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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01026220
Registration number
NCT01026220
Ethics application status
Date submitted
3/12/2009
Date registered
4/12/2009
Date last updated
28/04/2022
Titles & IDs
Public title
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
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Scientific title
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma
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Secondary ID [1]
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NCI-2011-01994
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Secondary ID [2]
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AHOD0831
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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:
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
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Stage III Childhood Hodgkin Lymphoma
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Stage IV Childhood Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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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
Treatment: Other - bleomycin sulfate
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - liposomal vincristine sulfate
Treatment: Drugs - vinorelbine tartrate
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide phosphate
Treatment: Drugs - prednisone
Treatment: Other - filgrastim
Treatment: Drugs - ifosfamide
Experimental: Regimen I (consolidation therapy) - Patients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.
Experimental: Regimen II (consolidation therapy) - Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
Experimental: Induction: all patient - All patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.
Treatment: Other: bleomycin sulfate
Given IV or SC
Treatment: Drugs: doxorubicin hydrochloride
Given IV
Treatment: Drugs: liposomal vincristine sulfate
Given IV
Treatment: Drugs: vinorelbine tartrate
Given IV
Treatment: Drugs: cyclophosphamide
Given IV
Treatment: Drugs: etoposide phosphate
Given IV
Treatment: Drugs: prednisone
Given IV
Treatment: Other: filgrastim
Given IV or SC
Treatment: Drugs: ifosfamide
Given IV
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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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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Second-event-free Survival
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Assessment method [1]
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Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
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Timepoint [1]
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At 4 years from enrollment
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Primary outcome [2]
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Safety Analysis and Monitoring of Toxic Death
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Assessment method [2]
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The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.
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Timepoint [2]
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Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).
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Secondary outcome [1]
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Event Free Survival
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Assessment method [1]
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Survival from enrollment to first event: relapse/progression, second malignancy, or death.
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Timepoint [1]
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At 3 years from enrollment
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Secondary outcome [2]
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Second-event-free Survival
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Assessment method [2]
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Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.
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Timepoint [2]
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At 4 years from enrollment
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Secondary outcome [3]
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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
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Assessment method [3]
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To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.
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Timepoint [3]
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3 years from enrollment
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Secondary outcome [4]
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Relapse-free Survival
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Assessment method [4]
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A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.
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Timepoint [4]
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3 years from enrollment
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Secondary outcome [5]
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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
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Assessment method [5]
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The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.
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Timepoint [5]
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During and after completion of study treatment.
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Secondary outcome [6]
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Overall Survival
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Assessment method [6]
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Survival from enrollment to death.
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Timepoint [6]
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At 3 years from enrollment
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Eligibility
Key inclusion criteria
* Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:
* Classical disease
* Nodular lymphocyte-predominant disease
* Stage III or IV disease with B symptoms, as defined by = 1 of the following:
* Unexplained weight loss > 10% within the past 6 months
* Unexplained recurrent fever > 38°C within the past month
* Recurrent drenching night sweats within the past month
* Creatinine clearance or radioisotope GFR = 70 mL/min OR maximum serum creatinine based on age/gender as follows:
* 0.4 mg/dL (1 to 5 months)
* 0.5 mg/dL (6 to 11 months)
* 0.6 mg/dL (12 to 23 months)
* 0.8 mg/dL (2 to 5 years)
* 1 mg/dL (6 to 9 years)
* 1.2 mg/dL (10 to 12 years)
* 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
* 1.7 mg/dL (males) or 1.4 mg/dL (females) (= 16 years)
* Total bilirubin = 1.5 times upper limit of normal (ULN) for age
* AST or ALT < 2.5 times ULN for age
* Shortening fraction = 27% by ECHO OR ejection fraction = 50% by MUGA (unless due to large mediastinal mass from HL)
* FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)
* For children who are unable to cooperate for PFTs, the criteria are:
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry > 92% on room air
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pathologic prolongation of QTc interval (> 450 milliseconds) on 12-lead ECG
* No prior chemotherapy, biological response modifiers (e.g., monoclonal antibody therapy), or radiotherapy
* At least 28 days since prior corticosteroids except for emergent treatment for respiratory distress or spinal cord compression, or for treatment of allergy to contrast agent required for CT scan
* No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)
* Concurrent corticosteroid therapy as treatment or prophylaxis for anaphylactic reactions allowed
* No concurrent pegfilgrastim
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Minimum age
No limit
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Maximum age
21
Years
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
7/12/2009
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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
31/03/2022
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Sample size
Target
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Accrual to date
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Final
166
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Recruitment hospital [5]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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5006 - North Adelaide
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
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Trial website
https://clinicaltrials.gov/study/NCT01026220
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kara Kelly, MD
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Address
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Children's Oncology Group
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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/NCT01026220
Download to PDF