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The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.
This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR101 | Active Comparator | AR101 powder provided in capsules & sachets |
|
| Placebo | Placebo Comparator | Placebo powder provided in capsules & sachets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR101 powder provided in capsules & sachets | Biological | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de dermatologie Pédiatrique, Hôpital Pellegrin-Enfants, place Amélie Raba-Léon | Bordeaux | 33076 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36915184 | Derived | Blumchen K, Kleinheinz A, Klimek L, Beyer K, Anagnostou A, Vogelberg C, Butovas S, Ryan R, Norval D, Zeitler S, Du Toit G. Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials. Allergy Asthma Clin Immunol. 2023 Mar 13;19(1):21. doi: 10.1186/s13223-023-00757-8. | |
| 34389504 |
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| ID | Title | Description |
|---|---|---|
| FG000 | AR101 | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. |
| 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 | Aug 28, 2018 | Jul 13, 2021 |
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| Placebo powder provided in capsules & sachets | Other | Study product formulated to contain only inactive ingredients for use as defined in the protocol |
|
| Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Approximately 9 months |
| Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge | The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower) | Approximately 9 months |
| Hopital Saint Vincent de Paul, Service d'Allergologie |
| Lille |
| 59020 |
| France |
| Paediatric Allergy and Pulmonology Center, Jeanne de Flandre Hospital, Lille University Hospital | Lille | 59037 | France |
| Service d'Allergologie Nouvel Hôpital Civil Hôpitaux Univesitaires de Strasbourg | Strasbourg | 67091 | France |
| Charité Universitaetsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie | Berlin | 13353 | Germany |
| University of Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Allergologie, Pneumologie und Mukoviszidose | Frankfurt am Main | 60590 | Germany |
| UCC Dept. of Paediatrics and Child, Cork University Hospital | Cork | Ireland |
| National Children's Research Centre, Our Lady's Children's Hospital Crumlin | Dublin | D12 V004 | Ireland |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Hospital General Universitario Gregorio Marañón, C/Manuel Esquerdo 46 | Madrid | 28007 | Spain |
| H. Infantil Universitario Niño Jesús, Servicio de Alergia | Madrid | 28009 | Spain |
| Hospital Clinico San Carlos, Madrid Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Sachsska Children and Youth Hospital | Stockholm | 118 83 | Sweden |
| James Paget University Hospital | Gorleston-on-Sea | Norfolk | NR31 6LA | United Kingdom |
| Guy & St Thomas' Hospital, NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| University Hospitals Southampton Foundation NHS Trust | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available. |
| 34320250 | Derived | Fernandez-Rivas M, Vereda A, Vickery BP, Sharma V, Nilsson C, Muraro A, Hourihane JO, DunnGalvin A, du Toit G, Blumchen K, Beyer K, Smith A, Ryan R, Adelman DC, Jones SM. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2022 Mar;77(3):991-1003. doi: 10.1111/all.15027. Epub 2021 Sep 24. |
| 32702315 | Derived | O'B Hourihane J, Beyer K, Abbas A, Fernandez-Rivas M, Turner PJ, Blumchen K, Nilsson C, Ibanez MD, Deschildre A, Muraro A, Sharma V, Erlewyn-Lajeunesse M, Zubeldia JM, De Blay F, Sauvage CD, Byrne A, Chapman J, Boralevi F, DunnGalvin A, O'Neill C, Norval D, Vereda A, Skeel B, Adelman DC, du Toit G. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 Oct;4(10):728-739. doi: 10.1016/S2352-4642(20)30234-0. Epub 2020 Jul 20. |
| FG001 |
| Placebo |
A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AR101 | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. |
| BG001 | Placebo | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Posted | Count of Participants | Participants | Approximately 9 months |
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| Secondary | Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Oral Food Challenge | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Posted | Count of Participants | Participants | Approximately 9 months |
|
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| Secondary | Proportion of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Oral Food Challenge. | The proportion of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge. | Posted | Count of Participants | Participants | Approximately 9 months |
|
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| Secondary | Maximum Severity of Symptoms at Any Challenge Dose During the Peanut Exit Oral Food Challenge | The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower) | Posted | Count of Participants | Participants | Approximately 9 months |
|
|
Approximately 9 months
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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 | AR101 | AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. | 0 | 132 | 1 | 132 | 130 | 132 |
| EG001 | Placebo | A placebo matching the AR101 drug product was supplied in 2 presentations. These were capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study, while the sachets were used during the Maintenance phase. | 0 | 43 | 2 | 43 | 42 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment | Paracetamol and a combination hormone birth control medication. Unrelated to treatment. |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic allergic reaction | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pharyngeal paraesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Tongue pruritus | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | 650-409-5164 | RegulatoryAffairs@aimmune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2018 | Jul 13, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| C537589 | Severe combined immunodeficiency with sensitivity to ionizing radiation |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Ireland |
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| United Kingdom |
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| Italy |
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| France |
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| Germany |
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| Spain |
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| Participants |
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| Participants |
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