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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| Life Sciences Research Partners | OTHER |
| Frans Van de Werf Fund for Clinical Cardiovascular Research | OTHER |
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In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmaco-invasive strategy | Experimental | Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. |
|
| Standard primary PCI | Active Comparator | Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenecteplase | Drug | Half dose Tenecteplase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Reperfusion | Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI | 30 min post angiogram/PCI |
| Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days | 30 days | |
| Total Stroke | Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion) | 30 days |
| Major Non-intrancranial Bleedings | 30 days |
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Inclusion Criteria:
Age equal or greater than 60 years
Onset of symptoms < 3 hours prior to randomisation
12-lead ECG indicative of an acute STEMI (ST-elevation will be measured from the J point; scale: 1 mm per 0.1 mV):
Informed consent received
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frans Van de Werf, MD, PhD | KU Leuven | Study Chair |
| Paul Armstrong, MD | University of Alberta, Edmonton, Canada | Study Chair |
| Peter Sinnaeve, MD, PhD | UZ Leuven, Belgium | Principal Investigator |
| Robert Welsh, MD | University of Alberta, Edmonton, Canada | Principal Investigator |
| Patrick Goldstein, MD | Lille University Hospital, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital - Cardiology Department | Liverpool | 2170 | Australia | |||
| Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23473396 | Background | Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10. | |
| 25161043 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmaco-invasive Strategy | Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. Tenecteplase: Half dose Tenecteplase Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year. Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 19, 2021 | Sep 20, 2022 |
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| Clopidogrel | Drug | 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year. |
|
| Coronary angiography | Procedure | Coronary angiography followed by PCI or CABG if required, rescue PCI if required |
|
| Primary PCI | Procedure | Primary PCI accoring to local standards |
|
| Campinas |
| Brazil |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Hospital Regional de Antofagasta | Antofagasta | 1240801 | Chile |
| Hospital Comunitario de Mejillones | Mejillones | 1310000 | Chile |
| Hospital de Melipilla | Melipilla | Chile |
| Hospital Regional de Rancagua | Rancagua | 2820000 | Chile |
| SAR Rancagua | Rancagua | 2830945 | Chile |
| Hospital San Juan de Dios | Santiago | 8350488 | Chile |
| Hospital de Talagante | Talagante | 9670468 | Chile |
| Hospital de Tocopilla | Tocopilla | 1340000 | Chile |
| CH Louis Pradel - Hospices civils de Lyon | Bron | 69677 | France |
| CH Cahors - SAMU 46 | Cahors | 46005 | France |
| CH de Chateauroux | Châteauroux | 36019 | France |
| CH Sud Francilien - Service Cardiologie | Corbeil-Essonnes | 91106 | France |
| Centre Hospitalier de Versailles | Le Chesnay | 78157 | France |
| CHRU de Lille | Lille | 59037 | France |
| CH St. Joseph - St Luc - Lyon | Lyon | 69365 | France |
| Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77 | Melun | France |
| Clinque du Pont de Chaume | Montauban | 82000 | France |
| CHU de Rennes | Rennes | France |
| CH Lucien Hussel | Vienne | 38209 | France |
| Hospital Gea Gonzalez | Mexico City | 14080 | Mexico |
| Instituto Nacional de Cardiologia Ignacio Chavez | Mexico City | 14080 | Mexico |
| JZU Blazo Orlandic | Bar | Montenegro |
| General Hospital Danilo the First Cetinje | Cetinje | Montenegro |
| General Hospital of Niksic | Nikšić | Montenegro |
| Clinical Centar of Montenegro | Podgorica | Montenegro |
| Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases" | Kemerovo | Russia |
| State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station | Kemerovo | Russia |
| Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences" | Tomsk | 634012 | Russia |
| Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station | Tomsk | 634059 | Russia |
| State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital" | Tver' | Russia |
| Tver Region State Budgetary Healthcare Institution "Tver Emergency Station" | Tver' | Russia |
| Clinical Center of Serbia, Cardiology Clinic | Belgrade | 11000 | Serbia |
| Military Medical Academy, Clinic for Emergency Internal Medicine | Belgrade | 11000 | Serbia |
| Institute for cardiovascular diseases Dedinje, Cardiovascular research sector | Belgrade | 11040 | Serbia |
| General Hospital Cuprija, Cardiology Department | Ćuprija | 35230 | Serbia |
| General Hospital Jagodina/Intenal Medicine department | Jagodina | 35000 | Serbia |
| Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic | Kamenitz | 21204 | Serbia |
| Clinical Center Kragujevac, Cardiology Clinic | Kragujevac | 34000 | Serbia |
| General Hospital Pancevo/Department of internal medicine - cardiology section | Pančevo | 26000 | Serbia |
| General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section | Smederevo | 11300 | Serbia |
| General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department | Šabac | 15000 | Serbia |
| Opsta bolnica Vrbas, Cardiology Department | Vrbas | Serbia |
| General Hospital Vrsac/Cardiology department with coronary unit | Vršac | 26300 | Serbia |
| Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos | Málaga | 29010 | Spain |
| Hospital de Antequera, Unidad de Cuidados Intensivos | Málaga | 29200 | Spain |
| Hospital Serrania Ronda, Unidad de Cuidados Intensivos | Málaga | 29400 | Spain |
| Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos | Málaga | 29740 | Spain |
| Background |
| Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26. |
| 24916050 | Background | Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10. |
| 26849132 | Background | Sinnaeve PR, Danays T, Bogaerts K, Van de Werf F, Armstrong PW. Drug Treatment of STEMI in the Elderly: Focus on Fibrinolytic Therapy and Insights from the STREAM Trial. Drugs Aging. 2016 Feb;33(2):109-18. doi: 10.1007/s40266-016-0345-6. |
| 41619999 | Derived | Armstrong PW, Zheng Y, Welsh RC, Sinnaeve PR, Van de Werf F, Westerhout CM, Bainey KR. Primary percutaneous coronary intervention within the first hour: Insights from early-treated patients with ST-elevation myocardial infarction. Am Heart J. 2026 May;295:107363. doi: 10.1016/j.ahj.2026.107363. Epub 2026 Jan 29. |
| 39952376 | Derived | Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Temple T, Ly E, Bogaerts K, Sinnaeve P, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-invasive strategy and dosing of tenecteplase in STEMI patients 60 to <75 years: An inter-trial comparison of the STREAM-1 and STREAM-2 trials. Am Heart J. 2025 Jun;284:20-31. doi: 10.1016/j.ahj.2025.02.002. Epub 2025 Feb 12. |
| 39689189 | Derived | Bainey KR, Welsh RC, Zheng Y, Arias-Mendoza A, Ristic AD, Averkov OV, Lambert Y, Kerr Saraiva JF, Sepulveda P, Rosell-Ortiz F, French JK, Music LB, Temple T, Ly E, Bogaerts K, Sinnaeve PR, Danays T, Westerhout CM, Van de Werf F, Armstrong PW; STREAM-2 Investigators. Pharmaco-Invasive Strategy With Half-Dose Tenecteplase in Patients With STEMI: Prespecified Pooled Analysis of Patients Aged >/=75 Years in STREAM-1 and 2. Circ Cardiovasc Interv. 2024 Dec;17(12):e014251. doi: 10.1161/CIRCINTERVENTIONS.124.014251. Epub 2024 Dec 17. |
| 37439219 | Derived | Van de Werf F, Ristic AD, Averkov OV, Arias-Mendoza A, Lambert Y, Kerr Saraiva JF, Sepulveda P, Rosell-Ortiz F, French JK, Music LB, Vandenberghe K, Bogaerts K, Westerhout CM, Pages A, Danays T, Bainey KR, Sinnaeve P, Goldstein P, Welsh RC, Armstrong PW; STREAM-2 Investigators. STREAM-2: Half-Dose Tenecteplase or Primary Percutaneous Coronary Intervention in Older Patients With ST-Segment-Elevation Myocardial Infarction: A Randomized, Open-Label Trial. Circulation. 2023 Aug 29;148(9):753-764. doi: 10.1161/CIRCULATIONAHA.123.064521. Epub 2023 Jul 13. |
| FG001 | Standard Primary PCI | Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. Primary PCI: Primary PCI accoring to local standards |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pharmaco-invasive Strategy | Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. Tenecteplase: Half dose Tenecteplase Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year. Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required |
| BG001 | Standard Primary PCI | Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. Primary PCI: Primary PCI accoring to local standards |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 | Successful Reperfusion | Worst-lead ST-segment elevation resolution ≥ 50% 30 min post angiogram/PCI | Posted | Count of Participants | Participants | 30 min post angiogram/PCI |
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| Primary | Composite Clinical Efficacy End Point: All Cause Death, Shock, CHF and Reinfarction at 30 Days | Posted | Count of Participants | Participants | 30 days |
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| Primary | Total Stroke | Number of patients with stroke (intracranial haemorrhage, ischaemic, haemorrhagic conversion) | Posted | Count of Participants | Participants | 30 days |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Major Non-intrancranial Bleedings | Posted | Count of Participants | Participants | 30 days |
|
|
30 days
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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 | Pharmaco-invasive Strategy | Half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by coronary angiography within 6-24 hours or rescue coronary intervention as required. Tenecteplase: Half dose Tenecteplase Clopidogrel: 300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year. Coronary angiography: Coronary angiography followed by PCI or CABG if required, rescue PCI if required | 37 | 401 | 69 | 401 | 0 | 401 |
| EG001 | Standard Primary PCI | Primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards. Primary PCI: Primary PCI accoring to local standards | 18 | 203 | 32 | 203 | 0 | 203 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| heart failure | Cardiac disorders | Systematic Assessment |
| ||
| reinfarction | Cardiac disorders | Systematic Assessment |
| ||
| intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| ischemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| major nonintracranial bleeding | Vascular disorders | Systematic Assessment |
| ||
| acute ventricle septum defect | Cardiac disorders | Systematic Assessment |
| ||
| coronary arterial dissection | Cardiac disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| myocardial rupture | Cardiac disorders | Systematic Assessment |
| ||
| pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| pulseless electrical activity | Cardiac disorders | Systematic Assessment |
| ||
| sudden death | Cardiac disorders | Systematic Assessment |
| ||
| ventricle rupture | Cardiac disorders | Systematic Assessment |
| ||
| ventricular asystole | Cardiac disorders | Systematic Assessment |
| ||
| ventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| ventricular fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| right venticular failure | Cardiac disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Multiple organ dysfunction syndrome | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Vascular stent thrombosis | General disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumotorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Frans Van de Werf | KU Leuven | 003216342111 | frans.vandewerf@kuleuven.be |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2022 | Dec 20, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Between 18 and 65 years |
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| >=65 years |
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| Brazil |
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| Mexico |
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| Australia |
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| Chile |
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| France |
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| Serbia |
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| Montenegro |
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| Russia |
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| Spain |
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