Efficacy Variables at Endpoint

B351 B301 B307

Efficacy variable 4 mg/d 12 mg/d 4 mg/d 12 mg/d 4 mg/d 4-12 mg/d

SGA efficacy variables

SGA of relief + < .01 < .05 < .05 + +

Original SGA of relief < .05 + < .05 + - -

SGA of abdominal + + + < .05 - - discomfort/pain

SGA of bowel habits + + + + + -

Daily diary variables

Days with significant:

Abdominal pain + < .05 + + + +

Abdominal bloating + < .01 + + - -

Number of:

Bowel movements < .01 < .001 < .001 < .01 < .05 < .001

Days without BMs + < .01 < .05 < .05 + < .05

% days with hard stools + < .01 + + + +

12

+ = Positive direction for tegaserod, P > .05 versus placebo.

- = Negative direction for tegaserod, P > .05 versus placebo.

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