Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial of Rebif New Formulation (44 Microgram [Mcg] Three Times Weekly [Tiw] and 44 Mcg Once Weekly [ow]) in Subjects at High Risk of Converting to Multiple Sclerosis (REFLEX)
Brief Summary: The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension.

The primary objective of the study is to evaluate the effect of fetal bovine serum \[FBS\]-free/human serum albumin \[HSA\]-free formulation of Interferon \[IFN\] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS.

The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS.

At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.


Options:
A: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)
B: Time to First Relapse by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Number of Subjects With Diagnosis of Multiple Sclerosis Within Eleven years after Clinically-Isolated Syndrome (CIS) According to McDonald 2001 and 2010 Criteria (Year 11); Disease Course as Assessed at the Time of BENEFIT 11 (Year 11); Percentage of Subjects Converting to Secondary Progressive Multiple Sclerosis (SPMS) (Year 11); Time to Secondary Progressive Multiple Sclerosis (SPMS) Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Expanded Disability Status Scale (EDSS) at Year 11 (Year 11); Number of Subjects With Confirmed and Sustained 1-point Expanded Disability Status Scale (EDSS) Progression at Year 11 (Year 11); Number of Subjects With Confirmed 2.5-point Expanded Disability Status Scale (EDSS) Progression at Year 11 (Year 11); Percentage of Subjects who Ever Reached a Disability Status Scale (DSS) 3 and 6 (Year 11); Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 3 by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 6 by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Multiple Sclerosis Functional Composite (MSFC) at Year 11 (Year 11); Multiple Sclerosis Severity Score (MSSS) at Year 11 (Year 11); Cognitive Function: Paced Auditory Serial Addition Test-3 (PASAT-3) at Year 11 (Year 11); Cognitive function: Symbol Digit Modalities Test (SDMT) (Year 11); Relapse-Based Efficacy domain: Hazard Ratio for Recurrent Relapses (Year 11); Relapse Based Efficacy Domain: Annualized Relapse Rate (Year 11); Time to use of Ambulatory Device Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Time to Dependence of Ambulatory Device for Walking Represented by Kaplan-Meier Estimates (Up to Year 11 (Day 3960)); Number of Subjects With Wheelchair Use After 11 years (Year 11)
C: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
D: To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study (End of Study)

Answer: C