Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score < (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Alternate endoscopic remission is defined as SES-CD Total Score ≤4 with at least a 2-point reduction from the AMAM study baseline and no subscore >1. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no individual assessment score >1 across all 20 individual assessments.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Clinical response by Patient Reported Outcome (PRO) was defined as a ≥30% decrease from baseline in stool frequency (SF) and/or abdominal pain (AP) score, with neither symptom worsening from baseline. SF was measured as the number of liquid or very soft stools per day. AP was scored daily on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.

Fecal calprotectin is an indicator of inflammation in the intestines with higher levels indicative of higher levels of inflammation.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study, and had evaluable fecal calprotectin data.

C-Reactive Protein is a biomarker of systemic inflammation measured in the blood, with elevated levels indicating increased inflammatory activity in the body.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study, and had evaluable C-Reactive Protein data.

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item participant completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Total scores range from 32 to 224; a higher score indicates a better quality of life.

All enrolled participants originating from the AMAM study who received at least one dose of study drug and had a baseline SES-CD total score ≥7 (or ≥4 for isolated ileal disease) in the AMAM study.