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| ID | Type | Description | Link |
|---|---|---|---|
| IRX-2 2016-B | Other Identifier | IRX Therapeutics |
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| Name | Class |
|---|---|
| Brooklyn ImmunoTherapeutics, LLC | INDUSTRY |
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The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.
This will be a Phase Ib study conducted to determine the safety and tolerability of an IRX-2 regimen in ESBC, to be administered pre-operatively before standard-of-care surgical resection and following standard-of-care diagnostic biopsy. This study will also include triple-negative breast cancer patients who will receive the IRX-2 regimen prior to chemotherapy.
Eligible subjects will have early stage breast cancer of any receptor sub-type, for which standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of tumor-bearing biopsy material must be available for research analysis.
Cohort B will enroll subjects triple negative breast cancer (defined by ER<10%, PR<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned. The IRX-2 regimen will be administered and completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy (2-3 cores), followed by commencement of chemotherapy preferably within one week after biopsy.
The IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered by subcutaneous injection into the periareolar skin of the affected breast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRX-2 Regimen -Early Stage Breast Cancer | Experimental | Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. |
|
| IRX-2 Regimen -Triple Negative Breast Cancer | Experimental | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | One dose of cyclophosphamide 300 mg/m2 IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients | The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen. | Day 1 to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Infiltrating Lymphocytes | Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen | At time of pre-surgical biopsy and time of tumor specimen resection at day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of Peripheral Lymphocytes | Fold change of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells | Day 1 to Day 26 |
| TIL Phenotype |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Page, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413574 | Derived | Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4. |
| Label | URL |
|---|---|
| Providence Cancer Center | View source |
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Providence Health & Services has agreed to allow IRX Therapeutics to have access PHI for auditing purposes. Any non-Providence Health & Services employee who will access PHI will be required to sign a confidentiality agreement and will not be permitted to remove PHI from Providence Health & Services.
5 years
IPD will be accessed for data verification purposes only.
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| ID | Title | Description |
|---|---|---|
| FG000 | IRX-2 Regimen -Early Stage Breast Cancer | Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
| FG001 | IRX-2 Regimen -Triple Negative Breast Cancer | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to poor accrual, site opted against enrolling patients into cohort B in favor of a different trial which is ongoing.
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| ID | Title | Description |
|---|---|---|
| BG000 | IRX-2 Regimen -Early Stage Breast Cancer | Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients | The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen. | No patients were enrolled into Arm B due to poor accrual and opted against Arm B in favor of the NeoIRX trial. | Posted | Count of Participants | Participants | Day 1 to Day 26 |
|
1 year, 3 months
Adverse event monitoring/recording happened at set time intervals as per study protocol
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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 | IRX-2 Regimen -Early Stage Breast Cancer | Enrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David B. Page | Earle A. Chiles Research Institute, Providence Cancer Institute | 503-215-6588 | david.page2@providence.org |
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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 | Jan 19, 2018 | Apr 27, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2018 | Apr 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D007213 | Indomethacin |
| D009853 | Omeprazole |
| C067316 | Geritol |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Indomethacin | Drug | Indomethacin 25 mg three times a day for 21 days |
|
|
| Omeprazole | Drug | One tablet of omeprazole daily for 21 days |
|
|
| Multivitamin | Dietary Supplement | Daily multivitamin containing 15-30 mg of zinc for 21 days. |
|
|
Post-IRX mean density of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells post-IRX within stromal tissue compartments.
| Day 1 to 26 |
| Intratumoral T-cell Clonality Response | Change in T-cell clonal responses by T-cell receptor DNA deep sequencing | Day 1-26 |
| Intratumoral Immune Response | The Nanostring PanCancer Immune panel was used to estimate increase in PD-L1 mRNA expression among tumor-bearing FFPE specimens. | Day 1-26 |
| BG001 | IRX-2 Regimen -Triple Negative Breast Cancer | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Menstrual Status | Count of Participants | Participants |
|
| Family History of Breast/Ovarian Cancer | Count of Participants | Participants |
|
| Known BRCA 1/2 Mutation | Count of Participants | Participants |
|
| OG001 | IRX-2 Regimen -Triple Negative Breast Cancer | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. |
|
|
| Secondary | Tumor Infiltrating Lymphocytes | Change in tumor infiltrating lymphocyte (TIL) score as measured by hematoxylin and eosin tumor infiltrating lymphocytes (H&E TIL) count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen | Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial. | Posted | Median | Full Range | percentage of stromal area | At time of pre-surgical biopsy and time of tumor specimen resection at day 26 |
|
|
|
| Other Pre-specified | Characterization of Peripheral Lymphocytes | Fold change of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells | Due to poor accrual we opted against enrolling in Cohort B in favor of the neoIRX trial. | Posted | Mean | 95% Confidence Interval | fold change | Day 1 to Day 26 |
|
|
|
| Other Pre-specified | TIL Phenotype | Post-IRX mean density of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells post-IRX within stromal tissue compartments. | Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial. | Posted | Mean | Standard Deviation | count/pixel | Day 1 to 26 |
|
|
|
| Other Pre-specified | Intratumoral T-cell Clonality Response | Change in T-cell clonal responses by T-cell receptor DNA deep sequencing | Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial. | Posted | Number | fold change | Day 1-26 |
|
|
|
| Other Pre-specified | Intratumoral Immune Response | The Nanostring PanCancer Immune panel was used to estimate increase in PD-L1 mRNA expression among tumor-bearing FFPE specimens. | Due to poor patient accrual we opted against enrolling into Cohort B in favor of the neoIRX trial. | Posted | Number | fold change | Day 1-26 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 16 |
| 16 |
| EG001 | IRX-2 Regimen -Triple Negative Breast Cancer | Enrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2. Cyclophosphamide: One dose of cyclophosphamide 300 mg/m2 IV infusion Indomethacin: Indomethacin 25 mg three times a day for 21 days Omeprazole: One tablet of omeprazole daily for 21 days Multivitamin: Daily multivitamin containing 15-30 mg of zinc for 21 days. | 0 | 0 | 0 | 0 | 0 | 0 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Abdominal Cramping | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Bruising/Bruising at Injection Site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Flu-like Symptoms | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Intermittent Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Left Axillary Lymph Node Pain | General disorders | Systematic Assessment |
|
| Left Breast Pain | General disorders | Systematic Assessment |
|
| Mild Pain with Injections | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pain with Injections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
|
| Stroma, Any PD-L1: Regulatory T-Cell |
|
| Stroma, Any PD-L1: Macrophage |
|
| Stroma, PD-L1-positive: T-Cell (any type) |
|
| Stroma, PD-L1-positive: Helper T-Cell |
|
| Stroma, PD-L1-positive: Cytotoxic T-Cell |
|
| Stroma, PD-L1-positive: Regulatory T-cell |
|
| Stroma, PD-L1-positive: Macrophage |
|
| Tumor, Any PD-L1: T-Cell (any type) |
|
| Tumor, Any PD-L1: Helper T-Cell |
|
| Tumor, Any PD-L1: Cytotoxic T-Cell |
|
| Tumor, Any PD-L1: Regulatory T-Cell |
|
| Tumor, Any PD-L1: Macrophage |
|
| Tumor, PD-L1-positive: T-Cell (any type) |
|
| Tumor, PD-L1-positive: Helper T-cell |
|
| Tumor, PD-L1-positive: Cytotoxic T-Cell |
|
| Tumor, PD-L1-positive: Regulatory T-Cell |
|
| Tumor, PD-L1-positive: Macrophage |
|
| Stoma and tumor, PD-L1-positive: PD-L1+ IC^3 |
|
| Title | Measurements |
|---|---|
|
| Any PD-L1: Regulatory T-cell |
|
| Any PD-L1: Macrophage |
|
| PD-L1-positive: T-cell (any type) |
|
| PD-L1-positive: Helper T-Cell |
|
| PD-L1-positive: Cytotoxic T-Cell |
|
| PD-L1-positive: Regulatory T-Cell |
|
| PD-L1-positive: Macrophage |
|
| Title | Measurements |
|---|---|
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| Patient 4 |
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| Patient 5 |
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| Patient 6 |
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| Patient 7 |
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| Patient 8 |
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| Patient 9 |
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| Patient 10 |
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| Patient 11 |
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| Patient 12 |
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| Patient 13 |
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| Patient 14 |
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| Patient 15 |
|
| Patient 16 |
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| Title | Measurements |
|---|---|
|
| Patient 4 |
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| Patient 5 |
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| Patient 6 |
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| Patient 7 |
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| Patient 8 |
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| Patient 9 |
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| Patient 10 |
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| Patient 11 |
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| Patient 12 |
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| Patient 13 |
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| Patient 14 |
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| Patient 15 |
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| Patient 16 |
|