Funding for this research was provided by:
Eli Lilly and Company
Received: 7 September 2018
Accepted: 29 March 2019
First Online: 18 April 2019
Ethics approval and consent to participate
: The study was designed by the sponsor, Eli Lilly and Company, an academic advisory board that included non-Lilly authors of this manuscript, and Incyte Corp. The study was conducted in accordance with ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines and was approved by Quorum Review IRB (#28020). Ethics approvals were obtained for all study sites, up to 405, in this on-going long-term extension study. All patients provided written informed consent for both the long-term extension study as well as the vaccine sub-study.
: Not applicable.
: KLW is a consultant for AbbVie, Amgen, BMS, Eli Lilly and Company, Pfizer, and UCB and has received grants from BMS and Pfizer. COB is a consultant for Eli Lilly and Company. WJK, JB, MI, and CEK are employees and stockholders of Eli Lilly and Company. RK is an employee of IQVIA, with which Eli Lilly and Company contracts for statistical support.
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