All adverse events and incidents of noncompliance with the protocol will be reported to the institutional review board (IRB). A serious adverse event is defined as an untoward medical occurrence that results in death, is life-threatening, requires hospitalization, results in persistent or significant disability, or requires intervention to prevent permanent disability or death. Other untoward medical occurrences that do not meet the above criteria will be classified as adverse events. Study personnel who are administering the research protocol in the CRC will monitor for adverse events, with the assistance of the CRC nursing staff. All suspected or confirmed adverse events will promptly be reported to the principal investigator (PI), who will collect data on these occurrences. The principal investigator will report serious adverse events to the IRB, NIH, and any other applicable authority, within 10 days of the PI's knowledge of the occurrence. Non-serious adverse events and incidents of noncompliance with the protocol will be reported at the time of annual continuing review.