Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Brief Summary: This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD


Options:
A: Inclusion Criteria:

* Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
* Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

* Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
* Female subject is pregnant or lactating
B: Inclusion Criteria:

* Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
* whose primary care physician agrees that it is appropriate to participate in this study
* who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
* who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
* who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator

Exclusion Criteria:

* Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
* having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
* having a known hypersensitivity to methylphenidate
* having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
* if female, have begun menstruation
C: Inclusion Criteria:

* Patients with a clinical diagnosis of DSM-IV ADHD
* Patients were previously treated with Immediate-Released Methylphenidate (IR-MPH) taken once a day, twice a day, three times a day, or four times a day over three months and who were also on IR-MPH the last month without severe adverse events or possible contraindications with MPH
* Patients whose parent or guardian has signed and dated an informed consent to participate in the survey of drug compliance
* Patients who are still at school

Exclusion Criteria:

* ADHD patients who have systematic disease or clinically significant gastrointestinal problems, including narrowing (pathologic or iatrogenic) of the gastrointestinal tract
* ADHD patients also diagnosed with psychosis except for Conduct Disorder and Oppositional Defiant Disorder
D: Inclusion Criteria:

* Male or female from 6 to 12 years of age at the time of screening, inclusive.
* Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.
* A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.
* Subject must have been in need of pharmacological treatment for ADHD.
* Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.
* For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria:

* Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination Disorders, Sleep Disorders, and Adjustment Disorders.
* Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. In cases where this was not clear, study staff were permitted to administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the intelligence quotient (IQ). Significant cognitive impairment for this protocol was defined as an estimated IQ below 80.
* Subjects with chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), severe hypertension, thyroid disease, structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.
* Use of monoamine oxidase inhibitors within 30 days of the screening visit.
* Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of stimulant medication for control of ADHD at screening was permitted if inclusion criterion number 6 was met.

Answer: A