Cohen, Stanley B.
Radominski, Sebastiao C.
Kameda, Hideto
Kivitz, Alan J.
Tee, Michael
Cronenberger, Carol
Zhang, Min
Hackley, Sarah
Rehman, Muhammad I.
von Richter, Oliver
Alten, Rieke
Funding for this research was provided by:
Pfizer
Article History
First Online: 14 January 2020
Compliance with Ethical Standards
:
: SBC has received research grants and consulting fees or honorarium from AbbVie, Amgen, Pfizer, and Sandoz. RA has no conflicts of interest that are directly relevant to the content of this article. HK has received consulting fees, speaking fees, and/or honoraria from AbbVie GK, Asahi Kasei Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan KK, Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma, Novartis, and Pfizer Japan and has received research grants from AbbVie GK, Asahi Kasei Pharma, Astellas Pharma, Chugai Pharmaceutical, Eisai, Mitsubishi Tanabe Pharma, and Novartis. AJK has received consulting fees and/or speaking fees and/or fees for participation on advisory committees or review panels from Sanofi, Regeneron, SUN Pharma Advanced Research, AbbVie, Janssen, Pfizer, UCB, Genzyme, Boehringer-Ingelheim, Celgene, Horizon, Merck, Novartis, and Flexion and has stock holdings for Pfizer, Sanofi, Amgen, and Gilead. MT has received research grants, speaking fees, and honoraria from Pfizer Philippines. SCR has received research grants from Pfizer. OvR is an employee of Hexal AG (a Sandoz company). CC, SH, MIR, and MZ are employees of, and hold stock or stock options from, Pfizer.
: The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and in compliance with International Conference on Harmonisation Good Clinical Practice guidelines. The independent ethics committee or institutional review board for each study center approved the study protocol; an independent data monitoring committee was responsible for monitoring safety and study conduct.
: All patients provided written informed consent before study entry. No additional informed consent was required because the three treatment periods were part of the same study.
: This study was sponsored by Pfizer Inc. Open access publication of this article was funded by Pfizer Inc.