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This study will evaluate the long-term safety and tolerability of rapastinel as an adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel | Experimental | Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel | Drug | Rapastinel pre-filled syringes for IV injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) | The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Harmonex, Inc. |
Not provided
| Label | URL |
|---|---|
| More Information | View source |
Not provided
Patients who either completed the RAP-MD-04 Double-blind Treatment Period (DBTP) or who did not meet criteria to be randomized into the DBTP of RAP-MD-04 and were therefore discontinued from that study were eligible for Study RAP-MD-06.
The study was planned to be terminated when 100 patients had completed the 52-week Open Label Treatment Period (OLTP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapastinel | Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2016 | Dec 6, 2019 |
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| Baseline to 52 Weeks |
| Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS) | The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement. | Baseline to 52 Weeks |
| Dothan |
| Alabama |
| 36303 |
| United States |
| NoesisPharma | Phoenix | Arizona | 85032 | United States |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States |
| California Pharmaceutical Research Institute, Inc | Anaheim | California | 92804 | United States |
| Southern California Research LLC. | Beverly Hills | California | 90036 | United States |
| ATP Clinical Research Inc. | Costa Mesa | California | 92626 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Irvine Center for Clinical Research, Inc | Irvine | California | 92614 | United States |
| Synergy Clinical Research Center of Escondido | Lemon Grove | California | 91945 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Pacific Research Partners; LLC. | Oakland | California | 94607 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Asclepes Research Centers | Panorama City | California | 91402 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| CITrials | Riverside | California | 92506 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| PCSD Feighner Research | San Diego | California | 92108 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc., | Sherman Oaks | California | 91403 | United States |
| Viking Clinical Research | Temecula | California | 92591 | United States |
| Pacific Clinical Research Medical | Upland | California | 91786 | United States |
| MCB Clinical Research Center | Colorado Springs | Colorado | 80910 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Reliable Clinical Research | Hialeah | Florida | 33012 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Innovative Clinical Research, Inc | Lauderhill | Florida | 33319 | United States |
| Innova Clinical Trials Inc. | Miami | Florida | 33145 | United States |
| International Research Associates, LLC | Miami | Florida | 33183 | United States |
| Research Centers of America | Oakland Park | Florida | 33334 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | United States |
| Millenia Psychiatry & Research, Inc | Orlando | Florida | 32839 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| University of South Florida, Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | United States |
| Institute for Advanced Medical Research | Atlanta | Georgia | 30005 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| Iris Research | Smyrna | Georgia | 30080 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| AMR - Baber Research, Inc. | Naperville | Illinois | 60563 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | United States |
| J Gary Booker, MD APMC | Shreveport | Louisiana | 71104 | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | United States |
| Pharmasite Research, Inc | Baltimore | Maryland | 21208 | United States |
| CBH Health | Gaithersburg | Maryland | 20850 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | United States |
| Coastal Research Associates | South Weymouth | Massachusetts | 02190 | United States |
| Adams Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Millennium Psychiatric Associates | St Louis | Missouri | 63141 | United States |
| Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska | 68526 | United States |
| Altea Research | Las Vegas | Nevada | 89102 | United States |
| Healthy Perspectives - Innovative Mental Health Services. PLLC | Nashua | New Hampshire | 03060 | United States |
| Hassman Research Institute, LLC | Berlin | New Jersey | 08009 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Pharmaceutical Research Associates Inc | Marlton | New Jersey | 08053 | United States |
| Global Medical Institute, LLC | Princeton | New Jersey | 08540 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Albuquerque Neuroscience, Inc | Albuquerque | New Mexico | 87109 | United States |
| SPRI Clinical Trials, Inc | Brooklyn | New York | 11235 | United States |
| Bioscience Research | Mount Kisco | New York | 10549 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10022 | United States |
| Eastside Comprehensive Medical Center, LLC | New York | New York | 10128 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Fieve Clinical Research | New York | New York | 10168 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Carolina Clinical Trials, Inc. | Charleston | North Carolina | 29407 | United States |
| New Hope Clinical Research Inc. | Charlotte | North Carolina | 28211 | United States |
| Richard H. Weisler, MD, PA | Raleigh | North Carolina | 27609 | United States |
| Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | 44718 | United States |
| Patient Priority Clinical Site, LLC | Cincinnati | Ohio | 45215 | United States |
| The Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center LLC | Dayton | Ohio | 45417 | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | 44125 | United States |
| Lindner Center of Hope | Mason | Ohio | 45040 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| IPS Research | Oklahoma City | Oklahoma | 73103 | United States |
| Red River Medical Research Center, LLC | Oklahoma City | Oklahoma | 73112 | United States |
| Sooner Clinical Research, Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 20006 | United States |
| Coastal Carolina Research Center, Inc. | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| Donald J. Garcia, Jr., MD, PA | Austin | Texas | 78737 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| Houston Clinical Trials, LLC | Bellaire | Texas | 77401 | United States |
| Relaro Medical Trials | Dallas | Texas | 75243 | United States |
| El Campo Clinical Trials | El Campo | Texas | 77347 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Earle Research | Houston | Texas | 77058 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Family Psychiatry of The Wood | The Woodlands | Texas | 77381 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Psychiatric and Behavioral Solutions | Salt Lake City | Utah | 84105 | United States |
| Pharmaceutical Research Associates, Inc | Salt Lake City | Utah | 84106 | United States |
| Psychiatric Alliance of the Blue Ridge, Inc. | Charlottesville | Virginia | 22903 | United States |
| NorthWest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population consisted of all screened patients who received at least 1 dose of rapastinel during the OLTP of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rapastinel | Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | The Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | The Safety Population consisted of all screened patients who received at least 1 dose of rapastinel during the OLTP of the study. | Posted | Number | Count of Participants | 52 Weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in Brief Psychiatric Rating Scale Positive Symptoms Subscale (BPRS+) | The BPRS+ is a subset of the BPRS that assesses 4 components of the BPRS+ related to the degree of psychosis: Conceptual Disorganization, Suspiciousness, Hallucinatory Behavior, and Unusual Thought Content assessed by the investigator using a 7-point scale ranging from 1=Not Present to 7=Extremely Severe for a total possible score of 0 (best) to 28 (worst). A negative change from Baseline indicates improvement. | The Safety Population consisted of all screened patients who received at least 1 dose of rapastinel during the OLTP of the study. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to 52 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Clinician Administered Dissociative States Scale (CADSS) | The Clinician Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during active dissociative experiences composed of 23 subjective self-reported and 5 objective observer-reported ratings, each scored from 0 (not at all) to 4 (extremely). Only the 23 subjective items will be collected and analyzed. The sum of each of the 23 subjective items was used for a total score of 0-92. A negative change from Baseline indicates improvement. | The Safety Population consisted of all screened patients who received at least 1 dose of rapastinel during the OLTP of the study. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline to 52 Weeks |
|
|
Adverse Events were collected up to 52 weeks during the OLTP.
The Safety Population consisted of all screened patients who received at least 1 dose of rapastinel during the OLTP of the study.
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 | Rapastinel | Rapastinel 450 milligrams (mg) intravenous (IV) open label weekly or every two weeks, based on investigator's discretion for 52 Weeks. | 0 | 617 | 28 | 617 | 285 | 617 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Alcohol use disorder | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gun shot wound | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 21.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2018 | Dec 6, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
|
|