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Safety Study-Open Label Mania Safety Data In the two long-term (six month) safety studies in pediatric patients (n= 292) between the ages of 10 and 17 years old, no clinically meaningful differences in the adverse reaction profile were observed when compared to adults

By electron microscopy, sinusoidal endothelial cells and hepatocytes in the portal (zone 1) and midzonal (zone 2) areas were normal, as were hepatocytes in the central regions (zone 3)

Likewise, GO analysis demonstrated enrichment of extracellular matrix remodeling and fibrotic pathways, consistent with disease progression (Supplemental Figure 8)

Additionally, chronic estradiol application promotes the expression of interleukin (IL)1, IL-6, IL-12p40, and Inducible nitric oxide synthase (iNOS) in macrophages following lipopolysaccharide (LPS) stimulation, further enhancing immune responses [105]