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The clinical package included randomized, placebo-controlled data anchored in improvement in annualized growth velocity over a one-year window, the type of surrogate endpoint that supports accelerated approval in this setting

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Batch proof How the proof path is structured

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Dosage may be repeated at weekly intervals if necessary

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In clinical trials, the most common adverse effects were gastrointestinal, including nausea, vomiting, diarrhea, and constipation

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