Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


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:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications
C: 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
D: 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.

Answer: C