Institutional Review Board Statement
ICH
The study was carried out in accordance with the Declaration of Helsinki (1964) guidelines and its amendments and the general principles of ICH Harmonised Tripartite Guidelines for Good Clinical Practice (ICH Topic E6, CPMP/ICH/135/95). At the beginning of the study, written informed consent, reviewed by the ethics committee, was obtained from each subject, according to ICH-GCP, the ethical principles that have their origin in the Declaration of Helsinki, and the regulatory and legal requirements in Italy. The study (NCT01948661) was approved by the local Ethical Committee (Comitato Etico Regione Liguria), Genoa, Italy.