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Australia puts the ethics committee at the centre by default, and reserves regulator-led assessment for its CTA scheme when product risk demands it

In a 36-week phase II RCT, patients receiving 80 mg resmetirom per day had significantly reduced hepatic lipid accumulation, but transient mild diarrhea and nausea were also more common [208]

Bossy M

An increased liver weight of 110% at one year was not associated with liver tumorigenesis, whereas liver tumorigenicity was seen if the one-year liver weight was 150% of control values (Carmichael et al