Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
Brief Summary: To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.


Options:
A: Inclusion Criteria:

* You must have been diagnosed with Diabetic Neuropathic Pain
* Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
* Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
* Patient must agree not to change dose of gabapentin between Visits 1 and 2
* You must have stable glycemic control

Exclusion Criteria:

* Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
* Current diagnosis or history of hemangiosarcoma
* Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
* Patients with uncontrolled narrow-angle glaucoma
* Presence of a current seizure disorder
B: Inclusion Criteria:

* Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
* Numerical Rating Scale leg pain score \> 4 (or if 3/10, greater or equal to back pain)
* MRI evidence of spinal pathology consistent with symptoms

Exclusion Criteria:

* Untreated coagulopathy
* Previous spine surgery
* No MRI study
* Leg pain \> 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.

Pregnancy
C: Inclusion Criteria:

* 18 years or older
* Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
* Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy.
* Currently on a stable dose of 1800 mg/day of gabapentin for ≥2 weeks with inadequate response OR
* Not currently treated with gabapentin, but previously treated with ≥1800 mg/day of gabapentin for 4 weeks or more with inadequate response.
* Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
* Provides written informed consent in accordance with all applicable regulatory requirements

Exclusion Criteria:

* Other chronic pain conditions not associated with PHN. However, the subject will not be excluded if:
* The pain is located at a different region of the body; and
* The pain intensity is not greater than the pain intensity of the PHN; and
* The subject can assess PHN pain independently of other pain
* Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
* Hepatic impairment defined as ALT or AST \> 2x upper limit of normal (ULN), or alkaline phosphatase or bilirubin \> 1.5x ULN
* Chronic hepatitis B or C
* Impaired renal function defined as creatinine clearance \<60 mL/min or requiring hemodialysis
* Corrected QT (QTc) interval ≥ 450 msec or QTc interval ≥480 msec for patients with Bundle Branch Block
* Uncontrolled hypertension at screen (sitting systolic \>160 mmHg and/or sitting diastolic \>90 mmHg)
* Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drugs
* Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
* Is considered to be clinically significant and may pose a safety concern, or,
* Could interfere with the accurate assessment of safety or efficacy, or,
* Could potentially affect a subject's safety or study outcome
* Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Meets criteria defined by the DSM-IV-TR for a major depressive episode or for active significant psychiatric disorders within last year
* Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication
* Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to enrollment
* History of clinically significant drug or alcohol abuse (DSM-IV-TR) or is unable to refrain from substance abuse throughout the study. Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted.
* Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device
* Has participated in a clinical study and was exposed to investigational or non-investigational drug or device:
* Within preceding month for studies unrelated to PHN, or
* Within preceding six months for studies related to PHN
* Treated previously with GEn
* History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds
D: Inclusion Criteria:

* Confirmed diagnosis of acute HZ
* Pain intensity \> 30 mm visual analog scale

Exclusion Criteria:

* Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
* Patients under age
* Uncompliance
* Pregnancy or lactation
* Surgery within the last 3 month
* Severe heart/lung/kidney disease
* Diseases influencing the quality of life
* Psychiatric diseases (e.g., depression, schizophrenia, dementia)
* Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
* Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
* Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)

Answer: A