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:

* 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
C: Inclusion Criteria:

* patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria
* written, informed consent
* able to understand and comply with the requirements of the study

Exclusion Criteria:

* pregnancy or breastfeeding
* unwillingness to discontinue other prescribed medications before entering in the study
* patients who had previously received trazodone without improvement or who did not tolerate the drug
* patients who had previously received pregabalin without improvement or who did not tolerate the drug (only for the phase II of the study)
D: Inclusion criteria:

* Meet the American College of Rheumatology criteria for Fibromyalgia diagnosis;
* On no medication for Fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study

  * Willing to stop all FMS medication for the duration of the study or be on a stable dose of such medication for at least 3 months

Exclusion criteria:

* Other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver disorders and/or bleeding problems

  * Allergy to thiamin
* Unwilling to stop vitamin supplementation for the duration of the study

  * PLEASE NOTE: Travel to and accomodations at the study site can NOT be compensated. Anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense.

Answer: B