Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.

Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.

The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).

The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.

Participants who received NSAIDs at Week 8 were reported.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.

A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.

Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:

ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:

ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:

ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:

ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:

ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:

ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.

Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.

Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.

Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.

BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = 'improved'/'very important' and 'improved'/'moderately important' 2 = 'improved'/'slightly important', 'improved'/'not at all important', 'no change' and 'worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober's test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.

The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.