The primary objective of this study is to evaluate and compare the safety and efficacy of
Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.
Evaluation of the safety and tolerability of treatment with TSO in the target population
across the dose range being tested is considered a primary objective, while the primary
efficacy objective will be assessed via the change from baseline in the Aberrant Behavior
Checklist (ABC) subscale scores.
Dose response will be considered a primary objective as well.
Secondary assessments of efficacy will be assessed via:
• The change from baseline in the Clinical Global Impression scale (CGI-I)