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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001239-29 | EudraCT Number |
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| Name | Class |
|---|---|
| ISA Pharmaceuticals B.V. | INDUSTRY |
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The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).
The secondary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemiplimab+ISA101b | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemiplimab | Drug | Administered intravenously (IV) every three weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS). | From enrollment to last dose (~up to 23 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. | From enrollment to last dose (~up to 23 months) |
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates | Tucson | Arizona | 85704 | United States | ||
| Arizona Oncology Associates |
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| Label | URL |
|---|---|
| A Plain Language Summary is available on TrialSummaries.com | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
229 participants were screened, and of these, 113 were enrolled and 116 were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | ISA 101b + Cemiplimab 350 mg Q3W | A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug |
| 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 31, 2021 | May 15, 2024 |
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| ISA101b | Biological | Administered by subcutaneous (SC) injection on day 1, day 29, and day 50 |
|
| From enrollment to last dose (~up to 23 months) |
| Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs) | From enrollment to last dose (~up to 23 months) |
| Number of Participants With Any Serious TEAE | From enrollment to last dose (~up to 23 months) |
| Number of Participants With at Least One Lab Abnormality | From enrollment to last dose (~up to 23 months) |
| Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3 | Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | From enrollment to last dose (~up to 23 months) |
| Duration of Response (DOR) | From enrollment to last dose (~up to 23 months) |
| Progression Free Survival (PFS) | From enrollment to last dose (~up to 23 months) |
| Overall Survival (OS) | From enrollment to last dose (~up to 23 months) |
| Tucson |
| Arizona |
| 85711 |
| United States |
| Regeneron Research Site | Orange | California | 92868 | United States |
| Universitair Ziekenhuis Gent | Ghent | East Flanders | 9000 | Belgium |
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| CHIREC Delta Hospital / Chirec Cancer Institute | Brussels | 1160 | Belgium |
| Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA | Santo Cristo | Rio de Janeiro | 20220-410 | Brazil |
| Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Centro De Novos Tratamentos Itajai | Itajaà | Santa Catarina | 88301-220 | Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca (COI Clinicas Oncologicas Integradas SA) | Rio de Janeiro | 22793-080 | Brazil |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS | Meldola | Emilia-Romagna | 47014 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| IRCCS-Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Maastricht University Medical Center | Maastricht | Limburg | 6229 HX | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| Leiden Universitair Medisch Centrum (LUMC) | Leiden | 2333 ZA | Netherlands |
| Radboudumc | Nijmegen | 6525 GA | Netherlands |
| State Budgetary Healthcare Institution Clinical Oncology Dispensary 1 Of Healthcare Department Of Krasnodar Region | Krasnodar | Krasnodarskiy Kray | 350040 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| University of Ulsan College of Medicine - Asan Medical Center (AMC) | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Hospital Doctor Josep Trueta - Institut Catala d'Oncologia (ICO) | Girona | Catalonia | 17007 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ISA 101b + Cemiplimab 350 mg Q3W | A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug |
| 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 | Objective Response Rate (ORR) | Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS). | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From enrollment to last dose (~up to 23 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Number | Events | From enrollment to last dose (~up to 23 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Count of Participants | Participants | From enrollment to last dose (~up to 23 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs) | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Count of Participants | Participants | From enrollment to last dose (~up to 23 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Serious TEAE | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Count of Participants | Participants | From enrollment to last dose (~up to 23 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Lab Abnormality | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Count of Participants | Participants | From enrollment to last dose (~up to 23 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3 | Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Count of Participants | Participants | From enrollment to last dose (~up to 23 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Median | 95% Confidence Interval | months | From enrollment to last dose (~up to 23 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Median | 95% Confidence Interval | Months | From enrollment to last dose (~up to 23 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The full analysis set (FAS) included all enrolled participants who received any study drug. | Posted | Median | 95% Confidence Interval | Months | From enrollment to last dose (~up to 23 months) |
|
|
From signing of informed consent to end of study (~up to 28 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISA 101b + Cemiplimab 350 mg Q3W | A dose of 100 μg/peptide ISA101b on days 1, 29, and 50 (total of 3 doses). Cemiplimab 350 mg (milligrams) given by IV (intravenous) infusion over 30 minutes Q3W (every 3 weeks) on days 8 and 29 in cycle 1, on days 1 and 22 in cycles 2 through 4, and on days 1, 22, and 43 in all subsequent cycles until disease progression or discontinuation of study drug | 68 | 113 | 34 | 113 | 99 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Renal haematoma | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (26.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2022 | May 15, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
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