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| ID | Type | Description | Link |
|---|---|---|---|
| HFpEF ATTR-CM prevalence study | Other Identifier | Alias Study Number | |
| 2020-002378-29 | EudraCT Number | ||
| ATTR-POP | Other Identifier | Alias Study Number |
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Sponsor terminated study early to not prolong timelines and to enable sharing of data collected which has potential to better support understanding of the prevalence of ATTR-CM in patients with HFpEF. Decision was not based on any safety findings.
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This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTR-CM positive | Other | Participants diagnosed with ATTR-CM by scintigraphy |
|
| ATTR-CM negative | Other | Participants who are scintigraphy negative for ATTR-CM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scintigraphy | Diagnostic Test | scintigraphy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Prevalence of ATTR-CM in HFpEF Participants Clinically At-Risk of Disease Among Total Evaluable Participants | Global prevalence of ATTR-CM in HFpEF participants was obtained by dividing the number of participants who were diagnosed with ATTR-CM in the study by the total number of HFpEF participants evaluated. Diagnosis of ATTR-CM was defined as: cardiac scintigraphy Grade 1, with confirmation of ATTR by cardiac biopsy; or cardiac scintigraphy Grade 2 or above. Exact 95% confidence intervals for the prevalence estimates were calculated using the method of Clopper and Pearson. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Prevalence of ATTR-CM in Participants With HFpEF Clinically At-Risk of Disease by Subgroups (Regions, Age, Gender) Among Total Evaluable Participants | The prevalence of ATTR-CM in HFpEF participants was evaluated for subgroups including regions (North America, Europe, and Asia), age categories (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-85 years, 85-89 years, >=90 years), and gender (male, female). The estimate of prevalence was defined as the number of participants meeting the diagnosis criteria of ATTR-CM divided by the number of evaluable participants in the study in the given subgroup category. Diagnosis of ATTR-CM was defined as: cardiac scintigraphy Grade 1, with confirmation of ATTR by cardiac biopsy; or cardiac scintigraphy Grade 2 or above. Exact 95% confidence intervals for the prevalence estimates were calculated using the method of Clopper and Pearson. |
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Inclusion Criteria:
Medical history of heart failure (HF) with:
Left ventricular ejection fraction (LVEF) >40%.
End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.
Willing and able to undergo scintigraphy.
Exclusion Criteria:
Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).
Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries).
Presence or history of any severe valvular heart disease (obstructive or regurgitant).
A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction.
Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern shore Research Institute LLC | Fairhope | Alabama | 36532 | United States | ||
| Heart Center Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39245873 | Derived | Yun S, Palladini G, Anderson LJ, Cariou E, Wang R, Angeli FS, Ebede B, Garcia-Pavia P. International prevalence of transthyretin amyloid cardiomyopathy in high-risk patients with heart failure and preserved or mildly reduced ejection fraction. Amyloid. 2024 Dec;31(4):291-301. doi: 10.1080/13506129.2024.2398446. Epub 2024 Sep 8. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 347 heart failure with preserved ejection fraction (HFpEF) participants within a clinically at-risk population were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With ATTR-CM | Participants enrolled in the study who were positive for transthyretin amyloid cardiomyopathy (ATTR-CM) by scintigraphy and were evaluable. |
| FG001 | Participants Without ATTR-CM |
| 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 20, 2020 | Feb 1, 2024 |
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To determine global prevalence of transthyretin amyloid cardiomyopathy in participants diagnosed with heart failure with preserved ejection fraction. No study treatment will be dispensed however, participants will undergo scintigraphy.
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| Day 1 |
| Number of Participants According to TTR Genotypes Among Participants Diagnosed With ATTR-CM | Number of participants diagnosed with ATTR-CM were evaluated for TTR genotypes (wild-type or hereditary form). | Day 1 |
| Number of HFpEF Participants With and Without ATTR-CM Based on New York Heart Association (NYHA) Classification | Participants were evaluated using the NYHA classification at Day 1. Class I: participants with cardiac disease but without resulting limitations of physical activity. Class II: participants with cardiac disease resulting in slight limitation of physical activity. Class III: participants with cardiac disease resulting in marked limitation of physical activity. Class IV: participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Day 1 |
| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in Participants With and Without ATTR-CM | Participants were evaluated using NT-proBNP cardiac biomarker that was assessed at Day 1. | Day 1 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Advance Medical Research Center | Miami | Florida | 33135 | United States |
| Bioclinical Research Alliance Inc. | Miami | Florida | 33155 | United States |
| Biogenix Molecular | Miami | Florida | 33165 | United States |
| CIRA (Nuclear Imaging Facility) | Miami | Florida | 33165 | United States |
| Nucleotron/ Doral Imaging Institute, CIRA DBA | Miami | Florida | 33165 | United States |
| Innova Pharma Research | Miami | Florida | 33175 | United States |
| Ocala Cardiovascular Research | Ocala | Florida | 34471 | United States |
| Chicago Medical Research, LLC | Hazel Crest | Illinois | 60429 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Stormont Vail Health | Topeka | Kansas | 66604 | United States |
| Cotton O'Neil Heart Center | Topeka | Kansas | 66606 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Corewell Health | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health Medical Group Cardiovascular Medicine | Grand Rapids | Michigan | 49525 | United States |
| Cardiology Associates of North Mississippi, LLC | Tupelo | Mississippi | 38801 | United States |
| Cardiology Associates Research, LLC | Tupelo | Mississippi | 38801 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| WakeMed Health and Hospital | Raleigh | North Carolina | 27610 | United States |
| The Jackson Clinic | Jackson | Tennessee | 38301 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| CardioVasc HR Inc | Saint-Jean-sur-Richelieu | Quebec | J3A 1C3 | Canada |
| Diex Recherche Trois-Rivieres | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Hôpital Louis Pradel | Bron | 69677 | France |
| Centre Hospitalier Saint-Joseph Saint-Luc | Lyon | 69365 | France |
| CHU Nimes - Hospital Caremeau | Nîmes | 30029 | France |
| CHU de Toulouse - Hôpital de Rangueil | Toulouse | 50032 - 31059 | France |
| Médecine Nucléaire de la Doua | Villeurbanne | 69100 | France |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna | BO | 40138 | Italy |
| U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS | Genova | Genoa | 16132 | Italy |
| U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS | Genova | 16132 | Italy |
| Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche | Pavia | 27100 | Italy |
| Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare | Pisa | 56124 | Italy |
| Nagoya Tokushukai General Hospital | Kasugai | Aichi-ken | 487-0016 | Japan |
| Fukuoka Tokushukai Hospital | Kasuga | Fukuoka | 816-0864 | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital | Lodz | Łódź Voivodeship | 90-549 | Poland |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Vall d´Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari De Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| St George's Hospital, St George's University Hospitals NHS Foundation Trust | London | SW17 0QT | United Kingdom |
Participants enrolled in the study who were negative for ATTR-CM by scintigraphy and were evaluable.
| FG002 | Non-evaluable Participants | Participants enrolled in the study who were non-evaluable. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Analysis population included all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With ATTR-CM | Participants enrolled in the study who were positive for transthyretin amyloid cardiomyopathy (ATTR-CM) by scintigraphy and were evaluable. |
| BG001 | Participants Without ATTR-CM | Participants enrolled in the study who were negative for ATTR-CM by scintigraphy and were evaluable. |
| BG002 | Non-evaluable Participants | Participants enrolled in the study who were non-evaluable. |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Global Prevalence of ATTR-CM in HFpEF Participants Clinically At-Risk of Disease Among Total Evaluable Participants | Global prevalence of ATTR-CM in HFpEF participants was obtained by dividing the number of participants who were diagnosed with ATTR-CM in the study by the total number of HFpEF participants evaluated. Diagnosis of ATTR-CM was defined as: cardiac scintigraphy Grade 1, with confirmation of ATTR by cardiac biopsy; or cardiac scintigraphy Grade 2 or above. Exact 95% confidence intervals for the prevalence estimates were calculated using the method of Clopper and Pearson. | Evaluable analysis set included all participants who met the inclusion/exclusion criteria and completed Visit 1, excluding participants with cardiac scintigraphy assessed as non-evaluable. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
|
| |||||||||||||||||||||||||
| Secondary | Global Prevalence of ATTR-CM in Participants With HFpEF Clinically At-Risk of Disease by Subgroups (Regions, Age, Gender) Among Total Evaluable Participants | The prevalence of ATTR-CM in HFpEF participants was evaluated for subgroups including regions (North America, Europe, and Asia), age categories (60-64 years, 65-69 years, 70-74 years, 75-79 years, 80-85 years, 85-89 years, >=90 years), and gender (male, female). The estimate of prevalence was defined as the number of participants meeting the diagnosis criteria of ATTR-CM divided by the number of evaluable participants in the study in the given subgroup category. Diagnosis of ATTR-CM was defined as: cardiac scintigraphy Grade 1, with confirmation of ATTR by cardiac biopsy; or cardiac scintigraphy Grade 2 or above. Exact 95% confidence intervals for the prevalence estimates were calculated using the method of Clopper and Pearson. | Evaluable analysis set included all participants who met the inclusion/exclusion criteria and completed Visit 1, excluding participants with cardiac scintigraphy assessed as non-evaluable. Here, "Number Analyzed" signifies number of participants evaluable for specified rows of the arm. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants According to TTR Genotypes Among Participants Diagnosed With ATTR-CM | Number of participants diagnosed with ATTR-CM were evaluated for TTR genotypes (wild-type or hereditary form). | Evaluable analysis set included all participants who met the inclusion/exclusion criteria and completed Visit 1, excluding participants with cardiac scintigraphy assessed as non-evaluable. | Posted | Count of Participants | Participants | Day 1 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of HFpEF Participants With and Without ATTR-CM Based on New York Heart Association (NYHA) Classification | Participants were evaluated using the NYHA classification at Day 1. Class I: participants with cardiac disease but without resulting limitations of physical activity. Class II: participants with cardiac disease resulting in slight limitation of physical activity. Class III: participants with cardiac disease resulting in marked limitation of physical activity. Class IV: participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Enrolled analysis set included all participants who met the inclusion/exclusion criteria and completed Visit 1. | Posted | Count of Participants | Participants | Day 1 |
|
| |||||||||||||||||||||||||||
| Secondary | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in Participants With and Without ATTR-CM | Participants were evaluated using NT-proBNP cardiac biomarker that was assessed at Day 1. | Enrolled analysis set included all participants who met the inclusion/exclusion criteria and completed Visit 1. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Nanogram per liter (ng/L) | Day 1 |
|
|
Day 1 up to 6 months of follow-up
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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 | Participants With ATTR-CM | Participants enrolled in the study who were positive for ATTR-CM by scintigraphy and were evaluable. | 3 | 56 | 0 | 56 | 11 | 56 |
| EG001 | Participants Without ATTR-CM | Participants enrolled in the study who were negative for ATTR-CM by scintigraphy and were evaluable. | 1 | 259 | 0 | 259 | 10 | 259 |
| EG002 | Non-evaluable Participants | Participants enrolled in the study who were non-evaluable. | 0 | 32 | 0 | 32 | 3 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gravitational oedema | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA v26.0 | Non-systematic Assessment |
| |
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA v26.0 | Non-systematic Assessment |
| |
| Posterior lens capsulotomy | Surgical and medical procedures | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2022 | Feb 1, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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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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| Participants |
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