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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7625A-013 | Other Identifier | Merck Registration Number | |
| 163275 | Registry Identifier | JAPIC-CTI |
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This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg for the treatment of Complicated Intra-abdominal Infections (cIAI) in Japanese participants. Efficacy will be primarily assessed by clinical response defined as complete resolution or significant improvement in signs and symptoms of the index infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7625A + metronidazole | Experimental | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days. The dose may be reduced to 750 mg (ceftolozane 500 mg/tazobactam 250 mg) for participants with a creatinine clearance (CrCl) of 30-50 mL/min. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) | Drug | MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". | Day 28 (28 days after initiating study therapy) |
| Percentage of Participants With Adverse Events (AEs) | The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Day 42 (up to 28 days after completing study therapy) |
| Percentage of Participants Discontinuing Study Drug Due to AEs | The percentage of participants withdrawing from study therapy due to an AE was determined. | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40913503 | Derived | Li Z, Kang Y, Gao H, Zhao Y, Luo D, Wang D, Zhang X, Yu J, Chu G, Cao J, Wang F, Zhao X, Jensen E, Lin G, Chen G. Pooled data from phase 3 clinical trials comparing the clinical activity of ceftolozane/tazobactam versus meropenem for the treatment of complicated intra-abdominal infections. Infect Dis (Lond). 2026 Jan;58(1):40-51. doi: 10.1080/23744235.2025.2544828. Epub 2025 Sep 6. | |
| 30528561 |
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Adult participants with complicated intra-abdominal infection (cIAI) were recruited at 37 study sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-7625A + Metronidazole | MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2015 |
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| metronidazole 500 mg | Drug | metronidazole 500 mg administered as an IV infusion |
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| Up to Day 14 |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". | Up to Day 42 (28 days after completing study therapy) |
| Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT | The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as "absence of the baseline pathogen in a specimen". Persistence was defined as "presence of the baseline pathogen in a specimen". Indeterminate was defined as "Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response". | Up to Day 14 |
| Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC | The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as "absence of the baseline pathogen in a specimen". Persistence was defined as "presence of the baseline pathogen in a specimen". Indeterminate was defined as "Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response". | Day 28 (28 days after initiating study therapy) |
| Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT | The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. | Up to Day 14 |
| Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC | The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. | Day 28 (28 days after initiating study therapy) |
| Derived |
| Mikamo H, Monden K, Miyasaka Y, Horiuchi T, Fujimoto G, Fukuhara T, Yoshinari T, Rhee EG, Shizuya T. The efficacy and safety of tazobactam/ceftolozane in combination with metronidazole in Japanese patients with complicated intra-abdominal infections. J Infect Chemother. 2019 Feb;25(2):111-116. doi: 10.1016/j.jiac.2018.10.012. Epub 2018 Dec 6. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-7625A + Metronidazole | MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". | Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at the TOC visit within the specified visit window are included. | Posted | Number | Percentage of Participants | Day 28 (28 days after initiating study therapy) |
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| Primary | Percentage of Participants With Adverse Events (AEs) | The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received ≥1 dose of study therapy are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 42 (up to 28 days after completing study therapy) |
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| Primary | Percentage of Participants Discontinuing Study Drug Due to AEs | The percentage of participants withdrawing from study therapy due to an AE was determined. | All participants who received ≥1 dose of study therapy are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 14 |
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| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". | Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at EOT visit within the specified visit window are included. | Posted | Number | Percentage of Participants | Up to Day 14 |
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| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU) | The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as "complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required". Clinical failure was defined as "death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care". Indeterminate was defined as "study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure". | Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at LFU visit within the specified visit window are included. | Posted | Number | Percentage of Participants | Up to Day 42 (28 days after completing study therapy) |
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| Secondary | Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT | The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as "absence of the baseline pathogen in a specimen". Persistence was defined as "presence of the baseline pathogen in a specimen". Indeterminate was defined as "Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response". | Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included. | Posted | Number | Percentage of Participants | Up to Day 14 |
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| Secondary | Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC | The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as "absence of the baseline pathogen in a specimen". Persistence was defined as "presence of the baseline pathogen in a specimen". Indeterminate was defined as "Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response". | Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included. | Posted | Number | Percentage of Participants | Day 28 (28 days after initiating study therapy) |
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| Secondary | Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT | The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. | Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Day 14 |
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| Secondary | Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC | The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown. | Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 28 (28 days after initiating study therapy) |
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Up to Day 42
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All participants who received ≥1 dose of study drug are included.
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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 | MK-7625A + Metronidazole | MK-7625A 1.5 g (ceftolozane 1 g + tazobactam 0.5 g) plus metronidazole 500 mg was administered as an IV infusion every 8 hours for 4 to 14 days. | 1 | 100 | 10 | 100 | 32 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Eating disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 11, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C519491 | ceftolozane |
| D000078142 | Tazobactam |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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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