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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/NCT02333331
Registration number
NCT02333331
Ethics application status
Date submitted
10/12/2014
Date registered
7/01/2015
Date last updated
5/01/2021
Titles & IDs
Public title
Dose Range Finding Study of Bimagrumab in Sarcopenia
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Scientific title
A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)
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Secondary ID [1]
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CBYM338E2202
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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:
Sarcopenia
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bimagrumab
Other interventions - placebo
Experimental: BYM338 70 mg - BYM338 70 mg intravenous infusion
Experimental: BYM338 210 mg - BYM338 210 mg intravenous infusion
Experimental: BYM338 700 mg - BYM338 700 mg intravenous infusion
Placebo Comparator: Placebo - Placebo intravenous infusion
Treatment: Drugs: bimagrumab
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
Other interventions: placebo
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
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Assessment method [1]
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Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
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Timepoint [1]
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Baseline, week 25
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Secondary outcome [1]
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Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
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Assessment method [1]
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Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
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Timepoint [1]
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Baseline, week 25
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Secondary outcome [2]
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Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
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Assessment method [2]
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Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).
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Timepoint [2]
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baseline, week 25
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Secondary outcome [3]
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Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
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Assessment method [3]
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Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
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Timepoint [3]
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baseline, week 25
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Secondary outcome [4]
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Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
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Assessment method [4]
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Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.
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Timepoint [4]
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baseline, week 25
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Eligibility
Key inclusion criteria
- Low muscle mass as confirmed by DXA;
- Low gait speed <0.8 m/s
- SPPB score less than or equal to 9;
- Weigh at least 35 kg;
- Adequate dietary intake;
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Minimum age
70
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
- A lower limb fracture in the past 6 months or any impairment or disease severely
affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease,
peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular
disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective
pain management);
- Requires regular assistance from another person for general activities of daily living
(e.g. bathing, dressing, toileting).
- Intraocular surgery and laser procedures for refractive correction within 6 months
prior to screening;
- Any underlying muscle disease including active myopathy or muscular dytrophy;
- Confirmed diagnosis of heart failure classified as New York Heart Association Class
III or IV (e.g. dilated cardiomyopathy);
- Type I diabetes or uncontrolled Type 2 diabetes;
- Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];
- History of confirmed chronic obstructive pulmonary disease with a severity grade > 2
on the Medical Research Council Dyspnea Scale;
- Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring
immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent;
- Known history or presence of severe active acute or chronic liver disease (e.g.,
cirrhosis);
- Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary
intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary
embolism within 12 weeks of screening;
- Active cancer (i.e., under current treatment), or cancer requiring treatment in the
last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis
(e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine
cervix);
- Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
9/12/2014
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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
28/06/2018
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Sample size
Target
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Accrual to date
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Final
217
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [2]
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Novartis Investigative Site - St Albans
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3021 - St Albans
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Massachusetts
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Minnesota
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North Carolina
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Ohio
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South Carolina
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Texas
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Wisconsin
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Belgium
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Brussel
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Belgium
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Leuven
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Czechia
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Brno
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Czechia
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Opava
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Czechia
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Praha 2
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Copenhagen NV
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Denmark
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Copenhagen
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France
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Paris
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France
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Pessac
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France
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Toulouse
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Germany
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Berlin
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Germany
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Wuerzburg
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Aichi
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Gifu
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokushima
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Japan
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Tokyo
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Korea, Republic of
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Gyeonggi Do
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Korea
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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Russian Federation
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Yaroslavl
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Spain
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Castilla La Mancha
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Spain
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Madrid
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Barcelona
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CH
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Switzerland
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Genève 14
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to determine the efficacy of repeat dosing with multiple dose
levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older
adults with sarcopenia. In addition, this study generated data on the safety, tolerability,
and pharmacokinetics of bimagrumab in older adults with sarcopenia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02333331
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02333331
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