Table 1.
Demographic and clinical characteristics of patients enrolled in the open-label extension
| Parameter | Value (Number = 560) |
|---|---|
| Age, years |
|
| Mean (SD) |
46.9 (10.8) |
| ≥ 65 years, number (%) |
23 (4.1) |
| Sex, number (%) |
|
| Male |
50 (8.9) |
| Female |
510 (91.1) |
| Race, number (%) |
|
| White |
512 (91.4) |
| Black |
34 (6.1) |
| Asian |
6 (1.1) |
| Other |
8 (1.4) |
| BMI, kg/m2 |
|
| Mean (SD) |
28.4 (4.6) |
| Range |
16.4–41.5 |
| Years since first FM symptoms |
|
| Mean (SD) |
9.9 (8.7) |
| Double-blind baseline values, mean (SD) |
|
| Pain VAS |
72.0 (13.3) |
| Fatigue VAS |
73.1 (14.8) |
| FIQ total score | 62.4 (14.1) |
BMI, body mass index; FIQ, Fibromyalgia Impact Questionnaire; FM, fibromyalgia syndrome; SD, standard deviation; VAS, visual analog scale.