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Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the test

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Additionally, 35% of subjects in the Tesamorelin group achieved a hepatic fat fraction below 5%, compared to only 4% in the control group

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Which single data gap (PK, dose-ranging efficacy, or long term safety) would most change your stance if answered convincingly