A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Inclusion Criteria:

• Japanese (both sexes)

• Outpatient

• Patients who are considered capable of understanding the study procedures andcompleting the pain diary and questionnaires appropriately by the investigator (sub-investigator)

• Patients who meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion Criteria:

• Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease

• Patients with pain other than FM that may affect assessments in this study

• Patients with a past history of or concurrent neurologic diseases that may affectassessments in this study

• Patients with a past history of or concurrent malignant tumor within 3 years

• Patients who are pregnant, nursing, or possibly pregnant, or intending to becomepregnant during the study period.