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Florindo d\u2019Onofrio received grants and honoraria from Lilly, Teva, Novartis, Neopharmed; Ilaria Maestrini received honoraria from Eli Lilly. Roberta Messina received honoraria as speaker from Novartis, Eli Lilly, and Teva. Armando Perrotta travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Eli-Lilly, Novartis, and Teva; Angelo Ranieri received speaker honoraria from Teva, Lilly; Fabrizio Vernieri received travel grants, honoraria for advisory boards, speaker panels, or clinical investigation studies from Allergan, Amgen, Angelini, Eli-Lilly, Lundbeck, Novartis, and Teva; Nicoletta Brunelli, Marilena Marcosano and Francesca Schiano Di Cola, Davide Bertuzzo have nothing to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki. All patients provided written informed consent. The study was approved by the Campus Bio-Medico University Ethical Committee n.30\/20, mutually recognized by the other local ethical committees, and registered at the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) and at ClinicalTrials.gov NCT04803513.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}