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FDA's briefing package concluded the evidence did not support inclusion across every criterion it weighed

the abdominal incision was closed with 30 silk sutures

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Large, randomized, placebo-controlled trials have been conducted in both men and women across multiple countries, and the consistent finding is that minoxidil slows or stops hair loss and produces visible regrowth in a large proportion of users

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

These occurred without causing harm to other organs [4,10]