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All class III medical devices must go through the Premarket Approval (PMA) process, which takes at least 180 days for FDA approval

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Care should be taken to avoid accidental self-injection: may cause irritation at site of injection

Early responders who lost at least 15 percent of their body weight by week 24 went on to achieve an incredible 27.7 percent mean weight loss by week 72 (Source: STEP UP Trial, Dicker et al., ECO Abstract 2026)

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Gallstones are more common in women, people who are overweight, over 40 years of age, during pregnancy, after sudden weight loss or in people who consume a high-fat, high-sugar, low-fiber diet