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Article History

Received: 18 December 2017

Accepted: 25 June 2018

First Online: 4 July 2018

Ethics approval and consent to participate

: This survey did not classify as clinical study based on §40 and §42 of the applicable German law (“Arzneimittelgesetz”). According to §67 Abs. 6 it also does not classify as non-interventional study, as that paragraph is strictly focused on prescription medicines. Therefore, and in line with the algorithm provided in EurdaLex volume 10 – Clinical Trial Guidelines, Boehringer Ingelheim classified the anonymous survey as non-trial activity based on SOP 001-MCS-90-118 (dated 2014). Accordingly, ethical committee approval was neither required nor recommended in Germany for an anonymous survey at the time it was performed. The authors concur with this assessment.According to survey design, customers having purchased one of the four products were invited by the pharmacist to participate in the anonymous survey. Based on the anonymous nature of the survey, no formal consent was obtained but participation was taken as consent.

: Not applicable

: In the last 5 years, PK served on advisory boards for AstraZeneca, Chiesi, GlaxoSmithKline, Menarini, Novartis, Takeda and Teva; received lecture fees from AstraZeneca, Boehringer Ingelheim, Cipla, Menarini, Novartis and Teva; participated in sponsored clinical trials from AstraZeneca, Boehringer Ingelheim and Novartis and has been reimbursed for attending scientific symposia from AstraZeneca, Boehringer Ingelheim, Menarini and Novartis.KMB declares that no personal payments were received from any pharmaceutical entity in the past 5 years. KMB is a full-time employee of insaf Respiratory Research Institute. His institution has received compensation for services on advisory boards or consulting for Ablynx, Almirall, AstraZeneca, Berlin Chemie, Boehringer, Chiesi, Cytos, Mundipharma, Novartis, Pohl Boskamp, Zentiva. His institution has received compensation for speaker activities in scientific meetings supported by Almirall, AstraZeneca, Berlin Chemie, Boehringer, Cytos, ERT, GSK, Novartis, Pfizer, Pohl Boskamp, Takeda. The institution has further received compensation for design and performance of clinical trials from Almirall, Altana/Nycomed, AstraZeneca, Boehringer, Cytos, GSK, Infinity, Medapharma, MSD, Mundipharma, Novartis, Parexel, Pearl Therapeutics, Pfizer, Revotar, Teva, Sterna, and Zentiva.US, TM and HG are employees of Sanofi Aventis.MCM is a past employee of Boehringer Ingelheim and currently a consultant to Sanofi-Aventis.

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