All AEs will be recorded by the Investigator from the time the subject signs informed consent to at least 30 days after the last dose of CT or until the last study visit, whichever period is longer. Adverse Events and serious adverse events (SAEs) will be recorded on the AE page of the CRF and in the subject's source documents. All SAEs must be reported to PIs within 24 hours of the Investigator's knowledge of the event by facsimile, or other appropriate method, using the SAE Report Form, or approved equivalent form. All SAEs will be also reported to Novartis safety desk within 15 days of learning.