Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period
Brief Summary: The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

* To demonstrate the effect of teriflunomide, in comparison to placebo, on:

  * Reducing conversion to definite multiple sclerosis (DMS)
  * Reducing annualized relapse rate (ARR)
  * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
  * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
  * Proportion of disability-free participants as assessed by the EDSS
  * Reducing participant-reported fatigue
* To evaluate the safety and tolerability of teriflunomide
* To evaluate the pharmacokinetics (PK) of teriflunomide
* Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes


Options:
A: Inclusion Criteria:

* Satisfactorily completion of HMR1726D/2001 study with respect to safety.
* If female subject, non-childbearing potential or child bearing potential with adequate contraception.
* Consent to practice/maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment.
* Clinically definite Multiple Sclerosis (MS) as established on entry into HMR1726D/2001 study.
* Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject entered HMR1726D/2001 study.
* Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of clinically definite MS.
* Willingness to participate in a long-term safety and efficacy trial.

Exclusion Criteria:

* Subject who did not complete HMR 1726D/2001 study for safety reasons.
* Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other major disease.
* Pregnancy.
* Breast-feeding.
* Wish to parent.
* Likelihood of requiring treatment during the study period with drugs not permitted.
* Disallowed therapies such asw immunomodulators, immunosuppressants.
* Recent history of drug or alcohol abuse.
* Liver function impairment.
* Abnormal mental conditions.
B: Inclusion Criteria:

* Multiple sclerosis \[MS\] subject who was ambulatory (EDSS of ≤ 5.5)
* Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
* Meeting McDonald's criteria for MS diagnosis;
* Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
* No relapse onset in the preceding 60 days prior to randomization;
* Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[ACTH\] or systemic steroid treatment.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
* Significantly impaired bone marrow function;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
C: Inclusion Criteria:

* First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)
* Onset of MS symptoms occurring within 90 days of randomization
* A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
* Significantly impaired bone marrow function
* Pregnancy or nursing
* Alcohol or drug abuse
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
D: Inclusion Criteria:

* Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale \[EDSS\] score ≤5.5 at screening visit.

Exclusion Criteria:

* Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia;
* Persistent significant or severe infection.
* Liver function impairment or known history of hepatitis.
* Use of adrenocorticotrophic hormone \[ACTH\] or systemic corticosteroids for 2 weeks prior to randomization.
* Human immunodeficiency virus \[HIV\] positive.
* Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months prior to randomization.
* Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab.
* Pregnant or breast-feeding woman.

Extension criteria:

The participants who met all the following criteria at the end of the core study period were eligible for enrolment into the open-label extension phase:

* Participants who had not discontinued treatment in the core period and who had a minimum treatment of 48 weeks and completed the EOT visit (Visit 18).
* Participants who had not met criteria for treatment withdrawal.
* An informed consent must be obtained in writing from the participant for this open-label extension phase prior to entering and prior to completion of any extension phase procedure.
* Participants who demonstrated a willingness and ability to roll over to the extension phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under open-label.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Answer: C