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Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex® (dexamethasone intravitreal implant) | dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant | Drug | dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Macular Oedema due to Retinal Vein Occlusion
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27286894 | Derived | Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2307-2318. doi: 10.1007/s00417-016-3394-y. Epub 2016 Jun 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex® (Dexamethasone Intravitreal Implant) | dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex® (Dexamethasone Intravitreal Implant) | dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. |
| 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 | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. | All enrolled patients | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
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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 | Ozurdex® (Dexamethasone Intravitreal Implant) | dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Hypertension | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Hypertension | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®. | Baseline, Month 6 |
| Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study. | Baseline, Month 6 |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. | Baseline, Week 6, Month 4, Month 12, Month 18, Month 24 |
| Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | Baseline, Month 24 |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO) | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina. | All enrolled patients with BRVO | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO) | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina. | All enrolled patients with CRVO | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
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|
|
| Secondary | Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion. | All enrolled patients who were treatment naïve | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex® | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®. | All enrolled patients previously treated with Ozurdex® | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion. | All enrolled patients previously naïve to Ozurdex® treatment | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment. | All enrolled patients with macular edema onset <3 months | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment. | All enrolled patients with macular edema onset ≥3 months | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex® | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®. | All enrolled patients only treated with Ozurdex | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study. | All enrolled patients receiving Ozurdex® and then other RVO treatments | Posted | Mean | Standard Deviation | Letters | Baseline, Month 6 |
|
|
|
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. | All enrolled patients | Posted | Mean | Standard Deviation | Letters | Baseline, Week 6, Month 4, Month 12, Month 18, Month 24 |
|
|
|
| Secondary | Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye | BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening. | All enrolled patients | Posted | Number | Percentage of Patients | Baseline, Month 24 |
|
|
|
| 98 |
| 375 |
| 252 |
| 375 |
| Cataract | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Cataract Surgery | Surgical and medical procedures | MedDRA version 16.1 | Systematic Assessment |
|
| Vitreous Haemorrhage | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Macular Fibrosis | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA version 16.1 | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Subscapular Cataract | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Sudden Falls Due to Legs Giving Way | Nervous system disorders | MedDRA version 16.1 | Non-systematic Assessment |
|
| Diabetes | Metabolism and nutrition disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Detached Retina | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Cardiopulmonary Arrest | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Macular Degeneration | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA version 16.1 | Systematic Assessment | MALES ONLY |
|
| Infarction | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Pulmonary Infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Retinal Ischaemia | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Herpetic Keratitis | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
|
| Acute Pancreatitis | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Coronary Artery Bypass | Surgical and medical procedures | MedDRA version 16.1 | Systematic Assessment |
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| Pulmonary Arterial Thrombosis | Vascular disorders | MedDRA version 16.1 | Systematic Assessment |
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| Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Prostate tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment | MALES ONLY |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D020246 |
| Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| Title | Measurements |
|---|---|
|
| Change from Baseline at Month 12 (N=306) |
|
| Change from Baseline at Month 18 (N=287) |
|
| Change from Baseline at Month 24 (N=274) |
|