2.1. Standard Protocol Approvals, Registrations
ICH
The clinical study was approved by the Bioethical Committee of the IRCCS San Matteo hospital, Pavia (protocol number: 15012020), and was conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments, with all ICH and ISO international standards (i.e., ICH Harmonized Guideline for GCP E6 (R2); UNI EN ISO 14155:2012 [The study was registered with 