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Importantly, treatment with marmelosin at both doses demonstrated a significant attenuation of these pathological changes, encompassing a reduction in interstitial inflammation, amelioration of pancreatic follicle cell swelling and necrosis, and a notable improvement in the organization of islet architecture (Figure 10AD)

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The agency's recommendations on bulk drug substances do not exist in isolation, nor do they answer every question about how these products fit within the broader requirements of the FD&C Act