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1 2 "The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study"

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The Core Issue Was Trust in the Quality System The Warning Letter highlights one message repeatedly: FDA no longer trusted the data generated by the facility

The film was hydrated for 1 h using phosphate buffer pH 7.4, and the dispersion was sonicated using a probe sonicator (PRO650, LABMAN, Chennai, Tamil Nadu, India) at a reduced temperature (using ice bath) to decrease the size of the nanovesicles