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Article History

Received: 8 April 2025

Accepted: 18 August 2025

First Online: 10 November 2025

Declarations

:

: This study was funded by Eli Lilly and Company under license from Incyte.

: D.B. Radtke, A. Prakash, and X. Zhang are employees and shareholders of Eli Lilly and Company. R.L. Decker is a former employee of Eli Lilly and Company. C.S. Ernest II is a former employee of Eli Lilly and Company and currently employed with Metrum Research Group.

: 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 received first regulatory authorization 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 .

: The protocol was approved by institutional review boards or ethics committees from all participating sites according to local requirements and was conducted according to International Conference on Harmonization Good Clinical Practice guidelines and the Declaration of Helsinki.

: Informed consent, or assent when appropriate, was provided for participation in the study and prior to any study-specific procedures.

: Not applicable.

: Not applicable.

: R.L.D., C.S.E., A.P., and X.Z. wrote the manuscript; R.L.D., C.S.E., A.P., and X.Z. designed the research; R.L.D., C.S.E., D.B.R., and A.P. performed the research; R.L.D., C.S.E., D.B.R., and X.Z. analyzed the data.