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However, such a relationship may be difficult to establish, as studies may have to account for variations in dosage amounts, formats, combination product use, and for the possibility of product recalls given the recent reported manufacturing issues surrounding acetaminophen

Clinical trial data from the NEJM Phase 2 study showed that gastrointestinal events were predominantly mild to moderate, occurred primarily during dose escalation, and were partially mitigated by starting at 2mg rather than 4mg

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