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The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The protocol was approved for ISPRO coordinating centre, Careggi Hospital, and Central Tuscany Local Health Unit by the local Ethics Committee (approvals n. CEAVC 17837_spec, and n. 17680_spec). Then, it was approved by the Ethics Committees of the other pilot sites. All participants provided written informed consent. The study was performed in accordance with the ethical standards as laid down in the\u00a01964 Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}]}}