The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment.

The score ranges from 1 = very much improved to 7 = very much worse

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .

SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).

Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.

Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week.

The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient .

SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS).

Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints.

Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))

The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.

FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))