- Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC) [ Time Frame: Week 15 or study discontinuation ] [ Designated as safety issue: No ]
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.
- Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint [ Time Frame: Week 15 or study discontinuation ] [ Designated as safety issue: No ]
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.
- Change From Baseline in Sleep Quality Score at Endpoint [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
- Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint [ Time Frame: Baseline, Week 15 or study discontinuation ] [ Designated as safety issue: No ]
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
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