Serious Adverse Event – is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria: 1) results in death; 2) is life-threatening (places the subject at immediate risk of death from the event as it occurs); 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect; or 6)any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.