Received: 22 October 2017
Accepted: 10 December 2018
First Online: 20 December 2018
Ethics approval and consent to participate
: The study protocol was approved by the Ethical Committees in all participant centres, in particular: Ethical Committee of “San Gerardo” Hospital, Monza, Ethical Committee of “Villa Marelli” Clinic, Milan, Ethical Committee of “Luigi Sacco” Hospital, Milan, Ethical Committee of “Spedali Civili” Hospital, Brescia, Ethical Committee of “San Martino” Hospital, Genova, Ethical Committee of “Policlinico Gemelli”, Rome the Ethical Committee of “Fallacara” Hospital, Bari.The study was conducted according to Good Clinical Practice principles in agreement to the Declaration of Helsinki. All patients signed an informed consent before enrolment.The study protocol was registered under the US National Institute of Health ClinicalTrials.gov register, reference number: NCT01390987. Study start date: June 2011.
: Not applicable.
: The authors declare that they have no competing interests.
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