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It is not intended to diagnose, treat, cure, or prevent any disease or medical condition, and must not be self-administered or applied to human subjects outside of a properly licensed, ethically approved, and institutionally supervised research environment

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The first tesamorelin human trials (Phase 1) began in the early 2000s, with Phase 3 trial dates spanning 2005-2008 (Study LIPO-010 Phase 3 completed 2008), leading to the November 2010 approval