A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia

Inclusion Criteria

• •approved for study participation by the Fibromyalgia Eligibility Review Committee
• •body mass index of 18.5 to 45 kilograms (kg)/square meter (m\^2) and a body weight ≥45 kg
• •agree to use only acetaminophen as rescue medication for FM-related pain (up to 1000 mg per dose and not to exceed 3000 mg/day for any indication throughout the study period)
• •non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) are unchanged for a minimum of 30 days prior to screening and will remain unchanged throughout the study
• •agree to maintain a usual and unchanged physical exercise regimen
• •must be of nonchildbearing potential or, defined as:
• •* women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or
• •* bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menstrual period) and
• •* menopausal women confirmed by a follicle-stimulating hormone \>35 units (U)/liter (L)
• •* men surgically sterile by documented vasectomy OR
• •If of childbearing potential, patients must meet any of the following criteria:
• •must use highly effective contraception method with their partners during the entire study period and for 5 months after the last dose of the study drug.
• •sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
• •female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
• •* must agree not to participate in another interventional study from the screening period through the end of study (EOS) visit o Additional criteria apply, please contact the investigator for more information