Chiu, Chao-Hua
Lin, Meng-Chih
Wei, Yu-Feng
Chang, Gee-Chen
Su, Wu-Chou
Hsia, Te-Chun
Su, Jian
Wang, Anne Kuei-Fang
Jen, Min-Hua
Puri, Tarun
Shih, Jin-Yuan
Funding for this research was provided by:
This study was funded by Eli Lilly and Company
Article History
Accepted: 6 May 2023
First Online: 17 June 2023
Declarations
:
: This study was funded by Eli Lilly and Company.
: Chao-Hua Chiu has received consulting fees or honorarium from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly and Company, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Pfizer, Roche, Shionogi and Takeda. Gee-Chen Chang, Meng-Chih Lin, Jian Su, Wu-Chou Su and Yu-Feng Wei have no conflicts to declare. Te-Chun Hsia has received payment for lectures including service on speakers bureaus from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Roche, Takeda, Merck Sharp & Dohme, Merck KGaA, Bristol Myers Squibb and Amgen. Jin-Yuan Shih has received grants from Roche and Genconn Biotech; consulting fees or honorarium from ACT Genomics, Amgen, Genconn Biotech, AstraZeneca, Roche, Bayer, Boehringer Ingelheim, Eli Lilly and Company, Pfizer, Novartis, Merck Sharp & Dohme, Chugai Pharmaceutical, Takeda, CStone Pharmaceuticals, Janssen, TTY Biopharm, Orient EuroPharma, Mundipharma, Ono Pharmaceutical and Bristol Myers Squibb; and travel support from AstraZeneca, Roche, Boehringer Ingelheim and Chugai Pharmaceutical. Anne Kuei-Fang Wang, Min-Hua Jen and Tarun Puri are employees of Eli Lilly and Company with stock options.
: All authors contributed to the study conception/design or acquisition, analysis and interpretation of the data. All authors critically revised the manuscript for important intellectual content and have read and approved the final manuscript.
: The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The protocol and amendments were approved by the ethics committees of all participating centers.
: Informed consent was obtained from all patients prior to participating in the study.
: Eli Lilly provides access to all individual participant data collected during the trial, after anonymisation, 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 EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once they 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 up to 2 years per proposal. For details on submitting a request, see the Vivli website.