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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00413218
Registration number
NCT00413218
Ethics application status
Date submitted
18/12/2006
Date registered
19/12/2006
Titles & IDs
Public title
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
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Scientific title
A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections
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Secondary ID [1]
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WSA-CS-008
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Secondary ID [2]
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9766-CL-0105
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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:
Candidiasis, Invasive
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Candidemia
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Mycoses
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Blood
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Isavuconazole
Treatment: Drugs - Caspofungin
Treatment: Drugs - Voriconazole
Experimental: Isavuconazole (ISA) - Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
Active comparator: Caspofungin (CAS)/Voriconazole - Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
Treatment: Drugs: Isavuconazole
Administered by intravenous infusion.
Treatment: Drugs: Caspofungin
Administered by intravenous infusion.
Treatment: Drugs: Voriconazole
Administered by intravenous infusion.
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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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Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use
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Assessment method [1]
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A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.
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Timepoint [1]
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End of Intravenous Treatment (EOIV) (Days 11-56)
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Secondary outcome [1]
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Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)
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Assessment method [1]
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A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.
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Timepoint [1]
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End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)
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Secondary outcome [2]
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Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2
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Assessment method [2]
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A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).
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Timepoint [2]
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EOT (Day 56) and FU2 (6 weeks after end of treatment)
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Secondary outcome [3]
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Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
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Assessment method [3]
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A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).
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Timepoint [3]
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EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
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Secondary outcome [4]
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Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
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Assessment method [4]
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A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).
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Timepoint [4]
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EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
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Secondary outcome [5]
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Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
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Assessment method [5]
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Success was defined as mycological response (eradication or presumed eradication).
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Timepoint [5]
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Day 7 and EOT (Day 56)
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Secondary outcome [6]
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Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
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Assessment method [6]
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Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.
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Timepoint [6]
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Day 7 and EOT (Day 56)
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Secondary outcome [7]
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All-Cause Mortality (ACM) at Day 14 and Day 56
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Assessment method [7]
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All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.
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Timepoint [7]
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Day 14 and Day 56
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Secondary outcome [8]
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Time to First Confirmed Negative Culture
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Assessment method [8]
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The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis
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Timepoint [8]
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Day 1 up to FU1 (2 weeks after EOT (Day 56))
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Eligibility
Key inclusion criteria
* Patients with candidemia or with an invasive Candida infection
* Presence of fever, hypothermia or other appropriate local sign of infection
* Female patients must be non-lactating and at no risk of pregnancy
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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
* Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens
* Patients with candidemia who failed a previous antifungal therapy for the same infection
* Patients previously enrolled in a phase III study with isavuconazole
* Patients with a body weight <40kg
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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 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
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
8/03/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
3/03/2015
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Sample size
Target
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Accrual to date
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Final
450
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Recruitment in Australia
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Recruitment hospital [1]
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Fremantle Hospital - Fremantle
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Mater Adult Hospital - South Brisbane
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Westmead Hospital - Westmead
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Princess Alexandra Hospital - Woolloongabba
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6160 - Fremantle
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- South Brisbane
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- Westmead
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4102 - Woolloongabba
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Ratchathewi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Inc
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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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Basilea Pharmaceutica
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
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Trial website
https://clinicaltrials.gov/study/NCT00413218
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Trial related presentations / publications
Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827. McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Astellas Pharma Global Development
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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?
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
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)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
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Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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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.clinicalstudydatarequest.com/
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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/NCT00413218