The study was completed largely due to the incredible efforts of the GPPA coordinators and Co-investigator. At present, the study is closed, no more patients are being enrolled, and as mentioned, all patients have either completed the study, withdrawn (early termination) or dropped out of the study due to lack of ability to follow up. The study currently retains its "blind" in that all of the raw data has been collected, all of the data remains in source documents (i.e. CRFs) but the data has not been entered into the secure electronic database, and subsequently, thus, no data analysis has occurred, interpretation provided or study conclusions drawn.