Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.
This study consisted of 16 visits (Screening, Baseline [Day 0], and 14 post-baseline assessment visits) that occurred at 4-week intervals through Week 56. Enrolled subjects were randomized 1:1 to receive ESBA1008 or EYLEA. All subjects received active intravitreal (IVT) injections at baseline with 2 additional loading doses of the assigned investigational product at 4-week intervals (ie, at Weeks 4 and 8) and then received further injections at 8-weeks intervals at Weeks 16, 24, and 32. Subjects in the ESBA1008 group also received an injection at Week 44, while subjects in the EYLEA group also received injections at Weeks 40 and 48. To maintain the study masking, subjects in the ESBA1008 group received sham injections at Weeks 40 and 48 (when the subjects in the EYLEA group received active injections), while subjects in the EYLEA group received a sham injection at Week 44 (when the subjects in the ESBA1008 group received an active injection). All subjects were followed up to Week 56. Week 40 visit was the end of assessment period for the 8-week treatment cycle.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESBA1008 | Experimental | ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
|
| EYLEA | Active Comparator | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESBA1008 solution | Drug | For intravitreal (IVT) injection |
| |
| Aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 | This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA Change From Baseline (No. of Letters) to Week 16 | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, GCRA, Pharma | Alcon Research | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28551167 | Derived | Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, Singerman L. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296-1304. doi: 10.1016/j.ophtha.2017.03.057. Epub 2017 May 24. |
Not provided
Not provided
Of the 173 enrolled, 83 subjects were exited as screen failures prior to randomization. One randomized subject did not receive treatment. Another subject randomized to ESBA 1008 received EYLEA treatment. This reporting group includes all randomized and treated subjects, as treated (ESBA1008: 44 subjects and EYLEA: 45 subjects).
Subjects were recruited from 41 investigational centers located in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ESBA1008 | ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
| FG001 | EYLEA | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with last observation carried forward (LOCF) imputation of missing values.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ESBA1008 | ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
| BG001 | EYLEA | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
| 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 | Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 | This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Week 12 |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 56 weeks). AEs were reported as pre-treatment and treatment-emergent. Ocular AEs are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-treatment | All subjects who consented to participate in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Age-related macular degeneration | Eye disorders | MedDRA (15.0) | Systematic Assessment | ESBA: Two subjects experienced AEs in the non-study eye; EYLEA: One subject experienced an AE in the non-study eye |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Group Lead, GCRA, Pharma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
For intravitreal (IVT) injection |
|
|
| BCVA Change From Baseline (No. of Letters) by Visit | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
| Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 | The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
| Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 | The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis. | Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
| One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month | The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
| One-Month BCVA Changes (No. of Letters) Following Treatment by Visit | The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
| Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis. | Week 36, Week 44, Week 48, Week 56 |
| Central Subfield Thickness (CSFT) Change From Baseline by Visit | CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ESBA1008 |
ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
| OG001 | EYLEA | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
|
|
|
| Secondary | BCVA Change From Baseline (No. of Letters) to Week 16 | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Week 16 |
|
|
|
|
| Secondary | BCVA Change From Baseline (No. of Letters) by Visit | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
|
|
|
| Secondary | Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56 | The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
|
|
|
| Secondary | Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56 | The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
|
|
|
| Secondary | One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month | The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
|
|
|
| Secondary | One-Month BCVA Changes (No. of Letters) Following Treatment by Visit | The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52 |
|
|
|
| Secondary | Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group | BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | letters | Week 36, Week 44, Week 48, Week 56 |
|
|
|
| Secondary | Central Subfield Thickness (CSFT) Change From Baseline by Visit | CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values. | Posted | Mean | Standard Deviation | microns | Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56 |
|
|
|
| 0 |
| 173 |
| 0 |
| 173 |
| EG001 | ESBA 1008 | All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution | 11 | 44 | 22 | 44 |
| EG002 | EYLEA | All subjects who were randomized and received at least 1 IVT injection of Aflibercept | 9 | 45 | 25 | 45 |
| Myocardial ischaemia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia escherichia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Heart rate irregular | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
|
| Cataract | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Macular fibrosis | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (15.0) | Systematic Assessment | ESBA: One subject experienced an AE in the non-study eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (15.0) | Systematic Assessment | ESBA: One subject experienced an AE in the non-study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (15.0) | Systematic Assessment | ESBA: One subject experienced an AE in the non-study eye |
|
| Vitreous detachment | Eye disorders | MedDRA (15.0) | Systematic Assessment | EYLEA: One subject experienced an AE in the non-study eye |
|
| Vitreous floaters | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Change from baseline at Week 8 |
|
| Change from baseline at Week 20 |
|
| Change from baseline at Week 24 |
|
| Change from baseline at Week 28 |
|
| Change from baseline at Week 32 |
|
| Change from baseline at Week 36 |
|
| Change from baseline at Week 40 |
|
| Change from baseline at Week 44 |
|
| Change from baseline at Week 48 |
|
| Change from baseline at Week 52 |
|
| Change from baseline at Week 56 |
|
| Avg Change from baseline over period of Weeks 4-24 |
|
| Avg Change from baseline over period of Weeks 4-40 |
|
| Avg Change from baseline over period of Weeks 4-56 |
|
| Avg Change from Week 12 over period Weeks 16-40 |
|
| Avg Change from Week 12 over period Weeks 16-56 |
|
| Change from Week 28 to Week 32 |
|
| Change from Week 36 to Week 40 |
|
| Change from Week 44 to Week 48 |
|
| Change from Week 48 to Week 52 |
|
| Change from Week 52 to Week 56 |
|
| Change from Week 32 at Week 36 |
|
| Change from Week 40 to Week 44 |
|
| Change from Week 44 to Week 48 |
|
| Change from Week 48 to Week 52 |
|
| Change from baseline at Week 8 |
|
| Change from baseline at Week 12 |
|
| Change from baseline at Week 16 |
|
| Change from baseline at Week 20 |
|
| Change from baseline at Week 24 |
|
| Change from baseline at Week 28 |
|
| Change from baseline at Week 32 |
|
| Change from baseline at Week 36 |
|
| Change from baseline at Week 40 |
|
| Change from baseline at Week 44 |
|
| Change from baseline at Week 48 |
|
| Change from baseline at Week 52 |
|
| Change from baseline at Week 56 |
|