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GRAS is not drug approval
Raresome report mild GI discomfort or acneiform eruptions
Injectable water is usually called sterile water for injection or bacteriostatic water for injection, depending on whether or not a preservative is included
What they found: Favorable safety profile , no serious adverse events at doses up to 100 g/kg Preliminary efficacy signals positive The program stopped before Phase 3 for unknown commercial reasons (the program passed through several sponsor rotations and no one ultimately carried it through) Why it matters: These are the only published clinical data in humans that we have
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