Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.

Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

FAS: all randomized participants who had either withdrawn as treatment failure or completed at least (>=)1 week of dosing and had >=1 valid CDAI score during active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside visit window. 'n'=participants evaluable at given time point for each group.

Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.

Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

FAS: all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.

Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.

Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.

FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.

Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

FAS population: included all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase.