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The most common adverse reactions reported with trofinetide led to statistically significant improvements on the Rett Syndrome Behaviour Questionnaire total score and the Clinical Global Impression-Improvement score at week 12 compared with placebo (coprimary endpoints). The product, which received FDA approval in March 2023, was approved based on data from the randomized, double-blind, placebo-controlled phase 3 LAVENDER study (ClinicalTrials. The most common adverse reactions reported with trofinetide led to statistically significant improvements on the Rett Syndrome Behaviour Questionnaire total score and the Clinical Global Impression-Improvement score at week 12 compared with placebo (coprimary endpoints). The dosage is determined by patient weight and can be administered orally or via gastrostomy tube.

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