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Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00489489
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : November 2, 2012
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Drug: Teriflunomide
Drug: Placebo (for Teriflunomide)
Drug: Interferon-β
Enrollment 118

Recruitment Details The recruitment initiated in May 2007 was completed in August 2008. A total of 159 patients were screened at 29 sites in 5 countries.
Pre-assignment Details

Randomization was stratified by country and dose level of interferon-β (high/low).

Assignment to groups was done centrally using an Interactive Voice Response System (IVRS] in a 1:1:1 ratio after confirmation of the selection criteria.

118 participants were randomized.

Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Period Title: Overall Study
Started 41 [1] 37 [1] 40 [1]
Treated 41 36 39 [2]
Completed 38 [3] 32 [3] 37 [3]
Not Completed 3 5 3
Reason Not Completed
Not treated due to protocol violation             0             1             1
Adverse Event             1             1             1
Protocol Violation             1             0             1
Progressive disease             0             1             0
Participant did not wish to continue             1             1             0
Other than above             0             1             0
[1]
randomized
[2]
One participant received teriflunomide 7 mg instead of teriflunomide 14 mg
[3]
completed treatment period
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β Total
Hide Arm/Group Description Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 41 37 38 116
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 37 participants 38 participants 116 participants
39.2  (9.0) 41.4  (6.8) 39.6  (8.1) 40.1  (8.0)
[1]
Measure Description: Baseline characteristics of the population included in the analyses: the 2 participants not treated were not included, and the participant who received teriflunomide 7 mg instead of teriflunomide 14 mg was included in the teriflunomide 7 mg group.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 37 participants 38 participants 116 participants
Female
31
  75.6%
25
  67.6%
25
  65.8%
81
  69.8%
Male
10
  24.4%
12
  32.4%
13
  34.2%
35
  30.2%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 37 participants 38 participants 116 participants
Europe 28 25 24 77
North America 13 12 14 39
[1]
Measure Description:

Europe: Germany, Italy and Spain

North America: Canada and United States

Time since first diagnosis of Multiple Sclerosis (MS)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 37 participants 38 participants 116 participants
8.78  (5.62) 8.35  (5.44) 7.97  (6.59) 8.38  (5.86)
Number of MS relapses  
Median (Full Range)
Unit of measure:  MS relapses
Number Analyzed 41 participants 37 participants 38 participants 116 participants
Within the past year
1
(0 to 4)
0
(0 to 3)
1
(0 to 3)
1
(0 to 4)
Within the past 2 years
1
(0 to 5)
1
(0 to 5)
1
(0 to 4)
1
(0 to 5)
Time since most recent MS relapse onset  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 41 participants 37 participants 38 participants 116 participants
27.68  (38.49) 28.97  (34.06) 24.71  (35.97) 27.12  (36.03)
MS subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 37 participants 38 participants 116 participants
Relapsing Remitting 38 30 34 102
Secondary Progressive 2 2 3 7
Progressive Relapsing 1 5 1 7
Baseline Expanded Disability Status Scale (EDSS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 41 participants 37 participants 38 participants 116 participants
2.61  (1.26) 2.41  (1.44) 2.46  (1.57) 2.50  (1.41)
[1]
Measure Description:

EDSS is an ordinal scale in half-point increments that qualifies disability in patients with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.

EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).

Dose level of interferon-β   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 37 participants 38 participants 116 participants
High dose 28 25 24 77
Low dose 13 12 14 39
[1]
Measure Description:

'High dose': Rebif® 44 μg 3 times per week subcutaneously and, Betaseron® 0.25 mg every other day subcutaneously

'Low dose': Rebif® 22 μg 3 times per week subcutaneously and, Avonex® 30 μg once a week intramuscularly

1.Primary Outcome
Title Overview of Adverse Events [AE]
Hide Description AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.
Time Frame from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Unit of Measure: participants
Any AE 35 33 32
- serious AE 1 2 0
- AE leading to death 0 0 0
- AE leading to study drug discontinuation 1 1 1
2.Primary Outcome
Title Overview of AE With Potential Risk of Occurrence
Hide Description

AE with potential risk of occurrence were defined as follows:

  • Hepatic disorders;
  • Immune effects, mainly effects on bone marrow and infection;
  • Pancreatic disorders;
  • Malignancy;
  • Skin disorders, mainly Hair loss and Hair thinning;
  • Pulmonary disorders;
  • Hypertension;
  • Peripheral neuropathy;
  • Psychiatric disorders;
  • Hypersensitivity.
Time Frame from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Unit of Measure: participants
Any AE with potential risk of occurence 24 25 26
- Hepatic disorder AE 5 8 11
- Pancreatic disorder AE 5 2 7
- Pulmonary disorder AE 0 0 0
- Immune effects related AE 13 18 19
- Hair loss / Hair thinning AE 0 3 3
- Hypertension-related AE 1 0 4
- Peripheral neuropathy AE 4 1 3
- Hypersensitivity AE 5 3 3
- Malignancy AE 0 0 0
- Psychiatric disorder AE 0 0 0
3.Primary Outcome
Title Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Hide Description

PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

Hepatic parameters thresholds were defined as follows:

  • Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];
  • Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;
  • Alkaline Phosphatase >1.5 ULN;
  • Total Bilirubin [TB] >1.5 or 2 ULN;
  • ALT >3 ULN and TB >2 ULN;
Time Frame from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Unit of Measure: participants
ALT >3 ULN 2 0 2
- ALT >5 ULN 1 0 1
AST >3 ULN 1 0 1
- AST >5 ULN 1 0 0
Alkaline Phosphatase >1.5 ULN 1 0 0
TB >1.5 ULN 0 0 0
ALT >3 ULN and TB >2 ULN 0 0 0
4.Secondary Outcome
Title Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)
Hide Description

Total lesion volume is the sum of the total volume of all T2-lesions and the total volume of all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.

Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on cubic root transformed volume data (treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors).

Time Frame baseline (before randomization) and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Least Squares Mean (Standard Error)
Unit of Measure: mililiters
-0.001  (0.030) 0.002  (0.032) -0.028  (0.030)
5.Secondary Outcome
Title Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)
Hide Description

Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.

To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as "offset" variable; treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates).

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: lesions per scan
0.570
(0.350 to 0.929)
0.099
(0.041 to 0.241)
0.089
(0.050 to 0.159)
6.Secondary Outcome
Title Cerebral MRI Assessment: Volume of Gd-enhancing T1-lesions Per Scan
Hide Description Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Unit of Measure: mililiters per scan
0.068 0.022 0.024
7.Secondary Outcome
Title Annualized Relapse Rate [ARR]: Poisson Regression Estimates
Hide Description

ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.

Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.

To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as "offset" variable; treatment group, region of enrollment and IFN-β dose level as covariates).

Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
Overall Number of Participants Analyzed 41 37 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per year
0.260
(0.108 to 0.625)
0.280
(0.101 to 0.774)
0.109
(0.031 to 0.388)
8.Secondary Outcome
Title Pharmacokinetic [PK]: Teriflunomide Plasma Concentration
Hide Description Plasma concentrations of teriflunomide were measured using validated liquid chromatography-tandem mass spectrometry methods.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants who had at least one PK sample. Participants were included in the treatment group according to the drug actually received.
Arm/Group Title Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + IFN-β
Hide Arm/Group Description:
Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: micrograms/mililiter (μg/mL)
21.437  (16.034) 47.761  (25.413)
Time Frame All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit.
Adverse Event Reporting Description The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake up to 112 days after last study drug intake or up to the first study drug intake in the extension study LTS6047, whichever occured first (40 weeks max)
 
Arm/Group Title Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + + IFN-β
Hide Arm/Group Description Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
All-Cause Mortality
Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + + IFN-β
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + + IFN-β
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/41 (2.44%)   2/37 (5.41%)   0/38 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  1/41 (2.44%)  0/37 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal stiffness * 1  0/41 (0.00%)  1/37 (2.70%)  0/38 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  0/41 (0.00%)  1/37 (2.70%)  0/38 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo + IFN-β Teriflunomide 7 mg + IFN-β Teriflunomide 14 mg + + IFN-β
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/41 (48.78%)   28/37 (75.68%)   29/38 (76.32%) 
Gastrointestinal disorders       
Diarrhoea * 1  4/41 (9.76%)  3/37 (8.11%)  3/38 (7.89%) 
Nausea * 1  1/41 (2.44%)  0/37 (0.00%)  2/38 (5.26%) 
Vomiting * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
General disorders       
Fatigue * 1  2/41 (4.88%)  1/37 (2.70%)  4/38 (10.53%) 
Infections and infestations       
Nasopharyngitis * 1  2/41 (4.88%)  3/37 (8.11%)  5/38 (13.16%) 
Respiratory tract infection * 1  2/41 (4.88%)  2/37 (5.41%)  0/38 (0.00%) 
Sinusitis * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
Upper respiratory tract infection * 1  4/41 (9.76%)  0/37 (0.00%)  2/38 (5.26%) 
Urinary tract infection * 1  4/41 (9.76%)  3/37 (8.11%)  1/38 (2.63%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
Investigations       
Alanine aminotransferase increased * 1  5/41 (12.20%)  5/37 (13.51%)  11/38 (28.95%) 
Aspartate aminotransferase increased * 1  1/41 (2.44%)  4/37 (10.81%)  3/38 (7.89%) 
Blood creatine phosphokinase increased * 1  0/41 (0.00%)  2/37 (5.41%)  1/38 (2.63%) 
Blood pressure increased * 1  0/41 (0.00%)  0/37 (0.00%)  3/38 (7.89%) 
Lipase increased * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
Lymphocyte count decreased * 1  1/41 (2.44%)  4/37 (10.81%)  3/38 (7.89%) 
Neutrophil count decreased * 1  1/41 (2.44%)  1/37 (2.70%)  4/38 (10.53%) 
White blood cell count decreased * 1  3/41 (7.32%)  3/37 (8.11%)  4/38 (10.53%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/41 (0.00%)  1/37 (2.70%)  2/38 (5.26%) 
Back pain * 1  0/41 (0.00%)  2/37 (5.41%)  3/38 (7.89%) 
Nervous system disorders       
Headache * 1  2/41 (4.88%)  2/37 (5.41%)  4/38 (10.53%) 
Sciatica * 1  0/41 (0.00%)  2/37 (5.41%)  1/38 (2.63%) 
Psychiatric disorders       
Anxiety * 1  0/41 (0.00%)  2/37 (5.41%)  1/38 (2.63%) 
Insomnia * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  3/41 (7.32%)  0/37 (0.00%)  2/38 (5.26%) 
Oropharyngeal pain * 1  1/41 (2.44%)  2/37 (5.41%)  2/38 (5.26%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  0/41 (0.00%)  3/37 (8.11%)  3/38 (7.89%) 
Dry skin * 1  0/41 (0.00%)  0/37 (0.00%)  2/38 (5.26%) 
Pruritus * 1  0/41 (0.00%)  2/37 (5.41%)  0/38 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The investigator can publish only the results of the work performed pursuant to this protocol. Prior to publication, the investigator provides the sponsor with the manuscript for review and comment at least 45 days in advance of its submission for publication.

The sponsor can require the investigator to withhold publication an additional 90 days to allow for filing a patent application or taking such other measures as sponsor deems appropriate to establish and preserve its proprietary rights.

Results Point of Contact
Name/Title: Trial Transparency Team
Organization: sanofi-aventis
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00489489     History of Changes
Other Study ID Numbers: PDY6045
2006-003134-14 ( EudraCT Number )
HMR1726D-2003 ( Other Identifier: HMR )
First Submitted: June 20, 2007
First Posted: June 21, 2007
Results First Submitted: October 3, 2012
Results First Posted: November 2, 2012
Last Update Posted: November 6, 2012