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The amendment authorising the conduct of the CEFI-SITA study within the MULTI-SITA project was approved by the Liguria Region Ethics Committee on 12 April 2022. The other participating centres followed the local ethical committees\u2019 requirements and prospectively enrolled patients once activated. All conscious patients at enrolment signed an informed consent to participate in the study. A waiver of informed consent for data collection from unconscious patients at the time of enrolment due to severe clinical conditions was obtained within the Liguria Region Ethics Committee approval, in line with the observational nature of the analyses and in order not to bias research results towards high cure rates and low mortality prejudicing scientific validity.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Outside the submitted work, Andrea Lombardi has received travel grant from Gilead Sciences, Takeda and Shionogi Inc., research grant from Gilead Sciences. Outside the submitted work, Daniele Roberto Giacobbe reports investigator-initiated grants from Pfizer, BioM\u00e9rieux, and Gilead Italia, and speaker\/advisor fees from Pfizer, Menarini, and Tillotts Pharma. Outside the submitted work, Matteo Bassetti has received funding for scientific advisory boards, travel, and speaker honoraria from Cidara, Gilead, Menarini, MSD, Mundipharma, Pfizer, and Shionogi. Outside the submitted work, Andrea Cortegiani received fees for lectures\/scientific advisory board from Gilead, Mundipharma, MSD, Pfizer. Outside the submitted work, Enrico Maria Trecarichi reports advisor fee from MSD Italia.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1339"}}