Updates are available Correction dated 2026-10-09
Click to view Correction: https://doi.org/10.1007/s40271-026-00845-y
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Authors
Heidenreich, Sebastian https://orcid.org/0000-0002-1909-5770
Simoncini, Tommaso
Cutts, Katelyn
Krucien, Nicolas
Kim, Janet
Todorova, Lora
Walker, Janet
Kristjansson, Clarissa
Hillard, Tim
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Funding
Funding for this research was provided by:
Astellas Pharma Europe
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Article History
Received: 3 November 2025
Accepted: 9 June 2026
First Online: 15 July 2026
Change Date: 1 October 2026
Change Type: Update
Change Details: The original online version of this article was revised to correct a value in the sentence beginning ‘The mean (standard deviation) age…’
Change Date: 9 October 2026
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40271-026-00845-y
Declarations
Conflict of interest: Sebastian Heidenreich, Katelyn Cutts and Nicolas Krucien: employees of Thermo Fisher Scientific. Sebastian Heidenreich and Nicolas Krucien are also minority stockholders in Thermo Fisher Scientific. Janet Kim: employee of Astellas Pharma. Tim Hillard: consultant and speaker for Astellas Pharma. Tommaso Simoncini: consultant for Abbott, Actavis, Applied Medical, Astellas Pharma, Estetra, Gedeon Richter, Johnson & Johnson, Medtronic, Mitsubishi Tanabe and Sojournix; speaker for Abbott, Applied Medical Gedeon Richter, Intuitive Surgical, Shionogi and Theramex. Janet Walker and Clarissa Kristjansson: none to declare.
Availability of data and material: Details for how researchers may request access to anonymised participant level data, trial level data and protocols from Astellas sponsored clinical trials can be found at .
Ethics approval: Ethical approval of this study was granted by Salus IRB (Salus institutional review board study no. 22089-01).
Consent to participate: Electronic informed consent was obtained from all participants.
Consent for publication: Not applicable.
Author contributions: SH, TS, KC, JK, LT, JW, CK and TH were involved in the planning and design of the trial. SH and KC were involved in acquisition of the data. SH, KC, NK, JK and LT contributed to analysis of the data. SH, TS, KC, NK, LT, JW, CK and TH were involved in the interpretation of the data. All authors contributed to the writing of the report, had full access to all of the results and can confirm the accuracy and completeness of the data reported.
