Nasu, Risa http://orcid.org/0000-0002-5258-8593
James, Douglas E.
Chigutsa, Emmanuel
Garhyan, Parag
Nagai, Yukiko
Funding for this research was provided by:
Eli Lilly Japan
Article History
Accepted: 27 February 2023
First Online: 27 March 2023
Declarations
:
: This study was funded by Eli Lilly and Company, IN, USA. The preparation of this manuscript and the open access publishing fee were sponsored by Eli Lilly Japan K.K.
: RN and YN are employees of Eli Lilly Japan K.K. and minor stock shareholders of Eli Lilly and Company. DEJ, EC, and PG are employees and minor stock shareholders of Eli Lilly and Company.
: The clinical studies cited herein were approved by an institutional review board at each site and were conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice guidelines.
: Patients provided written informed consent prior to participation in the clinical studies cited herein.
: Not applicable.
: Eli Lilly and Company 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 ExternalRef removed.
: Not applicable.
: All authors meet the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this manuscript to be published.