 All AEs, regardless of seriousness, severity, or presumed relationship to study therapy, will be recorded using medical terminology in the source document and on the CRF. Whenever possible, diagnoses will be given when signs and symptoms are due to a common etiology e.g., cough, runny nose, sneezing, sore throat, and head congestion should be reported as upper respiratory infection. Investigators will record on the CRF their opinion concerning the relationship of the AE to study therapy. All measures required for AE management will be recorded in the source document and reported according to sponsor instructions. 