Please select the eligibility criteria that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Brief Summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Options:
A: Inclusion Criteria:

* patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* psychiatric illness
* depression of generalised anxiety disorder
* suicidal risk
* substance abuse
* active cardiac disease
* pulmonary dysfunction
* liver disease
* renal impairment
* autoimmune disease
* chronic inflammatory rheumatoid disease
* current systemic infection
* epileptic
* active cancer
* sleep apnea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* for men : prostatic enlargement of genito-urinary disorders
* for women : pregnancy or breast feeding
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: A