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Article History

Received: 1 March 2024

Accepted: 19 August 2024

First Online: 2 September 2024

Declarations

:

: The trial will be conducted under this protocol, ICH GCP guidelines, the Helsinki Declaration, and the applicable local guidelines and laws. The established procedures for quality control will be followed. Eventual changes to the protocol will be reported immediately to the relevant authorities and the patients. Participation in the trial is voluntary and does not affect the individual’s assessment and treatment process. The participants will be informed, both orally and in writing, of the study’s purpose and implications. Written informed consent to participate will be obtained from all participants before randomisation. Participants may withdraw their consent at any time without explanation.

: The patients will be adequately informed about the publication of trial data by informed consent at inclusion. All data published will be anonymised and without the possibility of identification of any details of individual participants.

: HVS: declares financial aid outside of the scope of this manuscript—specifically, travel reimbursement, speaking and lecture fees from MSD Denmark, and project support from Pfizer. AR: declares research grant from Pfizer and MSD for genetic testing of men with prostate cancer. He has also received fees for consulting services and advisory boards for Astellas, MSD, Pfizer, Bayer, Orion, Intuitive, Medtronic, Recordati and Janssen. MF: Speaker for Boston Scientific and Astellas Pharma.  MT: Declares financial aid outside of the scope of this manuscript—specifically, consulting services for Neurescue. The remaining authors declare that they have no competing interests.