Placebo

SPS/BIS

Number of patients

250

468

Baseline number of CSBMs/week

Mean (SE)

1.1 (0.08)

1.0 (0.06)

Mean of CSBMs/week over 4 weeks

Adjusted* mean (SE)

1.8 (0.18)

4.4 (0.13)

Comparison vs. Placebo

Adjusted* mean (SE)

95% Confidence Interval

p-value

2.5 (0.22)

(2.1, 3.0)

<0.0001