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Article History

Received: 21 February 2018

Accepted: 9 July 2018

First Online: 13 August 2018

Ethics approval and consent to participate

: The study was performed in accordance with the principles of the Declaration of Helsinki. All investigation sites received approval from ethics committees or institutional review boards. For the SPIRIT-P1 study, the institutional review board for the primary investigator was the Western Institutional Review Board (#1–838,258-1), and for the SPIRIT-P2 study, the institutional review board for the primary investigator was the Bellberry Human Research Ethics Committee (#2015–01-049-AA). Patients provided written informed consent before any study-related procedures were undertaken.

: Not applicable.

: LCC has served on advisory boards for, and received research funding and speakers’ fees from Abbvie, Pfizer, MSD, UCB, and Celgene. PSH has served on advisory boards for and received speakers’ fees from Amgen, Abbvie, BMS, Janssen, Pfizer, MSD, UCB, and Celgene, and has received research funding from Abbvie and Pfizer. AO has served as a consultant for Eli Lilly, Janssen, Novartis, Pfizer and UCB, and has received research funding from Celgene, Eli Lilly, Horizon, Janssen, and Novartis (to Johns Hopkins University). OB, LK, DHA, CLS, and JB were employees and minor shareholders of Eli Lilly and Company or its subsidiaries.

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