Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).


Options:
A: Inclusion Criteria:

* Present with knee pain due to osteoarthritis (OA) based on OA clinical and radiographic diagnostic criteria.
* Knee Pain for \> 14 days of each month for the 3 months directly preceding study entry.
* Taking nonsteroidal anti-inflammatory drugs (NSAIDs) for knee pain due to OA on most days in the 3 months immediately preceding study entry.

Exclusion Criteria:

* History of intolerance or nonresponsiveness to an adequate trial of duloxetine used for any indication, in the opinion of the investigator.
* Previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
* Have major depressive disorder (MDD) as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
* Judged clinically by the investigator to be at suicidal risk by examination or using the Columbia Suicide Severity Rating Scale (C-SSRS).
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
* Positive urine drug screen for any substance of abuse or excluded medication.
* Opioid dependent in the opinion of the investigator, taking opioids more than 3 days a week, or unwilling to discontinue opioids during the study period.
* Known hypersensitivity to duloxetine or its inactive ingredients.
* History of intolerance or hypersensitivity to NSAIDS, Cyclooxygenase (COX-2) inhibitors, or proton pump inhibitors.
* History of peptic ulcer disease, bleeding disorder, gastrointestinal bleeding, or any abnormal bleeding.
* Baseline hemoglobin measurement of \<11 grams per deciliter (g/dL) for males, or \<10 g/dL for females.
* Serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or any other medical or psychiatric condition that would compromise participation or be likely to lead to hospitalization or a change in medication during the course of the study.
* Uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, uncontrolled or poorly controlled hypertension, or history of seizures.
* Active liver injury (such as hepatitis) or any degree of hepatic insufficiency (Child-Pugh Class C).
* Frequent falls that could result in hospitalization or could compromise response to treatment.
* Confounding painful condition that may interfere with assessment of the index knee.
* Chronic widespread pain affecting all four quadrants of the body, or diagnosis of fibromyalgia.
* Received intra-articular hyaluronate (Synvisc), steroids, joint lavage, or other invasive therapies to the knee in the past 6 months.
* Arthroscopy of the index knee within the past year or joint replacement of the index knee at anytime.
* Diagnosis of inflammatory arthritis (that is, rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, etc.) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
* Prior synovial fluid analysis showing a white blood cell count greater than or equal to 2000 cubic millimeters (mm\^3) that is indicative of a diagnosis other than OA, or have a history of gout or pseudogout.
* Radiographic evidence of end-stage (bone on bone) OA in either knee.
* Knee replacement surgery planned within the next 6 months.
* Nonambulatory or requiring the use of crutches, a walker, or more than 1 cane.
* Body mass index (BMI) \>40.
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:

* Age 18 to 65 years.
* Specific diagnosis of FM by the participant's rheumatologist or physician, including written confirmation, from a physician, of the FM diagnosis.
* Confirmation of the FM diagnosis by American College of Rheumatology Criteria and a physical tender point examination.
* Ability to give informed consent.
* If female, nonpregnant/nonlactating.
* If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation) during the trial.

Exclusion Criteria:

* Bipolar disorders, any psychotic disorder.
* the existence of concomitant rheumatological disorders, including rheumatoid arthritis, systemic lupus erythematosus, Hashimoto's disease, Sjogren's syndrome or scleroderma.
* Substance dependence (except nicotine dependence) in the previous 3 months.
* Currently suicidal or high suicide risk.
* Serious or unstable medical disorders.
* Any psychotropic drug treatment in the previous 2 weeks before screening.
* A positive urine pregnancy test.
* Screening laboratory values three times the limits of normal or judged clinically significant by the investigator.
* History of hypersensitivity to milnacipran.
* Seizure disorder, traumatic brain injury, any CNS disorder that affects cognitive status.
* Concomitant meds: A minimum of 30 days on stable dose of analgesics and a minimum of 4 week washout from antidepressants and fibromyalgia specific medication ( e.g. pregabalin, neurontin) and supplements ( St John's wort, SAM-E).
* Narrow angle glaucoma.
D: Inclusion Criteria:

* Diabetes type 1 or 2
* Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months

Exclusion Criteria:

* Major Depression
* Uncontrolled diabetes

Answer: B