Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia in Patients Receiving Long-term Milnacipran Treatment
Brief Summary: The purpose of this study is to evaluate the durability of effect of milnacipran for the treatment of fibromyalgia in patients receiving long-term milnacipran treatment and to characterize the effects of milnacipran on multiple symptoms of fibromyalgia, as demonstrated by changes in symptoms following the discontinuation of milnacipran.


Options:
A: Inclusion Criteria:

1. Must be between the ages of 18 to 65 years of age
2. Must have been diagnosed with fibromyalgia by a rheumatologist
3. Must have an overall body pain average score ≥ 4
4. Must be on stable doses of your current medication for at least past four weeks
5. Must report all medication including herbal supplements and over-the-counter medications that you are currently taking to a member of the research team.
6. Must limit any changes in your medication(s)during the 21-week study time period unless medically necessary
7. Must be willing to maintain a medication diary provided to you during the 21-week study period
8. Must be willing to abstain (not take) any fibromyalgia related medication (including over-the-counter)for at least 6-hours prior to each of the three testing visits. (Otherwise, you may take these medication immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
9. Must experience the symptoms of fibromyalgia syndrome (FMS) that decreases (limits) your ability to perform daily activities.

Exclusions Criteria:

1. You have uncontrolled hypertension(high blood pressure) systolic \>160 mm Hg or diastolic blood pressure \> 100 mm Hg)
2. If you have a history of: heart disease, glaucoma, or hepatitis
3. You have been diagnosed with any type of peripheral neuropathy
4. You have a body mass index (BMI) of more than 34
5. You currently or frequently have thoughts of harming yourself or committing suicide.
6. You are in the process of filing, or plan to file for disability benefits within the study timeline.
7. You plan to undergo an elective surgery within the study timeline.
8. You have been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue diseases)
9. You are currently pregnant, are planning to become pregnant, or are breastfeeding
10. You have been diagnosed with schizophrenia or manic-depressive.
11. You are currently taking any of the following medications:

    1. fluoxetine, Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem
    2. sertraline, Brand Name: Zoloft
    3. paroxetine, Brand Names: Paxil, Paxil CR, Pexeva
    4. citalopram, Brand Name: Celexa
    5. escitalopram, Brand Names: Lexapro
    6. venlafaxine, Brand Names: Effexor, Effexor XR
    7. mirtazapine, Brand Names: Remeron, Remeron SolTab
    8. duloxetine, Brand Name: Cymbalta NOTE: If you are taking any of the medication(s) listed above and are willing to discontinue its use for the duration of this study, you must first discuss your decision with your primary care physician (or prescribing doctor)regarding the appropriate regimen to wean off your current medication and receive his/her written consent before proceeding with enrollment. We will provide you a "Dear Doctor" letter that explains the study details.
12. If you are currently taking or have ever taken Savella® (milnacipran)
13. You are currently participating in other pain research study or have previously been enrolled in any study or class in which cognitive behavioral therapy or educational formats were used to help control pain or stress related to fibromyalgia
14. You are unwilling or unable to comply with the study guidelines

Note: If you have ever experienced an adverse event while taking any type of antidepressant, please alert the research team, while it may not exclude you from participating in the study, it is important that we are aware of the incident in order to keep you safe.
B: Inclusion Criteria:

* Currently participating in Study MLN-MD-06
* Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)

Exclusion Criteria:

* Significant risk of suicide
* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
* Myocardial infarction and/or stroke within the prior 12 months
* Mean systolic blood pressure \> 180 mm Hg or mean diastolic blood pressure \> 110 mm Hg at Screening (Visit 1)
* Active liver disease
* Severe renal impairment
* Platelet and bleeding disorders
* Female patients who are pregnant or breastfeeding
C: Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression
D: Inclusion Criteria:

* patient who completed the 3-month F02207 GE 302 study
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

* known hypersensitivity to milnacipran
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding

Answer: B