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Both SPIRIT-P1 and SPIRIT-P2 were registered at. SPIRIT-P1 was registered as NCT01695239 on 25-September-2012 (); SPIRIT-P2 was registered as NCT02349295 on 10-October-2014 ().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.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"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, Gr\u00fcnenthal, 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.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"38"}}