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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
[DOI] [PubMed] [Google Scholar] Hood R.R., DeVoe D.L
[PubMed] [Google Scholar] 24.Serrat MA
Age Ageing 33 , 3441 (2004)
