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Federico Bertolini, Giovanni Ostuzzi, Michela Pievani, Andrea Aguglia, Francesco Bartoli, Paola Bortolaso, Camilla Callegari, Mariarita Caroleo, Giuseppe Carr\u00e0, Mariangela Corbo, Armando D\u2019Agostino, Pasquale De Fazio, Fabio Magliocco, Edoardo Giuseppe Ostinelli, Marco Piero Piccinelli, Federico Tedeschi and Corrado Barbui have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"The study dataset is available from the authors on reasonable request.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"The study protocol was approved by the local ethics committee of the coordinating centre (Ethics Committee for Clinical Trials of the Provinces of Verona and Rovigo, protocol n. 57622 of the 09\/12\/2015) and of each participating centre.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Participants provided written consent to data collection.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"GO, GC, GM and CB contributed to study design. 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