Document is current

Article History

Accepted: 8 October 2020

First Online: 23 December 2020

Declarations

:

: This work was supported by Eli Lilly and Company. The study sponsor provided the study drug and collaborated with the investigators to design the study; collect, analyze, and interpret the data; and write this report. The corresponding author had access to study data, and all authors approved submission for publication.

: Kensei Yamaguchi received grants and personal fees from Eli Lilly and Company. Shuichi Hironaka received personal fees from Bristol-Myers Squibb, Ono Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., Yakult Honsha Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly and Company, Chugai Pharmaceutical Co. Ltd., Nihonkayaku, and Tsumura and Co. Yoshito Komatsu reports fees from Ono Pharmaceutical Co. Ltd., Merck Sharp & Dohme, Eli Lilly and Company, AstraZeneca, Daiichi Sankyo Co. Ltd., Taiho Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Linical Co. Ltd., Tennessee Coalition for Open Government, Nassau Community College, Kyowa Hakko Kirin Co. Ltd., Takeda Pharmaceutical Co. Ltd., Sanofi, Yakult Honsha Co. Ltd., Bristol-Myers Squibb, Boehringer Ingelheim, Bayer, Pfizer, and Novartis. Takao Tamura reports grants and personal fees from Chugai Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Ono Pharmaceutical Co. Ltd., Merck Serono Co. Ltd, Bristol-Myers Squibb, and Takeda Pharmaceutical Co. Ltd. Yongzhe Piao, Gosuke Homma, Min-Hua Jen, and Astra M. Liepa are employees of Eli Lilly and Company and received salaries. Min-Hua Jen and Astra M. Liepa are also shareholders of Eli Lilly and Company. Yasuhiro Shimada, Naotoshi Sugimoto, Tomohiro Nishina, Yasushi Omuro, and Kei Muro have no conflicts of interest that are directly relevant to the content of this article.

: Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at.

: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

: Informed consent to be included in the study, or the equivalent, was obtained from all patients.

: YP, GH, MHJ, and AML conceived and designed the study. KY, YS, SH, NS, YK, TN, YO, TT, and KM collected the data. M-HJ analyzed the data. All authors contributed to the interpretation of the data and the writing of the manuscript.

: Not applicable.

: Not applicable.