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The studies tested various doses including 0.25 mg, 0.5 mg, and 1 mg daily via subcutaneous administration over periods ranging from single doses to 24 weeks of continuous therapy

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The FDA has cited concerns over the lack of large-scale, randomized, placebo-controlled human trials demonstrating its safety and efficacy

The 10 mg lyophilized format allows precise reconstitution and accurate dosing

An enema involves injecting fluid into the rectum

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