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Excluded or Cautioned Populations in Phase 3 Trials Phase 3 REDEFINE/REIMAGINE protocols typically excluded participants with: Type 1 diabetes

Expired folic acid supplements may not deliver enough folate to the parent and the developing fetus

Chronic sleep loss is associated with reduced intracellular glutathione levels and increased lipid peroxidation, shifting cells toward an oxidized redox state and increasing vascular and metabolic vulnerability (22)

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Riboflavin also plays a role in thyroxine metabolism, and its deficiency may contribute to mental illness, because riboflavin activates vitamin B6, leading to lower thyroxine levels, reduced hypothalamic serotonin synthesis, and decreased levels of S-adenosylmethionine (SAMe), because of disrupting the folate-methylation pathways involved in SAMe synthesis, all of which are associated with antidepressant effects, consequently, low levels of these compounds may cause depression ( Figure 4 ) (48, 49)