Funding for this research was provided by:
Eli Lilly and Company
Received: 3 July 2019
Accepted: 9 January 2020
First Online: 21 January 2020
: Not applicable.
: SPIRIT-P1, SPIRIT-P2, and SPIRIT-P3 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 #1-778053-1) and SPIRIT-P2 was approved by the Bellberry Human Research Ethics Committee (Application #2015-01-049-AA). SPIRIT-P3 Institutional Review Board tracking number # 20151638. For all the three studies, approval was also obtained from each additional site. All patients in both studies gave written informed consent.
: Not applicable.
: B. Combe received grant/research support from Pfizer, MSD, and Roche-Chugai; is a consultant for Pfizer, UCB, Bristol-Myers Squibb, Janssen, Eli Lilly and Company, MSD, Roche-Chugai, AbbVie, Sanofi, and Gilead; and is on Speakers bureau for Pfizer, Bristol-Myers Squibb, Gilead, Eli Lilly and Company, Roche-Chugai, and MSD.P. Rahman has received consulting fees or other remuneration and is on Speakers bureau for AbbVie, Eli Lilly and Company, Janssen, Pfizer, Novartis, and UCB and received grant/research support from Janssen.H. Kameda has received consulting fees or other remuneration and is on Speakers bureau for AbbVie, Asahi Kasei Pharma, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Chugai, and Pfizer.J.D. Cañete has received consulting fees or other remuneration from Janssen, Novartis, Mylan, Eli Lilly and Company, Pfizer, and UCB and is on Speakers bureau for Janssen, and Novartis.G. Gallo, N. Agada, and W. Xu are employees and shareholders of Eli Lilly and Company.M.C. Genovese received grant/research support and is a consultant for Eli Lilly and Company, and Novartis.