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2.5 Inclusion criteria Subjects who are voluntarily able to give informed consent Subjects who can participate in all aspects of this clinical study Males and females aged from ≥ 18 to ≤ 80 years, at screening visit Diagnosis of moderate to severe UC established at least 3 months before screening by clinical and endoscopic evidence, corroborated by a histopathology report and confirmed by the investigator Moderately to severely active UC as determined by a total Mayo score of 7 to 12 confirmed by a central reader within 28 days prior to randomization Demonstrated an inadequate response to, loss of response, or intolerance to standard treatment consisting of corticosteroids and/or 6-mercaptopurine or azathioprine Patients receiving 5-ASA derivatives, corticosteroids, or immunosuppressive agents may be included in the study on condition that will receive stable doses of aforementioned drugs for 14 days before randomization (i.e., the dosage of each medication must remain unchanged for 14 consecutive days before the randomization visit) At screening, females of childbearing potential must be non-pregnant and non-lactating or females should be of non-childbearing potential Female patients of childbearing potential, with a fertile male sexual partner, must use highly effective contraception from screening until 15 weeks after the last dose of UST and 6 months after the last dose of IFX study drug Female subjects must not donate ovarian oocytes until 6 months after the last dose of the study drug Negative urine or serological pregnancy test at the screening visit 2.6 Exclusion criteria Previous exposure to IFX or UST or any other investigational IFX or UST-containing product Has a history of hypersensitivity or allergies to the ingredients of IFX or UST formulations Unstable angina Moderate or severe heart failure (defined as New York Heart Association Class III or IV) Chronic respiratory failure History of any major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease that in the opinion of the investigation would cofound the study results Current or recent history of alcohol dependence or illicit drug abuse PML diagnosis positive PML subjective symptom checklist prior to the randomization Chronic hepatitis B or C infection
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