Participants were assessed at consecutive infliximab infusions up to a maximum of 7 infusions. Patients who discontinued infliximab prior to the 7th infusion were administratively censored. Data collected on all participants included age, sex, weight, IBD diagnosis, disease duration and location, smoking history, IBD medication exposures and responses, hospitalizations, history of surgical resection, and symptoms based on the clinical scoring index, HBI and partial Mayo score at the time of infusion [30, 31]. Blood samples were drawn at each infusion for infliximab trough concentration determination. Colonoscopy and histopathology reports were reviewed prior to study enrollment (baseline colonoscopy). Participant follow-up was continued up to one year following the period of blood collection (up to 7 infusions), with patient charts reviewed monthly for the confirmation of completion of a second colonoscopy (follow-up colonoscopy) with available histopathology.

Participants with UC were required to have biopsies obtained from at least the rectum, sigmoid, descending and ascending colon. Participants with CD were required to have biopsies obtained from all segments where disease had been previously described (ileum, ileo-colonic, or colonic) with individuals with colonic disease having biopsies taken from multiple colonic sites.

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