CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All 39 subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as not in remission in that study from that time-point onwards.

Time to disease progression is defined as the earliest of:

• time to an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
• time to use of rescue therapy, or,
• time to subject withdrawal from the study.

Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study C87047 (NCT00329550). As so few subjects experienced disease progression in this study it was not possible to calculate the median time to disease progression. Please see post-hoc outcome measure 80 where the number of subjects with disease progression is presented.

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at this time-point are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy have been set to missing in that study. [Week 8 is the start of Study C87047].

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). Subjects in the Full Analysis Set (FAS) with data at both time-points are included. Data collected after receipt of rescue therapy in a study have been set to missing in that study.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Responders at Week 6 of double-blind main study, C87037 (NCT00291668) could enter this open-label extension study, C87047 (NCT00329550). All subjects in the Full Analysis Set (FAS) were included in this summary. If a subject withdrew or received rescue therapy, they were counted as a non-responder in that study from that time-point onwards.

Disease progression is defined as:

• an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits,
• use of rescue therapy, or,
• subject withdrawal from the study.

Responders at Week 6 of Study C87037 (NCT00291668) could enter this extension study, C87047 (NCT00329550). As it was not possible to calculate the time to disease progression (outcome measure 22) due to the very small number of subjects meeting this definition, the post-hoc outcome of number of subjects with disease progression is presented here.