Adverse Events (? 1%) Leading to Discontinuation (Phase III)

%

Placebo 4 mg/d 4-12 mg/d 12 mg/d Events (n = 837) (n = 844) (n = 275) (n = 560)

Total 5.7 7.7 7.6 6.6

Abdominal pain 1.9 1.5 2.5 1.3

Diarrhea 0.4 1.7 1.5 1.6

Flatulence 0.7 1.1 1.1 0.4

Headache 0.8 0.7 2.2 0.4

Dizziness 1.0 1.3 0.4 0.2

2

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