Funding for this research was provided by:
Janssen Research and Development (n/a)
Received: 24 September 2019
Accepted: 6 February 2020
First Online: 6 March 2020
Ethics approval and consent to participate
: This study (NCT02181673; registered July 4, 2014) was conducted according to Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by each site’s governing ethical body; Schulman IRB (now Advarra, Columbia, MD) provided centralized institutional review board approvals for sites in the USA (Reference# 201404246) and Canada (Reference# 201404730). All patients provided written informed consent.
: Not applicable.
: PM has received research grants, consultation fees, and/or speaker honoraria from Amgen, Eli Lilly, Novartis, Pfizer (more than $10,000 each), and AbbVie, BMS, Celgene, Galapagos, Genentech, Gilead, Janssen, Leo, Merck, SUN, and UCB (less than $10,000 each).MEH has received consulting fees, speaking fees, and/or honoraria from AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, and Novartis (less than $10,000 each).SK, SDC, DDH, KHL, SX, and ECH own stock or stock options in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary.AK has received consulting fees from AbbVie, Amgen, Janssen, UCB, Eli Lilly, Novartis, and Pfizer (less than $10,000 each), and research support from those companies.