An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome

Exclusion Criteria

• •Has been treated with insulin within 12 weeks of Baseline
• •Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
• •Has a history of, or current, cerebrovascular disease or brain trauma
• •Has significant, uncorrected visual or uncorrected hearing impairment
• •Has a history of, or current, malignancy
• •Has any of the following:
• •1. QTcF interval of \>450 ms at Screening or Baseline
• •2. History of a risk factor for torsades de pointes (e.g., heart failure or family history of long QT syndrome)
• •3. History of clinically significant QT prolongation that is deemed to put the subject at increased risk of clinically significant QT prolongation
• •4. Other clinically significant finding on ECG at Screening or Baseline