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Contamination during reconstitution Every time a needle pierces the rubber stopper, there is an opportunity for bacteria to enter the vial

This dose selection was informed by the Phase 2 observation that the 36 mg and 45 mg doses showed only modestly different efficacy but the 45 mg dose carried higher rates of gastrointestinal adverse events

Khera co-authored an editorial that was published Saturday alongside the study in the New England Journal of Medicine

There should be no floating particles, no cloudiness, and no discoloration

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