Text and Data Mining valid from 2018-11-12
Received: 19 March 2018
Accepted: 26 October 2018
First Online: 12 November 2018
Ethics approval and consent to participate
: This prospective study complies with the principles outlined in the declaration of Helsinki (64th World Medical Association General Assembly, Fortaleza, Brazil, October 2013) and was approved by the institutional review board of the Fondazione Policlinico A. Gemelli (protocol ID 6118/13). The aims and methodologies of this study were explained to the patients, and all subjects provided written informed consent. The study protocol was registered on clinicaltrials.gov (NCT03343743).
: Not applicable. This manuscript contains no individual person’s data in any form.
: The authors declare that they have no competing interests.
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