Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


Options:
A: 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
B: Inclusion Criteria:

* Participants will be 18 to 70 years of age
* Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male.
* Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
* History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis)
* Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months.
* English speaking

Exclusion Criteria:

* Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study.
* TENS use in the last 5 years
* Pacemaker
* Uncontrolled blood pressure or diabetes
* Neuropathic pain condition
* Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
* Spinal fusion - cervical or lumbar
* Metal implants in cervical or lumbar region
* Severe skin allergy to adhesive
* Allergy to nickel
* Pain level less than 4
* Pregnancy
* Epilepsy
* Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan
* Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results
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:

* Patients must meet the 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 must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Answer: C