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Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction (ALFACHIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549939
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : February 8, 2011
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neurogenic Urinary Bladder
Interventions Drug: Alfuzosin
Drug: Placebo
Enrollment 172
Recruitment Details The study was conducted at 55 sites in 18 countries. A total of 261 patients were screened between September 2007 and November 2008.
Pre-assignment Details

172/261 patients were randomized in the 12-week double blind phase.

89/261 patients were not randomized for the following reasons:

  • Adverse event (1 patient*),
  • Inclusion/Exclusion criteria not met (69 patients*),
  • Subject's request (11 patients*),
  • Other (13 patients*).

'*' Patients could have several reasons.

Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo [Not Specified] [Not Specified]
Period Title: 12-week Double Blind Treatment Period
Started 57 [1] 57 58
Completed 56 55 56
Not Completed 1 2 2
Reason Not Completed
Adverse Event             1             1             2
Too many blood draws             0             1             0
[1]
29 (Alfuzosin 0.1 mg/kg/day matching placebo) + 28 (Alfuzosin 0.2 mg/kg/day matching placebo)
Period Title: 40-week Open Label Treatment Period
Started 0 [1] 80 [2] 83 [3]
Completed 0 75 78
Not Completed 0 5 5
Reason Not Completed
Adverse Event             0             2             1
Lack of Efficacy             0             1             0
Protocol Violation             0             1             0
Other             0             1             4
[1]
54 patients continued and switched to Alfuzosin: 26 to 0.1 mg/kg/day and 28 to 0.2 mg/kg/day.
[2]
54 patients continued Alfuzosin 0.1 mg/kg/day and 26 patients started Alfuzosin 0.1 mg/kg/day.
[3]
55 patients continued Alfuzosin 0.2 mg/kg/day and 28 patients started Alfuzosin 0.2 mg/kg/day.
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day Total
Hide Arm/Group Description Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 57 57 58 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 58 participants 172 participants
8.3  (4.4) 7.9  (3.9) 8.7  (3.9) 8.3  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 58 participants 172 participants
Female
28
  49.1%
27
  47.4%
30
  51.7%
85
  49.4%
Male
29
  50.9%
30
  52.6%
28
  48.3%
87
  50.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 58 participants 172 participants
United States 6 7 5 18
Portugal 2 1 3 6
Serbia 4 6 7 17
Taiwan 0 1 1 2
Estonia 1 1 1 3
Slovakia 6 7 1 14
Spain 2 3 2 7
Turkey 1 2 3 6
Russian Federation 8 7 4 19
India 2 9 9 20
France 1 2 4 7
Canada 3 1 2 6
Malaysia 3 0 0 3
Poland 15 10 14 39
Germany 3 0 2 5
Urinary Tract Infection (UTI) history in the last 3 months  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 58 participants 172 participants
No UTI episode 48 50 40 138
One UTI episode 8 5 16 29
Two UTI episodes 1 2 2 5
Study drug formulation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 58 participants 172 participants
Solution (2-7 years) 28 28 28 84
Solution (8-16 years) 8 10 9 27
Tablets (8-16 years) 21 19 21 61
1.Primary Outcome
Title Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O
Hide Description

Detrusor Leak Point Pressure (LPP) was measured by cystometry.

For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.

Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment.

The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).

Time Frame 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat (ITT) population was used for the analysis. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 57 58
Measure Type: Number
Unit of Measure: participants
< 40 cmH2O ("Success") 23 23 28
≥ 40 cmH2O or missing ("Failure") 34 34 30
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.1 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Detrusor Leak Point Pressure (LPP)
Hide Description Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.
Time Frame baseline and 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post-baseline LPP values. Patients were included in the treatment group to which they were allocated as per randomization.
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 54 53 56
Mean (Standard Deviation)
Unit of Measure: cmH2O
Baseline 54.2  (12.6) 53.3  (13.4) 50.9  (10.0)
12 Weeks 48.2  (23.4) 41.6  (18.2) 39.4  (19.5)
3.Secondary Outcome
Title Absolute Change in Detrusor LPP
Hide Description Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline
Time Frame 12 weeks ((double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 54 53 56
Least Squares Mean (Standard Error)
Unit of Measure: cmH2O
-5.4  (2.8) -11.7  (2.8) -12.5  (2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.1 mg/kg/Day
Comments

Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:

  • treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),
  • age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),
  • anticholinergic/antimuscarinic use (yes or no),

and using centered baseline detrusor LPP as covariate.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1040
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference versus Placebo
Estimated Value -6.2
Confidence Interval (2-Sided) 95%
-13.72 to 1.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1040
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference versus Placebo
Estimated Value -7.1
Confidence Interval (2-Sided) 95%
-14.51 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.77
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Relative Change in Detrusor LPP
Hide Description Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline
Time Frame 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 54 53 56
Least Squares Mean (Standard Error)
Unit of Measure: percentage of cmH2O
-9.2  (5.53) -20.6  (5.56) -23.5  (5.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.1 mg/kg/Day
Comments

Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:

  • treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),
  • age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),
  • anticholinergic/antimuscarinic use (yes or no),

and using centered baseline detrusor LPP as covariate.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1338
Comments P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference versus Placebo
Estimated Value -11.4
Confidence Interval (2-Sided) 95%
-26.27 to 3.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1152
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference versus Placebo
Estimated Value -14.3
Confidence Interval (2-Sided) 95%
-29.10 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.48
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Detrusor Compliance
Hide Description

Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.

It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet).

Time Frame baseline and 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intent-to-treat (ITT) population excluding the patients who didn't have baseline and/or post baseline detrusor compliance values. Patients were included in the treatment group to which they were allocated as per randomization.
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 54 52 55
Mean (Standard Deviation)
Unit of Measure: mL/cmH20
Baseline 3.4  (2.8) 3.4  (2.8) 3.3  (2.5)
12 weeks 4.8  (5.0) 5.3  (4.9) 5.8  (5.9)
6.Secondary Outcome
Title Relative Change in Detrusor Compliance
Hide Description Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline
Time Frame 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the same population as previously (i.e. ITT population excluding the patients who didn't have baseline and/or post-baseline value).
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 54 52 55
Least Squares Mean (Standard Error)
Unit of Measure: percentage of mL/cmH2O
113.6  (35.26) 126.6  (35.76) 98.6  (35.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.1 mg/kg/Day
Comments

Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:

  • treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),
  • age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),
  • anticholinergic/antimuscarinic use (yes or no),

and using centered baseline detrusor compliance as covariate.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7889
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alfuzosin 0.2 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7889
Comments P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Hide Description

When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.

A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism.

Time Frame 12 weeks (double blind treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the intent-to-treat (ITT) population. All randomized patients were included in the analysis in the treatment group to which they were allocated as per randomization.
Arm/Group Title Placebo Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 57 57 58
Measure Type: Number
Unit of Measure: participants
No symptomatic UTI 50 53 51
One symptomatic UTI 5 3 6
Two symptomatic UTI 2 1 1
8.Secondary Outcome
Title Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Hide Description Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.
Time Frame 52 weeks (double blind treatment period + open label extension treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received). It included 3 + 3 patients treated during the 1st treatment period only, 26 + 28 patients treated during the 2nd treatment period only and 54 + 55 patients treated during both periods.
Arm/Group Title Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 83 86
Measure Type: Number
Unit of Measure: participants
No symptomatic UTI 66 70
One symptomatic UTI 12 13
Two symptomatic UTI 3 0
Three symptomatic UTI 1 1
Four symptomatic UTI 1 2
Time Frame All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
Adverse Event Reporting Description The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin, whatever the study period and regardless of the amount of treatment received) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose).
 
Arm/Group Title Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   10/83 (12.05%)   7/86 (8.14%) 
Congenital, familial and genetic disorders     
ARNOLD-CHIARI MALFORMATION  1  1/83 (1.20%)  0/86 (0.00%) 
Infections and infestations     
VIRAL INFECTION  1  0/83 (0.00%)  1/86 (1.16%) 
PYELONEPHRITIS  1  0/83 (0.00%)  1/86 (1.16%) 
PNEUMONIA  1  1/83 (1.20%)  1/86 (1.16%) 
LOBAR PNEUMONIA  1  1/83 (1.20%)  0/86 (0.00%) 
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  0/83 (0.00%)  1/86 (1.16%) 
VENTRICULOPERITONEAL SHUNT MALFUNCTION  1  1/83 (1.20%)  1/86 (1.16%) 
CONTUSION  1  1/83 (1.20%)  0/86 (0.00%) 
Metabolism and nutrition disorders     
MALNUTRITION  1  1/83 (1.20%)  0/86 (0.00%) 
Nervous system disorders     
EPILEPSY  1  2/83 (2.41%)  0/86 (0.00%) 
TETHERED CORD SYNDROME  1  1/83 (1.20%)  1/86 (1.16%) 
Renal and urinary disorders     
RENAL IMPAIRMENT  1  1/83 (1.20%)  0/86 (0.00%) 
URETHRAL HAEMORRHAGE  1  1/83 (1.20%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
RESPIRATORY FAILURE  1  1/83 (1.20%)  0/86 (0.00%) 
TONSILLAR HYPERTROPHY  1  1/83 (1.20%)  0/86 (0.00%) 
Skin and subcutaneous tissue disorders     
DECUBITUS ULCER  1  0/83 (0.00%)  2/86 (2.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alfuzosin 0.1 mg/kg/Day Alfuzosin 0.2 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   37/83 (44.58%)   43/86 (50.00%) 
Gastrointestinal disorders     
DIARRHOEA  1  8/83 (9.64%)  10/86 (11.63%) 
VOMITING  1  4/83 (4.82%)  6/86 (6.98%) 
General disorders     
PYREXIA  1  7/83 (8.43%)  10/86 (11.63%) 
Infections and infestations     
NASOPHARYNGITIS  1  6/83 (7.23%)  12/86 (13.95%) 
CYSTITIS  1  5/83 (6.02%)  9/86 (10.47%) 
URINARY TRACT INFECTION  1  9/83 (10.84%)  6/86 (6.98%) 
PHARYNGITIS  1  8/83 (9.64%)  5/86 (5.81%) 
RESPIRATORY TRACT INFECTION  1  7/83 (8.43%)  5/86 (5.81%) 
UPPER RESPIRATORY TRACT INFECTION  1  4/83 (4.82%)  5/86 (5.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 12.1
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.

If no publication has occurred within 12 months after trial completion, the investigators can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not to exceed 90 days.

To protect by a property right any information the sponsor can postpone the publication, for a period not to exceed 18 months.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00549939    
Other Study ID Numbers: EFC5722
2004-002397-38 ( EudraCT Number )
First Submitted: October 25, 2007
First Posted: October 26, 2007
Results First Submitted: January 13, 2011
Results First Posted: February 8, 2011
Last Update Posted: October 29, 2014