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Population and endpoints A definitive trial would enroll patients with biopsy-confirmed MASH and clinically meaningful fibrosis typically stage F2F3, the range where progression risk and regulatory interest are highest and would be powered against the two histologic endpoints regulators recognize: resolution of steatohepatitis without worsening of fibrosis, and improvement in fibrosis by at least one stage without worsening of steatohepatitis

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In agreement, even small changes in FSD have been demonstrated to have profound effects on the ACR [ 57 ]