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Authors
Corriero, Alberto https://orcid.org/0000-0002-9760-9394
Soloperto, Rossana
Giglio, Mariateresa
Salvagno, Michele
Trerotoli, Paolo
Grasso, Salvatore
Ribezzi, Mario
Mosca, Adriana
Petrillo, Claudio
De Toma, Nicolangelo
Magnesa, Giovanna
Giacomucci, Angelo
Accattoli, Riccardo
Gadaleta, Raffaella Maria
Florio, Marilina
Cariello, Marica
Moschetta, Antonio
Puntillo, Filomena
Taccone, Fabio Silvio
Ranieri, Vito Marco
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Article History
Received: 6 June 2025
Accepted: 15 October 2025
First Online: 10 November 2025
Declarations
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: The PROACT Trial protocol and informed consent forms will be approved by each hospital’s Research Ethics Board. Researchers will carry out this study in line with the GCP and the Declaration of Helsinki. Before randomization, patients or their legal representatives shall provide written informed consent.Consenting individuals will be made aware that if they choose to decline enrollment or withdraw from the study, it will not impact their care. Coded identification, password-protected documents and webpages, lockable filing cabinets, and offices will all be used to guarantee confidentiality.
: No identifiable personal data or images of participants will be published. As part of the informed consent process, participants or their legally authorized representatives will provide consent for the use of anonymized study data in scientific publications and presentations.
: The authors declare that UNI‑PHARMA S.A. provided the investigational product and placebo in‑kind for this trial. Study design, data collection, analyses, interpretation, and manuscript preparation are the responsibility of the academic investigators. Relevant relationships with UNI‑PHARMA have been disclosed and managed per institutional policies.
