The actual clinical trial which has been completed is the first investigator initiated trial for the principal investigator and the co-investigators. After IRB approval was obtained IRB #1107-2005, the study enrolled its first patient in March of 2006 and the last patient in December of 2008. The study was also registered with www.clinical trials.gov on October 11, 2005. A Data Safety and Monitoring Board (DSMB) was chartered and formed and met a total of 2 times with one final meeting to be arranged. An external study monitor performed monitoring visits during the first year of the study in order to assure proper protocol compliance, regulatory compliance and study procedure conductance.