Table 3: Number of Flare Events Per Time of Exposure to Study Medicationa

BMI <30 kg/m2 BMI ≥30 kg/m2
Continuous Use Celecoxib 200 mg qd Intermittent Use Celecoxib 200 mg qd p Value Continuous Use Celecoxib 200 mg qd Intermittent Use Celecoxib 200 mg qd p Value
ITT population, n 209 205 222 222
 No. of flare events per month, mean (SD) 0.55 (0.78) 0.88 (0.86) <0.0001 0.54 (0.69) 0.97 (1.13) <0.0001
 Median 0.38 0.63 0.36 0.71
 Range 0.00-7.50 0.00-4.29 0.00-4.29 0.00-9.40
FmITT population, n 146 121 153 151
 No. of flare events per month, mean (SD) 0.51 (0.88) 0.91 (1.01) 0.0008 0.47 (0.74) 0.98 (1.32) <0.0001
 Median 0.20 0.57 0.19 0.55
 Range 0.00-7.50 0.00-4.29 0.00-4.29 0.00-9.40

a Time of exposure is the time in months from the first dose of double-blind study medication at the beginning of Period III to the last dose of study medication. Patients may have more than one flare.
ITT, intent-to-treat; FmITT: flare-modified ITT.