<qa>  What is a serious and unexpected AE?Serious Adverse Events. An SAE is any untoward medical occurrence that at any dose: is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disabilityincapacity. Important medical events may be considered serious when, based on appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. If a serious and unexpected AE occurs for which there is evidence suggesting a causal relationship between the drug and the event the event must be reported as a serious and unexpected suspected adverse reaction. SAE will be reported to the local IRB and the FDA within 5 calendar days. 