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Article History

Received: 1 July 2025

Accepted: 30 November 2025

First Online: 15 December 2025

Declarations

:

: This study was conducted in accordance with the principles of Good Clinical Practice and Good Laboratory Practice as referenced in the International Council for Harmonization guidelines, as well as all applicable regulations, including any institutional review board requirements relevant to clinical studies. The study also complied with the recommendations in the most recent version of the Declaration of Helsinki. Participants provided written informed consent before any study-related procedures were undertaken. The protocol was approved by the institutional review board of Hospital Universitario de La Princesa, Madrid (Spain), and the Clinical Research Ethics Committee of Universidad Autónoma de Madrid, Spain (register code CEI-131- 2722).

: Not applicable.

: The authors ABGV, NGG, JDT and PHR were the study coordinators and received research support and honoraria from Pfizer S.L.U. ABGV has received honoraria for conferences and/or advisory boards from Lilly, Novartis, TEVA, Lundbeck, Abbvie and Almirall. NGG has received honoraria for conferences and/or advisory boards from Lilly, Novartis, TEVA, Lundbeck, Abbvie. JDT has received honoraria for conferences and/or advisory boards from Lilly, Novartis, TEVA, Lundbeck, Abbvie. PHR has received honoraria of Lundbeck, Novartis, Abbvie and TEVA. MARD is employee of Universidad Autónoma de Madrid which received funding from Pfizer S.L.U. CMA and BAP are employees of Pfizer S.L.U. JSA was employee of Pfizer S.L.U. when the study was initiated. JRG was specialist consultant without honoraria from Pfizer S.L.U.