Funding for this research was provided by:
Italian Ministry of Health (GR-2011-02351347)
Received: 31 October 2018
Accepted: 26 April 2019
First Online: 24 June 2019
Ethics approval and consent to participate
: There are no immediate ethical problems regarding this trial. Research has not identified any significant adverse effects or risks from any of the compared interventions, and we have no advance knowledge of which intervention is most efficacious. During the trial period, any adverse event will be reported.The trial is approved by the Comitato Etico IRCCS Fatebenefratelli (number 67/2014), and is registered under Clinical Trials.org as NCT02370316. The participation in the study is voluntary. All participants signed a written informed consent approved by the Comitato Etico IRCCS Fatebenefratelli after that a staff member has explained in detail the aim and the design of the study. Participants are informed that if decide not to participate in the study their decision will not affect their treatment in any way. Lastly, they are informed that the can withdraw their participation at any time.In accordance with the SPIRIT guidelines [CitationRef removed], we will report positive, negative, and neutral findings in the trial and we describe the RCT in accordance to the SPIRIT checklist and flow-chart for Randomized Controlled Trials of nonpharmacologic treatments [CitationRef removed] (please see Additional file InternalRef removed).
: Not applicable.
: The authors declare that they have no competing interests.
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