NOTE: Maintenance steroid therapies of ≤ 20 mg/day prednisone, ≤ 4 mg/day dexamethasone, ≤ 80 mg/day hydrocortisone, or equivalent are allowed provided that the subject is on a stable dose for at least 2 weeks prior to first dose of study drug or the dose has not been adjusted upwards in the 2 weeks prior to first dose of study drug.