This will involve the collection of an additional tube of blood (one approximately 10 mL sample) for DNA isolation will be obtained at Visit 1. If, however, the blood sample is not collected during Visit 1, it may be collected at any time (after randomization) during the subject's participation in the study. The collection of the sample will occur after the blood is drawn for safety testing and should not add to much additional (about 5 minutes )time to the study visit. Subjects can still participate in the main study, if they choose not to participate in this optional study.