Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.

Safety as assessed by the evaluation of adverse events

The proportion of patients with at least 1 episode of acute pouchitis during the 48 weeks of treatment. Acute Pouchitis defined as: modified pouchitis disease activity index (mPDAI) score ≥ 5 points OR an increase of ≥ 2 points vs. baseline, AND Endoscopic component of the mPDAI Score \>= 2 points (within 7 days prior or post the collection date of the symptomatic component of the mPDAI score)

Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.

Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.

MMS is used to assess disease activity in participants with UC and has following components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,scores ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding, ulceration\]).RB reported most severe amount of blood passed per rectum in 24-hour period,scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (\<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated.

Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.

SALT I is a well-validated metric used to determine the degree of hair loss based on the percentage (%) of scalp surface area involved on the top (40%), back (24%), left side (18%) and right side (18%) of the scalp for AA. Investigator determines the % scalp hair loss in a given quadrant, multiply this by the total scalp area delineated by that quadrant, and sum the resultant numbers for each quadrant to give the total % scalp hair loss with a maximum score of 100. Score range from 0% (no scalp hair loss) to 100% (complete scalp hair loss), higher scores indicated more scalp hair loss. Percent change from baseline in SALT I is reported in terms of Least square mean and standard error.

Baseline (Day -1), Day 1, Day 7 and Day 8.