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In pooled STEP 1-3 data on the 2.4 mg dose, nausea occurred in 43.9% (vs 16.1% placebo), diarrhea in 29.7% (vs 15.9%), vomiting in 24.5% (vs 6.3%), and constipation in 24.2% (vs 11.1%)

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If regulators maintain the current framework, others will argue that patients should have broader access to emerging therapies