The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12.The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study.

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from Baseline in the PROMIS score for sleep disturbance at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.

Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.

This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.