Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Brief Summary: The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Inclusion Criteria:

* Diagnosis of Relapsing Remitting MS according to the 2017 revised McDonald cri-teria 27 OR one demyelinating episode in conjunction with at least one asympto-matic high intensity T2 lesion with size and location compatible with MS.
* Untreated OR treated with first-line injectables (interferon or glatiramer acetate)
* Between the age of 18 and 50 years (inclusive) of age
* No more than ten years of disease duration
* During the previous year, clinical or radiological disease activity defined as at least one of the following:

  * ≥ 1 relapse
  * ≥ 2 T2 lesions
  * ≥ 1 Gd+ lesions
* Expanded Disability Status Scale: 0 - 5,5 (inclusive)
* In fertile females, willing to comply with effective contraceptive methods. These include birth control pills, surgical sterilization of patient or partner or intrauterine device. Non-fertile women is defined as more than 12 months of amenorrhea without an alternative medical cause or, in case of ambiguities, an follicle stimulation hormone level in the postmenopausal range.

Exclusion Criteria:

* Diagnosis of Progressive MS
* Pregnant or lactating women: human chorionic gonadotropin (s-HCG) will be tested on all women at screening, before each study-related infusion and in any situation where there is a reason to suspect pregnancy during the trial, eg delayed menstrual period more than five days above expected time.
* Patients having contraindication for or otherwise not compliant with MRI investigations
* Simultaneous treatment with other immunosuppressive drugs
* Active, severe infections Signs of infections are assessed before inclusion and each study-related infusion through clinical examination and further evaluated by laboratory and other relevant investigations in case of suspected ongoing infection. Hepatitis serology (HBsAg and anti-HBc) will be evaluated before treatment onset.
* Severe cardiac disorder, eg signs of congestive heart failure or coronary artery disease. This will be evaluated through clinical assessment before inclusion.
* Vaccination within 4 weeks of first dose of study medication.
* Documented allergy or intolerance to any of the investigational products.
* Severe psychiatric condition
B: Inclusion Criteria:

* Male or female, between 18 and 65 years of age (inclusive, at time of informed consent)
* Has definite MS according to the McDonald criteria
* Has relapsing-remitting disease with 1 or more relapses within 12 months prior to Study Day 1
* Must have been clinically stable and not has a relapse within 28 days prior to Study Day 1
* Has MRI consistent with MS at the pre-study evaluation according to the Fazekas criteria
* Has a EDSS score from 0 to 5.5, inclusive
* Weighed between 40-120 kilogram (kg), inclusive
* If female, she must:

  1. be post-menopausal or surgically sterilized; or
  2. uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
  3. be neither pregnant nor breast-feeding
* If male, he must be willing to use contraception to avoid pregnancies
* Be willing and able to comply with study procedures for the duration of the study
* Voluntarily provides written informed consent, and for United states of America (USA) sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA)

Exclusion Criteria:

* Has secondary progressive MS (SPMS) or primary progressive MS (PPMS)
* Prior use of disease modifying drugs (DMDs) within the last 3 months, or 2 or more prior treatment failures with DMDs on the basis of efficacy
* Has significant leukopenia (white blood cell count less than 0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1
* Has received cladribine, mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab
* Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1
* Has compromised immune function or infection
* Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1
* Has received cytokine-based therapy, intravenous immunoglobulin therapy, or plasmapheresis within 3 months prior to Study Day 1
* Has platelet and absolute neutrophil counts below the lower limit of normal range within 28 days prior to Study Day 1
* Has prior or current history of malignancy
* Has a history of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy
* Has systemic disease that, in the opinion of the Investigator, might interfere with subject safety, compliance or evaluation of the condition under Study (for example, insulin-dependent diabetes, Lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
* Has a psychiatric disorder that, in the opinion of the Investigator, was unstable or would preclude safe participation in the study
* Has allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients
* Has used any investigational drug or experimental procedure within 6 months prior to Study Day 1
C: Key Inclusion Criteria:

* Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:

  * Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR
  * Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* History of malignancy
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* History of abnormal laboratory results based on investigator judgment
* History of human immunodeficiency virus (HIV) or other immunodeficient conditions
* History of drug or alcohol abuse within the 2 years prior to randomization
* An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
* Positive screening for active infection with Hepatitis B virus or Hepatitis C virus
* Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening
* Exposure to varicella zoster virus within 21 days before Screening.
* Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase \>2 times the upper limit of normal (ULN) and serum creatinine \>ULN.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
D: Inclusion Criteria:

* Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
* Relapsing-remitting multiple sclerosis (MS)
* Ages 18-55 years inclusive
* For sexually active female and male participants of reproductive potential, use of reliable means of contraception

Exclusion Criteria:

* Secondary or primary progressive multiple sclerosis at screening
* Incompatibility with MRI
* Contra-indications to or intolerance of oral or IV corticosteroids
* Known presence of other neurologic disorders
* Pregnancy or lactation
* Lack of peripheral venous access
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
* Congestive heart failure
* Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
* History or known presence of recurrent or chronic infection
* History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)
* History of alcohol or drug abuse within 24 weeks prior to randomization
* History of or currently active primary or secondary immunodeficiency
* History of coagulation disorders
* Treatment with any investigational agent within 4 weeks of screening
* Receipt of a live vaccine within 6 weeks prior to randomization
* Incompatibility with Avonex use
* Previous treatment with rituximab
* Previous treatment with lymphocyte-depleting therapies except mitoxantrone
* Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
* Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
* Systemic corticosteroid therapy within 4 weeks prior to randomization

Answer: B