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The Phase 2 trial is the only controlled human efficacy study

This plan is available in these Wisconsin counties: La Crosse, Monroe, Pepin, and Trempealeau

Both were removed from the FDA's Category 2 interim compounding bulks list in September 2024 following nominators' withdrawal, and the FDA's Pharmacy Compounding Advisory Committee subsequently recommended against including them on the 503A Bulks list, leaving compounding in regulatory limbo as of early 2026

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