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Trial record 27 of 811 for:    Psoriasis 4

A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris

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: NCT01116895
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : October 3, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: LEO 22811
Drug: Placebo
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg Placebo
Hide Arm/Group Description LEO 22811 0.5 mg: Oral solution LEO 22811 1.5 mg: Oral solution LEO 22811 3.0 mg: Oral solution Placebo: Oral solution
Period Title: Overall Study
Started 16 15 18 14
Completed 12 8 14 11
Not Completed 4 7 4 3
Arm/Group Title LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg Placebo Total
Hide Arm/Group Description LEO 22811 0.5 mg: Oral solution LEO 22811 1.5 mg: Oral solution LEO 22811 3.0 mg: Oral solution Placebo: Oral solution Total of all reporting groups
Overall Number of Baseline Participants 16 15 18 14 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 18 participants 14 participants 63 participants
47.5  (9.3) 49.8  (14.1) 42.4  (13.6) 44.9  (12.0) 46.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 18 participants 14 participants 63 participants
Female
2
  12.5%
4
  26.7%
4
  22.2%
1
   7.1%
11
  17.5%
Male
14
  87.5%
11
  73.3%
14
  77.8%
13
  92.9%
52
  82.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 18 participants 14 participants 63 participants
Canada
7
  43.8%
8
  53.3%
8
  44.4%
7
  50.0%
30
  47.6%
France
9
  56.3%
7
  46.7%
10
  55.6%
7
  50.0%
33
  52.4%
1.Primary Outcome
Title Percentage Change in Psoriasis Area and Severity Index (PASI)
Hide Description

The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness.

The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale:

0. = no involvement

  1. = <10%
  2. = 10–29%
  3. = 30–49%
  4. = 50–69%
  5. = 70–89%
  6. = 90–100%

For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined.

PASI was calculated based on the investigator’s assessment of the disease locally (head, trunk, arm, legs) using the following formula:

Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.

Time Frame Baseline (Day 0) to end of treatment (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description:
Placebo: Oral solution
LEO 22811 0.5 mg: Oral solution
LEO 22811 1.5 mg: Oral solution
LEO 22811 3.0 mg: Oral solution
Overall Number of Participants Analyzed 14 16 15 18
Mean (Standard Deviation)
Unit of Measure: percentage of change in PASI index score
-5.6  (44.9) -7.6  (29.1) -0.3  (43.5) -12.7  (45.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LEO 22811 0.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-32.6 to 28.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, LEO 22811 1.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-26.2 to 35.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, LEO 22811 3.0 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -6.7
Confidence Interval (2-Sided) 95%
-36.2 to 22.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Participants With at Least 75% Reduction in PASI (PASI 75)
Hide Description [Not Specified]
Time Frame From baseline (Day 0) to end of treatment (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description:
Placebo: Oral solution
LEO 22811 0.5 mg: Oral solution
LEO 22811 1.5 mg: Oral solution
LEO 22811 3.0 mg: Oral solution
Overall Number of Participants Analyzed 14 16 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
0
   0.0%
1
   6.3%
0
   0.0%
2
  11.1%
No
14
 100.0%
15
  93.8%
15
 100.0%
16
  88.9%
3.Secondary Outcome
Title Participants With at Least 50% Reduction in PASI (PASI 50)
Hide Description [Not Specified]
Time Frame From baseline (Day 0) to end of treatment (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description:
Placebo: Oral solution
LEO 22811 0.5 mg: Oral solution
LEO 22811 1.5 mg: Oral solution
LEO 22811 3.0 mg: Oral solution
Overall Number of Participants Analyzed 14 16 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
2
  14.3%
1
   6.3%
2
  13.3%
4
  22.2%
No
12
  85.7%
15
  93.8%
13
  86.7%
14
  77.8%
4.Secondary Outcome
Title Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)
Hide Description At Visits 1 to 8 the investigator made a global assessment of the disease severity (IGA) using a 6-point scale (clear, almost clear, mild, moderate, severe, very severe). This assessment represents average lesion severity on head, trunk, arm and legs. The assessment was based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. Participants classified as clear or almost clear according to IGA was considered to have “controlled disease”.
Time Frame At end of treatment (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description:
Placebo: Oral solution
LEO 22811 0.5 mg: Oral solution
LEO 22811 1.5 mg: Oral solution
LEO 22811 3.0 mg: Oral solution
Overall Number of Participants Analyzed 14 16 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Controlled
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
Non-controlled
14
 100.0%
16
 100.0%
15
 100.0%
17
  94.4%
5.Secondary Outcome
Title Participants With Satisfactory Response According to IGA
Hide Description “Satisfactory response” was defined as participants classified as “Clear” or “Almost Clear” or “Mild” according to the IGA.
Time Frame At end of treatment (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description:
Placebo: Oral solution
LEO 22811 0.5 mg: Oral solution
LEO 22811 1.5 mg: Oral solution
LEO 22811 3.0 mg: Oral solution
Overall Number of Participants Analyzed 14 16 15 18
Measure Type: Count of Participants
Unit of Measure: Participants
Satisfactory
2
  14.3%
1
   6.3%
1
   6.7%
2
  11.1%
Unsatisfactory
12
  85.7%
15
  93.8%
14
  93.3%
16
  88.9%
Time Frame From Day 0 to Follow-up (Day 122 + 28±2 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Hide Arm/Group Description Placebo: Oral solution LEO 22811 0.5 mg: Oral solution LEO 22811 1.5 mg: Oral solution LEO 22811 3.0 mg: Oral solution
All-Cause Mortality
Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/18 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      1/16 (6.25%)      1/15 (6.67%)      0/18 (0.00%)    
Renal and urinary disorders         
Proteinurea * 1  0/14 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/18 (0.00%)  0
Reproductive system and breast disorders         
Prostatitis * 1  0/14 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA (6.1)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo LEO 22811 0.5 mg LEO 22811 1.5 mg LEO 22811 3.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/14 (71.43%)      11/16 (68.75%)      11/15 (73.33%)      15/18 (83.33%)    
Cardiac disorders         
Myocardial ischaemia * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Sinus tachycardia * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Eye disorders         
Keratoconjunctivitis sicca * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Visual disturbance * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  3/18 (16.67%) 
Abdominal pain upper * 1  0/14 (0.00%)  1/16 (6.25%)  1/15 (6.67%)  0/18 (0.00%) 
Aphthous stomatitis * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
Diarrhoea * 1  3/14 (21.43%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Duodenal ulcer * 1  0/14 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Dyspepsia * 1  1/14 (7.14%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Gastrooesophageal reflux disease * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
General disorders         
Asthenia * 1  0/14 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  2/18 (11.11%) 
Chest pain * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Fatigue * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Influenza like illness * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Infections and infestations         
Bacillary angiomatosis * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Bronchitis * 1  0/14 (0.00%)  2/16 (12.50%)  0/15 (0.00%)  0/18 (0.00%) 
Ear infection * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Folliculitis * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
Furuncle * 1  1/14 (7.14%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
Gastrointestinal fungal infection * 1  0/14 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Gingival infection * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Herpes simplex * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Herpes zoster * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Nasopharyngitis * 1  3/14 (21.43%)  1/16 (6.25%)  3/15 (20.00%)  2/18 (11.11%) 
Otitis externa * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Pharyngitis * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
Tooth abscess * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Upper respiratory tract infection * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Vaginal mycosis * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Investigations         
Alanine aminotransferase increased * 1  1/14 (7.14%)  1/16 (6.25%)  1/15 (6.67%)  1/18 (5.56%) 
Aspartate aminotransferase increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Blood alkaline phosphatase increased * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Blood testosterone decreased * 1  0/14 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Blood triglycerides increased * 1  2/14 (14.29%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
C-reactive protein increased * 1  2/14 (14.29%)  3/16 (18.75%)  0/15 (0.00%)  2/18 (11.11%) 
Electrocardiogram normal * 1  1/14 (7.14%)  0/16 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Gamma-glutamyltransferase increased * 1  1/14 (7.14%)  2/16 (12.50%)  1/15 (6.67%)  1/18 (5.56%) 
Low density lipoprotein increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Lymphocyte count decreased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Lymphocyte count increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Mean cell volume increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Neutrophil count increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Platelet count increased * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
White blood cell count increased * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  2/18 (11.11%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Hypercholesterolaemia * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Back pain * 1  0/14 (0.00%)  1/16 (6.25%)  1/15 (6.67%)  0/18 (0.00%) 
Ganglion * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Musculoskeletal chest pain * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Psoriatic arthropathy * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Nervous system disorders         
Amnesia * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Dizziness * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  2/18 (11.11%) 
Headache * 1  1/14 (7.14%)  0/16 (0.00%)  0/15 (0.00%)  4/18 (22.22%) 
Migraine * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Tremor * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  2/18 (11.11%) 
Psychiatric disorders         
Affective disorder * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Anxiety * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Insomnia * 1  2/14 (14.29%)  0/16 (0.00%)  0/15 (0.00%)  0/18 (0.00%) 
Libido decreased * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Stress symptoms * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders         
Glycosuria * 1  0/14 (0.00%)  0/16 (0.00%)  1/15 (6.67%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/14 (7.14%)  0/16 (0.00%)  1/15 (6.67%)  1/18 (5.56%) 
Nasal congestion * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  1/18 (5.56%) 
Pharyngolaryngeal pain * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders         
Acne * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Dermatitis acneiform * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Eczema * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Hyperhidrosis * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Ingrowing nail * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Pain of skin * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Pruritus * 1  1/14 (7.14%)  2/16 (12.50%)  1/15 (6.67%)  3/18 (16.67%) 
Psoriasis * 1  0/14 (0.00%)  2/16 (12.50%)  4/15 (26.67%)  3/18 (16.67%) 
Rash * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Rash maculo-papular * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
Rash papular * 1  0/14 (0.00%)  0/16 (0.00%)  0/15 (0.00%)  1/18 (5.56%) 
Skin fissures * 1  0/14 (0.00%)  1/16 (6.25%)  0/15 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA (6.1)
*
Indicates events were collected by non-systematic assessment
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.
Individual publications or presentations of data by one or more Investigator(s) shall not be made before the results of the joint publication have been made public. The company retains the right to have any publication submitted to the company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
Phone: +45 4494 5888
EMail: disclosure@leo-pharma.com
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01116895     History of Changes
Other Study ID Numbers: LEO 22811-S22
First Submitted: May 4, 2010
First Posted: May 5, 2010
Results First Submitted: February 19, 2018
Results First Posted: October 3, 2018
Last Update Posted: December 20, 2018