Document is current

Article History

Accepted: 30 March 2025

First Online: 23 April 2025

Declarations

:

: This work was funded by Eli Lilly and Company, who also sponsored the original studies, medical writing support, and open-access publication of the manuscript.

: Douglas James and Jason Bailey are full-time employees of Eli Lilly and Company and/or one of its subsidiaries and are minority holders of company stock. Jan-Stefan van der Walt, Julia Winkler, and Rik Schoemaker are full-time employees of Occams Coöperatie UA, Amstelveen, the Netherlands. At the time the study was conducted, Jan-Stefan van der Walt was a full-time employee of Eli Lilly and Company, Indianapolis, IN, USA, and was a minority holder of company stock.

: All studies included in this analysis were approved by appropriate ethics committees and were conducted in accordance with the principles of the Declaration of Helsinki and the International Council on Harmonisation Good Clinical Practice guidelines.

: Written informed consent was obtained from all participants of the studies included in this analysis.

: 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 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, 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 .

: Not applicable.

: J.-S.v.d.W. conceived and designed the study. J.B. was responsible for scientific oversight of immunogenicity and biomarker sample analysis. D.E.J., J.W., and R.S. analyzed the data. D.E.J., J.-S.v.d.W., J.B., J.W., and R.S. interpreted the data. D.E.J., J.B., and J.-S.v.d.W. drafted the manuscript. J.W. and R.S. critically revised the manuscript for important intellectual content. All authors read and approved the final version of the manuscript.