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Authors
Molero Senosiaín, Mercedes
Burgos-Blasco, Barbara
Perez-García, Pilar
Sánchez-Ventosa, Álvaro
Villalba-González, Marta
López Pérez, María Dolores
Díaz, José Carlos
Díaz-Mesa, Vanesa
Villarrubia Cuadrado, Alberto
Artiaga Elordi, Enrique
Larrosa Poves, Jose Manuel
Blasco, Alejandro
Mateo, Antonio
Civiale, Claudine
Bonino, Laura
Cano-Ortiz, Antonio
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Funding
Funding for this research was provided by:
SIFI S.p.A.
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Article History
Received: 8 November 2024
Accepted: 24 January 2025
First Online: 21 February 2025
Declarations
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: All the authors except Claudine Civiale and Laura Bonino report no conflicts of interest. Claudine Civiale and Laura Bonino work at SIFI S.p.A Via Ercole Patti 36, 95025, Lavinaio, Aci S. Antonio (CT)—Italy.
: The investigation was conducted at four clinical sites in Spain in accordance with the Declaration of Helsinki, ISO (EN) 14155:2020 rev.4, ICH-Good Clinical Practice, Regulation (EU) 2017/745, the European Clinical Trials Directive and the applicable laws and regulations. The clinical investigation was approved by an independent ethics committee (IEC of Hospital Universitario Clínico San Carlos de Madrid; approval provided on January 2, 2023, C.I. 22/723-O_P). All subjects provided written informed consent.
