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10.3390/metabo10010034 56 GermainA.LevineS

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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 12–16 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