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Seven-Year Orphan Drug Exclusivity (ODE) Drugs designated as orphan drugs by the FDAs Office of Orphan Products Development and approved for the orphan indication earn 7 years of exclusivity that blocks any same-drug approval for the same orphan indication

We simply do not know, and these are not trivial questions: good science is about minimizing the impact of stray variables and zeroing in on the specific question we are asking

Therefore, improvement of NOS dysfunction by BH 4 supplementation with sepiapterin probably involves both reversal of NOS uncoupling by replenishing BH 4 , and protection of the oxidase site by scavenging of peroxynitrite due to the antioxidant properties of BH 4

[Rutaceae], restores the AMPK/SIRT1/PPAR- axis, normalizing lipid turnover and reducing hepatic TG accumulation (Zhang et al., 2014)

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