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They pointed out in their manuscript that although the joint modulation of surface chemistry and PS-80 density, is a useful tool to adjust BBB penetration, functional or behavior evaluations, for instance, cell death, neuroinflammation, or larger animal models, are lacking in the study

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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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