Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Brief Summary: The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.


Options:
A: Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

1. Diagnosis of moderately to severely active ulcerative colitis
2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:

   1. Immunomodulators
   2. Tumor necrosis factor-alpha (TNFα) antagonists
   3. Corticosteroids
3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria:

1. Evidence of abdominal abscess at the initial screening visit
2. Extensive colonic resection, subtotal or total colectomy
3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
4. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
5. Chronic hepatitis B or C infection
6. Active or latent tuberculosis
B: Inclusion Criteria:

* Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study

Exclusion Criteria:

* Any other treatment for the maintenance of remission of Crohn's disease
C: Inclusion Criteria:

* All subjects must give written informed consent by parent or guardian
* Male or female subjects, \> 6 - 17 years
* Patients must have endoscopic or radiographic confirmed Crohn's Disease.
* Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.

Exclusion Criteria:

* Adolescent women of childbearing potential and / or sexually active unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
* Adolescent women who are pregnant or breastfeeding
* Subjects with an ostomy or ileocolic anastomosis from surgery as these operations interfere with the PCDAI assessment
* Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be discontinued 4 weeks prior to study initiation.
* Patients with abnormal liver function tests
* Prednisone greater than 10 mg or \> 0.2 mg/kg orally
D: Inclusion Criteria:

* \> 18 yr old
* diagnosis of Crohn's disease
* intestinal lesions demonstrated during the last 6 months
* disease duration \< 6 months
* patients at high risk of disabling disease (having 2 criteria out of the 3 following: age \< 40, perinanal disease, steroid for the first flare)

Exclusion Criteria:

* prior prescription of immunosuppressants
* severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease)
* intestinal resection
* active infectious disease including HIV
* hepatic failure
* renal failure
* pregnancy
* high probability of poor compliance

Answer: A