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Table 2 Per protocol analysis of primary and secondary end points

From: Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial

Variable Pelubiprofen 30 mg (n =62) Celecoxib 200 mg (n =58) Difference
Mean (SD) 97.5% CI, one-sided
Patient’s pain VAS, 0–100 mm, mean (SD)     
  Week 0 69.1 (17.2) 64.0 (19.3)   
  Week 6 42.9 (21.4) 42.7 (24.2)   
  Difference (Week 0 – Week 6) 26.2 (19.5) 21.2 (20.8) 5.0 (20.1) −2.3, ∞
KHAQ, mean (SD)     
  Week 0 1.0 (0.7) 1.0 (0.7)   
  Week 6 0.8 (0.7) 0.8 (0.7)   
  Difference (Week 0 – Week 6) 0.2 (0.5) 0.2 (0.5) 0.0 (0.5) −0.2, ∞
Duration of morning stiffness, min, median     
  Week 0 30.0 30.0   
  Week 6 10.0 15.0   
  Difference (Week 0 – Week 6)* 0.0 0.0   
Frequency of rescue medication, times in last two weeks, mean (SD)     
  Week 0 2.8 (4.0) 2.2 (3.2)   
  Week 6 1.4 (2.9) 1.5 (3.4)   
  Difference (Week 0 – Week 6) 1.4 (3.7) 0.7 (3.4) 0.7 (3.5) −0.6, ∞
Total dose of rescue medication, tablets in last two weeks, mean (SD)     
  Week 0 3.0 (4.0) 2.2 (3.2)   
  Week 6 1.6 (3.1) 1.5 (3.6)   
  Difference (Week 0 – Week 6) 1.4 (3.6) 0.7 (3.5) 0.7 (3.6) −0.6, ∞
  1. SD, standard deviation; CI, confidence interval; VAS, visual analog scale; KHAQ, Korean health assessment questionnaire.
  2. *p =0.99 by Wilcoxon’s rank sum test.