 This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a posttreatment follow-up period 12 weeks following the Mo 6 visit. Study visits will occur at Screening, Day 1, Week 2 only for subjects participating in the pharmacokinetic subset, Mo 1, 2, 3, Mo 6Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit. 