Clinical Trial Results:
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study
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Summary
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EudraCT number |
2008-003485-25 |
Trial protocol |
LT FR EE DE PL LV IT |
Global end of trial date |
23 May 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Dec 2016
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First version publication date |
01 Dec 2016
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Other versions |
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Summary report(s) |
synopsis CSR V00034 CR 4 02 1B |
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 |
V00034 CR 402 1B
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pierre Fabre Médicament
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Sponsor organisation address |
45, Place Abel Gance, Boulogne, France, 92100
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Public contact |
Elisabeth COPPEL
, Pierre Fabre Medicament
IRPF
3 av Hubert Curien-31100 Toulouse, elisabeth.coppel@pierre-fabre.com
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Scientific contact |
Elisabeth COPPEL
, Pierre Fabre Medicament
IRPF
3 av Hubert Curien-31100 Toulouse, elisabeth.coppel@pierre-fabre.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 |
22 Jan 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 May 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
23 May 2009
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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 |
To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
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Protection of trial subjects |
The trial was conducted according to Good Clinical Practices (CPMP/ICH/135/95), ICH E11, the Declaration of Helsinki and its subsequent amendments thereto and local legal regulations.
Due to the absence of risk with the products and the study procedures, patients were allowed to participate to another clinical trial after study termination.
The investigator registered side effects at each visit during clinical examination and questioning the parent(s)/guardian(s). At any time, if the patient's medical status required any other therapeutic (other that stated in protocol), the investigator could perform a final visit with a complete evaluation, then exclude the patient from the study and prescribe the appropriate treatment.
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Background therapy |
During disease exacerbation phases (presence of inflammatory lesions), a moderately potent corticosteroid cream (Locapred®, desonide 0.1%) was allowed, used as follows: - Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face, Locapred® was used until complete resolution of the inflammatory signs. Conditions of use of Locapred® were explained to the parents. * When necessary, other treatments of atopic dermatitis signs/symptoms (antihistamines, antiseptics, zinc creams / ointments) were allowed and carefully notified. * Foaming gel Klorane® provided by the sponsor was allowed for children washing/cleansing. | ||
Evidence for comparator |
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Actual start date of recruitment |
30 Oct 2008
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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 |
Romania: 86
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Country: Number of subjects enrolled |
Poland: 113
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Country: Number of subjects enrolled |
Estonia: 118
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Country: Number of subjects enrolled |
France: 35
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Country: Number of subjects enrolled |
Germany: 26
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Country: Number of subjects enrolled |
Italy: 2
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Country: Number of subjects enrolled |
Latvia: 117
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Country: Number of subjects enrolled |
Lithuania: 89
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Worldwide total number of subjects |
586
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EEA total number of subjects |
586
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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) |
2
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Children (2-11 years) |
584
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Adolescents (12-17 years) |
0
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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 |
591 patients were screened and 588 randomized and included. 2 patients did not take any treatment and therefore, the APT safety population was made of 586 patients. | |||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Main inclusion criteria were - Age between 2 and 7 years, - atopic dermatitis according to the diagnostic criteria of the UK Working Party, - IGA score is ≤ 1 at inclusion, | |||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental Group | |||||||||||||||||||||||||||
Arm description |
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Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
V0034CR
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
One application bid (morning and evening) on the whole body including face.
When inflammatory lesions were present (disease exacerbation phases), a moderately potent corticosteroid was allowed, used as followed:
- Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face,
- V0034CR : once a day (preferably in the morning) on the whole body including face.
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Arm title
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Vehicle Group | |||||||||||||||||||||||||||
Arm description |
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Arm type |
Vehicle | |||||||||||||||||||||||||||
Investigational medicinal product name |
Vehicle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
One application bid (morning and evening) on the whole body including face.
When inflammatory lesions were present (disease exacerbation phases), a moderately potent corticosteroid was allowed, used as followed:
- Locapred®: once a day (preferably in the evening) only on the lesions of the body and the face,
- Vehicle: once a day (preferably in the morning) on the whole body including face.
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Baseline characteristics reporting groups
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Reporting group title |
Experimental Group
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Reporting group description |
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Reporting group title |
Vehicle Group
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Safety data set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Safety had to be analysed in all randomized patients having used at least once the study medication
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Subject analysis set title |
Efficacy data set
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Subject analysis set type |
Modified intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All Patients Treated data set for efficacy , i.e. all randomized patients having used at
least once the study medication and for which the main criterion is assessed at least once after
inclusion.
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End points reporting groups
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Reporting group title |
Experimental Group
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Reporting group description |
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Reporting group title |
Vehicle Group
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Reporting group description |
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Subject analysis set title |
Safety data set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Safety had to be analysed in all randomized patients having used at least once the study medication
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Subject analysis set title |
Efficacy data set
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Subject analysis set type |
Modified intention-to-treat | ||
Subject analysis set description |
All Patients Treated data set for efficacy , i.e. all randomized patients having used at
least once the study medication and for which the main criterion is assessed at least once after
inclusion.
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End point title |
Mean POEM (Patient -Oriented Eczema Mesure) score | ||||||||||||
End point description |
The POEM score is a fully validated self or parental assessment of the frequency of the most bothering symptoms impacting the quality of life of the patient. The POEM score consists of 7 main symptoms: itchiness, dryness, skin-bleeding, skin weeping/oozing, sleep disturbance, skin flakes and cracks. Each symptom is scored on a five grade scale from 0 to 4, resulting a maximum score 28, where:
- 0: no symptoms during the last week;
- 1: one to two days of symptom's presence;
- 2: three to four days of symptom's presence;
- 3: five to six days of symptom's presence;
- 4: everyday presence of the symptoms.
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End point type |
Primary
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End point timeframe |
Mean POEM score over the 12 weeks of treatment.
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Statistical analysis title |
Mean POEM score over 12 weeks | ||||||||||||
Statistical analysis description |
Analysis of variance for the POEM score using a Mixed Model for Repeated Measures (MMRM) with treatment, country and visit as fixed effects and subject as random effect.
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Comparison groups |
Experimental Group v Vehicle Group
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Number of subjects included in analysis |
573
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
= 0.2343 [2] | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Variance | ||||||||||||
Confidence interval |
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95% | ||||||||||||
sides |
2-sided
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lower limit |
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upper limit |
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| Notes [1] - The initial POEM score was around 5.3/28 in both groups, which corresponds to atopic dermatitis of mild severity. [2] - The results of the primary analysis (MMRM) exhibited a difference in favour of the study drug (-0.34) but the difference was not statistically significant (p=0.2343). |
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Adverse events information
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Timeframe for reporting adverse events |
During the whole study period.
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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 |
11.0
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Reporting groups
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Reporting group title |
Experimental Group
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Reporting group description |
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Reporting group title |
Vehicle Group
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Reporting group description |
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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? Yes | |||
Date |
Amendment |
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29 Sep 2008 |
Substantial and general amendment.
Following recommendations of Competent Authorities:
- Addition of non inclusion criteria,
- Addition of the warnings of associated treatment,
- Modification in the "withdrawal criteria" section. |
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14 Oct 2008 |
Substantial and local amendment.
Following recommendations of Ethics Committee in Milan and Competent Authorities in Italy, change of phase of the study. |
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19 Dec 2008 |
Substantial and local amendment.
Following recommendations of Competent Authorities in Czech Republic, Change of phase of the study. |
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10 Feb 2009 |
Substantial and general amendment.
- Addition of a contractor in charge of Investigational Product management,
- Correction of the Associate Clinical Study Coordinator contact details,
- Addition of investigators |
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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 | |||
