Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
Brief Summary: The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
* Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
* Have a pain intensity \>4 on Numerical Rating Scale

Exclusion Criteria:

* Life-long history of seizure disorder or epilepsy
* Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
* Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
* History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
* Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
B: 40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.
C: Inclusion Criteria:

* A clinical diagnosis of osteoarthritis of the hip or knee
* End-stage degenerative joint disease
* Eligibility for primary unilateral total or partial joint replacement surgery
* Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic medication

Exclusion Criteria:

* Has a life-long history of seizure disorder or epilepsy
* Had any of the following within the preceding 1 year: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
* Had a severe traumatic brain injury within 15 years of screening (consisting of one or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)
* Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other autoimmune disease
* History of alcohol or drug abuse
* chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months
* Severely impaired renal function or moderately to severely impaired hepatic function
* History of cancer within past 2 years
D: Inclusion Criteria:

* A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
* require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
* post-washout baseline pain intensity score \>4 on an 11-point numerical rating scale

Exclusion Criteria:

* History of seizure disorder or epilepsy
* uncontrolled hypertension
* currently treated with monoamine oxidase inhibitors
* systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
* history of malignancy within the past 2 years, with the exception of basal cell carcinoma

Answer: D