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Nutrients 10(4):522

Several factors explain the lack of approval: insufficient clinical trials (no completed Phase 3 trials for most indications), safety concerns (FDA has identified specific adverse events), commercial considerations (patent status affects development investment), regulatory pathway (approval requires specific, rigorous documentation), and competition (Tesamorelin already approved for related indication)

However, when deprived of their usual microbiota either through a germ-free environment or antibiotics, mice become more susceptible to certain inflammation triggers, hinting at the multifaceted roles of these microorganisms [22]

10.1016/j.pharmthera.2018.03.004 30 DaiP.WangJ.LinL.ZhangY.WangZ

The bloodbrain barrier and epilepsy

While research indicates some potential for oral supplementation to raise blood levels, the effectiveness and clinical significance of these increases are still debatable