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The clinical studies showing efficacy used concentrations in the range that produces measurable results without irritation

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Animal Toxicology Studies Animal toxicology studies tested doses from 0.0027 mg/lb to 9.1 mg/lb via intraperitoneal, intramuscular, intravenous, and oral routes for up to 6 weeks, finding: No acute toxic or lethal dose No gross or histologic toxicity in major organs No hepatotoxicity or nephrotoxicity Negative Ames test (no mutagenicity) Negative chromosomal aberration tests (no genotoxicity) No teratogenicity in rat pregnancy studies No local injection site irritation The LD1 (minimum lethal dose) could not be achieved despite aggressive testing

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