Adverse Events > 5% (Long-term Study: 12 Months)

Event

Headache 30%

Abdominal pain 17%

Upper respiratory 16%tract infection

Diarrhea 15%

Back pain 9%

Sinusitis 8%

Nausea 8%

Flatulence 8%

2

Total patients, N = 567 (4-12 mg/d)

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