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Article History

Accepted: 28 February 2021

First Online: 29 March 2021

Declarations

:

: Funding for this study was received from Eli Lilly and Company.

: Shweta Urva, Tonya Quinlan, John Landry, Jennifer Martin, and Corina Loghin are employees and shareholders of Eli Lilly and Company.

: The study was approved by the appropriate institutional and/or national research ethics committee, and was conducted in accordance with the ethical standards of the institutional and/or national research committee, the Declaration of Helsinki, and current guidelines for studies in patients with renal impairment.

: All participants gave their written informed consent prior to the start of any study-related activities.

: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of PK or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU 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, 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.

: SU, JL, JM, and CL contributed to the study design; CL provided medical oversight during the trial; JL was responsible for the statistical analyses; and TQ was responsible for oversight of the PK analyses. SU and CL are the guarantors of this work and, as such, take responsibility for the integrity of the data and the accuracy of the data analysis. All authors participated in interpretation of the data and critical review of the manuscript, had full access to all the data in the study, and approved this manuscript to be submitted for publication.