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Over time, a patient (under the guidance of their practitioner) may gradually increase their dose up to a maximum of 2.4mg, depending on each persons individual response to the medication

The proposed 2- to 7-day invitation window was selected to promote timely contact with patients following the clinical encounter and to minimize recall bias by focusing responses on the recent episode of care

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For the purpose of FDA subpart H approval, at 18 months, a histopathologic interim analysis will be performed on the first 750 enrolled patients with fibrosis stage 2-3, to assess for fibrosis improvement 1 point without NASH worsening, or NASH resolution without worsening of fibrosis