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Article History

Received: 19 December 2024

Accepted: 8 May 2025

First Online: 1 July 2025

Declarations

:

: The study protocol was approved by Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs) at each participating institution, including Vienna General Hospital (Allgemeines Krankenhaus Wien) IRB/IEC; Ethics Committee of the Medical Association of Westphalia-Lippe and the Medical Faculty of the Westphalian Wilhelms University of Münster (Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster); Ethics Committee at the Hesse State Medical Association (Ethikkommission bei der Landesärztekammer Hessen); Hospital of the Brothers of Mercy Vienna (Krankenhaus Barmherzige Brüder Wien); Clinical Research Ethic Committee ​​León Health Area (Comité Ético de Investigación Clínica [CEIC] Area de Salud de León); Clinical Research Ethic Committee of the José María Morales Meseguer General University Hospital (CEIC del Hospital General Universitario José María Morales Meseguer); Clinical Research Ethic Committee of the Virgen de la Arrixaca Hospital (CEIC del Hospital Virgen de la Arrixaca); and Ethics and Scientific Committee for Research, Studies and Evaluations in the Field of Health (Comite ethique et scientifique pour les recherches, les etudes et les evaluations dans le domaine de la sante [CESREES]). The need for informed consent was waived by Ethics Committee of the Medical Association of Westphalia-Lippe and the Medical Faculty of the Westphalian Wilhelms University of Münster (Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster) and many other IECs/IRBs at each participating institution whose names are mentioned above. The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. An informed consent form waiver or opt-out letter process, as applicable, has been followed based on country- and site-specific requirements.

: Not applicable.

: M. Boegemann: Employment: Janssen; Honoraria: Advanced Accelerator Applications, Amgen, Astellas Pharma, AstraZeneca, Bayer/Vital, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen, Janssen-Cilag, Merck, MSD, Novartis, Pfizer, Roche, Sanofi/Aventis; Consulting or Advisory Role: Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Ipsen, Janssen-Cilag, Merck, MSD, Novartis, Roche, Sanofi; Research Funding: Ipsen (Inst); Janssen-Cilag; Travel, Accommodation, Expenses: Amgen, Bayer, BMS GmbH & Co. KG, Janssen-Cilag. M. Bennamoun: Financial Interests, Invited Speaker: Janssen, AstraZeneca, Ipsen, Astellas. L.M. Dourthe: Honoraria: Janssen, Ipsen, Bayer, Pfizer. J.A. Encarnacion: Nothing to declare. A. Hegele: Advisor/Honoraria/Scientific lecture: Astra Zeneca, APOGEPHA, Pfizer, BMS, Ipsen, Janssen, Merck, MSD, Dr. Pfleger. E. Hellmis: Advisor/Honoraria: Accord Healthcare, APOGEPHA, Astellas, AstraZeneca, Bayer Vital, BMS, Eisai, Hexal, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Recordati, Roche, Takeda. I. Latorzeff: Advisor/Honoraria: Astellas, Bayer, BioProtect, Boston Scientific, Janssen, Ipsen. W. Leicht: Nothing to declare. J. Oñate-Celdrán: Astellas, Bayer, Ipsen, GSK, Janssen, Recordati. A. Rosino-Sánchez: Advisor/Honoraria: AstraZeneca – MSD, Astellas, Bayer, GP Pharm, Ipsen, Janssen, Recordati. K. Hanna: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. J. Lencart: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. M. Lukac: Employee: Parexel International S.R.O. On Behalf of Janssen Pharmaceutica LLC, a Johnson & Johnson Company. C.A. Schioppa: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. S. Van Sanden: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. G. Kramer: Honoraria or Consultation fee: Accord Healthcare, Astella, AstraZeneca, Bayer, Ferring, Ipsen, Janssen, MSD, Novartis, Pfizer, Takeda.