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Article History

Received: 20 July 2020

Accepted: 7 December 2020

First Online: 27 January 2021

Ethics approval and consent to participate

: SPIRIT-P1 and SPIRIT-P2 were conducted in accordance with Good Clinical Practice, the principles of the Declaration of Helsinki, and local laws and regulations. SPIRIT-P1 was approved by the Western Institutional Review Board (approval #1-838258-1), and SPIRIT-P2 was approved by the Bellberry Human Research Ethics Committee (Application #2015-01-049-AA). For both studies, approval was also obtained from each additional site. All patients in both studies gave written informed consent.

: Not applicable.

: BC has received grant/research support and/or is on the speakers bureau for and/or is a consultant for AbbVie, BMS, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer, Roche-Chugai, and UCB; T-FT is a consultant for and/or is on the speakers bureau for AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly and Company, GSK-Stiefel, Janssen-Cilag, Novartis, and Pfizer; JEH is a consultant for and/or is on the speakers bureau for Eli Lilly and Company, Genentech, Janssen, Pfizer, and Regeneron; ATS, C-YL, SYP, AK, and MMH are current employees and shareholders of Eli Lilly and Company; PN is a consultant for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB; is on the speakers bureau of: AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB; and has received research funding from AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB.