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See Detailed Description
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maraviroc | Drug | Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay | Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism | Baseline, Day 4, 7, 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Achieving HIV-1 RNA <400 Copies/mL | Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point | Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 |
| Subjects Achieving HIV-1 RNA <50 Copies/mL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Miami | Florida | 33137 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCR5-Tropic HIV-1 | Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofileâ„¢ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Trofile Assay and HIV RNA quantification assay | Procedure | Trofile Assay and HIV RNA quantification assay |
|
Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point
| Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 |
| Subjects With Virologic Failure | For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ. | Baseline up to Week 24 |
| Time to Virologic Failure | For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ. | Baseline up to Week 24 |
| Change in Lymphocyte Subset CD4 From Baseline | Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1 | Day 1 (Baseline), Day 7, 14, 28 and Weeks 24 |
| Change in Lymphocyte Subset CD8 From Day 1 | Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1 | Day 1(Baseline), Day 7, 14, 28 and Weeks 24 |
| Change in Lymphocyte Subsets; CD4 and CD8 From Screening. | Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening} | Screening (Day -14 to 0), Day 1. |
| Change in Detectable Tropism From Screening | Number of subjects who switch their tropism status from screening to Baseline | Screening (Day -21 to 0), Baseline. |
| Change in Detectable Tropism From Baseline | Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation | Baseline, Day 15 and Week 24/End of Study/Discontinuation |
| Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening | Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening | Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure. |
| Number of Subjects With Susceptibility to Maraviroc | Phenotypic susceptibility to maraviroc | Screening (Day -21 to 0), Day 14, Week 24 |
| Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24 | Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24 | Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24 |
| Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc | Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24 |
| Chicago |
| Illinois |
| 60613 |
| United States |
| Pfizer Investigational Site | Topeka | Kansas | 66606-1670 | United States |
| Pfizer Investigational Site | Topeka | Kansas | 66606 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68198-5400 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14215 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| Pfizer Investigational Site | Hampton | Virginia | 23666 | United States |
| Pfizer Investigational Site | Montreal | Quebec | H2L 5B1 | Canada |
| FG001 | Non-CCR5-Tropic HIV-1 | Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofileâ„¢ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CCR5-Tropic HIV-1 | Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofileâ„¢ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs. |
| BG001 | Non-CCR5-Tropic HIV-1 | Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofileâ„¢ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study. |
| 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 |
|
| 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Subjects Achieving HIV-1 RNA <400 Copies/mL | Number of Subjects Achieving HIV-1 RNA <400 Copies/mL at each time point | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 |
|
| ||||||||||||||||||||||
| Secondary | Subjects Achieving HIV-1 RNA <50 Copies/mL | Number of Subjects Achieving HIV-1 RNA <50 Copies/mL at each time point | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24 |
| |||||||||||||||||||||||
| Secondary | Subjects With Virologic Failure | For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ. | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Baseline up to Week 24 |
| |||||||||||||||||||||||
| Secondary | Time to Virologic Failure | For this protocol, virologic failure will be confirmed by a repeat viral load test within 2 weeks of first viral load meeting any of the following criteria: 1. Failing to achieve a reduction in HIV-1 RNA > 0.5 log10 copies/mL from baseline by the second viral load determination (unless the viral load is below level of quantification [LOQ]); 2. Experiencing a > 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline > 0.5 log10 copies/mL; or 3. Experiencing an HIV-1 RNA >1000 copies/mL after having achieved an HIV-1 RNA below LOQ. | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Baseline up to Week 24 |
| |||||||||||||||||||||||
| Secondary | Change in Lymphocyte Subset CD4 From Baseline | Calculated average of CD4 at Day 7, 14, 28 and Week 24 minus CD4 at Day 1 | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Day 1 (Baseline), Day 7, 14, 28 and Weeks 24 |
| |||||||||||||||||||||||
| Primary | Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay | Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism | Study was canceled: no efficacy data (primary/secondary) was collected per protocol for limited number of patients left in study; only safety data was summarized. | Posted | Baseline, Day 4, 7, 14 |
| |||||||||||||||||||||||
| Secondary | Change in Lymphocyte Subset CD8 From Day 1 | Calculated average of CD8 at Day 7, 14, 28 and Week 24 minus CD8 at Day 1 | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Day 1(Baseline), Day 7, 14, 28 and Weeks 24 |
| |||||||||||||||||||||||
| Secondary | Change in Lymphocyte Subsets; CD4 and CD8 From Screening. | Calculated avergae of {CD4 or CD8 at Day 1 - CD4 or CD8 at Screening} | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -14 to 0), Day 1. |
| |||||||||||||||||||||||
| Secondary | Change in Detectable Tropism From Screening | Number of subjects who switch their tropism status from screening to Baseline | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -21 to 0), Baseline. |
| |||||||||||||||||||||||
| Secondary | Change in Detectable Tropism From Baseline | Number of subjects who switch their tropism status from Baseline to Days 7, 14, and Week 24/End of Study(EOS)/Discontinuation | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Baseline, Day 15 and Week 24/End of Study/Discontinuation |
| |||||||||||||||||||||||
| Secondary | Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening | Change in detectable resistance (genotype) and susceptibility (phenotype) to drugs in the regimen from Screening | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure. |
| |||||||||||||||||||||||
| Secondary | Number of Subjects With Susceptibility to Maraviroc | Phenotypic susceptibility to maraviroc | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -21 to 0), Day 14, Week 24 |
| |||||||||||||||||||||||
| Secondary | Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24 | Change in gene sequence in gp-160, and the V3 loop from Screening visit (Day -21 to 0) to Day 14, time of virologic failure (See Section 6.5.1) and Week 24 | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24 |
| |||||||||||||||||||||||
| Secondary | Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc | Study was canceled with only 16 subjects of 60 subjects required to enroll. | Posted | Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24 |
|
|
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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 | CCR5-Tropic HIV-1 | Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofileâ„¢ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs. | 4 | 9 | 9 | 9 | ||
| EG001 | Non-CCR5-Tropic HIV-1 | Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofileâ„¢ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study. | 0 | 7 | 4 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oesophageal disorder | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v12.0 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA v12.0 | Systematic Assessment |
| |
| Staphylococcal Skin Infection | Infections and infestations | MedDRA v12.0 | Systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA v12.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA v12.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA v12.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v12.0 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA v12.0 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA v12.0 | Systematic Assessment |
| |
| Human Papilloma Virus Test Positive | Investigations | MedDRA v12.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA v12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v12.0 | Systematic Assessment |
|
Study terminated prematurely due to slow enrollment. Premature termination of study was not due to any safety concerns. Efficacy data not summarized due to low sample size; only safety was summarized.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 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.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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