Received: 5 March 2020
Accepted: 6 May 2020
First Online: 20 May 2020
Ethics approval and consent to participate
: The study has been performed in accordance with the Declaration of Helsinki. All subjects provided informed written informed consent to participate in the study. The study was approved by the institutional ethics committee of the coordinating center (Ethics Committee of the Umbria Region, no. 3896/14 and 5964/15) and participating centers.
: Not applicable.
: The authors declared no conflict of interest.