A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03404206
Collaborator
(none)
387
1
3
4.9
79.6
Study Details
Study Description
Brief Summary
To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
387 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Actual Study Start Date
:
Feb 12, 2018
Actual Primary Completion Date
:
Jul 6, 2018
Actual Study Completion Date
:
Jul 10, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naproxen Sodium (Aleve, BAY117031) Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization |
Drug: Naproxen Sodium (Aleve, BAY117031)
220 mg x 2 tablets, oral, single dose
|
| Active Comparator: Ibuprofen (Advil) Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization |
Drug: Ibuprofen (Advil)
200 mg x 2 tablets, oral, single dose
|
| Placebo Comparator: Placebo Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
Drug: Placebo
Matching placebo, 2 tablets, oral, single dose
|
Outcome Measures
Primary Outcome Measures
- Time to First Use of Rescue Medication [Up to 24 hours]
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
Secondary Outcome Measures
- Sum of Pain Intensity Difference (SPID) [Up to 24 hours]
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
- Total Pain Relief (TOTPAR) [Up to 24 hours]
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Healthy, ambulatory, male or female volunteers 16-40 years of age;
-
Body mass index 18.0 to 30.0 kg/m^2 inclusive;
-
Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
-
Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;
Exclusion Criteria:
-
History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
-
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
-
Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jean Brown Research | Salt Lake City | Utah | United States | 84124 |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
- Click here to find results for studies related to Bayer products
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03404206
Other Study ID Numbers:
- 19762
- 2017-005049-67
First Posted:
Jan 19, 2018
Last Update Posted:
Jul 18, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Bayer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at one center in the United States, between 12 February 2018 (first patient first visit) and 10 July 2018 (last patient last visit). |
|---|---|
| Pre-assignment Detail | Overall, 387 participants completed surgical teeth extraction, and all of them were randomized and received the treatment. |
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Ibuprofen (Advil) | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| Period Title: Overall Study | |||
| STARTED | 166 | 166 | 55 |
| COMPLETED | 162 | 164 | 55 |
| NOT COMPLETED | 4 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Ibuprofen (Advil) | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization | Total of all reporting groups |
| Overall Participants | 166 | 166 | 55 | 387 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
19.0
(2.96)
|
19.0
(2.62)
|
19.0
(2.91)
|
19.0
(2.80)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
77
46.4%
|
89
53.6%
|
30
54.5%
|
196
50.6%
|
| Male |
89
53.6%
|
77
46.4%
|
25
45.5%
|
191
49.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
23
13.9%
|
25
15.1%
|
10
18.2%
|
58
15%
|
| Not Hispanic or Latino |
143
86.1%
|
141
84.9%
|
45
81.8%
|
329
85%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
148
89.2%
|
148
89.2%
|
48
87.3%
|
344
88.9%
|
| Black or African American |
2
1.2%
|
4
2.4%
|
1
1.8%
|
7
1.8%
|
| American Indian or Alaska Native |
3
1.8%
|
4
2.4%
|
2
3.6%
|
9
2.3%
|
| Asian |
1
0.6%
|
2
1.2%
|
1
1.8%
|
4
1%
|
| Native Hawaiian or Other Pacific Islander |
1
0.6%
|
3
1.8%
|
1
1.8%
|
5
1.3%
|
| Other |
11
6.6%
|
5
3%
|
2
3.6%
|
18
4.7%
|
| Pain Intensity Score (Count of Participants) | ||||
| No Pain (0) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Mild Pain (1) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Moderate Pain (2) |
69
41.6%
|
67
40.4%
|
23
41.8%
|
159
41.1%
|
| Severe Pain (3) |
97
58.4%
|
99
59.6%
|
32
58.2%
|
228
58.9%
|
Outcome Measures
| Title | Time to First Use of Rescue Medication |
|---|---|
| Description | Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. |
| Time Frame | Up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol population |
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Ibuprofen (Advil) | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| Measure Participants | 166 | 165 | 54 |
| Minimum |
1.22
|
1.22
|
1.18
|
| 25th Percentile |
11.017
|
8.267
|
2.117
|
| 50th Percentile |
NA
|
10.533
|
2.533
|
| 75th Percentile |
NA
|
14.117
|
12.100
|
| Maximum |
22.17
|
18.28
|
21.75
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Ibuprofen (Advil) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Sum of Pain Intensity Difference (SPID) |
|---|---|
| Description | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. |
| Time Frame | Up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol population |
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Ibuprofen (Advil) | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| Measure Participants | 166 | 165 | 54 |
| Mean (Standard Deviation) [Scores on a scale * hours] |
83.29
(57.177)
|
48.54
(40.705)
|
9.96
(58.197)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Ibuprofen (Advil) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -34.73 | |
| Confidence Interval |
(2-Sided) 95% -45.67 to -23.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -73.43 | |
| Confidence Interval |
(2-Sided) 95% -89.01 to -57.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen (Advil), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -38.7 | |
| Confidence Interval |
(2-Sided) 95% -54.29 to -23.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Total Pain Relief (TOTPAR) |
|---|---|
| Description | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. |
| Time Frame | Up to 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol population |
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Ibuprofen (Advil) | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| Measure Participants | 166 | 165 | 54 |
| Mean (Standard Deviation) [Scores on a scale * hours] |
47.16
(28.228)
|
28.96
(21.097)
|
13.40
(23.328)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Ibuprofen (Advil) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -18.21 | |
| Confidence Interval |
(2-Sided) 95% -23.52 to -12.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Naproxen Sodium (Aleve, BAY117031), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -33.72 | |
| Confidence Interval |
(2-Sided) 95% -41.29 to -26.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen (Advil), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least squares means |
| Estimated Value | -15.51 | |
| Confidence Interval |
(2-Sided) 95% -23.09 to -7.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From start of study drug up to 10 days after the administration of study drug | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Naproxen Sodium (Aleve, BAY117031) | Placebo | Ibuprofen (Advil) | |||
| Arm/Group Description | Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization | Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | |||
All Cause Mortality |
||||||
| Naproxen Sodium (Aleve, BAY117031) | Placebo | Ibuprofen (Advil) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/166 (0%) | 0/55 (0%) | 0/166 (0%) | |||
Serious Adverse Events |
||||||
| Naproxen Sodium (Aleve, BAY117031) | Placebo | Ibuprofen (Advil) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/166 (0.6%) | 0/55 (0%) | 0/166 (0%) | |||
| Infections and infestations | ||||||
| Appendicitis | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Naproxen Sodium (Aleve, BAY117031) | Placebo | Ibuprofen (Advil) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/166 (15.1%) | 16/55 (29.1%) | 31/166 (18.7%) | |||
| Ear and labyrinth disorders | ||||||
| Ear pain | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Eye disorders | ||||||
| Eye pain | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Eye swelling | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Abdominal pain upper | 0/166 (0%) | 0 | 1/55 (1.8%) | 1 | 0/166 (0%) | 0 |
| Aphthous ulcer | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Breath odour | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Constipation | 0/166 (0%) | 0 | 1/55 (1.8%) | 1 | 0/166 (0%) | 0 |
| Nausea | 9/166 (5.4%) | 10 | 11/55 (20%) | 12 | 17/166 (10.2%) | 20 |
| Paraesthesia oral | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Vomiting | 1/166 (0.6%) | 1 | 7/55 (12.7%) | 10 | 7/166 (4.2%) | 9 |
| General disorders | ||||||
| Pyrexia | 0/166 (0%) | 0 | 1/55 (1.8%) | 1 | 1/166 (0.6%) | 1 |
| Immune system disorders | ||||||
| Hypersensitivity | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Infections and infestations | ||||||
| Alveolar osteitis | 4/166 (2.4%) | 4 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Ear infection | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Periodontitis | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Pharyngitis streptococcal | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Upper respiratory tract infection | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Incision site pain | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Pain in extremity | 0/166 (0%) | 0 | 1/55 (1.8%) | 1 | 0/166 (0%) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 4/166 (2.4%) | 5 | 1/55 (1.8%) | 1 | 5/166 (3%) | 5 |
| Headache | 3/166 (1.8%) | 3 | 7/55 (12.7%) | 7 | 6/166 (3.6%) | 6 |
| Paraesthesia | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Tremor | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Psychiatric disorders | ||||||
| Nervousness | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Epistaxis | 1/166 (0.6%) | 1 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
| Oropharyngeal pain | 2/166 (1.2%) | 2 | 0/55 (0%) | 0 | 0/166 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Urticaria | 0/166 (0%) | 0 | 0/55 (0%) | 0 | 1/166 (0.6%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Bayer |
| Phone | 1-888-8422937 |
| clinical-trials-contact@bayer.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03404206
Other Study ID Numbers:
- 19762
- 2017-005049-67
First Posted:
Jan 19, 2018
Last Update Posted:
Jul 18, 2019
Last Verified:
Jun 1, 2019