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Per the applicant, the Axoguard HA+ Nerve Protector TM meets the requirements at 419.66(b)(3)

Teichert J, Preiss R, McCormick DB: [17] High-performance liquid chromatography methods for determination of lipoic and dihydrolipoic acid in human plasma

This creates a well-documented vicious cycle: stress increases histamine release, histamine amplifies nervous system reactivity (histamine H3 receptors modulate neurotransmitter release, and elevated brain histamine disrupts sleep, worsens anxiety, and heightens stress perception), which in turn drives more stress and further mast cell activation

[DOI] [PMC free article] [PubMed] [Google Scholar] 150.Cui Y., Yang Y., Ni Z., Dong Y., Cai G., Foncelle A., Ma S., Sang K., Tang S., Li Y., et al