Carsetti, Andrea
Amici, Mirco
Bernacconi, Tonino
Brancaleoni, Paolo
Cerutti, Elisabetta
Chiarello, Marco
Cingolani, Diego
Cola, Luisanna
Corsi, Daniela
Forlini, Giorgio
Giampieri, Marina
Iuorio, Salvatore
Principi, Tiziana
Tappatà, Giuseppe
Tempesta, Michele
Adrario, Erica
Donati, Abele
Article History
Received: 7 December 2019
Accepted: 15 April 2020
First Online: 18 April 2020
Ethics approval and consent to participate
: This trial will be conducted according to Good Clinical Practice, Helsinki declaration and national regulation for clinical trial conduction. This protocol has been approved by local ethical committee “Comitato Etico Regione Marche” (Prot. 2019 141, Prot. 2019 141/5682) for the coordinator center. The satellite centers will submit the protocol to their Ethical Committee for approval before the start of enrollment.Potentially eligible patients will receive printed and verbal information about the trial. Patients will be enrolled after the subscription of written informed consent. The consent will be asked to legal representative for interdicted patients. The participation to the study is free and patients can ask to abandon the study at any time. They can withdraw the consent to participate and they can ask the elimination of acquired data.
: Not applicable.
: The authors declare that they have no competing interests. The study has not received funding/assistance from any commercial organization.