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12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA,(methylphenidate transdermal system)

clinical trials. Those children not optimized on DAYTRANA from the previous trials entered a four- week stepwise DAYTRANA dose-optimization phase. All children then entered an 11-month DAYTRANA dose maintenance phase. DAYTRANA was applied each morning to the hip area and worn for approximately nine hours daily. During the dose- optimization phase, titration to a higher dose was permitted after a minimum of three days. Tapering to a lower dose was permitted throughout the dose optimization period and dose adjustments were also permitted during the dose maintenance period.

All of the children in this open-label, flexible-dose trial participated in one of four trials in which the children previously received DAYTRANA, OROS methylphenidate or a placebo. All of the children previously used DAYTRANA for at least a minimum of three days and a maximum of 37 months. While this study evaluated the safety and effectiveness of DAYTRANA for up to 12 months, DAYTRANA has not been studied versus placebo for longer than 7 weeks. Physicians, who prescribe DAYTRANA for long-term use, should periodically re- evaluate patients to assess the usefulness of DAYTRANA for the individual patient.

Children were diagnosed with ADHD using DSM-IV-TR(R) criteria. Researchers assessed safety and tolerability, through physical exams, skin evaluations, laboratory tests, and monitoring of vital signs, including ECGs throughout the study.

The ADHD-RS-IV assesses 18 individual symptoms of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(R)), a publication of the American Psychiatric Association.

Of the 327 children enrolled, 157 completed the study. Investigators used data from the intent-to-treat population (324 children) for the efficacy evaluations. Of the safety population (326 children) 7 percent withdrew due to skin irritation at the patch application site, and 9 percent withdrew due to adverse even
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