The study will be conducted over 24 weeks on active therapy followed by a four-week
observational visit. The total length of the study will be 28 weeks.
Study visits will occur at Screening, Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24 followed
by an observational visit. Additionally, all subjects will be contacted by phone 1 week
following the Baseline visit to ensure daily pain assessments are being recorded. If any
signs or symptoms are reported at the time of the call, an unscheduled study visit will be
conducted to assess whether an infection is present.
Adverse events will be collected throughout the study.