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This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks | Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear). | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline | Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. | 54 weeks |
| Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Italy,Greece, decresg@wyeth.com | Principal Investigator |
| Trial Manager | For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com | Principal Investigator |
| TRial manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Hungary, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For Turkey, Erisc@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feldkirch | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25913550 | Derived | Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available. | |
| 25087839 | Derived | Griffiths CE, Luger TA, Brault Y, Germain JM, Mallbris L. Retreatment in patients with psoriasis achieving response with etanercept after relapse due to treatment interruption: results from the CRYSTEL study. J Eur Acad Dermatol Venereol. 2015 Mar;29(3):468-73. doi: 10.1111/jdv.12585. Epub 2014 Aug 4. |
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Subjects were screened up to 4 weeks.
Subjects were recruited in multiple countries worldwide from to.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous | etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks |
| FG001 | Intermittent | etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included. |
| 54 weeks |
| Number of Patients With Survey Response of "Somewhat Satisfied" or Better | Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied. | 54 weeks |
| Trial Manager |
| For Germany, MedinfoDEU@wyeth.com |
| Principal Investigator |
| Trial Manager | For UK, ukmedonfo@wyeth.com | Principal Investigator |
| Vienna |
| 1090 |
| Austria |
| Vienna | 1160 | Austria |
| Brussels | B-1070 | Belgium |
| Brussels | B-1200 | Belgium |
| Edegem | B-2650 | Belgium |
| Ghent | B-9000 | Belgium |
| Leuven | B-3000 | Belgium |
| Liège | 4000 | Belgium |
| Prague | 180 01 | Czechia |
| Aarhus C | 8000 | Denmark |
| Odense C | 5000 | Denmark |
| Roskilde | 4000 | Denmark |
| Kuopio | 702 11 | Finland |
| Lahti | 151 70 | Finland |
| Besançon | 25030 | France |
| Bordeaux | 33075 | France |
| Boulogne-Billancourt | 92104 | France |
| Brest | 29609 | France |
| Créteil | 94000 | France |
| Dijon | 21079 | France |
| Lille | 59037 | France |
| Lyon | 60002 | France |
| Lyon | 69437 | France |
| Marseille | 13915 | France |
| Marseille Cédex 09 | 13009 | France |
| Montpellier Cédex 5 | 34000 | France |
| Nancy | 54000 | France |
| Nantes | 44093 | France |
| Nice | 06200 | France |
| Nîmes | 30029 | France |
| Paris | 75018 | France |
| Pessac | 33600 | France |
| Pierre-Bénite | 69495 | France |
| Poitiers | 86000 | France |
| Reims | 51092 | France |
| Rouen | 76000 | France |
| Saint-Etienne | 42055 | France |
| Strasbourg | 6700 | France |
| Toulouse | 31059 | France |
| Tours | 37044 | France |
| Bochum | 44791 | Germany |
| Düsseldorf | 40225 | Germany |
| Erlangen | 91052 | Germany |
| Essen | 45147 | Germany |
| Frankfurt | 60590 | Germany |
| Hamburg | 20158 | Germany |
| Kiel | 24105 | Germany |
| Leipzig | 04103 | Germany |
| Magdeburg | 39120 | Germany |
| Mainz | D-55101 | Germany |
| Münster | 48149 | Germany |
| Nordheide | 21244 | Germany |
| Osnabrück | 48149 | Germany |
| Tübingen | 72076 | Germany |
| Würzburg | 97080 | Germany |
| Athens | 124 62 | Greece |
| Athens | Greece |
| Thessaloniki | 54636 | Greece |
| Budapest | 1135 | Hungary |
| Ancona | 60020 | Italy |
| Cagliari | 09124 | Italy |
| Genova | 16132 | Italy |
| Modena | 41100 | Italy |
| Padova | 35100 | Italy |
| Pavia | 27100 | Italy |
| Roma | 00133 | Italy |
| Roma | 00168 | Italy |
| Roma | 00185 | Italy |
| Terni | 05100 | Italy |
| Torino | Italy |
| Amsterdam | 1081 HV | Netherlands |
| Amsterdam | 1105 - AZ | Netherlands |
| Capelle aan den IJssel | 2906 ZC | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Nijmegen | 6525 GL | Netherlands |
| Rotterdam | 1081 HV | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Voorburg | 2275 CX | Netherlands |
| Bergen | 5021 | Norway |
| Oslo | 0407 | Norway |
| Stavanger | 4068 | Norway |
| Warsaw | 02-008 | Poland |
| Lisbon | 1069-166 | Portugal |
| Lisbon | 1169-100 | Portugal |
| Barcelona | 08915 | Spain |
| Bilbao | 48009 | Spain |
| Llobregat | 8907 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28041 | Spain |
| Málaga | 29010 | Spain |
| Valencia | 46014 | Spain |
| Danderyds | 182 88 | Sweden |
| Gothenburg | 413 45 | Sweden |
| Linköping | 581 85 | Sweden |
| Lund | 221 85 | Sweden |
| Stockholm | 171 76 | Sweden |
| Umeå | 901 85 | Sweden |
| Basel | 4056 | Switzerland |
| Bern | 3010 | Switzerland |
| Geneva | 1205 | Switzerland |
| Bornova-Izmir | 35100 | Turkey (Türkiye) |
| Capa-Istanbul | 34390 | Turkey (Türkiye) |
| Kocamustafapasa-Istanbul | 34122 | Turkey (Türkiye) |
| Aberdeen | AB25 1LD | United Kingdom |
| Airdrie | ML6 0JS | United Kingdom |
| Birmingham | United Kingdom |
| Cardiff | CF14 4XW | United Kingdom |
| Coventry | CV2 2DX | United Kingdom |
| Dublin | United Kingdom |
| Dundee | DD1 9SY | United Kingdom |
| Glasgow | G11 6NT | United Kingdom |
| Lancaster | LA1 4RP | United Kingdom |
| Leeds | LS1 3EX | United Kingdom |
| Leicester | LE1 5WW | United Kingdom |
| Liverpool | United Kingdom |
| London | E11 1NR | United Kingdom |
| London | NW3 2QG | United Kingdom |
| London | SE1 7EH | United Kingdom |
| London | W 12 | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Newport | United Kingdom |
| Norwich | NR4 7UY | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| Sheffield | 1OUK - S10 | United Kingdom |
| Suffolk | IP4 5PD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous | etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks |
| BG001 | Intermittent | etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved. |
| 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 Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks | Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear). | The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF). | Posted | Mar 2009 | Mean | Standard Deviation | units on scale | 54 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline | Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. | The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF). | Posted | Feb 2009 | Number | percentage improvement | 54 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear" | Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included. | The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases). | Posted | Mar 2009 | Median | 95% Confidence Interval | days | 54 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Survey Response of "Somewhat Satisfied" or Better | Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied. | The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. | Posted | Mar 2009 | Number | participants | 54 weeks |
|
|
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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 | Continuous | etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks | 23 | 281 | ||||
| EG001 | Intermittent | etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved. | 31 | 273 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
| ||
| Abscess | General disorders | Non-systematic Assessment |
| ||
| Accidental Injury | General disorders | Non-systematic Assessment |
| ||
| Anaphylactoid reaction | General disorders | Non-systematic Assessment |
| ||
| Back pain | General disorders | Non-systematic Assessment |
| ||
| Cellulitis | General disorders | Non-systematic Assessment |
| ||
| Hernia | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Lab test abnormal | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Left heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarct | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial ischemia | Cardiac disorders | Non-systematic Assessment |
| ||
| Palpitation | Cardiac disorders | Non-systematic Assessment |
| ||
| Varicose vein | Vascular disorders | Non-systematic Assessment |
| ||
| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Gamma glutamyl transpeptidase increased | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal carcinoma | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Edema | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Peripheral edema | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Ataxia | Nervous system disorders | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Incoordination | Nervous system disorders | Non-systematic Assessment |
| ||
| Speech disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal septum disorder | General disorders | Non-systematic Assessment |
| ||
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Abortion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Kidney calculus | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Kidney pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Testis disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Unintended pregnancy | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urogenital disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental injury | General disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Back pain | General disorders | Non-systematic Assessment |
| ||
| Flu syndrome | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Injection site reaction | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Metabolic and nutritional | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nervous | Nervous system disorders | Non-systematic Assessment |
| ||
| Cough increased | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Special senses | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Urogenital | Renal and urinary disorders | Non-systematic Assessment |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
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| Male |
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| Greece |
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| Finland |
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| Spain |
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| Turkey |
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| Austria |
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| United Kingdom |
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| Switzerland |
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| Italy |
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| France |
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| Czech Republic |
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| Hungary |
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| Belgium |
|
| Poland |
|
| Denmark |
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| Netherlands |
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| Germany |
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| Norway |
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| Sweden |
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| Participants |
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