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With regard to the substantial clinical improvement criterion, the applicant asserted that TERLIVAZ represents a substantial clinical improvement over existing technologies because among HRS patients who failed previous therapy with available off-label treatments, TERLIVAZ has been shown to significantly improve renal function

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Because the administration of thrombolytic(s) would be expected to increase resource consumption, the small difference in average costs between these two sets of cases could also suggest that the administration of thrombolytic(s) was not consistently reported

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