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A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTP001 | Experimental | LTP001 orally once daily in the morning for approximately 26 weeks. |
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| Placebo | Experimental | Placebo orally once daily in the morning for approximately 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTP001 | Drug | LTP001 administered once daily in the morning |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted | Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome. | Baseline, up to approximately 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Treatment Epoch in FVC | Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome. | Baseline, up to approximately 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Additional protocol-defined inclusion / exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Kansas Hospital |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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The screening period took place over 42 days to assess participants eligibility to take part. Written informed consent was obtained from each participant before any study specific proceedure(s) were performed. The study was explained to each participant or designee, who answered and questions, and written information was also provided.
Participants took part at 15 investigative sites in 7 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | LTP001 6mg | LTP001 6mg orally once daily in the morning for approximately 26 weeks. |
| FG001 | Placebo | Placebo orally once daily in the morning for approximately 26 weeks. |
| 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 | Oct 9, 2023 | Aug 12, 2025 |
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| Drug |
Placebo to LTP001 administered once daily in the morning |
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| Standard of Care (SoC) | Drug | nintedanib, pirfenidone, or neither |
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| Progression-free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of the any of the following events: Absolute reduction from baseline of ≥10% predicted in FVC, Nonelective hospitalization for respiratory events, Lung Transplant, Death. PFS was analyzed based on Kaplan-Meier estimates. | Baseline, up to approximately 26 weeks |
| Number of Participants With Absolute Decline of ≥10% Predicted in FVC | Binary output of absolute decline of ≥ 10% predicted in FVC (Yes/No) at the end of treatment epoch. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO) | Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD) | The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. A positive change from baseline in 6MWD is considered a favourable outcome. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire | The King's Brief Interstitial Lung Disease (K-BILD) is a 15-item HRQOL questionnaire that range from 0 to 100. Higher scores indicate better health-related quality of life, with 100 representing the best possible health status. A positive change from baseline in K-BILD questionnaire is considered a favourable outcome. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire | The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A higher score means less impact on quality of life. A positive LCQ change score indicates an improvement. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire | The Raghu-Scale for Pulmonary Fibrosis (R-Scale for PF) is a questionnaire designed to assess the impact of lung disease on quality of life. The R-Scale-PF uses a numerical rating scale to assess the severity of five symptoms: cough, shortness of breath, fatigue, depressed mood, and overall sense of wellbeing, over the past two weeks. Each item is scored from 0 to 10, with lower scores indicating better health-related quality of life. The total R-Scale-PF score ranges from 0 to 50. A decrease from baseline in R-Scale for PF is considered a favourable outcome. | Baseline, up to approximately 26 weeks |
| Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire | Living with idiopathic pulmonary fibrosis (L-IPF) is a tool that assesses symptoms and impacts of IPF. The Symptoms Module consists of 20 questions to assess symptoms experienced from IPF over the last 24 hours. The Impacts Module consists of 20 questions on how IPF affects quality of life over the last 7 days. The total score ranging from 0 to 100, with higher scores indicating greater symptom severity. A positive change from baseline in L-IPF is considered a favourable outcome. | Baseline, up to approximately 26 weeks |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | Ranelagh Partido de Berazate | Buenos Aires | 1884 | Argentina |
| Novartis Investigative Site | Paraná | 3100 | Argentina |
| Novartis Investigative Site | Camperdown | New South Wales | 2050 | Australia |
| Novartis Investigative Site | Chermside | Queensland | 4032 | Australia |
| Novartis Investigative Site | Spearwood | Western Australia | 6163 | Australia |
| Novartis Investigative Site | Prague | 140 59 | Czechia |
| Novartis Investigative Site | Munich | Bavaria | 81377 | Germany |
| Novartis Investigative Site | Coswig | 01640 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Amsterdam | North Holland | 1081 HV | Netherlands |
| Novartis Investigative Site | Nieuwegein | Utrecht | 3435 CM | Netherlands |
| Novartis Investigative Site | Bialystok | 15-044 | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LTP001 6mg | LTP001 6mg orally once daily in the morning for approximately 26 weeks. |
| BG001 | Placebo | Placebo orally once daily in the morning for approximately 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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/Ethnicity, Customized | 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 | Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted | Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | Percentage of predicted FVC | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to End of Treatment Epoch in FVC | Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | mL | Baseline, up to approximately 26 weeks |
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| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from the date of randomization to the date of the any of the following events: Absolute reduction from baseline of ≥10% predicted in FVC, Nonelective hospitalization for respiratory events, Lung Transplant, Death. PFS was analyzed based on Kaplan-Meier estimates. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Median | 95% Confidence Interval | Days | Baseline, up to approximately 26 weeks |
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| Secondary | Number of Participants With Absolute Decline of ≥10% Predicted in FVC | Binary output of absolute decline of ≥ 10% predicted in FVC (Yes/No) at the end of treatment epoch. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. | Posted | Count of Participants | Participants | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO) | Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | mL/min/mmHg | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD) | The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. A positive change from baseline in 6MWD is considered a favourable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | meters | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire | The King's Brief Interstitial Lung Disease (K-BILD) is a 15-item HRQOL questionnaire that range from 0 to 100. Higher scores indicate better health-related quality of life, with 100 representing the best possible health status. A positive change from baseline in K-BILD questionnaire is considered a favourable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | score on scale | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire | The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A higher score means less impact on quality of life. A positive LCQ change score indicates an improvement. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | score on scale | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire | The Raghu-Scale for Pulmonary Fibrosis (R-Scale for PF) is a questionnaire designed to assess the impact of lung disease on quality of life. The R-Scale-PF uses a numerical rating scale to assess the severity of five symptoms: cough, shortness of breath, fatigue, depressed mood, and overall sense of wellbeing, over the past two weeks. Each item is scored from 0 to 10, with lower scores indicating better health-related quality of life. The total R-Scale-PF score ranges from 0 to 50. A decrease from baseline in R-Scale for PF is considered a favourable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | score on scale | Baseline, up to approximately 26 weeks |
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| Secondary | Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire | Living with idiopathic pulmonary fibrosis (L-IPF) is a tool that assesses symptoms and impacts of IPF. The Symptoms Module consists of 20 questions to assess symptoms experienced from IPF over the last 24 hours. The Impacts Module consists of 20 questions on how IPF affects quality of life over the last 7 days. The total score ranging from 0 to 100, with higher scores indicating greater symptom severity. A positive change from baseline in L-IPF is considered a favourable outcome. | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Only participants with evaluable measurements are included. | Posted | Mean | Standard Deviation | score on scale | Baseline, up to approximately 26 weeks |
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Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 30 weeks.
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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 | LTP001 6 mg | LTP001 6mg orally once daily in the morning for approximately 26 weeks. | 1 | 23 | 2 | 23 | 14 | 23 |
| EG001 | Placebo | Placebo orally once daily in the morning for approximately 26 weeks. | 0 | 23 | 1 | 23 | 7 | 23 |
| EG002 | Total | Total | 1 | 46 | 3 | 46 | 21 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Bladder disorder | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2024 | Aug 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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