Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trichuris Suis Ova in Autism Spectrum Disorders
Brief Summary: The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder


Options:
A: Inclusion Criteria (most important):

* ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified \[PDD NOS\])
* Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)
* At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
* Intelligence quotient (IQ) score \> 60

Exclusion Criteria (most important):

* weight under 20 kg
* Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder, PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia, another psychotic disorder, substance abuse;Have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; Patients who have taken (or are currently taking) anticonvulsants for seizure control.
* patients at serious suicidal risk.
* Contraindication to the use of atomoxetine
* Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.
B: Inclusion Criteria:

* Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
* SRS-2, proxy version, total t-score \>=66 at screening
* A full scale IQ score \>=70 on the WASI®-II
* Subject has an appropriate study partner, in the opinion of the investigator
* For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of \<1% per year during the treatment period and for at least 28 days after the last dose of study drug
* Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit

Exclusion Criteria:

* Pregnancy or breastfeeding, or intention to become pregnant during the study
* Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
* Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
* Substance use disorders during the last 12 months
* Significant risk for suicidal behavior, in the opinion of the investigator
* Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
* Clinical diagnosis of peripheral neuropathy
* Within the last 2 years, unstable or clinically significant cardiovascular disease
* Uncontrolled hypertension
* Unexplained syncopal episode within the last 12 months
* Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
* Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
* History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Confirmed clinically significant abnormality in parameters of hematology
* Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
* Medical history of malignancy, if not considered cured
C: Inclusion Criteria:

* medically healthy outpatients between 6 and 12 years of age (cut off: 12 years and 11 months)
* Intelligence Quotient (IQ) equal to or greater than 50 (Stanford-Binet)
* Social Responsiveness Scale (SRS) Total Score equal to or greater than 70
* ability to complete laboratory and cognitive testing
* diagnosis of Autism Spectrum Disorder (ASD) based on expert clinical opinion and confirmed on the Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS)
* Clinical Global Impression (CGI) severity rating of 4 or higher
* care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interact with the participant on a regular basis
* stable medications for at least 4 weeks
* no planned changes in psychosocial interventions during the trial
* no concurrent participation in any other clinical research trials
* willingness to provide blood samples and electrocardiogram

Exclusion Criteria:

* diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder
* regular nasal obstruction or nosebleeds
* active and unstable medical problems (e.g., migraine; asthma; seizure disorder; anaphylaxis; epilepsy; diabetes; serious liver, renal, or cardiac pathology)
* clinically significant abnormal vital signs or ECG reading
* evidence of a genetic mutation know to cause ASD (e.g., Fragile X Syndrome) or metabolic disorder
* significant hearing or vision impairments
* drinks large volumes of water (e.g., habitual or psychogenic polydipsia)
* pregnant or sexually active females not using a reliable method of contraception (urine pregnancy test will be conducted)
* history of hypersensitivity to vasopressin, its analogs (e.g., Desmopressin), or compounding preservatives (e.g., chlorobutanol)
* current use of any medications known to interact with vasopressin including: 1) carbamazepine (i.e., Tegretol); chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants (all of which may potentiate the antidiuretic effect of vasopressin when used concurrently); 2) demeclocycline; norepinephrine; lithium; heparin; alcohol (all of which may decrease the antidiuretic effect of vasopressin when used concurrently); 3) ganglionic blocking agents including benzohexonium, chlorisondamine, pentamine (all of which may produce a marked increase in sensitivity to the pressor effects of vasopressin)
* prior or current use of vasopressin
* abnormal chemistry result
D: Inclusion Criteria:

1. Age 18-35, inclusive, at the time of consent
2. Outpatient
3. Meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM-IV-TR, and supported by the ADOS or ADI-R.
4. Have an IQ of 70 or greater
5. Participants who are taking other medications prior to enrollment must be on a stable dose of concomitant medication, including psychotropic, anticonvulsant, or sleep aid for at least 3 months prior to baseline ratings
6. Be judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subjects and guardians)
7. Have a personal or family history of allergies.

Exclusion Criteria:

1. History of Bipolar disorder or Psychotic Disorders (e.g. schizophrenia or schizoaffective disorders).
2. Previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
3. Uncontrolled seizure disorders (seizures within the past 6 months)
4. Pregnant or breast feeding at screening, or at any time during the study
5. Chronic medical illness that would interfere with or contraindicate participation in the study, or clinically significant abnormalities in baseline laboratory testing or physical exam.
6. Treatment in the last 12 weeks with cyclosporine, methotrexate, infliximab or immunomodulatory agents
7. Treatment in the last 2 weeks with antibiotics, antifungal or antiparasitic medications
8. Presence of any organic or systemic disease or need for a therapeutic intervention, which would confound the interpretation of results.
9. History of previous treatment with Trichuris Suis Ova (TSO).

Answer: D