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Re: Investor2014 post# 417871

Tuesday, 06/06/2023 1:46:02 PM

Tuesday, June 06, 2023 1:46:02 PM

Post# of 517128
In communication with the FDA, the Company received the Agency’s input on the study endpoints, which were utilized in this clinical study. The Rett Syndrome Behavior Questionnaire (RBSQ) total score and Clinical Global Impression Improvement Scale (CGI-I) score are co-primary endpoints in the statistical analysis plan with specified linear mixed-effects models for repeated measures (MMRM) as the primary analysis methods.

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