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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00068601
Registration number
NCT00068601
Ethics application status
Date submitted
10/09/2003
Date registered
11/09/2003
Date last updated
30/12/2019
Titles & IDs
Public title
S0230 Goserelin in Preventing Ovarian Failure in Women Receiving Chemotherapy for Breast Cancer
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Scientific title
Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer
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Secondary ID [1]
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S0230
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Secondary ID [2]
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CDR0000327758
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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:
Breast Cancer
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Infertility
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Menopausal Symptoms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - goserelin acetate
Active comparator: Standard Chemotherapy - Patients receive cyclophosphamide-containing chemotherapy alone.
Experimental: Chemotherapy Plus Goserelin - Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
Treatment: Drugs: cyclophosphamide
Part of planned chemotherapy regimen
Treatment: Drugs: goserelin acetate
Given subcutaneously
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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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Rate of Premature Ovarian Failure at 2 Years
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Assessment method [1]
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Ovarian failure at two years is defined as amenorrhea (absence of menstrual bleeding) for the preceding six months AND the presence of follicle-stimulating hormone (FSH) in the post-menopausal range.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Rate of Ovarian Dysfunction at 2 Years
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Assessment method [1]
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Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Rate of Ovarian Dysfunction at 1 Year
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Assessment method [2]
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Ovarian dysfunction is defined as amenorrhea for the preceding three months and the presence of FSH, estradiol and/or inhibin B levels in the postmenopausal range.
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Timepoint [2]
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1 year
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer
* Stage I-IIIA
* Operable disease
* Bilateral synchronous invasive breast cancer allowed provided primary tumors were diagnosed no more than 1 month apart and both tumors are hormone receptor negative
* Must be planning to receive 3-8 months of a preoperative or postoperative chemotherapy regimen containing alkylating agents (anthracyclines or non-anthracyclines), meeting 1 of the following criteria:
* 3-month/4-course anthracycline-based regimen
* 6- to 8-month/course anthracycline-based regimen
* 6- to 8-month/course non-anthracycline-based regimen
* Hormone receptor status:
* Estrogen receptor negative
* Progesterone receptor negative
PATIENT CHARACTERISTICS:
Age
* 18 to 49
Sex
* Female
Menopausal status
* Premenopausal
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer or any in situ cancer from which the patient has been disease-free for at least 5 years after treatment with curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior cytotoxic chemotherapy
Endocrine therapy
* No other concurrent hormonal therapy
Radiotherapy
* Concurrent radiotherapy to the breast, chest wall, or lymph nodes allowed
Surgery
* See Disease Characteristics
Other
* Concurrent participation in other therapeutic clinical trials, including SWOG-S0221, allowed
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Minimum age
18
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Maximum age
49
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Other
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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
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
1/10/2003
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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
1/09/2016
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Sample size
Target
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Accrual to date
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Final
257
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Mater Hospital - North Sydney - North Sydney
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Royal North Shore Hospital - St. Leonards
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Newcastle Mater Misericordiae Hospital - Waratah
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Royal Adelaide Hospital Cancer Centre - Adelaide
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Flinders Medical Centre - Bedford Park
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Royal Hobart Hospital - Hobart
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Recruitment hospital [7]
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Ballarat Oncology and Haematology Services - Ballarat
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Box Hill Hospital - Box Hill
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Monash Medical Center - Clayton Campus - Clayton
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Peter MacCallum Cancer Centre - East Melbourne
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Maroondah Hospital - East Ringwood
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St. Vincent's Hospital - Melbourne - Fitzroy
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Royal Melbourne Hospital - Parkville
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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2065 - St. Leonards
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2298 - Waratah
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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7000 - Hobart
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Recruitment postcode(s) [7]
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3350 - Ballarat
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Recruitment postcode(s) [8]
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3128 - Box Hill
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3168 - Clayton
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Recruitment postcode(s) [10]
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3002 - East Melbourne
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Recruitment postcode(s) [11]
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3135 - East Ringwood
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Recruitment postcode(s) [12]
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3065 - Fitzroy
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Recruitment postcode(s) [13]
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3050 - Parkville
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Recruitment postcode(s) [14]
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6000 - Perth
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Recruitment outside Australia
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Belgium
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Huy
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Belgium
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Verviers
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Hungary
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Budapest
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Italy
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Bergamo
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Italy
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Biella
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Italy
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Carpi
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Italy
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Lecco
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Italy
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Milano
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New Zealand
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Auckland
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Lausanne
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Locarno
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Switzerland
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Lugano
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Switzerland
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Switzerland
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Thun
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Funding & Sponsors
Primary sponsor type
Other
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Name
SWOG Cancer Research Network
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Other
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Cancer and Leukemia Group B
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Other
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Eastern Cooperative Oncology Group
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Other
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ETOP IBCSG Partners Foundation
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer. PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.
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Trial website
https://clinicaltrials.gov/study/NCT00068601
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Trial related presentations / publications
Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015 Mar 5;372(10):923-32. doi: 10.1056/NEJMoa1413204.
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Public notes
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Contacts
Principal investigator
Name
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Halle C Moore, MD
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Address
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The Cleveland Clinic
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Contact person for scientific queries
No information has been provided regarding IPD availability
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 are available at
https://clinicaltrials.gov/study/NCT00068601
Download to PDF