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Claudia Fabiani was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Carla Gaggiano, Alejandra De-la-Torre, Juanita Cardona-L\u00f3pez, Silvana Guerriero, Gaafar Ragab, Maria Pia Paroli, Luciana Breda, Emanuela Del Giudice, Maria Tarsia, Jurgen Sota, Adele Civino, Marco Cattalini, Antonio Vitale, Stefano Gentileschi, Angela Mauro, Sulaiman Al-Mayouf, Soad Hashad, Alex Fonollosa, Shereen Hassan Aboul Naga, Rana Hussein Amin, Lampros Fotis, Maria Francesca Gicchino, Valeria Caggiano, Rosanna Dammacco, Maria Cristina Maggio, Daniela Rodr\u00edguez-Camelo, Maria Sole Chimenti, Juliana Lopez-Bonilla, Ezgi Deniz Batu, Seza Ozen, Francesca Minoia, Abdurrahman Tufan, Mohamed Tharwat Hegazy, Kalpana Babu, Jessica Sbalchiero, Abdelhafeez Moshrif, Patrizia Barone, Perla Ayumi Kawakami-Campos, Alessandro Conforti, Marcello Govoni, Giovanni Conti, Maissa Thabet, Francesco La Torre, Ester Carreno, Vishali Gupta, Bruno Frediani, and Luca Cantarini have nothing to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This study protocol (NCT05200715) adheres to the principles outlined in the Declaration of Helsinki. 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