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| ID | Type | Description | Link |
|---|---|---|---|
| A7501012 |
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Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| asenapine | Experimental |
| |
| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine - Open Label | Drug | Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse or an Impending Relapse | A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary. | time of first relapse up to Day 182 (double blind phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Early Discontinuation for Any Reason | The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse). | time of discontinuation up to Day 182 (double blind phase) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21367356 | Derived | Kane JM, Mackle M, Snow-Adami L, Zhao J, Szegedi A, Panagides J. A randomized placebo-controlled trial of asenapine for the prevention of relapse of schizophrenia after long-term treatment. J Clin Psychiatry. 2011 Mar;72(3):349-55. doi: 10.4088/JCP.10m06306. Epub 2011 Feb 22. |
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Prior to randomization, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). Only subjects who had continued stable presentation of symptoms during this phase were randomized into the double-blind phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase. |
| FG001 | Placebo | Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Time to Relapse or an Impending Relapse | A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary. | ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded. | Posted | Number | relapses | time of first relapse up to Day 182 (double blind phase) |
|
Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled).
During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
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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 | Asenapine | Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSPHAGIA | Gastrointestinal disorders | 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPOAESTHESIA ORAL | Gastrointestinal disorders | 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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| Placebo - Double Blind | Drug | Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks. |
|
| Asenapine - Double Blind | Drug | Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks. |
|
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| OTHER |
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| Placebo |
Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Asenapine |
Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase. |
| OG001 | Placebo | Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase. |
|
|
| Secondary | Time to Early Discontinuation for Any Reason | The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse). | Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial. | Posted | Number | participants | time of discontinuation up to Day 182 (double blind phase) |
|
|
|
| 6 |
| 194 |
| 121 |
| 194 |
| EG001 | Placebo | Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase. | 22 | 192 | 127 | 192 |
| EG002 | Asenapine During Open-Label Phase and Not Randomized | Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase. | 39 | 314 | 170 | 314 |
| INGUINAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | 11.0 | Systematic Assessment |
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| HYPOTHERMIA | General disorders | 11.0 | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | 11.0 | Systematic Assessment |
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| ADNEXITIS | Infections and infestations | 11.0 | Systematic Assessment |
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| APPENDICITIS | Infections and infestations | 11.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | 11.0 | Systematic Assessment |
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| EXTERNAL EAR CELLULITIS | Infections and infestations | 11.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | 11.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | 11.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | 11.0 | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| OVERDOSE | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| RADIUS FRACTURE | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| SPINAL CORD INJURY | Injury, poisoning and procedural complications | 11.0 | Systematic Assessment |
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| BLOOD GLUCOSE DECREASED | Investigations | 11.0 | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | 11.0 | Systematic Assessment |
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| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | 11.0 | Systematic Assessment |
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| HYPOGLYCAEMIA | Metabolism and nutrition disorders | 11.0 | Systematic Assessment |
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| CONVULSION | Nervous system disorders | 11.0 | Systematic Assessment |
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| DISTURBANCE IN ATTENTION | Nervous system disorders | 11.0 | Systematic Assessment |
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| POOR QUALITY SLEEP | Nervous system disorders | 11.0 | Systematic Assessment |
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| TARDIVE DYSKINESIA | Nervous system disorders | 11.0 | Systematic Assessment |
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| UNRESPONSIVE TO STIMULI | Nervous system disorders | 11.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | 11.0 | Systematic Assessment |
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| DEPRESSIVE SYMPTOM | Psychiatric disorders | 11.0 | Systematic Assessment |
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| HALLUCINATION, AUDITORY | Psychiatric disorders | 11.0 | Systematic Assessment |
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| HALLUCINATION, VISUAL | Psychiatric disorders | 11.0 | Systematic Assessment |
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| HOMICIDAL IDEATION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| MAJOR DEPRESSION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| PARANOIA | Psychiatric disorders | 11.0 | Systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SCHIZOPHRENIA, PARANOID TYPE | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SCHIZOPHRENIA, UNDIFFERENTIATED TYPE | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | 11.0 | Systematic Assessment |
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| THINKING ABNORMAL | Psychiatric disorders | 11.0 | Systematic Assessment |
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| BALANOPOSTHITIS | Reproductive system and breast disorders | 11.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | 11.0 | Systematic Assessment |
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| STEVENS-JOHNSON SYNDROME | Skin and subcutaneous tissue disorders | 11.0 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | 11.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | 11.0 | Systematic Assessment |
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| WEIGHT DECREASED | Investigations | 11.0 | Systematic Assessment |
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| WEIGHT INCREASED | Investigations | 11.0 | Systematic Assessment |
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| AKATHISIA | Nervous system disorders | 11.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | 11.0 | Systematic Assessment |
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| PARKINSONISM | Nervous system disorders | 11.0 | Systematic Assessment |
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| SEDATION | Nervous system disorders | 11.0 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | 11.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | 11.0 | Systematic Assessment |
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| DELUSION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| HALLUCINATION | Psychiatric disorders | 11.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | 11.0 | Systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | 11.0 | Systematic Assessment |
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Sponsor will be provided an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
Materials for intended disclosure must be provided to sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, then the disclosure must be delayed for a period not to exceed an additional 60 days.
| Days 15 - 21 (N asenapine = 184; N placebo = 175) |
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| Days 22 - 28 (N asenapine = 181; N placebo = 165) |
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| Days 29 - 35 (N asenapine = 176; N placebo = 154) |
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| Days 36 - 42 (N asenapine = 176; N placebo = 143) |
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| Days 43 - 49 (N asenapine = 173; N placebo = 136) |
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| Days 50 - 56 (N asenapine = 166; N placebo = 129) |
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| Days 57 - 63 (N asenapine = 166; N placebo = 126) |
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| Days 64 - 70 (N asenapine = 163; N placebo = 122) |
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| Days 71 - 77 (N asenapine = 162; N placebo = 120) |
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| Days 78 - 84 (N asenapine = 162; N placebo = 116) |
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| Days 85 - 91 (N asenapine = 158; N placebo = 113) |
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| Days 92 - 98 (N asenapine = 153; N placebo = 105) |
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| Days 99 - 105 (N asenapine = 150; N placebo = 100) |
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| Days 106 - 112 (N asenapine = 150; N placebo = 98) |
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| Days 113 - 119 (N asenapine = 149; N placebo = 97) |
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| Days 120 - 126 (N asenapine = 148; N placebo = 88) |
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| Days 127 - 133 (N asenapine = 148; N placebo = 87) |
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| Days 134 - 140 (N asenapine = 146; N placebo = 86) |
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| Days 141 - 147 (N asenapine = 145; N placebo = 84) |
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| Days 148 - 154 (N asenapine = 142; N placebo = 82) |
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| Days 155 - 161 (N asenapine = 141; N placebo = 78) |
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| Days 162 - 168 (N asenapine = 139; N placebo = 75) |
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| Days 169 - 175 (N asenapine = 137; N placebo = 73) |
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| Days 176 - 182 (N asenapine = 135; N placebo = 71) |
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| Days 183 - 189 (N asenapine = 75; N placebo = 39) |
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| Days 190 - 196 (N asenapine = 9; N placebo = 9) |
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| Days 197 - 203 (N asenapine = 2; N placebo = 2) |
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| Days 204 - 210 (N asenapine = 0; N placebo = 1) |
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