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Table 3 Secondary efficacy analyses during the treatment in PP populationa

From: Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial

Efficacy endpoint GS/ CS
(N = 209)
RP
(N = 223)
Difference between the treatmentsb CI (95%)
Absolute change in overall OA assessment by the patient (VAS), mm, mean (se)
Week 6 - 20.2 (1.9) - 18.8 (1.9) - 1.37 (2.2) (− 5.72; 3)
Week 12 - 24.4 (1.9) - 24.5 (1.9) 0.2 (2.2) (− 4.2; 4.5)
Week 24 - 35. 5 (1.9) - 32.6 (1.9) - 2.9 (2.3) (−7.3; 1.5)
Absolute change in overall OA assessment by the physician (VAS), mm, mean (se)
Week 6 - 20 (1.5) - 21.6 (1.4) 1.6 (1.7) (− 1.7; 5)
Week 12 - 27.1 (1.5) - 28.5 (1.5) 1.4 (1.7) (− 1.9; 4.8)
Week 24 - 37.6 (1.5) - 36.7 (1.5) - 0.9 (1.7) (− 4.3; 2.5)
Absolute change in SF-12 physical component, points, mean (se)
Week 24 5 (0.7) 5.7 (0.7) - 0.7 (0.7) (−2.1; 0.8)
Absolute change in SF-12 mental component, points, mean (se)
Week 24 2.7 (0.9) 1.12 (0.9) 1. 6 (0.9) (− 0.2; 3.4)
Treatment response rate by OMERACT-OARSI criteria, n (%)     
Week 6 130 (62.5) 137 (61.4) 1.1 (− 8.1; 10.2)
Week 12 143 (69.8) 155 (69.8) - 0.1 (− 8.8; 8.7)
Week 24 166 (83.4) 172 (80.4) 3 (− 4.4; 10.5)
Number of tablets of rescue medication administered per week, mean (se)
SV to RV 3.8 (4.8) 3.7 (4.7)   
RV to V2 1.4 (2.2) 1.3 (2)   
V2 to V3 0.9 (1.8) 0.9 (1.7)   
V3 to V4 0.8 (1.7) 0.8 (1.7)   
V4 to FV 0.7 (1.6) 0.8 (1.5)   
  1. aEstimates of the mixed model for repeated measures adjusted per baseline score and site. b Difference between the treatments evaluated by the mean (se) for VAS and SF-12 variables, and as percentage of responders to the treatment for OMERACT-OARSI criteria. CI (95%) two-sided confidence interval for change mean, with confidence coefficient of 95%, GS/ CS glucosamine sulfate/ chondroitin sulfate, OA osteoarthritis; se: standard estimate, OMERACT-OARSI Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International, PP per protocol, RP reference product, SF-12 Short Form 12 questionnaire, VAS visual analogue scale