 Day 1 will be defined as administration of the first dose of study drug. Clinic Visits will be conducted during Screening Days -30 to -1 and at Baseline Day 0, and Week 2, and Week 6, and Months 3, 6, and 12 2 weeks of the scheduled date for post-Baseline visits. Monthly telephone contacts 1 week of the scheduled date will be made during months in which no investigative site visits are scheduled Months 4, 5, 7, 8, 9, 10, and 11 for assessment of adverse events and concomitant medications. A final telephone contact to assess adverse events and concomitant medication usage will be made 30 days after the last dose of study drug. 