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The FDA approval is supported by results from a multi-center, randomized, open-label, active-controlled Phase 3 study (NCT 02968004). In clinical trials with GENOTROPIN in pediatric patients aged three years and older who have growth failure due to complications from open heart surgery, abdominal surgery or multiple accidental traumas, or those patients with PWS, the following drug-related events were reported: edema, aggressiveness, arthralgia, benign intracranial hypertension, hair loss, headache, and myalgia. Growth hormone should not be used in children who were treated with GENOTROPIN.

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