in this analysis were performed in accordance with the provisions of the Declaration of Helsinki (1996 version), in accordance with the International Conference on Harmonization Tripartite Guideline for Good Clinical Practice, and in accordance with applicable regulatory requirements and Boehringer Ingelheim Standard Operating Procedures. All patients provided written informed consent. This article does not report individual patient data; all data presented here are anonymised. The clinical trial protocols and the informed consent and patient information forms were reviewed and received approval/favorable opinion from a constituted local Institutional Review Board or an Independent Ethics Committee at each center prior to the start of the study.
: D. M. G. H. reports personal fees from AstraZeneca, Chiesi and Pfizer, and grants and personal fees from Boehringer Ingelheim, GlaxoSmithKline and Novartis, outside the submitted work. T. C. reports grants and consultancy fees from AstraZeneca, Sanofi/Roche and Novartis, personal fees and consultancy fees from Genentech, and grants from Genentech, outside the submitted work. J. M. F. reports grants from Boehringer Ingelheim, paid directly to UBC, during the conduct of the study; and personal fees from Boehringer Ingelheim, outside the submitted work. E. O. M. reports personal fees from ALK, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Stallergenes, Meda, Merck, Mylan, Sanofi/Regeneron and Teva, outside the submitted work. W. P.-R., P. M.-Z. and M. E. are employees of Boehringer Ingelheim. L. Z.-P. was employed as a contractor by Boehringer Ingelheim during the conduct of the study and is now a contractor at Elderbrook Solutions GmbH.