Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sapropterin as a Treatment for Autistic Disorder: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial
Brief Summary: This study is intended to provide a definitive test of the hypothesis that elevating sapropterin (tetrahydrobiopterin, a cofactor for several key brain enzymes)concentrations in the CNS will result in measurable improvements in core symptoms of autism in young individuals, under age 6 years. The study will entail a double-blind, placebo-controlled 16-week intervention.


Options:
A: Inclusion Criteria

* Autism based on DSM-IV criteria
* IQ \> 35
* Medically fit for the study in the judgment of the study officials

Exclusion Criteria

* Prior administration of secretin
* Acute or chronic pancreatitis
* Use of anticholinergics within 72 hours of study entry or anticipated need for anticholinergics during study
* Allergies to pork products
* Use of investigational drug within 1 month of study entry
* Change in any medication or other therapeutic modality being used to treat any neurodevelopmental or gastrointestinal symptoms of the underlying autism disorder within 1 month of study entry
* Any medical condition which, in the judgment of the investigator, would make the patient unable to safely participate in the study or comply with all study procedures
* Any medical diagnosis which could account for autistic spectrum disorder (i.e., Rett syndrome, Fragile X, tuberous sclerosis, disintegrative disorder, epilepsy, Landau Kleffner, other mental retardation syndromes, or history of severe motor delays or current sensory or motor impairment such as cerebral palsy)
* Hearing or visual impairments
* Use of psychotropic medications (except for occasional symptomatic use for sleep, etc.) within 6 months of study entry
B: Inclusion Criteria:

* Parents sign informed consent
* Child meets criteria for autistic disorder (based on score on the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS), given by a certified administrator, research reliable)
* Child has a Developmental Quotient (DQ) ≥ 50 (Vineland Adaptive Scales, Interview Edition)
* Parents agree to delay initiation of other treatments during double-blind trial

Exclusion Criteria:

* Child has had seizures in past 6 months or a change in seizure medications in past 4 weeks.
* Child has \> 18 points on subscale of (Autism Behavior Checklist) ABC-I
* Child is taking any psychoactive medication other than supplements, anticonvulsants, or soporifics (melatonin, diphenhydramine)
* Child has had any change in standing medications in the past 4 weeks.
* Child has known genetic disorders
* Child has known severe neurological disorders, including cerebral palsy
C: Inclusion Criteria:

* Male and Female
* 18 to 55 years old
* Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
* Have a high, normal or near normal Intelligent Quotient
* Speak and Understand English fluently

Exclusion Criteria:

* Born prior to 35 weeks gestational age
* Any primary psychiatric diagnosis other than autism at the time of screening
* Medical history of neurological disease
* Medical history of known MRI/structural lesion of the brain
* Patients who are pregnant
* With a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well being
* With evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
* Taking psychoactive medications
* Who plan to initiate or change nonpharmacologic interventions during the study course
* Who are unable to tolerate venipuncture procedures for blood sampling
D: Inclusion Criteria:

* Participants meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD and Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD-10) criteria for Autism diagnosis
* SRS-2 (T-score) greater than or equal to (\>/=) 66
* CGI-S \>/=4 (moderately ill)
* Participants have an Intelligence Quotient (IQ) \>/=70 (Wechsler Abbreviated State of Intelligence)
* A body mass index (BMI) between 18 to 40 kilograms per square meter (kg/m\^2) inclusive
* Language, hearing and vision compatible with the study measurements as judged by the investigator
* Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior.

Exclusion Criteria:

* Alcohol and/or substance abuse/dependence during the last 12 months
* A significant risk for suicidal behavior, in the opinion of the investigator
* Systolic blood pressure greater than (\>) 140 or less than (\<) 90 millimeters of mercury (mm Hg), and diastolic blood pressure \>90 or less than (\<) 50 mm Hg
* Resting pulse rate \>90 or \<40 beats per minute
* Use of prohibited medications or herbal remedies within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
* Initiation of a new major change in psychological intervention within 4 weeks prior to randomization. Minor changes in ongoing treatment are not considered significant
* Participation in an investigational drug or device study within 60 days prior to randomization

Answer: B