1. Italian Medicines Agency-AIFA; Rome Italy
2. Cardiovascular and Cell Sciences Research Institute; St George's University; London UK
3. IRCCS San Raffaele; Rome Italy
4. Department of Innovative Clinical Trials; University Medical Centre Göttingen; Göttingen Germany
5. Fondazione Giovanni Lorenzini Medical Science Foundation; Milan, Italy and Houston USA
6. European Medicines Agency-EMA; London UK
7. Medicines and Healthcare Products Regulatory Agency-MHRA; London UK
8. St Thomas' Hospital; London UK
9. Department of Experimental Medicine and Surgery, School of Medicine and Surgery; University of Tor Vergata; Rome Italy