Patients were recruited and enrolled in the study protocol at the Teaching Hospital of the Cagliari University. Written informed consent was obtained from all patients and controls in accordance with the ethical standards (institutional and national) of the local human research committee. The study protocol, including informed consent procedures, conforms to the ethical guidelines of the Declaration of Helsinki and was approved by the Ethics Committee of the Cagliari University Hospital on 27 May 2020; protocol number GT/2020/10894 and extension approved 27 January 2021.
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