Subjects taking nonsteroidal anti-inflammatory drugs (NSAID) or other analgesics may enroll in the trial, but will discontinue any analgesic therapy for the duration of the study, starting at the first screening visit. Subjects will be allowed to take rescue medication (up to six 325 mg tablets [total of 1950 mg] of acetaminophen per day; provided by the Sponsor) for residual low back or other body pain starting at the first screening visit during screening and treatment periods except during the 24 hours prior to the second Screening visit, Baseline (Day 1), Week 2, Week 5, Week 10, Week 15, Week 20, Week 30, Week 40, and Week 52 (EOS).