 Each PI will be responsible for ensuring the integrity of the data from their site. Prior to the data being stored in the main database a sign-off will be required by each site PI. In addition, the Study Coordinator and Study PI will be responsible for checking all data for quality issues and reliability on a regular basis. The main database will be monitored for accuracy and quality of data by the Principal Investigator at the St. Marks Hospital site in Salt Lake City, Utah. All investigators will be kept current on anyall adverse event reports and interim analyses. 