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Most common side effects (12mg dose, across TRIUMPH-4 and TRIUMPH-1): Nausea: 43% TRIUMPH-4 / ~38% TRIUMPH-1 (mostly during dose escalation) Diarrhea: 33% / ~28% (peaks weeks 48, improves by week 16) Dysesthesia: 20.9% (tingling sensations onset variable, long-term persistence unknown) Vomiting: 21% / ~25% (decreases after month 3) Constipation: 25% Discontinuation rates: 18.2% in TRIUMPH-4 (osteoarthritis population), 11.3% in TRIUMPH-1 (general obesity population)

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2017 Oct;130(4):825-829 (View) Montagnana M, Trenti T, Aloe R, Cervellin G, Lippi G

The FDA conducts a standard review process lasting approximately 10 months

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