Follow-up Phase Patients will return between Days 13 to 20 for follow-up. The follow-up procedures will include a physical examination, body weight, vital signs, clinical laboratory safety tests (hematology, serum chemistry and urinalysis) (5cc), urine pregnancy test (females of childbearing potential only) and the recording of adverse events and concomitant medications. Once this visit is complete the patient will have completed the study. This visit should take about one hour to complete.