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Claudine Civiale and Laura Bonino work at SIFI S.p.A Via Ercole Patti 36, 95025, Lavinaio, Aci S. Antonio (CT)\u2014Italy.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"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 Cl\u00ednico San Carlos de Madrid; approval provided on January 2, 2023, C.I. 22\/723-O_P). All subjects provided written informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}