Clinical Trial Results:
An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs
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Summary
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EudraCT number |
2014-004335-39 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
24 Oct 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2016
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First version publication date |
25 Apr 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
N01223
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01063764 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Japan Co. Ltd.
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Sponsor organisation address |
8-17-1 Nishi-Shinjuku, Tokyo, Japan, 160-0023
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Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 4815 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jan 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Oct 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
First Period:
The primary objective was to evaluate the efficacy of Levetiracetam (LEV) dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric subjects aged ≥4 to <16 years and with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drugs (AEDs).
Second Period:
To provide LEV treatment to subjects who were judged by the investigators to benefit from long-term treatment and who are willing to continuously receive this drug and to continuously evaluate the safety of long-term administration of LEV at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.
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Protection of trial subjects |
Not applicable
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Background therapy |
One or two anti-epileptic drug(s) | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
29 Jan 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 73
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Worldwide total number of subjects |
73
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
44
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Adolescents (12-17 years) |
29
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Full Analysis Set (FAS) includes all subjects taking at least one dose of study medication. Per-Protocol Set (PPS) is a subset of the FAS, consisting of subjects without major protocol violations affecting the primary efficacy variable. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
Participant Flow refers to the Full Analysis Set. First Period started after Baseline (Week 0 to Week 8). | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Levetiracetam | ||||||||||||||||||||
Arm description |
•First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Levetiracetam tablet
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Investigational medicinal product code |
ucb L059
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Other name |
Keppra
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
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Investigational medicinal product name |
Levetiracetam dry syrup
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Investigational medicinal product code |
ucb L059
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Other name |
EKeppra
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Pharmaceutical forms |
Powder for syrup
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Routes of administration |
Oral use
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Dosage and administration details |
First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
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Baseline characteristics reporting groups
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Reporting group title |
Levetiracetam
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Reporting group description |
•First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Levetiracetam
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Reporting group description |
•First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped. | ||
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End point title |
Change from Baseline in partial seizure frequency per week over the 14-weeks Treatment Period [1] | ||||||||||
End point description |
The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:
(B values- T values) / B values x 100.
Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.
Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Partial seizures can be classified into:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Primary
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End point timeframe |
From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The efficacy of LEV in this study was considered positive if the lower limit of the 2-sided 95 % CI of the median percentage reduction in the partial seizure frequency per week was greater than 16.3 %. This was based on the median percentage reduction of the seizure frequency per week in the placebo in N159. Furthermore, a percentage reduction greater than 16.3 % was considered clinically relevant. Descriptive statistics with 95 % CI of the median percentage reduction were presented. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Incidence of Treatment-Emergent Adverse Events (TEAEs) during the Second Period (up to three years until the time of approval granted) [2] | ||||||||||
End point description |
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.
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End point type |
Primary
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End point timeframe |
During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There was no statistical analysis for this endpoint in this open-label study. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in partial seizure frequency per week over the 10-week Evaluation Period | ||||||||||
End point description |
The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:
(B values- E values) / B values x 100.
Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.
Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
Partial seizures can be classified into:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Partial seizure frequency per week over the 14-weeks Treatment Period | ||||||||||
End point description |
The seizure frequency per week was calculated as:
Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
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| No statistical analyses for this end point | |||||||||||
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End point title |
Partial seizure frequency per week over the 10-weeks Evaluation Period | ||||||||||
End point description |
The seizure frequency per week was calculated as:
Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Percentage of partial seizures 50 % responders over the 14-weeks Treatment Period | ||||||||||
End point description |
50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.
Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
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| No statistical analyses for this end point | |||||||||||
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End point title |
Percentage of partial seizures 50 % responders over the 10-weeks Evaluation Period | ||||||||||
End point description |
50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.
Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of seizure-free subjects over the 14-weeks Treatment Period | ||||||||
End point description |
Seizure-free means not having a seizure of type I (Partial seizure).
Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of seizure-free subjects over the 10-weeks Evaluation Period | ||||||||
End point description |
Seizure-free means not having a seizure of type I (Partial seizure).
Partial seizures can be classified into one of the following three groups:
- Simple partial seizures
- Complex partial seizures
- Partial seizures evolving to secondarily generalized seizures.
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End point type |
Secondary
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End point timeframe |
10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)
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| No statistical analyses for this end point | |||||||||
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End point title |
Incidence of treatment-emergent Adverse Drug Reactions (ADRs) during the Second Period (up to three years until the time of approval granted) | ||||||||
End point description |
An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.
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End point type |
Secondary
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End point timeframe |
During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)
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| No statistical analyses for this end point | |||||||||
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End point title |
Change from Baseline in partial seizure frequency per week for the Second Period (up to three years from informed consent until the time of approval granted) | ||||||||||
End point description |
The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.
Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:
(B values- E values) / B values x 100.
Positive values in percent reduction show a decrease from Baseline.
Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.
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End point type |
Secondary
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End point timeframe |
From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)
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| No statistical analyses for this end point | |||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events (AEs) were collected over the whole study from Baseline (Visit 2) over the complete First Period (14 weeks plus up to 6-week Down-titration and Follow-up) and the Second Period (Week 22 to the end of study).
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Adverse event reporting additional description |
AEs refer to the Full Analysis Set (FAS). FAS includes all subjects which received at least one dose of study medication.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Levetiracetam
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Reporting group description |
•First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. •Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted. •Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/24018745 |
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