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This double-blind placebo-controlled study was performed between May 2011 and October 2016 at Nova Southeastern University (Fort Lauderdale, FL, USA) at three locations: The Mailman Segal Center (informed consent and behavioral assessments: visits 1, 3, 4, 5, 6, and 7), Nova Southeastern University Clinic (pediatric visits 2 and 8, including blood sampling), and the blood samples were quantified at the College of Pharmacy