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Inflammation, repair signaling, angiogenesis, immune modulation, and remodeling occur at the same time

15 Interestingly, the majority of ASD-related gene mutations (such as MEF2C, FMR1, PTEN, TSC1, TSC2 mutations) result in enhanced gene transcription and mRNA translation, ultimately leading to an aberrant increase in the strength or number of synapses within certain neural networks

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Key gaps include: No large-scale randomised controlled trials in humans the evidence basis for clinical use is extrapolated from animal data and small pilot studies No long-term safety data effects beyond 1216 weeks are not well characterised Variable results in human sleep trials some early human studies showed modest or inconsistent effects on sleep architecture compared to animal data, suggesting the translation may not be linear No FDA approval DSIP is not approved for any therapeutic use in the United States Stability concerns DSIP degrades relatively quickly in circulation