The CTEP CTCAE version 4.0 will be used to identify the type, and to grade the severity of adverse events in this trial. An adverse event will be considered a Serious Adverse Event (SAE) if that event led to death, resulted in a life-threatening illness or injury, resulted in permanent impairment of a body structure or body function, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in medical or surgical intervention to prevent permanent impairment to body structure or body function.