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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03546907
Registration number
NCT03546907
Ethics application status
Date submitted
17/05/2018
Date registered
6/06/2018
Titles & IDs
Public title
Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
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Secondary ID [1]
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2017-003290-34
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Secondary ID [2]
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ACT15104
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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:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAR440340
Treatment: Drugs - Placebo
Treatment: Drugs - Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
Treatment: Drugs - Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
Treatment: Drugs - Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
Treatment: Drugs - Any short-acting ß agonist as prescribed by treating physician as standard of care
Placebo comparator: Placebo - Participants received placebo matched to SAR440340 administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W). Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, End of Treatment (EOT) visit occurred 2 weeks after last administration of IMP i.e., at Week 52).
Experimental: SAR440340 - Participants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52).
Treatment: Drugs: SAR440340
Pharmaceutical form: Solution for injection; Route of administration: SC
Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection; Route of administration: SC
Treatment: Drugs: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled
Treatment: Drugs: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
Treatment: Drugs: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
Treatment: Drugs: Any short-acting ß agonist as prescribed by treating physician as standard of care
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled
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Intervention code [1]
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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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Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants
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Assessment method [1]
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Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
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Timepoint [1]
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From Baseline up to Week 52
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Secondary outcome [1]
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Average Change in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 16 Through Week 24
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Assessment method [1]
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FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. A mixed-effect model with repeated measures (MMRM) was first used to model the change from baseline at each post randomization timepoint up to Week 24, then the predicted values of Week 16 to Week 24 were averaged to provide an overall assessment of change from baseline in FEV1.
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Timepoint [1]
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From Baseline to Week 16 through Week 24
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Secondary outcome [2]
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Change From Baseline in Post-bronchodilator Forced Expiratory Volume (FEV1) in 1 Second at Week 24
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Assessment method [2]
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FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol \[100 micrograms {mcg}\] or ipratropium bromide \[20 mcg\]).
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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Time to First Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
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Assessment method [3]
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The time to first moderate or severe exacerbation was defined as onset date of first moderate or severe AECOPD minus randomization date + 1. The median time to first severe exacerbation was derived from Kaplan-Meier estimates. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death.
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Timepoint [3]
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From Baseline up to 52 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria :
* Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
* Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1% predicted <80%, but greater than equal to [>=] 30%).
* Participants with COPD assessment test (CAT) score >=10 at Screening.
* Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a participant in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] had been excluded).
* Participants with a documented history (e.g., medical record verification) of >=2 moderate exacerbations or >=1 severe exacerbation within the year prior to screening. A moderate exacerbation was defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a "moderate exacerbation" unless documentation was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was defined as an AECOPD that required a hospitalization.
* Participants with standard of care background therapy, for 3 months and at a stable dose for at least 1 month, including either:
* Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.
or
* Triple therapy: LABA + LAMA + ICS.
* Current or former smokers with a smoking history of >=10 packs/year.
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Minimum age
40
Years
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Maximum age
75
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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:
* Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia).
* Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within previous 1 month or more than 4 courses of intravenous glucocorticosteroids within the previous 6 months.
* Participants with bronchial thermoplasty procedure (up to 3 years prior to Visit 1).
* A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines.
* Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc.) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
* Diagnosis of a-1 anti-trypsin deficiency.
* Advanced COPD with need for chronic (greater than [>] 15 hours/day) oxygen support.
* Participant with a moderate or severe acute exacerbation of COPD event within previous 4 weeks.
* A participant who has experienced an upper or lower respiratory tract infection within previous 4 weeks.
* Prior history of or planned pneumonectomy or lung volume reduction surgery.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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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
16/07/2018
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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
21/02/2020
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Sample size
Target
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Accrual to date
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Final
343
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 0360005 - Bedford Park
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Recruitment hospital [2]
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Investigational Site Number 0360002 - Chermside
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Recruitment hospital [3]
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Investigational Site Number 0360004 - Clayton
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Recruitment hospital [4]
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Investigational Site Number 0360003 - Frankston
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Investigational Site Number 0360006 - Kent Town
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Recruitment hospital [6]
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Investigational Site Number 0360001 - Murdoch
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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5067 - Kent Town
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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California
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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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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Regeneron Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 \[IL-33\] monoclonal antibody \[mAb\]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. * Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. * Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.
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Trial website
https://clinicaltrials.gov/study/NCT03546907
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Trial related presentations / publications
Rabe KF, Celli BR, Wechsler ME, Abdulai RM, Luo X, Boomsma MM, Staudinger H, Horowitz JE, Baras A, Ferreira MA, Ruddy MK, Nivens MC, Amin N, Weinreich DM, Yancopoulos GD, Goulaouic H. Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial. Lancet Respir Med. 2021 Nov;9(11):1288-1298. doi: 10.1016/S2213-2600(21)00167-3. Epub 2021 Jul 21.
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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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?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/07/NCT03546907/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT03546907/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03546907