Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
Brief Summary: The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.


Options:
A: Inclusion Criteria:

* 18 years or older
* have had Crohn's Disease for at least 3 months
* moderate to severely active Crohn's Disease
* have had an inadequate response or intolerance to other Crohn's Disease treatments
B: Inclusion Criteria:

* UC diagnosed according to the Lennard-Jones criteria (Appendix 1) with endoscopic colorectal lesions, whatever their extension may be
* A Mayo Disease Activity Index £ 4, with no item \>1 for the clinical part of the score and from 0 to 2 for the endoscopic part at the time of inclusion
* Steroid-dependence defined by at least 1 unsuccessful attempt to stop systemic steroid therapy during the last 12 weeks. Steroid therapy might have been completely stopped if it has been restarted within the last 30 days
* To be receiving a treatment of prednisone at a dose between 10 and 40mg, stable for at least 2 weeks at the time of inclusion
* Under an adequate contraception for male or female subjects of childbearing potential

Exclusion Criteria:

* Indication to a colectomy.
* Alcoholism (more than 21 glasses per week for male subjects and 14 glasses per week for female subjects). 1 glass corresponds to 3 cl of strong alcohol, 10 cl glass of wine or a half pint of beer.
* Pregnant or breast-feeding female subjects.
* No efficacious contraception.
* NSAIDS or cotrimoxazole intake upon inclusion, or probenecid intake within 1 month prior to inclusion.
* Anti-TNFa treatment within 2 months prior to inclusion.
* Azathioprine, mercaptopurine, cyclosporin or thalidomide within 1 month prior to inclusion.
* Modification of mesalazine or olsalazine dosage within 1 month prior to inclusion.
* Chronic (broncho) pneumopathy.
* Renal failure (creatinaemia \> upper limit of normal laboratory values limit).
* Liver disease apart from primary sclerosing cholangitis.
* Unexplained rise higher than twice the normal level for transaminases, alkaline phosphatases and/or bilirubin.
* Folate level \< normal level.
* Past history of malignant condition (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
C: Inclusion Criteria:

* Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
* Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
* Women of childbearing potential must use an acceptable contraceptive method while on study treatment

Exclusion Criteria:

* Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
D: Inclusion Criteria:

* Diagnosis of moderate to severe ulcerative colitis outpatient
* Disease duration at time of screening of \>/= 12 weeks

Exclusion Criteria:

* Extensive colonic resection or subtotal or total colectomy
* Presence of an ileostomy or colostomy
* Moderate to severe anemia
* A history or evidence of colonic mucosal dysplasia
* Pregnant or lactating
* Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
* Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
* Poorly controlled diabetes
* Impaired renal function
* Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
* Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
* Positive screening test for latent mycobacterium tuberculosis (TB) infection
* Demyelinating disease
* Received any investigational treatment within 12 weeks prior to initiation of study treatment
* Previous exposure to rhuMAb Beta7

Answer: C