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To investigate the safety of long term administration of E2080 in the patients with Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rufinamide | Experimental | Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rufinamide | Drug | The target dosage is approximately 45 mg/kg/day, taken orally twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide | Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect. | From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency". The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period. |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroki Takano | Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
Participants who successfully completed Study 304 were enrolled into this study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rufinamide | Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all treated participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rufinamide | Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period. |
| 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 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide | Safety was assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, blood pressure, pulse rate, physical examination, and 12-lead electrocardiogram (ECG). Treatment-emergent adverse events (TEAEs) were defined as AEs that started on or after the date and time of administration of first dose of test drug, but not later than 30 days after discontinuation from the study, or if the AE was present prior to the administration of the first dose of test drug and increased in National Cancer Institute Common Toxicity Criteria (NCI CTC version 3.0) grade during the study or 30 days after discontinuation from the study. AEs were considered serious if it resulted in; death, was life-threatening, hospitalization/prolonged hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect. | Safety analysis set included all treated participants. | Posted | Number | Participants | From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months |
From date of first dose up to 15 days after the last dose of study treatment, up to approximately 2 years and 10 months
Safety analysis set included all treated participants.
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 | Rufinamide | Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Customer Joy Department. EJ | Eisai Co., Ltd. | 8133817-3700 | _ML_CLNCL@hhc.eisai.co.jp |
Not provided
| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C079703 | rufinamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
| Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days) | Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. | Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
| Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures | Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner. | Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
| Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders) | Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used. | Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
| Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency | Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used. | Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
| Matsuyama |
| Ehime |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Yokohama | Kanagawa | Japan |
| Goshi^shi | Kumamoto | Japan |
| Iwanuma-shi | Miyagi | Japan |
| Ōmura | Nagasaki | Japan |
| Nara | Nara | Japan |
| Niigata | Niigata | Japan |
| Yufu-shi | Oita Prefecture | Japan |
| Neyagawa | Osaka | Japan |
| Osaka | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Moriyama-shi | Shiga | Japan |
| Shizuoka | Shizuoka | Japan |
| Kodaira | Tokyo | Japan |
| Kokubunji-shi | Tokyo | Japan |
| Shinjuku | Tokyo | Japan |
| Toyoma-shi | Toyama | Japan |
| Okayama | Japan |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Rufinamide | Ralfinamide was administered orally twice daily after breakfast and dinner. Participants on placebo in Study 304 were titrated over to rufinamide within 2 weeks during the Conversion Period. As a general rule, the dose of rufinamide at the end of the Conversion Period was maintained throughout the Maintenance Period. |
|
|
| Secondary | Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency". The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period in Study 304 as the baseline and the tonic-atonic seizure frequency at Weeks 12, 24, 32, 40, 52 and Week 52 Last Observation Carried Forward (LOCF) as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period. | Efficacy Analysis Set included all participants with evaluable efficacy data. | Posted | Median | Full Range | Percent Change in Seizure Frequency | Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
|
|
|
| Secondary | Percent Change in the Total Seizure Frequency From Baseline (Per 28 Days) | Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period of Study 304 as the baseline and the total seizure frequency per 28 days at Weeks 12, 24, 32, 40, 52 and Week 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. | Efficacy Analysis Set included all participants with evaluable efficacy data. | Posted | Median | Full Range | Percent Change in Seizure Frequency | Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
|
|
|
| Secondary | Percent Change in the Frequency of Seizures Other Than Tonic-Atonic Seizures | Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Weeks, 12, 24, 32, 40, 52 and 52 LOCF as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure frequency, Absence seizure, Atypical absence seizure, Myoclonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, and Unclassified epileptic seizure. This data was based on the diary data collected for 7 days after each visit. Seizure frequency was counted based on the classification established by the ILAE. The diary recorder monitored the participant and recorded the seizure diary in a consistent manner. | Efficacy Analysis Set included all participants with evaluable efficacy data. | Posted | Median | Full Range | Percent Change in Seizure Frequency | Baseline (Observation period in Study 304), Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
|
|
|
| Secondary | Percentage of Participants Who Achieved 100%, 75%, 50% or 25% Reduction in Tonic-Atonic Seizure Frequency (Responders) | Categorized percent change in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used. | Efficacy Analysis Set included all participants with evaluable efficacy data. | Posted | Number | Percentage of participants | Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
|
|
|
| Secondary | Percentage of Participants With An Increase In Tonic-Atonic Seizure Frequency | Number of participants with an increase in Tonic-atonic seizure frequency per 28 Days by visit relative to the baseline (Observation Phase in Study 304) was determined based on the diary data collected for 7 days after each visit. The Efficacy Analysis Set was used. | Efficacy Analysis Set included all participants with evaluable efficacy data. | Posted | Number | Percentage of participants | Week 12, Week 24, Week 32, Week 40, Week 52 and Week 52 LOCF |
|
|
|
| 0 |
| 54 |
| 9 |
| 54 |
| 54 |
| 54 |
| Status epilepticus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Percent Change in Week 32 |
|
|
| Percent Change in Week 40 |
|
|
| Percent Change in Week 52 |
|
|
| Percent Change in Week 52 LOCF |
|
|
|
| Percent Change in Week 32 |
|
|
| Percent Change in Week 40 |
|
|
| Percent Change in Week 52 |
|
|
| Percent Change in Week 52 LOCF |
|
|
|
| Partial Seizure Week 32 |
|
|
| Partial Seizure Week 40 |
|
|
| Partial Seizure Week 52 |
|
|
| Partial Seizure Week 52 LOCF |
|
|
| Absence Seizure Week 12 |
|
|
| Absence Seizure Week 24 |
|
|
| Absence Seizure Week 32 |
|
|
| Absence Seizure Week 40 |
|
|
| Absence Seizure Week 52 |
|
|
| Absence Seizure Week 52 LOCF |
|
|
| Atypical Absence Seizure Week 12 |
|
|
| Atypical Absence Seizure Week 24 |
|
|
| Atypical Absence Seizure Week 32 |
|
|
| Atypical Absence Seizure Week 40 |
|
|
| Atypical Absence Seizure Week 52 |
|
|
| Atypical Absence Seizure Week 52 LOCF |
|
|
| Myoclonic Seizure Week 12 |
|
|
| Myoclonic Seizure Week 24 |
|
|
| Myoclonic Seizure Week 32 |
|
|
| Myoclonic Seizure Week 40 |
|
|
| Myoclonic Seizure Week 52 |
|
|
| Myoclonic Seizure Week 52 LOCF |
|
|
| Tonic Seizure Week 12 |
|
|
| Tonic Seizure Week 24 |
|
|
| Tonic Seizure Week 32 |
|
|
| Tonic Seizure Week 40 |
|
|
| Tonic Seizure Week 52 |
|
|
| Tonic Seizure Week 52 LOCF |
|
|
| Tonic-clonic Seizure Week 12 |
|
|
| Tonic-clonic Seizure Week 24 |
|
|
| Tonic-clonic Seizure Week 32 |
|
|
| Tonic-clonic Seizure Week 40 |
|
|
| Tonic-clonic Seizure Week 52 |
|
|
| Tonic-clonic Seizure Week 52 LOCF |
|
|
| Atonic Seizure Week 12 |
|
|
| Atonic Seizure Week 24 |
|
|
| Atonic Seizure Week 32 |
|
|
| Atonic Seizure Week 40 |
|
|
| Atonic Seizure Week 52 |
|
|
| Atonic Seizure Week 52 LOCF |
|
|
| Unclassified Seizure Week 12 |
|
|
| Unclassified Seizure Week 24 |
|
|
| Unclassified Seizure Week 32 |
|
|
| Unclassified Seizure Week 40 |
|
|
| Unclassified Seizure Week 52 |
|
|
| Unclassified Seizure Week 52 LOCF |
|
|
| Title | Measurements |
|---|---|
|
| Week 12 75% Reduction - No |
|
| Week 12 50% Reduction - Yes |
|
| Week 12 50% Reduction - No |
|
| Week 12 25% Reduction - Yes |
|
| Week 12 25% Reduction - No |
|
| Week 24 100% Reduction - Yes |
|
| Week 24 100% Reduction - No |
|
| Week 24 75% Reduction - Yes |
|
| Week 24 75% Reduction - No |
|
| Week 24 50% Reduction - Yes |
|
| Week 24 50% Reduction -No |
|
| Week 24 25% Reduction - Yes |
|
| Week 24 25% Reduction - No |
|
| Week 32 100% Reduction - Yes |
|
| Week 32 100% Reduction - No |
|
| Week 32 75% Reduction - Yes |
|
| Week 32 75% Reduction - No |
|
| Week 32 50% Reduction - Yes |
|
| Week 32 50% Reduction - No |
|
| Week 32 25% Reduction - Yes |
|
| Week 32 25% Reduction - No |
|
| Week 40 100% Reduction - Yes |
|
| Week 40 100% Reduction - No |
|
| Week 40 75% Reduction - Yes |
|
| Week 40 75% Reduction - No |
|
| Week 40 50% Reduction - Yes |
|
| Week 40 50% Reduction - No |
|
| Week 40 25% Reduction - Yes |
|
| Week 40 25% Reduction - No |
|
| Week 52 100% Reduction - Yes |
|
| Week 52 100% Reduction - No |
|
| Week 52 75% Reduction - Yes |
|
| Week 52 75% Reduction -No |
|
| Week 52 50% Reduction - Yes |
|
| Week 52 50% Reduction - No |
|
| Week 52 25% Reduction - Yes |
|
| Week 52 25% Reduction - No |
|
| Week 52 (LOCF) 100% Reduction - Yes |
|
| Week 52 (LOCF) 100% Reduction - No |
|
| Week 52 (LOCF) 75% Reduction - Yes |
|
| Week 52 (LOCF) 75% Reduction -No |
|
| Week 52 (LOCF) 50% Reduction - Yes |
|
| Week 52 (LOCF) 50% Reduction - No |
|
| Week 52 (LOCF) 25% Reduction - Yes |
|
| Week 52 (LOCF) 25% Reduction - No |
|
| Title | Measurements |
|---|---|
|
| Week 24 Increase - No |
|
| Week 32 Increase - Yes |
|
| Week 32 Increase - No |
|
| Week 40 Increase - Yes |
|
| Week 40 Increase - No |
|
| Week 52 Increase - Yes |
|
| Week 52 Increase -No |
|
| Week 52 LOCF Increase - Yes |
|
| Week 52 LOCF Increase - No |
|