Any serious adverse events will be reported to the Ethics Committee of the FAMERP within 24 hours of the occurrence. All serious adverse events will also be reported to Novartis Drug Safety & Epidemiology (DS&E) within 24 hours of the investigator (or designee) being aware of the serious adverse event. Specific definitions of adverse events, and serious adverse events, are outlined below, along with reporting criteria required by Novartis.