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A Therapeutic Use Exemption (TUE) was not applicable to this Non-Approved Substance

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Renal, Liver, and Heart Histology The same scoring system as in the previous studies [12,13,14,15,16,20,22,23,24] was used to grade renal (i.e., the degeneration of Bowmans space and glomeruli, degeneration of the proximal and distal tubules, vascular congestion, and interstitial edema), liver (i.e., vacuolization of hepatocytes and pyknotic hepatocyte nuclei, activation of Kupffer cells, and enlargement of sinusoids) and heart (i.e., dilatation and congestion of blood vessels within the myocardium and coronary arteries) histology

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