Adherence and Monitoirng Statement: The Data Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol approved by the IRB at both Emory University School of Medicine and Duke University School of Medicine. The Principal investigator (PI) will review all data collection forms at least annually for completeness and accuracy of the data as well as protocol compliance. The PI will review this protocol on a continuing basis for subject safety and include the results of the review in annual progress reports submitted to the IRB. Adverse events and serious adverse events will also be reviewed by the PI weekly.