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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/NCT00163553
Registration number
NCT00163553
Ethics application status
Date submitted
9/09/2005
Date registered
14/09/2005
Date last updated
30/01/2009
Titles & IDs
Public title
Neuraxial Pethidine After Lumbar Surgery Trial
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Scientific title
Neuraxial Pethidine After Lumbar Surgery Trial
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Secondary ID [1]
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01833
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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:
Sciatica
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Condition category
Condition code
Neurological
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Other neurological disorders
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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 - Pethidine
Treatment: Drugs - Placebo
Experimental: P - Epidural pethidine group
Placebo Comparator: N - placebo group
Treatment: Drugs: Pethidine
Treatment: Drugs: Placebo
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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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Cumulative 24-hour pethidine consumption
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Assessment method [1]
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Timepoint [1]
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24 hours
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Secondary outcome [1]
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Patient data:
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Age
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Gender
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Body mass index
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Current medications
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Preoperative opioid analgesic use (none, low, high - high dose being > 300 mg codeine or dextropropoxyphene daily or oral morphine or parenteral opioid use)
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Compensable status (HNC, TAC, WCV or PMI/SUR) 22
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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Surgical data:
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Assessment method [8]
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Timepoint [8]
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Secondary outcome [9]
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Anatomical extent of surgery (number of spinal levels)
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Assessment method [9]
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Timepoint [9]
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Secondary outcome [10]
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Highest anatomical surgical level
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Assessment method [10]
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Timepoint [10]
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Secondary outcome [11]
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Experience level of primary surgeon (trainee or consultant)
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Assessment method [11]
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Timepoint [11]
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Secondary outcome [12]
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Anatomical level of epidural tip (identified from postoperative X-Ray when taken as routine care only)
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Assessment method [12]
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Timepoint [12]
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Secondary outcome [13]
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Dural tear at the time of surgery (yes/no)
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Assessment method [13]
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Timepoint [13]
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Secondary outcome [14]
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Spinal instrumentation (yes/no)
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Assessment method [14]
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Timepoint [14]
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Secondary outcome [15]
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Other end-points (all at 1, 4, 24 and 48 hours unless stated):
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Assessment method [15]
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Timepoint [15]
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Secondary outcome [16]
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Cumulative pethidine dose
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Assessment method [16]
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Timepoint [16]
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Secondary outcome [17]
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Cumulative morphine dose
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Assessment method [17]
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Timepoint [17]
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Secondary outcome [18]
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VAS scores for pain at rest and during movement
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Assessment method [18]
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Timepoint [18]
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Secondary outcome [19]
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Sedation score (1 - 4) 16
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Assessment method [19]
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Timepoint [19]
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Secondary outcome [20]
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VAS scores for nausea, pruritis
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Assessment method [20]
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0
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Timepoint [20]
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Secondary outcome [21]
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Other adverse events: agitation, tremor, hallucinations, seizure
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Assessment method [21]
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Timepoint [21]
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Secondary outcome [22]
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Patient satisfaction scale for pain control during study (48 hours)
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Assessment method [22]
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Timepoint [22]
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48 hours
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Secondary outcome [23]
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(very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 17
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Assessment method [23]
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Timepoint [23]
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Secondary outcome [24]
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Plasma pethidine and norpethidine levels (24 hours)
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Assessment method [24]
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Timepoint [24]
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24 hours
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Secondary outcome [25]
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Physiotherapy assessment of ability to deep breathe & cough (unable, poor, adequate, good)
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Assessment method [25]
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Timepoint [25]
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Secondary outcome [26]
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Length of inpatient stay
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Assessment method [26]
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Timepoint [26]
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Eligibility
Key inclusion criteria
- Adults undergoing lumbar spinal surgery
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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
- Lack of informed patient consent
- Acute or chronic renal failure
- Known allergy or intolerance to pethidine or tramadol
- Chronic respiratory insufficiency
- Epidural contraindicated (coagulopathy, systemic infection)
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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?
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Intervention assignment
Single group
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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
Unknown status
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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
1/12/2004
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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
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Austin Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The hypothesis is that epidural pethidine is an effective form of pain relief following
lumbar spinal surgery, resulting in significantly lower usage of concomitantly administered
(intravenous) patient-controlled analgesia (PCA) pethidine.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00163553
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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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Dean A Cowie, MBBS, FANZCA
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Address
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Austin Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dean A Cowie, MBBS, FANZCA
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Address
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Country
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Phone
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61-3-9496-3227
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00163553
Download to PDF