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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005272-28 | EudraCT Number |
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The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Experimental | 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
|
| Naproxen Sodium IR (Aleve, BAYH6689) | Active Comparator | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) |
|
| Placebo | Placebo Comparator | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Drug | 660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. | From 0 to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Summed, Time-weighted Pain Intensity Differences (SPID) | Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26588111 | Derived | Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Sodium ER (BAYH6689) | 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
| FG001 | Naproxen Sodium IR (Aleve, BAYH6689) | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) |
| FG002 | Placebo | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Sodium ER (BAYH6689) | 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) | SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. | Intent-to-treat (ITT) | Posted | Mean | Standard Error | Score on the scale | From 0 to 24 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen Sodium ER (BAYH6689) | 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Medical Affairs | Bayer HealthCare LLC, Consumer Care | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Naproxen Sodium IR (Aleve, BAYH6689) | Drug | 220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours |
|
| Naproxen Sodium ER Placebo | Drug | Matching placebo of 660 mg Naproxen Sodium ER for 24 hours |
|
| Naproxen Sodium IR Placebo | Drug | Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours |
|
| 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose |
| Summed, Time-weighted Total Pain Relief Scores (TOTPARs) | TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24. | 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose |
| Pain Intensity Differences (PIDs) by Time From Initial Dose | Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe | At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
| Pain Relief From Initial Dose | Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
| Median Time to First Intake of Rescue Medication | Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group. | Up to 24 hours postdose |
| Cumulative Percentage of Participants Who Took Rescue Medication | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
| Number of Times the Participants Took Rescue Medication Over the 24-hour Period | 24 hours postdose |
| Global Assessment of the Investigational Product as a Pain Reliever | Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent | 24 hours postdose or immediately before the first intake of rescue medication |
| Naproxen Sodium IR (Aleve, BAYH6689) |
1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) |
| BG002 | Placebo | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Intensity Score | Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe | Number | Participants |
|
| OG001 | Naproxen Sodium IR (Aleve, BAYH6689) | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) |
| OG002 | Placebo | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) |
|
|
| Secondary | Summed, Time-weighted Pain Intensity Differences (SPID) | Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. | Intent-to-treat (ITT) | Posted | Mean | 95% Confidence Interval | Score on the scale | 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose |
|
|
|
| Secondary | Summed, Time-weighted Total Pain Relief Scores (TOTPARs) | TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24. | Intent-to-treat (ITT) | Posted | Mean | 95% Confidence Interval | Score on the scale | 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose |
|
|
|
| Secondary | Pain Intensity Differences (PIDs) by Time From Initial Dose | Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe | Intent-to-treat (ITT) | Posted | Mean | 95% Confidence Interval | Score on the scale | At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
|
|
|
| Secondary | Pain Relief From Initial Dose | Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | Score on the scale | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
|
|
|
| Secondary | Median Time to First Intake of Rescue Medication | Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group. | Intent-to-treat (ITT) | Posted | Median | Full Range | Hours | Up to 24 hours postdose |
|
|
|
| Secondary | Cumulative Percentage of Participants Who Took Rescue Medication | Intent-to-treat (ITT) | Posted | Number | Percentage of participants | At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose |
|
|
|
| Secondary | Number of Times the Participants Took Rescue Medication Over the 24-hour Period | Intent-to-treat (ITT) | Posted | Mean | Standard Deviation | Rescue medication intakes | 24 hours postdose |
|
|
|
| Secondary | Global Assessment of the Investigational Product as a Pain Reliever | Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent | Intent-to-treat (ITT) | Posted | Number | Participants | 24 hours postdose or immediately before the first intake of rescue medication |
|
|
|
| 0 |
| 120 |
| 28 |
| 120 |
| EG001 | Naproxen Sodium IR (Aleve, BAYH6689) | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) | 0 | 120 | 36 | 120 |
| EG002 | Placebo | 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) | 0 | 60 | 23 | 60 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
|
| From 0 to 12 hours, LS Mean |
|
| From 0 to 16 hours, LS Mean |
|
| From 16 to 24 hours, LS Mean |
|
|
| From 0 to 12 hours |
|
| From 0 to 16 hours |
|
| From 0 to 24 hours |
|
| From 16 to 24 hours |
|
|
| 0.75 hours, LS Mean |
|
| 1 hours, LS Mean |
|
| 2 hours, LS Mean |
|
| 3 hours, LS Mean |
|
| 4 hours, LS Mean |
|
| 5 hours, LS Mean |
|
| 6 hours, LS Mean |
|
| 8 hours, LS Mean |
|
| 12 hours, LS Mean |
|
| 16 hours, LS Mean |
|
| 20 hours, LS Mean |
|
| 24 hours, LS Mean |
|
|
| 0.75 hours |
|
| 1 hour |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 8 hours |
|
| 12 hours |
|
| 16 hours |
|
| 20 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| 0.75 hours |
|
| 1 hour |
|
| 2 hours |
|
| 3 hours |
|
| 4 hours |
|
| 5 hours |
|
| 6 hours |
|
| 8 hours |
|
| 12 hours |
|
| 16 hours |
|
| 20 hours |
|
| 24 hours |
|
| Title | Measurements |
|---|---|
|
| 2 - Good |
|
| 3 - Very good |
|
| 4 - Excellent |
|