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The FDA evaluates nominated substances using a balancing test that considers physical and chemical characterization, safety issues, available evidence of effectiveness or lack of effectiveness, and historical use in compounding

10.3390/ijms232213886 269 WangY.WangM.FanK.LiT.YanT.WuB.et al (2018b)

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Faverzani JL, Hammerschmidt TG, Mescka CP, Guerreiro G, Lopes FF, Delgado CA, de Moura Coelho D, Sitta A, Deon M, Wajner M, Vargas CR (2023) Increased cytokine levels induced by high phenylalanine concentrations in late diagnosis PKU patients compared to early diagnosis: anti-inflammatory effect of L-carnitine