Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
Brief Summary: The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.


Options:
A: Inclusion Criteria:

1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
2. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR) Japanese version and have both of the following conditions which are persistent for more than or equal to 4 weeks before the start of observation period:

   * Sleep latency of more than or equal to 30 minutes for more than or equal to 3 days a week
   * Total sleep time of less than or equal to 390 minutes for more than or equal to 3 days a week
3. Participants who meet both of the following based on polysomnogram (PSG) in observation period:

   * Objective sleep latency of more than or equal to 20 minutes for 2 consecutive PSG days
   * Objective total sleep time of less than or equal to 420 minutes for 2 consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days

Exclusion Criteria:

1. Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia.
2. Participants with insomnia caused by pharmacological actions (drug-induced insomnia).
3. Participants with comorbid sleep disorder associated with other disease(s) such as psychiatric and/or physical disease(s).
4. Participants with a complication of psychiatric disorders in Axis I or personality disorder in Axis II defined in DSM-IV-TR Japanese version.
5. Participants with organic mental disorder.
B: Inclusion Criteria:

* • Diagnosis of insomnia based on DSM-IV criteria for insomnia due to a general medical condition (low-back pain);

  * The insomnia must not predate the onset of low-back pain by more than 1 month;
  * Usual nightly TST (Total Sleep Time) \< 6.5 hours and/or usual SOL (Sleep Onset Latency) \> 30 minutes for the last month prior to screening;
  * ISI (Insomnia Severity Index) \> 14 (at least moderate insomnia);
  * Age 21-64 years;
  * Greater than 40 on VAS (Visual Analog Scale) for pain (scale is 0-no pain to 100-worst imaginable pain);
  * Patient Global Impression of Pain of at least 3 (on a 1-5 scale, indicating at least moderate severity);
  * reported Back pain must be greater than reported leg pain, and there must be no signs of spinal nerve root compression;
  * presence of normal motor strength on exam;
  * duration of chronic low back pain of greater than three months;
  * low back pain location must be inferior to T12 and superior to the gluteal fold.

Exclusion Criteria:

* • Significant medical or neurological illness in excess of that which is directly responsible for the chronic low back pain;

  * the presence of an active and significant psychiatric disease with a substantive impact on sleep;
  * meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
  * current pregnancy; history of hypersensitivity, intolerance, or contraindication to Naproxen/Lansoprazole or Eszopiclone;
  * baseline creatinine of 2.0 or greater; patient taking other medications having significant renal effects (e.g. lithium, ACE inhibitor, angiotensin receptor antagonist, or thiazide/loop diuretics);
  * patients taking other anticoagulants; patients having an allergy to aspirin; history of diagnosed gastric or duodenal ulcer;
  * history of bleeding or clotting diathesis; lifetime history of myocardial infarction or cerebrovascular accident;
  * Elevated PT/PTT/INR (Prothrombin Time, Partial Thromboplastin Time, International Normalized Ratio)at screening;
  * Abnormal kidney function detected in screening labs;
  * history of back related surgery within the past 3 months; history of corticosteroid use in the past 30 days;
  * presence of currently pending litigation or worker's compensation claim related to the chronic low back pain;
  * inability to follow study procedures or complete the study; or the use of any medications that could affect sleep within 5 half-lives of screening;
  * history of back surgery within the past 2 years with the exception of a discectomy;
  * pregnant or lactating females;
  * women of child-bearing potential who will not agree to use approved means of birth control during the trial;
  * history of any surgery within the past one month; history of any major physical trauma within the last 6 months;
  * history of corticosteroid use within the last 90 days; diagnosis of rheumatoid or psoriatic arthritis;
  * history of fibromyalgia;
  * presence of spondyloarthropathy;
  * presence of sciatica;
  * spinal stenosis;
  * presence of any vertebral fractures, spondylolisthesis; or radicular back pain.
C: Inclusion Criteria

* Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
* Subject must be 25-64 years of age (inclusive) on the day of signing consent.
* Subject must be diagnosed with rheumatoid arthritis as defined by the American College of Rheumatology.
* Subject must be on stable regimen for treatment of rheumatoid arthritis for a minimum of 90 days prior to study start.
* Subject must report a wake time after sleep onset (WASO) of greater than or equal to 45 minutes and less than or equal to 6.5 hours of total sleep time at least three times a week over the previous month and symptoms of insomnia must post date onset of rheumatoid arthritis.
* Subject physical exam must show no clinically significant abnormal findings (other than those related to rheumatoid arthritis) at screening.
* Subject must have no clinically significant abnormal laboratory findings at screening (other than those related to rheumatoid arthritis).
* Subject must have no clinically significant ECG abnormalities at screening.

Exclusion Criteria

* Subject has diagnosis of fibromyalgia, or juvenile rheumatoid arthritis.
* Subject has history of circadian rhythm disorder, or travels across \>3 time zones on a regular basis.
* Female subject is pregnant, lactating or within 6-months post partum.
* Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening.
* Subject has clinically significant unstable medical abnormality or unstable chronic disease (other than insomnia and rheumatoid arthritis) including severe cardiac, renal, or hepatic or respiratory disease, seizure disorder.
* Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in any investigational drug study during participation in this study.
* Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
* Subject has a current primary psychiatric diagnosis of any of the following disorders: dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymic disorder; major depressive disorder, bipolar disorders; cyclothymic disorder, other mood disorders, primary anxiety disorders, primary panic disorders, or any nocturnal panic disorder.
* Subject has any of the following Personality Disorders diagnoses: schizotypal, schizoid, borderline personality disorder; or any other personality disorder that would compromise the investigator's ability to evaluate the safety and efficacy of the study medication.
* Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis \[e.g. sleep apnea\]; diagnosed and untreated restless leg syndrome (RLS) or periodic leg movement syndrome (PLMS).
* Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
* Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
* Subject is a rotating or third/night shift worker.
* Subject is a staff member or relative of a staff member.
D: Inclusion Criteria:

* Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance

Exclusion Criteria:

* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
* Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
* Serious medical illness or instability
* Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
* Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
* Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
* Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake

Answer: A