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Trial record 56 of 108 for:    CALCIUM CATION

Trial of Verapamil in Chronic Rhinosinusitis

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: NCT02454608
Recruitment Status : Terminated (Evidence that the dose is insufficient.)
First Posted : May 27, 2015
Results First Posted : December 28, 2016
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin Bleier, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sinusitis
Nasal Polyps
Interventions Drug: Verapamil HCl
Other: Placebo
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control Open Label
Hide Arm/Group Description

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Period Title: Double-Blind Period
Started 15 14 0 [1]
Completed 15 12 0 [1]
Not Completed 0 2 0
Reason Not Completed
Lack of Efficacy             0             2             0
[1]
This arm is not part of this period of the study
Period Title: Open Label Period
Started 0 [1] 0 [1] 29
Completed 0 [1] 0 [1] 10
Not Completed 0 0 19
Reason Not Completed
Lost to Follow-up             0             0             11
Withdrawal by Subject             0             0             8
[1]
This arm is not part of this period of the study
Arm/Group Title Treatment Control Open Label Total
Hide Arm/Group Description

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 29 49
Hide Baseline Analysis Population Description
Intention-to-treat analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 29 participants 49 participants
49.1  (14.7) 48.4  (11.3) 47.8  (11.7) 48.7  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 29 participants 49 participants
Female
4
  40.0%
4
  40.0%
10
  34.5%
18
  36.7%
Male
6
  60.0%
6
  60.0%
19
  65.5%
31
  63.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 29 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  10.0%
1
   3.4%
2
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
0
   0.0%
2
   6.9%
4
   8.2%
White
7
  70.0%
8
  80.0%
24
  82.8%
39
  79.6%
More than one race
1
  10.0%
1
  10.0%
2
   6.9%
4
   8.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 29 participants 49 participants
10 10 29 49
1.Primary Outcome
Title Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Hide Description Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome
Time Frame baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-27.3  (7.52) 0.4  (7.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Hide Description Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.
Time Frame baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-44.03  (7.66) -6.07  (7.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)
Hide Description Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome
Time Frame baseline to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Open Label
Hide Arm/Group Description:
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Overall Number of Participants Analyzed 29
Mean (Standard Error)
Unit of Measure: units on a scale
Medicine Completers, baseline Number Analyzed 7 participants
31.8  (5.24)
Medicine Completers, week 56 Number Analyzed 7 participants
24.14  (6.17)
Surgical Completers, baseline Number Analyzed 3 participants
72.00  (4.58)
Surgical Completers, week 12 Number Analyzed 3 participants
8.00  (2.08)
4.Primary Outcome
Title Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)
Hide Description Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.
Time Frame baseline to week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Open Label
Hide Arm/Group Description:
Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year
Overall Number of Participants Analyzed 29
Mean (Standard Error)
Unit of Measure: units on a scale
Medicine Completers, baseline Number Analyzed 7 participants
64.3  (7.5)
Medicine Completers, week 56 Number Analyzed 7 participants
35.0  (9.2)
Surgical Completers, baseline Number Analyzed 3 participants
90.0  (5.8)
Surgical Completers, week 12 Number Analyzed 3 participants
16.7  (6.7)
5.Secondary Outcome
Title Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)
Hide Description Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.
Time Frame baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.3  (0.63) -0.25  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Objective Sinonasal Symptoms on Lund-McKay Score(LMS)
Hide Description Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.5  (4.4) 17.7  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame Mean change between baseline and week 8 measurements.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.4  (9.16) 4  (30.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Systolic Blood Pressure
Hide Description [Not Specified]
Time Frame Mean change between baseline and week 8 measurements
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
-4.5  (13.2) -6.6  (19.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Diastolic Blood Pressure
Hide Description [Not Specified]
Time Frame Mean change between baseline and week 8 measurements
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.6  (10.26) 1  (7.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control Open Label
Hide Arm/Group Description

Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

Placebo, capsules for oral administration, TID, for 8 weeks

Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl.

Verapamil HCl, capsules for oral administration, 80mg, TID, for 1 year

Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.

All-Cause Mortality
Treatment Control Open Label
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Control Open Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Control Open Label
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      5/10 (50.00%)      18/29 (62.07%)    
Cardiac disorders       
Slow, Fast or Irregular Heart Rate *  2/10 (20.00%)  2 1/10 (10.00%)  1 2/29 (6.90%)  3
Ear and labyrinth disorders       
Dizziness *  4/10 (40.00%)  4 3/10 (30.00%)  3 2/29 (6.90%)  2
Gastrointestinal disorders       
Constipation *  6/10 (60.00%)  6 1/10 (10.00%)  1 8/29 (27.59%)  10
Heartburn *  2/10 (20.00%)  2 2/10 (20.00%)  2 5/29 (17.24%)  6
Abdominal Pain *  0/10 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  2
General disorders       
Acute Sinusitis *  3/10 (30.00%)  3 4/10 (40.00%)  4 0/29 (0.00%)  0
Swelling of Hands or Feet *  3/10 (30.00%)  3 0/10 (0.00%)  0 2/29 (6.90%)  2
Lightheadedness *  5/10 (50.00%)  5 2/10 (20.00%)  2 2/29 (6.90%)  2
Headache *  3/10 (30.00%)  3 2/10 (20.00%)  2 6/29 (20.69%)  6
Fainting *  0/10 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Blurred Vision *  2/10 (20.00%)  2 0/10 (0.00%)  0 0/29 (0.00%)  0
Nausea *  3/10 (30.00%)  3 0/10 (0.00%)  0 3/29 (10.34%)  3
Tiredness *  5/10 (50.00%)  5 2/10 (20.00%)  2 6/29 (20.69%)  6
Hepatobiliary disorders       
Yellow Eyes or Skin *  0/10 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash *  1/10 (10.00%)  1 0/10 (0.00%)  0 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin Bleier
Organization: Massachusetts Eye and Ear Infirmary
Phone: (617) 573-6966
EMail: Benjamin_Bleier@MEEI.HARVARD.EDU
Publications:
Layout table for additonal information
Responsible Party: Benjamin Bleier, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02454608     History of Changes
Other Study ID Numbers: 15-009H
First Submitted: May 11, 2015
First Posted: May 27, 2015
Results First Submitted: August 29, 2016
Results First Posted: December 28, 2016
Last Update Posted: June 14, 2018