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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03138499
Registration number
NCT03138499
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Date last updated
12/04/2022
Titles & IDs
Public title
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
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Scientific title
Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
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Secondary ID [1]
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2017-000847-41
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Secondary ID [2]
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CA209-812
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 812
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hodgkin's Disease
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Condition category
Condition code
Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Brentuximab vedotin
Experimental: Module A - Nivolumab combined with Brentuximab
Experimental: Module B - Brentuximab alone
Other interventions: Nivolumab
Specified dose on specified days
Other interventions: Brentuximab vedotin
Specified dose on specified days
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Intervention code [1]
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Other interventions
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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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Progression Free Survival (PFS)
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Assessment method [1]
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Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
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Timepoint [1]
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From randomization to date of death, or disease progression (up to approximately 45 months)
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Secondary outcome [1]
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Complete Response Rate (CRR):
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Assessment method [1]
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Complete Response Rate (CRR) is defined as the number of participants who have achieved complete response (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
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Timepoint [1]
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From randomization up to approximately 45 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
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Timepoint [2]
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From randomization up to approximately 45 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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The time from first response (Complete response (CR) or partial response (PR)) to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
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Timepoint [3]
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From randomization to date of documented progression or death (up to approximately 45 months)
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Secondary outcome [4]
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Duration of Complete Response (DOCR)
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Assessment method [4]
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Duration of complete response (DOR) is defined as the time from first complete response to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3.
Per the Lugano criteria:
Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
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Timepoint [4]
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From randomization to date of documented progression or death (up to approximately 45 months)
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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Overall Survival (OS) is defined as the time between the date of randomization and the date of death estimated using the Kaplan-Meier (KM) product-limit method
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Timepoint [5]
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From randomization to the date of death (up to approximately 3 years 7 months)
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Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who
are relapsed or refractory with one of the following:
I. Autologous stem cell transplant (ASCT) ineligible patients
ii. Patients after failure of ASCT
- Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and
avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan
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Minimum age
18
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
- Known central nervous system lymphoma
- Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)
- Participants with known history of pancreatitis or progressive multifocal
leukoencephalopathy (PML)
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
Open (masking not used)
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Who is / are masked / blinded?
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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
Terminated
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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
26/06/2017
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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
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Actual
22/02/2021
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
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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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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Indiana
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Country [5]
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United States of America
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State/province [5]
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Kansas
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United States of America
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State/province [6]
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Louisiana
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Country [7]
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United States of America
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Massachusetts
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United States of America
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Michigan
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Pennsylvania
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Country [11]
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United States of America
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State/province [11]
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South Carolina
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Country [12]
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State/province [12]
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Tennessee
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State/province [13]
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Texas
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Japan
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State/province [14]
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Miyagi
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Puerto Rico
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State/province [15]
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San Juan
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Seagen Inc.
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Ono Pharmaceutical Co. Ltd
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether an investigational immuno-therapy
combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
participants of this trial will comprise of patients who have relapsed or did not respond to
treatment and are not eligible for stem cell transplant
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03138499
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03138499
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