Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, 13-Week, Adaptive-Design Study of 4 Fixed Oral Doses of DVS SR in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.


Options:
A: Inclusion Criteria:

* Age 24 years or older
* Primary diagnosis of rheumatoid arthritis from a board-certified rheumatologist
* Willing to maintain stable doses of concurrent non-steroidal anti-inflammatory drugs or other acceptable medications or therapies for the duration of the study
* Brief Pain Inventory Average Pain \>= 4 at the screening visit
* Widespread Pain Index \>= 5 at the screening visit
* Able to give informed consent

Exclusion Criteria:

* Diagnosis of primary fibromyalgia
* Diagnosis of cold sensitive conditions such as Raynaud's syndrome, cryoglobulinemia and paroxysmal cold hemoglobinuria
* Diagnosis of psychotic disorders, such as schizophrenia, schizoaffective disorder, delusional disorder and shared psychotic disorder
* Patients being treated with SSRIs, MAO inhibitors or tricyclic, tetracyclic or atypical antidepressants for pain may participate in this study if they are washed off these medications before study entry. Patients currently receiving therapy with SSRIs or tricyclic, tetracyclic or atypical antidepressants for depression may be washed off these medications before study entry pending permission of the prescribing physician and if they have never received a diagnosis of major depressive disorder or had a history of suicidal ideation.
* Patients on thioridazine or MAO inhibitors
* Patients taking codeine or other opioids/opiates. Patients who are taking medications such as pregabalin (Lyrica) and gabapentin (Neurontin) for pain may be enrolled in this study.
* Known hypersensitivity to milnacipran
* Patients with a significant risk of suicide as assessed by the Beck depression inventory form
* Patients with a history of suicide
* Pregnant or breast-feeding women
* Patients with an actively pending worker's compensation claim or auto no-fault claim; patients with current worker's compensation, auto no-fault compensation, or litigation; or any patient with significant secondary gain issues per discretion of the researchers.
* Patients with myocardial infarction within the past 12 months, active cardiac disease (chest pain or evidence of ischemia on stress test), acute congestive heart failure requiring hospitalization in the past 12 months, clinically significant cardiac rhythm or conduction abnormalities requiring hospitalization in the past 12 months
* Patients with severe liver impairment (AST or ALT \> 3 times the upper limit of normal)

  * For patients 2-3 times the upper limit of normal, we will obtain enrollment permission from the patient's hepatologist and monitor values at each study visit. If values increase above 3 times the upper limit of normal, the patient will be discontinued from the study.
  * For patients 1-2 times the upper limit of normal, we will obtain enrollment permission from the patient's physician and monitor per request of the physician.
* Patients with severe or end stage renal disease, defined as a GFR \< 15 ml/min or on dialysis
* Patients with a recent (≤ 12 months) history of seizures.
* Patients with uncontrolled narrow-angle glaucoma.
* Patients who have been treated with an experimental agent within the last three months.
B: 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
C: Inclusion Criteria:

* Age: 45-80 years
* ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
* VAS pain score \>5/10 within 48 hrs of the phone screen and visit 1 (Screening)
* Knee OA for a minimum of 12 months
* Need for daily pain medication to manage symptoms of OA

Exclusion Criteria:

Currently taking MAO inhibitors or any centrally acting drug for analgesia, depression

* Narrow angle glaucoma
* Uncontrolled hypertension
* Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state.
* If a female, pregnant, trying to become pregnant, or lactating
* Major depressive disorder
* Substantial alcohol use or history of significant liver disease
* Use of MAO inhibitors, triptans, serotonin precursors (tryptophan)
* Use of potent CYP1A2 inhibitors, Thioridazine, and anti-depressants
* Diabetes, type 1 or type 2
* Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
* MRI safety necessitates the exclusion of subjects having one or more of the following:

  * Metal fragments in the eye or face, or having worked previously in the metal industry
  * Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac, defibrillators, and cochlear implants or nerve stimulators.
  * Surgery on the blood vessels of the brain
  * Claustrophobia (fear of enclosed places)
  * Piercings or tattoos
  * More than 250 lbs in weight
  * Obvious brain abnormalities
D: Inclusion Criteria:

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* psychiatric illness,
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease

Answer: B