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Article History

Accepted: 3 July 2025

First Online: 1 August 2025

Declarations

:

: Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. Funding for this study was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA; no grant number is applicable.

: T.F. is an employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, at the time of this work. Z.P.P-G. and I.F.T. received research funding from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

: The study protocols and amendments were approved by local institutional review boards or ethics committees at each participating institution. The studies were conducted in accordance with local laws, Good Clinical Practice guidelines, and the Declaration of Helsinki.

: All patients provided written informed consent.

: Conceptualization: ZPP-G, TF, and IFT; Formal analysis: ZPP-G and IFT; Resources: TF; Supervision: IFT and TF; Writing – review & editing: ZPP-G, IFT, and TF. All authors read and approved the final version of the manuscript.

: Original code is provided as supplementary material.

: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. MSD is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. The MSD data sharing website (available at: ) outlines the process and requirements for submitting a data request. Applications will be promptly assessed for completeness and policy compliance. Feasible requests will be reviewed by a committee of MSD subject matter experts to assess the scientific validity of the request and the qualifications of the requestors. In line with data privacy legislation, submitters of approved requests must enter into a standard data-sharing agreement with MSD before data access is granted. Data will be made available for request after product approval in the US and EU or after product development is discontinued. There are circumstances that may prevent MSD from sharing requested data, including country or region-specific regulations. If the request is declined, it will be communicated to the investigator. Access to genetic or exploratory biomarker data requires a detailed, hypothesis-driven statistical analysis plan that is collaboratively developed by the requestor and MSD subject matter experts; after approval of the statistical analysis plan and execution of a data-sharing agreement, MSD will either perform the proposed analyses and share the results with the requestor or will construct biomarker covariates and add them to a file with clinical data that is uploaded to an analysis portal so that the requestor can perform the proposed analyses.