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Avoralstat (n=71) was generally well tolerated with no signals for a safety concern; there were no serious adverse events or discontinuations due to adverse events (AEs), and compared to placebo (n=18), no notable difference in AEs. Four moderate-severity AEs were reported in 2 subjects; syncope after a single 250 mg dose (1 subject) and abdominal pain, back pain, and eczema after multiple doses of 800 mg avoralstat (1 subject).
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