Please select the eligibility criteria that correspond to the clinical trial below.
Title: A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Brief Summary: Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.


Options:
A: Inclusion Criteria:

* Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

* Patients with other pain conditions cannot participate.
B: Inclusion Criteria:

1. 18 years of age or above
2. Have a diagnosis of Diabetes mellitus for at least a year
3. Agree not to smoke whilst resident in the CRC
4. Able to understand the patient information sheet and provide written informed consent
5. Score above 12 on the LANSS
6. Have neuropathic pain of diabetic origin
7. Score above 25 on MMSE
8. Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used.

Exclusion Criteria:

1. There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid)
2. There is evidence of a recent ischaemic event
3. There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
4. Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
5. Currently receiving treatment for malignancy
6. Suffer from seizures including epilepsy
7. There is evidence of a history of dependence on or abuse of alcohol/recreational drugs
8. Need to use a wheel chair (incompatible with studies in a sleep laboratory)
9. Involved in a clinical trial in last 3 months
10. Pregnant, lactating or inadequate contraception
11. Vision inadequate for the performance tests (as assessed at screening)
12. Colour Blind
13. Will not co-operate with study procedures
14. Will not give permission to inform GP
C: Inclusion Criteria:

* Patient has moderate to severe nerve pain due to one of the following conditions: Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy
* Patient is able to complete questionnaires in either English or Spanish
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient is either pregnant or breastfeeding
* Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)
* Patient has a history of congestive heart failure
* Patient has a seizure disorder
* Patient has a history of drug and/or alcohol abuse within the past 1 year
* Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain
* Patient has had cancer (except basal cell carcinoma) within the past two years
* Patient anticipates the need for surgery while participating in the study
* Patient has a reported history of hepatitis B, C, or HIV infection
* Patient has another type of pain that is more painful than the nerve pain
* Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder
* Patient is involved in litigation or receives worker's compensation related to nerve pain
D: Inclusion Criteria:

* Diagnosis of Type 1 or 2 diabetes mellitus.
* Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.

Exclusion Criteria:

* Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
* Presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain.

Answer: A