Conflict of interest
The authors declare that they have no conflict of interest.
Consent to participate
As per policy of Pisa University Hospital all the subjects signed to consent to participate in the research study.
Consent for publication
As per policy of Pisa University Hospital all the subjects signed to consent to participate in the research study and to consent publication of anonymized data.
Availability of data and material
Data are sensitive and will be shared with investigators on the basis of reasonable projects.
Ethics approval
The protocol of this study followed the principles of the Declaration of Helsinki and Title 45, US Code of Federal Regulations, Part 46, Protection of Human Subjects, Revised November 13, 2001, effective December 13, 2001, and was approved by the local Institutional Ethics Committee (Study protocol N. 140/2014, approved on March 13, 2014).