Clinical Trial Results:
A Phase 3b, multicenter, interventional, open-label study of adult subjects with moderate to severe plaque psoriasis who have a suboptimal response to secukinumab or ixekizumab and are switched to risankizumab.
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Summary
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EudraCT number |
2019-000904-14 |
Trial protocol |
GB DE ES IT |
Global end of trial date |
07 Nov 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Nov 2023
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First version publication date |
19 Nov 2023
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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 |
M19-164
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04102007 | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
AbbVie Deutschland GmbH & Co. KG
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Sponsor organisation address |
AbbVie House, Vanwall Business Park, Vanwall Road, Berkshire, United Kingdom, SL6 4UB
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Public contact |
Global Medical Services, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
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Scientific contact |
Global Medical Services, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Nov 2022
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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 |
07 Nov 2022
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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 |
The objective of this study is to evaluate the efficacy and safety of switching to risankizumab for subjects with moderate to severe plaque psoriasis who have been treated with labeled dose of secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response. Suboptimal response is defined as a static Physician's Global Assessment (sPGA) 2 or 3, and a Body Surface Area (BSA) 3% - < 10% after at least 6 months treatment with secukinumab or ixekizumab.
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Protection of trial subjects |
Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Nov 2019
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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 |
Israel: 34
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Country: Number of subjects enrolled |
Australia: 3
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Country: Number of subjects enrolled |
Taiwan: 22
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Country: Number of subjects enrolled |
United States: 64
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Country: Number of subjects enrolled |
Spain: 17
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Country: Number of subjects enrolled |
United Kingdom: 12
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Country: Number of subjects enrolled |
Germany: 65
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Country: Number of subjects enrolled |
Italy: 27
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Worldwide total number of subjects |
244
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EEA total number of subjects |
109
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
215
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From 65 to 84 years |
29
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 244 subjects were enrolled and took at least 1 dose of study drug (ITT: Intent-to-treat Population) from 44 sites across 8 countries including Australia, Germany, Israel, Italy, Spain, Taiwan, United Kingdom, and the United States | ||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The study consisted of a 30-day Screening Period | ||||||||||||||||||||||||||
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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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Risankizumab | ||||||||||||||||||||||||||
Arm description |
Risankizumab is administered as a subcutaneous (SC) injection in a pre-filled syringe (PFS) | ||||||||||||||||||||||||||
Arm type |
Drug | ||||||||||||||||||||||||||
Investigational medicinal product name |
Risankizumab
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Investigational medicinal product code |
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Other name |
SKYRIZI
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Pharmaceutical forms |
Suspension for injection in pre-filled injector
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Routes of administration |
Cutaneous use
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Dosage and administration details |
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Intent-to-Treat (ITT) Population
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
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End points reporting groups
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Reporting group title |
Risankizumab
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Reporting group description |
Risankizumab is administered as a subcutaneous (SC) injection in a pre-filled syringe (PFS) | ||
Subject analysis set title |
Intent-to-Treat (ITT) Population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Intent-to-Treat (ITT) Population, which is defined as all subjects who had at least 1 dose of study drug
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End point title |
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 [1] | |||||||||
End point description |
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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End point type |
Primary
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End point timeframe |
At Week 16
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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: There is no statistical test for this study |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) | |||||||||
End point description |
The sPGA is a 5-point score ranging from O to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with O being clear and 1 being almost clear.
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End point type |
Secondary
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End point timeframe |
At Week 16
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 | |||||||||
End point description |
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
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End point type |
Secondary
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End point timeframe |
At Week 16
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a Psoriasis Symptoms Scale (PSS) 0 | |||||||||
End point description |
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
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End point type |
Secondary
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End point timeframe |
At Week 16
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving Static Physician Global Assessment (sPGA) 0/1 | |||||||||
End point description |
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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End point type |
Secondary
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End point timeframe |
At Week 52
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a sPGA Clear Response (sPGA 0) | |||||||||
End point description |
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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End point type |
Secondary
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End point timeframe |
At Week 52
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) 0/1 | |||||||||
End point description |
The DLQI is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life
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End point type |
Secondary
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End point timeframe |
At Week 52
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| No statistical analyses for this end point | ||||||||||
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End point title |
Proportion of Participants Achieving a PSS 0 | |||||||||
End point description |
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in patients with moderate to severe psoriasis (Appendix 8.2). The symptoms included are:
pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe).
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End point type |
Secondary
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End point timeframe |
At Week 52
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| No statistical analyses for this end point | ||||||||||
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End point title |
Time to Achieve sPGA 0/1 | ||||||||||||||
End point description |
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
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End point type |
Secondary
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End point timeframe |
Up to Week 52
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Time to Achieve sPGA 0 | ||||||||||||||
End point description |
"9999" Explanation: If a participant never attained the endpoint, then the outcome was censored at the last visit where variable was measured
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End point type |
Secondary
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End point timeframe |
Up to 52 Weeks
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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 |
From Baseline Day 1 up to Week 52
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
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Reporting groups
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Reporting group title |
Risankizumab
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Reporting group description |
Risankizumab is administered as a subcutaneous (SC) injection in a pre-filled syringe (PFS) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| 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 | |||
