Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
Brief Summary: The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.


Options:
A: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia at least 1 year before screening
* experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
* agree to be hospitalized for a minimum of 14 days at the start of the study
* capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
* resided at the same address continuously for at least 30 days prior to screening
* able and willing to fill out self administered questionnaires
* washout of antiparkinsonian medications, beta-blockers
* antiepileptics, lithium 3 days prior to the start of the run-in phase

Exclusion Criteria:

* DSM-IV Axis I diagnosis other than schizophrenia
* DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
* preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
* injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
* previous history of lack of response to risperidone when acutely psychotic
* history of neuroleptic malignant syndrome
* significant risk of suicidal or violent behavior
B: Inclusion Criteria:

* Patients with schizophrenia for more than 1 year
* A total score in the Positive and Negative Syndrome Scale (PANSS) \< 120
* Signed informed consent
* Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
* Men must agree to use a double-barrier method of birth control
* Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
* A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
* Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
* A diagnosis of substance dependence within 6 months before screening
* History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
* Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
* Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
* Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
C: Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
* Current psychotic episode (schizophrenia exacerbation) \< 2 weeks duration at Visit 1
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* CGI-S score ≥ 4

Exclusion Criteria:

* Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
* Bipolar I and II disorder
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Women who are pregnant or breast feeding
D: Inclusion Criteria:

* Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
* have a PANSS score of \<120
* have a body mass index (BMI) \>/=15.0 kilogram (kg)/meter (m)2
* and have resided at the same address for at least 30 days

Exclusion Criteria:

* Patients unable to provide their own consent
* have been involuntarily committed to psychiatric hospitalization
* have primary, active DSM-IV-TM diagnosis other than schizophrenia
* who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
* have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
* have a history of neuroleptic malignant syndrome (NMS)
* are at significant risk of suicidal or violent behavior
* current presence of any significant or unstable medication condition
* treatment with any protocol disallowed therapies
* clinically significant result from screening laboratory or ECG.

Answer: B