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Article History

Received: 3 April 2020

Accepted: 18 January 2021

First Online: 5 February 2021

Ethics approval and consent to participate

: Each collaborating clinic has obtained theEthics Committee of the Area VastaEmilia Nord: (number 104; date of approval 17/07/2017) Approval for their participation in the study and has obtained formal local approval prior to enrolling their first subject.Subjects are enrolled into the clinical investigation only after signing the written Patient Informed Consent Formprior to the first assessment (baseline, t0). The study is conducted in accordance with the most recent version of the Declaration of Helsinki, the EN ISO 14155:2011 and any regional or national regulations, as appropriate.All the personal data will be anonymised, assigning a code to each patient, exclusive of the study, so that they no longer relate to identifiable people.

: Not applicable.No private information of patients is intended for publication.

: The authors declare that they have no competing interests.