Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week, Open-Label, Multicenter Study of the Safety and Tolerability of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder
Brief Summary: This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).


Options:
A: Inclusion Criteria:

* Males and females between the ages of 5 and 17 years 2 months.
* Weight of 15 kg or greater.
* DSM-IV diagnosis of Autistic Disorder.
* Inpatient or outpatient.
* Medication free for at least 2 weeks for all psychotropic medications (4 weeks for fluoxetine or depot neuroleptics).
* Anticonvulsants used for treatment of seizure disorder permitted if the dosage has been stable for 4 weeks and patient seizure free for at least 6 months.
* Clinical Global Impression Severity score of at least 4 and a)18 or greater on the Irritability Scale of the Aberrant Behavior Checklist or b) .5 total score on the Ritvo-Freeman scale.
* Mental age of at least 18 months.
* Negative pregnancy test

Exclusion Criteria:

* IQ below 18 months.
* Females with a positive pregnancy test. - Evidence of a prior adequate trial with risperidone.
* Evidence of hypersensitivity to risperidone.
* Past history of neuroleptic malignant syndrome.
* DSM-IV diagnosis of Pervasive Developmental Disorder other than Autistic Disorder.
* Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or unstable seizure disorder.
* Weight less than 15 kg.
B: Inclusion Criteria - Rollover:

* Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]
* No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole

Inclusion Criteria - De Novo:

* Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and demonstrates serious behavioral problems - diagnosis confirmed by Autism Diagnostic Interview-Revised (ADI-R) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication
* Mental age of at least 18 months
* Male or female 6 to 17 years of age, inclusive, at the time of enrollment

Exclusion Criteria:

* Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
* Patients previously treated and not responding to aripiprazole treatment
* The patient is currently diagnosed with another disorder on the autism spectrum, including pervasive developmental disorder-not otherwise specified (PDD-NOS), Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
* A seizure in the past year
* History of severe head trauma or stroke
* Non-pharmacologic therapy (e.g. psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
C: Inclusion Criteria:

* Weight of at least 15 kg (33.75 lbs)
* Meets DSM-IV criteria for autistic disorder
* Outpatient
* Medication-free for at least 2 weeks prior to baseline for all psychotropic medications. More information about this criterion, including exceptions, can be found in the protocol.
* Clinical Global Impression Scale Severity score (CGI-S) of at least 4
* Irritability subscale of the Aberrant Behavior Checklist (ABC) score of at least 18
* An IQ of at least 35 or a mental age of at least 18 months
* In good physical health

Exclusion Criteria:

* Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, any other pervasive developmental disorder (PDD), schizophrenia, psychotic disorder, or bipolar disorder
* Current or past history of alcohol or other substance abuse within 6 months of study entry
* Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis)
* A significant medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
* Pregnant
* Prior adequate use of aripiprazole. More information about this criterion can be found in the protocol.
* Evidence of hypersensitivity to aripiprazole
* History of neuroleptic malignant syndrome
D: Inclusion criteria:

* Age: 18-60
* Gender: All
* Language: Communicative in English
* Participants with a prior diagnosis of DSM-5 ASD at some point in their lifetime OR a DSM-4 diagnosis of Autism OR a DSM-4 diagnosis of Asperger's syndrome OR a DSM-4 diagnosis of Pervasive Developmental Disorder Not Otherwise Specified.
* Symptoms of irritability, agitation or aggression as reported by parent and/or participant
* Aberrant behavior checklist - Irritability Subscale (ABC-I) score of 16 or higher
* No changes in psychotropic medications within the past 14 days.
* Either lives with a primary caregiver or closely engaged with a primary caregiver who interacts with the patient daily
* BMI \> 17.5 and \< 45

Exclusion criteria:

* Age \< 18 or \> 60
* BMI \< 17.5 or \> 45
* Currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes)
* Changes in psychotropic medication management within the past 14 days
* Previous allergy to transdermal patches
* Patients with heart rate \> 100 or \< 50 or known history of cardiac rhythm abnormalities
* Systolic blood pressure \> 150 or \< 95; diastolic blood pressure \> 90 or \< 50
* No symptoms of irritability, agitation, or aggression as reported by parent and/or participant
* ABC-I score of less than 16
* No primary caregiver, or primary caregiver unable to assist with rating scales

Answer: B