Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Withdrawal Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary 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:

* Diagnosis of primary fibromyalgia
* 13-17 years of age
* To be eligible for screening, have average pain rating in the previous week of at least 3 but no more than 9 on an 11-point numeric rating scale
* To be eligible to enter into the open-label treatment period, have a 1-week mean of daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in the week before Baseline (Visit 2)
* To be eligible for randomization and entry into the double-blind treatment period, have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily pain ratings, in the week before Baseline (Visit 2)
* Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

Exclusion Criteria:

* Severe psychiatric illness
* Severe renal impairment
* Evidence of active liver disease
* Pregnant or breastfeeding
* Significant risk of suicidality
* Unable, unwilling or inadvisable to discontinue prohibited medications
* History of alcohol abuse or drug abuse or dependence, within previous year
* Current systemic infection
* Autoimmune disease
* History of seizure disorder (other than febrile seizures)
C: Inclusion Criteria:

* Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
* 18 through 68 years of age

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
* Patients who do not indicate their pain levels as less than substantial despite their best care
* History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
* Presence of current depression as determined by psychiatric diagnostic interview
* Presence of brain lesion on MRI anatomical study
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