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Table 2 Statistical analysis on the mean change from baseline in WOMAC-Pain scores through scheduled visits

From: TLC599 in patients with osteoarthritis of the knee: a phase IIa, randomized, placebo-controlled, dose-finding study

Interval

Treatment

Number

LS mean (SE)

90% CI

Difference vs placebo

LS mean (SE)

90% CI

p-value

D3 - W12

Placebo (N = 25)

25

− 0.47 (0.092)

(− 0.619, − 0.313)

   

TLC599 12 mg (N = 26)

26

− 0.83 (0.090)

(− 0.984, − 0.685)

− 0.37 (0.129)

(− 0.583, − 0.154)

0.0027

TLC599 18 mg (N = 24)

24

− 0.64 (0.094)

(− 0.794, − 0.481)

− 0.17 (0.131)

(− 0.390, 0.047)

0.0971

D3 - W16

Placebo (N =2 5)

25

− 0.48 (0.091)

(− 0.633, − 0.332)

   

TLC599 12 mg (N = 26)

26

− 0.85 (0.088)

(− 0.999, − 0.705)

− 0.37 (0.127)

(− 0.580, − 0.158)

0.0024

TLC599 18 mg (N = 24)

24

− 0.62 (0.093)

(− 0.772, − 0.463)

− 0.13 (0.129)

(− 0.350, 0.080)

0.1498

D3 - W20

Placebo (N = 25)

25

− 0.49 (0.091)

(− 0.647, − 0.343)

   

TLC599 12 mg (N = 26)

26

− 0.85 (0.089)

(− 1.000, − 0.704)

− 0.36 (0.127)

(− 0.570, − 0.145)

0.0033

TLC599 18 mg (N = 24)

24

− 0.63 (0.093)

(− 0.782, − 0.472)

− 0.13 (0.130)

(− 0.349, 0.084)

0.1558

D3 - W24

Placebo (N = 25)

25

− 0.51 (0.092)

(− 0.666, − 0.361)

   

TLC599 12 mg (N = 26)

26

− 0.87 (0.089)

(− 1.014, − 0.718)

− 0.35 (0.128)

(− 0.565, − 0.139)

0.0037

TLC599 18 mg (N = 24)

24

− 0.62 (0.093)

(− 0.780, − 0.469)

− 0.11 (0.130)

(− 0.328, 0.106)

0.1985

  1. LS means, CIs, and p-values were obtained from an MMRM model including factors of treatment, visit, and baseline value as fixed factors, center as a random factor, and treatment by visit as interaction terms. CI confidence interval, D day, LS least squares, mITT modified intent to treat, MMRM mixed effect model repeat measurement, SE standard error, W week