Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD).
Brief Summary: This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.


Options:
A: Inclusion Criteria:

-

Patients must have:

Rigorously diagnosed Attention Deficit Hyperactivity Disorder (ADHD).
B: Inclusion Criteria:

* Must sign informed consent.
* Male or female 6-12 years old.
* Negative pregnancy test.
* Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
* No co-morbid illness that could affect safety, tolerability or interfere with participation.
* Blood pressure (BP) within the 95th percentile for age, gender, and height.
* Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).
* At risk for suicidal or violent behavior towards self or others.
* History of a suicide attempt.
* History of a structural cardiac abnormality or other serious cardiac problems.
* Non-responder to psychostimulant treatment.
* Is overweight.
* Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
* Has Conduct Disorder.
* Known history of alcohol or other substance abuse within the last 6 months.
* Any abnormal thyroid function.
* A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
* Has had treatment with any known liver altering agents within 30 days prior to Screening.
* Taking any excluded medication.
* Previous use of DAYTRANA.
* Taking other medications that have Central Nervous System (CNS) effects.
* Female subject is pregnant or lactating.
* Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
* Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
* Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
* A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
C: Inclusion Criteria:

* 6-17 years old
* diagnosis of ADHD according to ICD-10 or DSM-IV criteria
* new initiation onto an approved medication to treat ADHD

Exclusion Criteria:

* no specific exclusion criteria
D: Inclusion Criteria:

* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

* Subjects who are known to not respond to methylphenidate
* Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
* Have marked anxiety, tension or agitation
* Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder

Answer: B