Ethics approval and consent to participate
Study AB09004 was conducted according to the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and national regulations. An independent data monitoring committee periodically reviewed blinded patient safety and efficacy data. The trial protocol was approved by the appropriate Independent Ethics Committee/Institutional Review Board of all participating sites (including the ethics committee of General Hospital of Thessaloniki ‘George Papanikolaou’) and all subjects provided informed consent.