D-Ribose for Fatigue in Subjects With Fibromyalgia

Major Inclusion Criteria:

- must have a diagnosis of primary fibromyalgia, as defined by the 1990 American
College of Rheumatology (ACR) Criteria for the Classification of Fibromyalgia made at
least 6 weeks prior to the Pretreatment Screening Visit;

- must have a score of ≥5 on the Subject's Assessment of Fatigue 11-point numerical
rating scale (NRS) at the Pretreatment Screening and Baseline Visits;

- if taking acetaminophen or other non-opioid analgesics, NSAIDs, fibromyalgia
medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose
of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to
the baseline visit;

- must have discontinued any ribose-containing products (including foods, drinks, and
supplements) at least 4 weeks prior to the Pretreatment Baseline Visit.

Major Exclusion Criteria:

- current major depressive episode (MDE);

- has been diagnosed with any autoimmune disease;

- has been diagnosed with type I or type II diabetes;

- has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell
carcinoma or cervical carcinoma in situ, that has not been in remission for at least
five years prior to the Pretreatment Screening Visit;

- has been diagnosed with chronic fatigue syndrome.