Donohue, James F.
Kerwin, Edward
Barnes, Chris N.
Moran, Edmund J.
Haumann, Brett
Crater, Glenn D.
Funding for this research was provided by:
Theravance Biopharma Ireland Limited (Not applicable)
Article History
Received: 6 December 2019
Accepted: 20 April 2020
First Online: 11 May 2020
Ethics approval and consent to participate
: This study was conducted in accordance with the protocol, the principles of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice, the United States Code of Federal Regulations, the principles of the World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, and all applicable regulatory requirements<b>.</b> The protocol was reviewed and approved by an institutional review board (Quorum Review IRB, Seattle, Washington). Written informed consent was obtained from all patients.
: Not applicable.
: JFD is a consultant and advisory committee member for Mylan Inc. and Sunovion Pharmaceuticals.EK has participated in consulting, advisory boards, speaker panels, or received travel reimbursement for Amphastar, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Mylan, Novartis, Oriel, Pearl, Sunovion, Teva and Theravance Biopharma US, Inc. He has conducted multicenter clinical research trials for approximately 40 pharmaceutical companies.CNB was an employee of Theravance Biopharma US, Inc. at the time this study was conducted.EJM, BH, and GDC are current employees of Theravance Biopharma US, Inc.