- At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread
pain for at least 3 months, and pain in at least 11 of 18 specific tender point
- At screening and randomization, patients must have a score of >/=40mm on the Visual
Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).
- Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or
self-evaluation of the pain associated with fibromyalgia.
- Patients with severe hepatic impairment.