A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601

Exclusion Criteria

• •significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
• •unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
• •history of chronic non-compliance with drug regimens
• •females currently breastfeeding
• •AST or ALT levels greater than 3 times the upper limit of normal at screen
• •Inability to withhold grapefruit or grapefruit products during the study