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    Clinical Trial Results:
    A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum versus Placebo in Patients with Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma

    Summary
    EudraCT number
    		 2014-004732-19
    Trial protocol
    		 DE   PL   ES  
    Global end of trial date
    13 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2018
    First version publication date
    10 May 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    6043-PG-PSC-206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LETI Pharma GmbH
    Sponsor organisation address
    Stockumer Str 28, Witten, Germany, 58453
    Public contact
    Medical Department, LETI Pharma GmbH, +49 2302 20286 0, info@leti.de
    Scientific contact
    Medical Department, LETI Pharma GmbH, +49 2302 20286 0, info@leti.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of the effective dose range and the optimum dose of Depigoid® Phleum (vs. placebo) administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. Efficacy parameters will be assessed in an Environmental Challenge Chamber (ECC).
    Protection of trial subjects
    Depigoid® Phleum pratense has been extensively used over the last years at both lower concentrations proposed in this study. It is estimated that more than 105,000 patients have been exposed to Depigoid® Phleum pratense or a mixture of grasses from 2000 until March 2016. More than 53,000 vials with the 100 DPP/mL concentration and more than 300,000 vials with the 1000 DPP/mL concentration have been sold in this period. Globally assessed, available results indicate that doses up to 10,000 DPP/mL of Depigoid®Phleum pratense do not bear an inappropriately high risk for patients included in the study. Stopping rules were implemented in this study in order to reduce the risk to participating patients. Patients who suffered from a systemic reaction ≥ Grade 2 or a severe local reaction or have a lung function test (LFT) result of ≤ 80% of predicted value (for forced expiratory volume in the first second [FEV1]) after the administration of the investigational medicinal product (IMP) during the build-up phase were withdrawn. Patients who suffered from repeated systemic reactions ≥ Grade 2 or severe local reactions or had LFT results of ≤ 80% of predicted value prior to administration of the IMP during the maintenance phase were withdrawn at the discretion of the investigator. In general, the occurrence of systemic reactions Grade 3 or 4, or LFT results ≤ 80% of predicted value prior to administration of the IMP at 2 study visits, at any time during the course of the study, elicited the patient’s termination of administration of IMP and withdrawal. To summarise, the benefits of this study outweighed the potential risks, provided that these rules were implemented and study patients were monitored properly.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 61
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    Germany: 116
    Worldwide total number of subjects
    217
    EEA total number of subjects
    217
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    217
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 584 [1]
    Number of subjects completed
    		 217

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 363
    Reason: Number of subjects
    		 Protocol deviation: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Reason: Number of subjects
    		 lost to follow up: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 584 patients were enrolled into the trial, of these 217 were randomized. 363 patients were screen failures, 1 protocol-deviation, 2 withdrawal of informed consent and 2 lost to follow-up.
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 Depigoid Phleum 1000 DPP/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    Depigoid Phleum 1000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Depigoid® Phleum (depigmented and glutaraldehyde polymerised grass pollen allergenic extract adsorbed to aluminium hydroxide [DPP])

    Arm title
    		 Arm 2
    Arm description
    		 Depigoid Phleum 3000 DPP/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    Depigoid Phleum 3000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total of 0.5 mL/day of 1 of 4 concentrations of Depigoid® Phleum (1000 DPP/mL, 3000 DPP/mL, 5000 DPP/mL or 8000 DPP/mL) or matching placebo. Administered on 6 days, at 4-week intervals during the treatment period (from Week 0 to Week 20)

    Arm title
    		 Arm 3
    Arm description
    		 Depigoid Phleum 5000 DPP/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    Depigoid Phleum 5000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total of 0.5 mL/day of 1 of 4 concentrations of Depigoid® Phleum (1000 DPP/mL, 3000 DPP/mL, 5000 DPP/mL or 8000 DPP/mL) or matching placebo. Administered on 6 days, at 4-week intervals during the treatment period (from Week 0 to Week 20)

    Arm title
    		 Arm 4
    Arm description
    		 Depigoid Phleum 8000 DPP/mL
    Arm type
    		 Experimental

    Investigational medicinal product name
    Depigoid Phleum 8000 DPP/mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total of 0.5 mL/day of 1 of 4 concentrations of Depigoid® Phleum (1000 DPP/mL, 3000 DPP/mL, 5000 DPP/mL or 8000 DPP/mL) or matching placebo. Administered on 6 days, at 4-week intervals during the treatment period (from Week 0 to Week 20)

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A total of 0.5 mL/day of 1 of 4 concentrations of Depigoid® Phleum (1000 DPP/mL, 3000 DPP/mL, 5000 DPP/mL or 8000 DPP/mL) or matching placebo. Administered on 6 days, at 4-week intervals during the treatment period (from Week 0 to Week 20)

    Number of subjects in period 1
    		Arm 1 Arm 2 Arm 3 Arm 4 Placebo
    Started
    40
    44
    42
    47
    44
    Completed
    34
    39
    36
    43
    41
    Not completed
    6
    5
    6
    4
    3
         Consent withdrawn by subject
    2
    -
    1
    -
    2
         Adverse event, non-fatal
    2
    4
    5
    4
    1
         accidentially unblinded
    1
    -
    -
    -
    -
         Protocol deviation
    1
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Depigoid Phleum 1000 DPP/mL

    Reporting group title
    Arm 2
    Reporting group description
    		 Depigoid Phleum 3000 DPP/mL

    Reporting group title
    Arm 3
    Reporting group description
    		 Depigoid Phleum 5000 DPP/mL

    Reporting group title
    Arm 4
    Reporting group description
    		 Depigoid Phleum 8000 DPP/mL

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Arm 1 Arm 2 Arm 3 Arm 4 Placebo Total
    Number of subjects
    		 40 44 42 47 44 217
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.08 ± 12.14 33.16 ± 13.25 33.90 ± 10.83 32.15 ± 11.87 33.20 ± 9.34 -
    Gender categorical
    Units: Subjects
        Female
    		 15 17 23 19 22 96
        Male
    		 25 27 19 28 22 121
    Race
    Units: Subjects
        Caucasian
    		 36 41 40 46 44 207
        Other
    		 4 3 2 1 0 10
    Smoking habit
    Units: Subjects
        current smoker
    		 6 8 4 5 6 29
        former smoker
    		 4 7 4 7 3 25
        never
    		 30 29 34 35 35 163
    Alkohol consumption
    Units: Subjects
        daily
    		 1 0 0 0 0 1
        never or occasionally
    		 39 44 42 47 44 216
    Perception of disease activity during grass pollen season 2015
    Units: Subjects
        moderate
    		 21 27 21 24 29 122
        severe
    		 19 17 21 23 15 95
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 35.08 ± 12.14 33.16 ± 13.25 33.90 ± 10.83 32.15 ± 11.87 33.20 ± 9.34 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 80.20 ± 16.31 72.73 ± 18.19 71.07 ± 13.90 75.36 ± 13.39 74.75 ± 17.37 -
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25.95 ± 5.42 24.48 ± 4.39 23.92 ± 3.74 25.03 ± 3.50 24.26 ± 4.30 -
    Age at diagnosis
    Units: years
        arithmetic mean (standard deviation)
    		 13.23 ± 12.03 10.32 ± 10.18 11.64 ± 12.21 12.87 ± 11.69 15.09 ± 13.30 -
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) population will include all randomised patients who received the IMP at least once and present both baseline and final primary efficacy assessments.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population consists of all patients who entered the study without major violation of study entry criteria and who completed the study without major protocol violations or terminated the study prematurely due to an AE that was related to the IMP or due to lack of efficacy.

    Subject analysis sets values
    		 FAS PP
    Number of subjects
    193
    189
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.06 ± 11.20
    32.98 ± 11.27
    Gender categorical
    Units: Subjects
        Female
    79
    77
        Male
    144
    112
    Race
    Units: Subjects
        Caucasian
    184
    180
        Other
    9
    9
    Smoking habit
    Units: Subjects
        current smoker
    26
    26
        former smoker
    23
    23
        never
    144
    140
    Alkohol consumption
    Units: Subjects
        daily
    1
    1
        never or occasionally
    192
    188
    Perception of disease activity during grass pollen season 2015
    Units: Subjects
        moderate
    109
    106
        severe
    84
    83
    Height
    Units: cm
        arithmetic mean (standard deviation)
    173.90 ± 9.51
    173.92 ± 9.60
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    75.38 ± 16.27
    75.26 ± 16.32
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    24.80 ± 4.37
    24.75 ± 4.37
    Age at diagnosis
    Units: years
        arithmetic mean (standard deviation)
    12.63 ± 11.92
    11.93 ± 11.15

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Depigoid Phleum 1000 DPP/mL

    Reporting group title
    Arm 2
    Reporting group description
    		 Depigoid Phleum 3000 DPP/mL

    Reporting group title
    Arm 3
    Reporting group description
    		 Depigoid Phleum 5000 DPP/mL

    Reporting group title
    Arm 4
    Reporting group description
    		 Depigoid Phleum 8000 DPP/mL

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) population will include all randomised patients who received the IMP at least once and present both baseline and final primary efficacy assessments.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol (PP) population consists of all patients who entered the study without major violation of study entry criteria and who completed the study without major protocol violations or terminated the study prematurely due to an AE that was related to the IMP or due to lack of efficacy.

    Primary: TNSS

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    End point title
    		 TNSS
    End point description
    The reduction of the TNSS assessed after provocation in an ECC in patients with grass pollen induced allergic rhinitis at baseline and after treatment for up to 20 weeks with 4 different doses of Depigoid® Phleum vs. placebo. The results from the End of Study visit (Visit E1) will be compared to those at baseline (Visit S3).
    End point type
    Primary
    End point timeframe
    Visit E1 - Visit S3
    End point values
    		 Arm 1 Arm 2 Arm 3 Arm 4 Placebo FAS
    Number of subjects analysed
    34
    39
    36
    43
    41
    193
    Units: TNSS
        arithmetic mean (standard deviation)
    -0.85 ± 1.78
    -1.36 ± 1.55
    -1.14 ± 1.91
    -1.84 ± 1.91
    -1.08 ± 1.74
    -1.28 ± 1.80
    Statistical analysis title
    		 Mean TNSS difference from Visit S3 to Visit E1
    Statistical analysis description
    Mean TNSS difference from Visit S3 to Visit E1 - Full Analysis Set Population
    Comparison groups
    Arm 1 v Arm 2 v Arm 3 v Arm 4 v Placebo v FAS
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2796
    Method
    		 Rank-ANCOVA
    Confidence interval

    Primary: TNSS

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    End point title
    		 TNSS
    End point description
    End point type
    Primary
    End point timeframe
    Visit E1 - Visit S3
    End point values
    		 Arm 1 Arm 2 Arm 3 Arm 4 Placebo PP
    Number of subjects analysed
    34
    39
    35
    41
    40
    189
    Units: TNSS
        arithmetic mean (standard deviation)
    -0.85 ± 1.78
    -1.36 ± 1.55
    -1.12 ± 1.94
    -1.76 ± 1.88
    -1.12 ± 1.75
    -1.26 ± 1.79
    Statistical analysis title
    		 Mean TNSS difference from Visit S3 to Visit E1
    Statistical analysis description
    Mean TNSS difference from Visit S3 to Visit E1 - Per Protocol Population
    Comparison groups
    Arm 1 v Arm 2 v Arm 3 v Arm 4 v Placebo v PP
    Number of subjects included in analysis
    378
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3959
    Method
    		 Rank-Ancova
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    217,5 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Depigoid Phleum 1000 DPP/mL

    Reporting group title
    Arm 2
    Reporting group description
    		 Depigoid Phleum 3000 DPP/mL

    Reporting group title
    Arm 3
    Reporting group description
    		 Depigoid Phleum 5000 DPP/mL

    Reporting group title
    Arm 4
    Reporting group description
    		 Depigoid Phleum 8000 DPP/mL

    Reporting group title
    Arm 5
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    3 / 42 (7.14%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 44 (2.27%)
    0 / 42 (0.00%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Tension headache
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1 Arm 2 Arm 3 Arm 4 Arm 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    41 / 44 (93.18%)
    37 / 42 (88.10%)
    46 / 47 (97.87%)
    37 / 44 (84.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 44 (9.09%)
    1 / 42 (2.38%)
    4 / 47 (8.51%)
    1 / 44 (2.27%)
         occurrences all number
    3
    4
    1
    4
    1
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    38 / 40 (95.00%)
    37 / 44 (84.09%)
    35 / 42 (83.33%)
    42 / 47 (89.36%)
    35 / 44 (79.55%)
         occurrences all number
    157
    171
    162
    228
    157
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    15 / 40 (37.50%)
    17 / 44 (38.64%)
    19 / 42 (45.24%)
    24 / 47 (51.06%)
    19 / 44 (43.18%)
         occurrences all number
    34
    45
    55
    59
    34
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 44 (0.00%)
    0 / 42 (0.00%)
    0 / 47 (0.00%)
    1 / 44 (2.27%)
         occurrences all number
    2
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 40 (25.00%)
    7 / 44 (15.91%)
    8 / 42 (19.05%)
    3 / 47 (6.38%)
    7 / 44 (15.91%)
         occurrences all number
    10
    9
    10
    3
    7
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 44 (0.00%)
    0 / 42 (0.00%)
    3 / 47 (6.38%)
    0 / 44 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 44 (4.55%)
    1 / 42 (2.38%)
    1 / 47 (2.13%)
    0 / 44 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Aug 2015
    Protocol Version 3.0 1. The first PEF measurement should be scheduled 30 minutes after initiation of exposure session on visits S3 and E1, as asthmatic patients are enrolled in the present trial 2. A final check (vital signs, PEF) should be performed before discharge of patients from Fraunhofer unit in order to guarantee patient’s well-being before return journey 3. Risk minimizing procedures in relation to the ECC session should be more restrictive to ensure that patients would be withdrawn earlier from test session if PEF values decreased.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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