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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06003426
Registration number
NCT06003426
Ethics application status
Date submitted
15/08/2023
Date registered
22/08/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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0
IM027-068
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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0
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Condition category
Condition code
Respiratory
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0
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0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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0
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0
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Connective tissue diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986278
Treatment: Drugs - BMS-986278 Placebo
Experimental: BMS-986278 Dose 1 -
Experimental: BMS-986278 Dose 2 -
Placebo comparator: BMS-986278 Placebo -
Treatment: Drugs: BMS-986278
Specified dose on specified days
Treatment: Drugs: BMS-986278 Placebo
Specified dose on specified days
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants that experience spontaneous syncopal events
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Assessment method [1]
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Cohort 1
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Timepoint [1]
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At approximately 4 weeks
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Primary outcome [2]
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Absolute change from baseline in forced vital capacity (FVC) measured in mL
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Assessment method [2]
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Cohort 2
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Timepoint [2]
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0
At Week 52
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Secondary outcome [1]
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0
Number of participants who discontinued treatment due to any low BP-related Adverse Events
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Assessment method [1]
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0
Cohort 1
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Timepoint [1]
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Up to approximately 4 weeks
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Secondary outcome [2]
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Disease progression
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Assessment method [2]
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Cohort 2
Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters:
* Absolute percent predicted forced vital capacity (ppFVC) decline of = 10% from baseline
* Acute exacerbation of pulmonary fibrosis
* Respiratory-related hospitalization
* All-cause mortality
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Timepoint [2]
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0
Up to approximately 4 years
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Secondary outcome [3]
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0
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
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Assessment method [3]
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0
Cohort 2
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Timepoint [3]
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0
At Week 52 and up to approximately 3 years
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Secondary outcome [4]
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0
Change from baseline in L-PF dyspnea domain score
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Assessment method [4]
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0
Cohort 2
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Timepoint [4]
0
0
At Week 52 and up to approximately 4 years
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Secondary outcome [5]
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0
Change from baseline in walking distance measured in 6-minute walk test (6MWT)
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Assessment method [5]
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0
Cohort 2
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Timepoint [5]
0
0
At Week 52
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Secondary outcome [6]
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Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Respiratory-related hospitalization, or all-cause mortality
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Assessment method [6]
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Cohort 2
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Timepoint [6]
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0
Up to approximately 4 years
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Secondary outcome [7]
0
0
Time to absolute percent ppFVC decline of = 10% from baseline
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Assessment method [7]
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Cohort 2
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Timepoint [7]
0
0
Up to approximately 4 years
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Secondary outcome [8]
0
0
Time to first acute exacerbation of pulmonary fibrosis
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Assessment method [8]
0
0
Cohort 2
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Timepoint [8]
0
0
Up to approximately 4 years
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Secondary outcome [9]
0
0
Time to first Respiratory-related hospitalization
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Assessment method [9]
0
0
Cohort 2
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Timepoint [9]
0
0
Up to approximately 4 years
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Secondary outcome [10]
0
0
Time to first pulmonary fibrosis-related hospitalization
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Assessment method [10]
0
0
Cohort 2
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Timepoint [10]
0
0
Up to approximately 4 years
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Secondary outcome [11]
0
0
Time to all-cause mortality
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Assessment method [11]
0
0
Cohort 2
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Timepoint [11]
0
0
Up to approximately 4 years
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Secondary outcome [12]
0
0
Change from baseline in L-PF fatigue domain score
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Assessment method [12]
0
0
Cohort 2
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Timepoint [12]
0
0
At Week 52 and up to approximately 3 years
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Secondary outcome [13]
0
0
Change from baseline in L-PF impacts module score
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Assessment method [13]
0
0
Cohort 2
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Timepoint [13]
0
0
At Week 52 and up to approximately 3 years
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Secondary outcome [14]
0
0
Change from baseline in cough numeric rating scale (NRS)
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Assessment method [14]
0
0
Cohort 2
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Timepoint [14]
0
0
At Week 52 and up to approximately 3 years
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Secondary outcome [15]
0
0
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score
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Assessment method [15]
0
0
Cohort 2
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Timepoint [15]
0
0
At Week 52
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Secondary outcome [16]
0
0
Change from baseline in EQ-5D-5L visual analog scale score
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Assessment method [16]
0
0
Cohort 2
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Timepoint [16]
0
0
At Week 52
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Secondary outcome [17]
0
0
Rate of decline from baseline in FVC (mL)
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Assessment method [17]
0
0
Cohort 2
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Timepoint [17]
0
0
At Week 52
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Secondary outcome [18]
0
0
Rate of decline in ppFVC from baseline
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Assessment method [18]
0
0
Cohort 2
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Timepoint [18]
0
0
At Week 52
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Secondary outcome [19]
0
0
Change in ppFVC from baseline
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Assessment method [19]
0
0
Cohort 2
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Timepoint [19]
0
0
At Week 52
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Secondary outcome [20]
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0
Proportion of participants with absolute decline in ppFVC =10%
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Assessment method [20]
0
0
Cohort 2
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Timepoint [20]
0
0
At Week 52
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Secondary outcome [21]
0
0
Proportion of participants with relative decline in ppFVC =10%
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Assessment method [21]
0
0
Cohort 2
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Timepoint [21]
0
0
At Week 52
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Secondary outcome [22]
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0
Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)
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Assessment method [22]
0
0
Cohort 2
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Timepoint [22]
0
0
At Week 52
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Secondary outcome [23]
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0
Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline
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Assessment method [23]
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0
Cohort 2
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Timepoint [23]
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0
At Week 52
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Secondary outcome [24]
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0
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)
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Assessment method [24]
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0
Cohort 2
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Timepoint [24]
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0
At Week 52
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Secondary outcome [25]
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0
Number of participants with Adverse Events (AEs)
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Assessment method [25]
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0
Cohort 2
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Timepoint [25]
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0
Up to 28 days after last dose
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Secondary outcome [26]
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0
Number of participants with Serious AEs (SAEs)
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Assessment method [26]
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Cohort 2
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Timepoint [26]
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0
Up to 28 days after last dose
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Secondary outcome [27]
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0
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)
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Assessment method [27]
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0
Cohort 2
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Timepoint [27]
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0
Up to 28 days after last dose
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Secondary outcome [28]
0
0
Number of participants with AEs related to IMP
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Assessment method [28]
0
0
Cohort 2
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Timepoint [28]
0
0
Up to 28 days after last dose
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Secondary outcome [29]
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0
Number of treatment-emergent deaths
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Assessment method [29]
0
0
Cohort 2
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Timepoint [29]
0
0
Up to 28 days after last dose
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Secondary outcome [30]
0
0
Number of participants with clinical laboratory abnormalities
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Assessment method [30]
0
0
Cohort 2
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Timepoint [30]
0
0
Up to 28 days after last dose
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Secondary outcome [31]
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0
Number of participants with electrocardiogram (ECG) abnormalities
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Assessment method [31]
0
0
Cohorts 1 and 2
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Timepoint [31]
0
0
Up to 28 days after last dose
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Secondary outcome [32]
0
0
Number of participants with vital sign abnormalities
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Assessment method [32]
0
0
Cohorts 1 and 2
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Timepoint [32]
0
0
Up to 28 days after last dose
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Secondary outcome [33]
0
0
Number of participants with physical examination abnormalities
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Assessment method [33]
0
0
Cohort 1
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Timepoint [33]
0
0
Up to 28 days after last dose
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Subjects with IPF aged = 40 years at the time of signing the informed consent.
* Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
* Other protocol-defined Inclusion/Exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/10/2026
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Actual
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Sample size
Target
1185
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Local Institution - 0293 - Darlinghurst
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Recruitment hospital [3]
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Westmead Hospital - Westmead
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Recruitment hospital [4]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [5]
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Local Institution - 0474 - Chermside
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Recruitment hospital [6]
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Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) - Greenslopes
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Recruitment hospital [7]
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Local Institution - 0421 - South Brisbane
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
0
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Eastern Health - Box Hill
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Recruitment hospital [10]
0
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Peninsula Health - Frankston Hospital - Frankston
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Recruitment hospital [11]
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Local Institution - 0357 - Heidelberg
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Recruitment hospital [12]
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Local Institution - 0253 - Melbourne
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Recruitment hospital [13]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [14]
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Institute for Respiratory Health - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4032 - Brisbane
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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4120 - Greenslopes
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Recruitment postcode(s) [7]
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4101 - South Brisbane
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3128 - Box Hill
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Recruitment postcode(s) [10]
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3199 - Frankston
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Recruitment postcode(s) [11]
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3084 - Heidelberg
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Recruitment postcode(s) [12]
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3004 - Melbourne
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Recruitment postcode(s) [13]
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6150 - Murdoch
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Recruitment postcode(s) [14]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
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Arizona
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0
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United States of America
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State/province [3]
0
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California
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0
United States of America
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State/province [4]
0
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Colorado
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0
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United States of America
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State/province [5]
0
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Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Delaware
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Country [7]
0
0
United States of America
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State/province [7]
0
0
District of Columbia
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Country [8]
0
0
United States of America
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State/province [8]
0
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Florida
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Country [9]
0
0
United States of America
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State/province [9]
0
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Georgia
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0
0
United States of America
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State/province [10]
0
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Illinois
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Country [11]
0
0
United States of America
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State/province [11]
0
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Indiana
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Country [12]
0
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United States of America
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Iowa
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United States of America
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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B
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Argentina
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C
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0
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Argentina
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0
Distrito Federal
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0
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Argentina
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M
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Argentina
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S
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Argentina
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T
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Argentina
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X
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Argentina
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Santa Fe
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Austria
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Oberoesterreich
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Austria
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Salzburger Land
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Austria
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Styria
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Namur
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Belgium
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VAN
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Belgium
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Brussels
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Minas Gerais
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Brazil
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Rio De Janeiro
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0
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Brazil
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RIO Grande DO SUL
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0
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Brazil
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0
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RJ
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0
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Brazil
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0
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RS
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0
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Brazil
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0
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SC
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Country [59]
0
0
Brazil
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0
0
SP
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0
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Brazil
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Sao Paulo
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0
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Canada
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Alberta
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Country [62]
0
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Canada
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British Columbia
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Country [63]
0
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Canada
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0
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Ontario
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0
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Canada
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0
0
Quebec
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0
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Chile
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0
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BI
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Country [66]
0
0
Chile
Query!
State/province [66]
0
0
Maule
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
RM
Query!
Country [68]
0
0
Chile
Query!
State/province [68]
0
0
Valparaiso
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
AH
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Anhui
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Beijing
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Guangdong
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Hainan
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Hebei
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Henan
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
HUB
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Jiangsu
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Jiangxi
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Jilin
Query!
Country [80]
0
0
China
Query!
State/province [80]
0
0
Liaoning
Query!
Country [81]
0
0
China
Query!
State/province [81]
0
0
Shanghai
Query!
Country [82]
0
0
China
Query!
State/province [82]
0
0
Sichuan
Query!
Country [83]
0
0
China
Query!
State/province [83]
0
0
Tianjin
Query!
Country [84]
0
0
China
Query!
State/province [84]
0
0
Zhejiang
Query!
Country [85]
0
0
China
Query!
State/province [85]
0
0
Changsha
Query!
Country [86]
0
0
China
Query!
State/province [86]
0
0
Chengdu Shi
Query!
Country [87]
0
0
China
Query!
State/province [87]
0
0
Guangzhou Shi
Query!
Country [88]
0
0
China
Query!
State/province [88]
0
0
Hohhot
Query!
Country [89]
0
0
China
Query!
State/province [89]
0
0
Jinan Shi
Query!
Country [90]
0
0
China
Query!
State/province [90]
0
0
Nanjing
Query!
Country [91]
0
0
China
Query!
State/province [91]
0
0
Shijiazhuang
Query!
Country [92]
0
0
China
Query!
State/province [92]
0
0
Wuhan
Query!
Country [93]
0
0
China
Query!
State/province [93]
0
0
Xi'an
Query!
Country [94]
0
0
China
Query!
State/province [94]
0
0
Yinchuan
Query!
Country [95]
0
0
Colombia
Query!
State/province [95]
0
0
ANT
Query!
Country [96]
0
0
Colombia
Query!
State/province [96]
0
0
DC
Query!
Country [97]
0
0
Colombia
Query!
State/province [97]
0
0
Santander
Query!
Country [98]
0
0
Colombia
Query!
State/province [98]
0
0
VAC
Query!
Country [99]
0
0
Colombia
Query!
State/province [99]
0
0
Bogotá
Query!
Country [100]
0
0
Colombia
Query!
State/province [100]
0
0
Manizales
Query!
Country [101]
0
0
Czechia
Query!
State/province [101]
0
0
JM
Query!
Country [102]
0
0
Czechia
Query!
State/province [102]
0
0
Olomouc
Query!
Country [103]
0
0
Czechia
Query!
State/province [103]
0
0
Prague
Query!
Country [104]
0
0
Denmark
Query!
State/province [104]
0
0
Region Midtjylland
Query!
Country [105]
0
0
Denmark
Query!
State/province [105]
0
0
Region Syddanmark
Query!
Country [106]
0
0
Denmark
Query!
State/province [106]
0
0
Hellerup
Query!
Country [107]
0
0
Finland
Query!
State/province [107]
0
0
Laensi-Suomen Laeaeni
Query!
Country [108]
0
0
Finland
Query!
State/province [108]
0
0
Helsinki
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Auvergne-Rhône-Alpes
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Pays De La Loire
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Provence-Alpes-Côte d'Azur
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Angers
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
Bobigny
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Brest
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Dijon
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Lille CEDEX
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Nice
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Paris
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Pessac
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Rennes
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Toulouse
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Tours
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Bavaria
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
BE
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
BW
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
BY
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
HE
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
HH
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Nordrhein Westfalen
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Northwest
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
SH
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Coswig
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Heidelberg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Leipzig
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Mainz
Query!
Country [136]
0
0
Greece
Query!
State/province [136]
0
0
Attica
Query!
Country [137]
0
0
Greece
Query!
State/province [137]
0
0
B
Query!
Country [138]
0
0
Greece
Query!
State/province [138]
0
0
Epirus
Query!
Country [139]
0
0
Greece
Query!
State/province [139]
0
0
Iraklio Kritis
Query!
Country [140]
0
0
Greece
Query!
State/province [140]
0
0
Thessaloniki
Query!
Country [141]
0
0
Greece
Query!
State/province [141]
0
0
Athens
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Corfu
Query!
Country [143]
0
0
Greece
Query!
State/province [143]
0
0
Larisa
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Rio
Query!
Country [145]
0
0
Hungary
Query!
State/province [145]
0
0
Budapest
Query!
Country [146]
0
0
Hungary
Query!
State/province [146]
0
0
Györ
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Delhi
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
DL
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
GJ
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
Gujarat
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
HR
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Karnataka
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
KA
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Maharashtra
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
MH
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
MP
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
RJ
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
UP
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Uttar Pradesh
Query!
Country [160]
0
0
India
Query!
State/province [160]
0
0
UT
Query!
Country [161]
0
0
India
Query!
State/province [161]
0
0
WB
Query!
Country [162]
0
0
India
Query!
State/province [162]
0
0
Ahmedabad
Query!
Country [163]
0
0
India
Query!
State/province [163]
0
0
Lucknow
Query!
Country [164]
0
0
Ireland
Query!
State/province [164]
0
0
LH
Query!
Country [165]
0
0
Ireland
Query!
State/province [165]
0
0
Dublin
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
HA
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Be'er Sheva
Query!
Country [168]
0
0
Israel
Query!
State/province [168]
0
0
Haifa
Query!
Country [169]
0
0
Israel
Query!
State/province [169]
0
0
Jerusalem
Query!
Country [170]
0
0
Israel
Query!
State/province [170]
0
0
Petah-Tikva
Query!
Country [171]
0
0
Israel
Query!
State/province [171]
0
0
Rehovot
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Tel Aviv-Yafo
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
BO
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Emilia-Romagna
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
FI
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
MI
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Modena
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
PI
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
RM
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
TS
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Ancona
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Bergamo
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Foggia
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Forli
Query!
Country [185]
0
0
Italy
Query!
State/province [185]
0
0
Milano
Query!
Country [186]
0
0
Italy
Query!
State/province [186]
0
0
Milan
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Naples
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Napoli
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Palermo
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Pavia
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Sassari
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Siena
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Chiba
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Fukuoka-Ken
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Fukuoka
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Fukushima
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Gunma
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Hirohima-ken
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Hokkaido
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Hyogo
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Mie
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
NGS
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Osaka
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
OSK
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
TKY
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Tochigi
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Tokushima
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Tokyo-to
Query!
Country [209]
0
0
Japan
Query!
State/province [209]
0
0
Tokyo
Query!
Country [210]
0
0
Japan
Query!
State/province [210]
0
0
Bunkyo-Ku
Query!
Country [211]
0
0
Japan
Query!
State/province [211]
0
0
Ginowan-Shi
Query!
Country [212]
0
0
Japan
Query!
State/province [212]
0
0
Hamamatsu-shi
Query!
Country [213]
0
0
Japan
Query!
State/province [213]
0
0
Himeji-Shi
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Iizuka-shi
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Izumo-Shi
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Kamogawa-Shi
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Kumamoto-Shi
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Minato-Ku
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Minato-ku
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Nagoya
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Seto
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Shinjuku-Ku
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Shinjyu-Ku
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Tenri-Shi
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Uruma-shi
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Yokohama-Shi
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Yoshida-Gun
Query!
Country [228]
0
0
Korea, Republic of
Query!
State/province [228]
0
0
Busan
Query!
Country [229]
0
0
Korea, Republic of
Query!
State/province [229]
0
0
Gyeonggi-Do
Query!
Country [230]
0
0
Korea, Republic of
Query!
State/province [230]
0
0
Seoul
Query!
Country [231]
0
0
Korea, Republic of
Query!
State/province [231]
0
0
Ulsan
Query!
Country [232]
0
0
Korea, Republic of
Query!
State/province [232]
0
0
Bucheon-Si
Query!
Country [233]
0
0
Korea, Republic of
Query!
State/province [233]
0
0
Bucheonsi Weonmigu
Query!
Country [234]
0
0
Korea, Republic of
Query!
State/province [234]
0
0
Deogyang-Gu, Goyang-Si
Query!
Country [235]
0
0
Korea, Republic of
Query!
State/province [235]
0
0
Dong-Gu
Query!
Country [236]
0
0
Korea, Republic of
Query!
State/province [236]
0
0
Gyeonggi-do
Query!
Country [237]
0
0
Korea, Republic of
Query!
State/province [237]
0
0
Haeundae-Gu
Query!
Country [238]
0
0
Korea, Republic of
Query!
State/province [238]
0
0
Iksansi
Query!
Country [239]
0
0
Korea, Republic of
Query!
State/province [239]
0
0
Incheon
Query!
Country [240]
0
0
Korea, Republic of
Query!
State/province [240]
0
0
Suwon, Gyeonggi-do
Query!
Country [241]
0
0
Malaysia
Query!
State/province [241]
0
0
Selangor Darul Ehsan
Query!
Country [242]
0
0
Malaysia
Query!
State/province [242]
0
0
Wilayah Persekutuan Kuala Lumpur
Query!
Country [243]
0
0
Malaysia
Query!
State/province [243]
0
0
Kuching
Query!
Country [244]
0
0
Mexico
Query!
State/province [244]
0
0
AGU
Query!
Country [245]
0
0
Mexico
Query!
State/province [245]
0
0
CHH
Query!
Country [246]
0
0
Mexico
Query!
State/province [246]
0
0
DIF
Query!
Country [247]
0
0
Mexico
Query!
State/province [247]
0
0
Jalisco
Query!
Country [248]
0
0
Mexico
Query!
State/province [248]
0
0
JAL
Query!
Country [249]
0
0
Mexico
Query!
State/province [249]
0
0
MIC
Query!
Country [250]
0
0
Mexico
Query!
State/province [250]
0
0
Nuevo Leon
Query!
Country [251]
0
0
Mexico
Query!
State/province [251]
0
0
OAX
Query!
Country [252]
0
0
Mexico
Query!
State/province [252]
0
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VER
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Mexico
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YUC
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Mexico
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Mexico
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Mexico City
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Netherlands
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Limburg
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Netherlands
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Netherlands
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ZH
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Amsterdam
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Netherlands
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Nieuwegein
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Peru
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LIM
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Peru
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PIU
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Peru
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Lima
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KP
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Poland
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MA
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Poland
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WN
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Poland
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Bedzin
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Poland
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Katowice
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Poland
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Lodz
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Portugal
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Braga
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Faro
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Portugal
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Portugal
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Loures
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Portugal
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Porto
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Portugal
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CB
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Spain
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Comunidad Valencia
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C
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Spain
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M
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Girona
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Spain
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Madrid
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Pamplona
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BE
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BS
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Geneve
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St Gallen
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CHA
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Taiwan
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Kao-Hsiung
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TXG
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Taiwan
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YUN
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taipei City
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Taipei
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Bangkok
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Songkla
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Turkey
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Adana
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Ankara
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Bursa
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Izmir
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Keçiören/Ankara
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Turkey
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Maltepe
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Pasaport
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Topkapi
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BIR
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BST
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DND
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EDH
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Greater London
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Oxfordshire
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PTE
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South West
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STY
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Yorkshire And The Humber
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Birmingham
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Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
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Trial website
https://clinicaltrials.gov/study/NCT06003426
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Address
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0
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0
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Phone
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0
855-907-3286
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See plan description
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Available to whom?
See plan description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06003426