Funding for this research was provided by:
Eli Lilly and Company (n/a)
Text and Data Mining valid from 2019-01-29
Received: 23 August 2018
Accepted: 18 January 2019
First Online: 29 January 2019
: 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. Both SPIRIT-P1 and SPIRIT-P2 were registered at ExternalRef removed. SPIRIT-P1 was registered as NCT01695239 on 25-September-2012 (ExternalRef removed); SPIRIT-P2 was registered as NCT02349295 on 10-October-2014 (ExternalRef removed).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
: D. D. Gladman is a consultant for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB, and has received grant/research support from AbbVie, Amgen, Celgene, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB.A.-M. Orbai is a consultant for Eli Lilly and Company, Novartis, and has received grant/research support from AbbVie, Celgene, Eli Lilly and Company, Horizon, Janssen, and Novartis.U. Kiltz has received grant and research support and consultancy fees from AbbVie, Biogen, Chugai, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB.J.C.-C. Wei has been consulted for Pfizer, Celgene, Chugai, UCB, and TSH (Taiwan); has received research grants from BMS, Janssen, Pfizer, Sanofi-Aventis, and Novartis; and has served on speakers bureaus for Abbott, BMS, Chugai, Eisai, Janssen, and Pfizer.H. Marzo-Ortega has received grant/research support from Janssen and is on the speaker bureau for AbbVie, Celgene, Janssen, MSD, Novartis, Pfizer, and UCB.G. Gallo, J. Birt, S. Rathmann, and D. Shrom are current employees and minor shareholders of Eli Lilly and Company.
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