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    Clinical Trial Results:
    An investigator-blinded, active controlled, randomized, two parallel group, multi-dose clinical trial to prove the non-inferior efficacy of Lactobacillus plantarum P 17630 100.000.000 CFU soft vaginal capsules (Proge Farm s.r.l.) versus miconazole nitrate 400 mg vaginal soft capsules in vaginal candidiasis.

    Summary
    EudraCT number
    		 2018-003095-12
    Trial protocol
    		 BG  
    Global end of trial date
    05 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPP17630-C-018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Proge Farm s.r.l.
    Sponsor organisation address
    Largo Guido Donegani 4/A, Novara, Italy, 28100
    Public contact
    Clinical Trials Information, R&D Solutions srl, info@rdsolutions.it
    Scientific contact
    Clinical Trials Information, R&D Solutions srl, info@rdsolutions.it
    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
    05 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority efficacy of LJ LACTO - Lactobacillus plantarum P 17630 100.000.000 CFU (Test) versus DAKTARIN - miconazole nitrate 400 mg soft capsules in patients with clinically symptomatic vulvovaginal candidiasis. The evaluation of the following symptoms: pruritus, discharge, pain, dryness will be done using a daily VAS scale.
    Protection of trial subjects
    No protections were established in the study protocol
    Background therapy
    		 No treatments were used across all arm/groups in the trial
    Evidence for comparator
    		 Daktarin 400 mg soft gelatine capsules is indicated for the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria. Furthermore the comparator present the same pharmaceutical form as the Test and it present a comparable treatment period to the studied product.
    Actual start date of recruitment
    11 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    200
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start date:11th September 2019 End date:26th February 2020 MC Comac Medical, 3 Urvich str, 1612 Sofia–Bulgaria; MC-1-Sevlievo EOOD, 60 Nikola Petkov Str., 5402 Sevlievo–Bulgaria; MBAL Trakia, bulevard Patriarh Evtimiy 84, 6004 Stara Zagora–Yugoiztochen–Bulgaria; Deva Maria University Hosp., Al. Stamboliiski str., 8000 Burgas, Vetren-Bulgaria

    Pre-assignment
    Screening details
    		 The present study was carried-out in 200 female patients with a medical history, physical and neurological examinations that support a clinical diagnosis of clinically symptomatic vulvovaginal candidiasis.

    Pre-assignment period milestones
    Number of subjects started
    		 200
    Number of subjects completed
    		 200

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Experimental arm Reference
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    DAKTARIN® - miconazole nitrate 400 mg soft vaginal capsules
    Investigational medicinal product code
    Reference
    Other name
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    DAKTARIN® - miconazole nitrate 400 mg soft vaginal capsules (Reference) by vaginal route each day, for a period of 3 consecutive days starting from the evening of Visit 1.During Visit 2, if the physician judged their complete recovery the patients stopped the therapy, otherwise their continue the assigned treatment for other 3 days

    Arm title
    		 Experimental arm Test
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LJ LACTO - Lactobacillus plantarum P 17630 100.000.000 CFU soft vaginal capsules
    Investigational medicinal product code
    Test
    Other name
    Pharmaceutical forms
    Vaginal capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    LJ LACTO - Lactobacillus plantarum P 17630 100.000.000 CFU soft vaginal capsules (Test) by vaginal route each day, for a period of 3 consecutive days starting from the evening of Visit 1.During Visit 2, if the physician judged their complete recovery the patients stopped the therapy, otherwise their continue the assigned treatment for other 3 days

    Number of subjects in period 1
    		Experimental arm Reference Experimental arm Test
    Started
    100
    100
    Completed
    97
    99
    Not completed
    3
    1
         Lost to follow-up
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 200 200
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 200 200
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.31 ± 6.39 -
    Gender categorical
    Female patients with a medical history, physical and neurological examinations that support a clinical diagnosis of clinically symptomatic Vulvovaginal candidiasis were selected for the study.
    Units: Subjects
        Female
    		 200 200
    Subject analysis sets

    Subject analysis set title
    Visit 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Eligibility criteria for diagnosis of VVC: clinical symptoms (pruritus, discharge, pain, dryness)

    Subject analysis set title
    Visit 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Subject analysis set title
    Visit 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Subject analysis set title
    Visit 4
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Subject analysis sets values
    		 Visit 1 Visit 2 Visit 3 Visit 4
    Number of subjects
    200
    198
    152
    196
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    200
    198
    152
    196
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.31 ± 6.39
    33.38 ± 6.37
    33.08 ± 6.43
    33.37 ± 6.41
    Gender categorical
    Female patients with a medical history, physical and neurological examinations that support a clinical diagnosis of clinically symptomatic Vulvovaginal candidiasis were selected for the study.
    Units: Subjects
        Female
    200
    198
    152
    196

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm Reference
    Reporting group description
    		 -

    Reporting group title
    Experimental arm Test
    Reporting group description
    		 -

    Subject analysis set title
    Visit 1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Eligibility criteria for diagnosis of VVC: clinical symptoms (pruritus, discharge, pain, dryness)

    Subject analysis set title
    Visit 2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Subject analysis set title
    Visit 3
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Subject analysis set title
    Visit 4
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    pruritus, discharge, pain, dryness

    Primary: Pruritus comparison V1

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    End point title
    		 Pruritus comparison V1
    End point description
    End point type
    Primary
    End point timeframe
    Visit 1
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 1
    Number of subjects analysed
    100
    100
    200
    Units: VAS scale
        number (not applicable)
    100
    100
    200
    Statistical analysis title
    		 Pruritus Statistical significant difference V1
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.058
         upper limit
    		 0.5184
    Variability estimate
    Standard error of the mean

    Primary: Pruritus comparison V2

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    End point title
    		 Pruritus comparison V2
    End point description
    End point type
    Primary
    End point timeframe
    V2
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    99
    99
    198
    Units: VAS scale
        number (not applicable)
    99
    99
    198
    Statistical analysis title
    		 Pruritus Statistical significant difference V2
    Comparison groups
    Experimental arm Test v Experimental arm Reference
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9816
         upper limit
    		 0.2341
    Variability estimate
    Standard error of the mean

    Primary: Pruritus comparison V3

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    End point title
    		 Pruritus comparison V3
    End point description
    End point type
    Primary
    End point timeframe
    V3
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 3
    Number of subjects analysed
    73
    79
    152
    Units: VAS scale
        number (not applicable)
    73
    79
    152
    Statistical analysis title
    		 Pruritus Statistical significant difference V3
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8069
         upper limit
    		 0.0421
    Variability estimate
    Standard error of the mean

    Primary: Pruritus comparison V4

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    End point title
    		 Pruritus comparison V4
    End point description
    End point type
    Primary
    End point timeframe
    V4
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 4
    Number of subjects analysed
    97
    99
    196
    Units: VAS Scale
        number (not applicable)
    97
    99
    196
    Statistical analysis title
    		 Pruritus Statistical significant difference V4
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5194
         upper limit
    		 0.1526
    Variability estimate
    Standard error of the mean

    Primary: Discharge comparison V1

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    End point title
    		 Discharge comparison V1
    End point description
    End point type
    Primary
    End point timeframe
    V1
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    100
    100
    200
    Units: VAS scale
        number (not applicable)
    100
    100
    200
    Statistical analysis title
    		 Discharge Statistical significant difference V1
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6169
         upper limit
    		 0.7369
    Variability estimate
    Standard error of the mean

    Primary: Discharge comparison V2

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    End point title
    		 Discharge comparison V2
    End point description
    End point type
    Primary
    End point timeframe
    V2
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    99
    99
    198
    Units: VAS scale
        number (not applicable)
    99
    99
    198
    Statistical analysis title
    		 Discharge Statistical significant difference V2
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8185
         upper limit
    		 0.3034
    Variability estimate
    Standard error of the mean

    Primary: Discharge comparison V3

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    End point title
    		 Discharge comparison V3
    End point description
    End point type
    Primary
    End point timeframe
    V3
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 3
    Number of subjects analysed
    73
    79
    152
    Units: VAS Scale
        number (not applicable)
    73
    79
    152
    Statistical analysis title
    		 Discharge Statistical significant difference V3
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6891
         upper limit
    		 0.145
    Variability estimate
    Standard error of the mean

    Primary: Dscharge comparison V4

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    End point title
    		 Dscharge comparison V4
    End point description
    End point type
    Primary
    End point timeframe
    V4
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 4
    Number of subjects analysed
    97
    99
    196
    Units: VAS Scale
        number (not applicable)
    97
    99
    196
    Statistical analysis title
    		 Discharge Statistical significant difference V4
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4041
         upper limit
    		 0.1446
    Variability estimate
    Standard error of the mean

    Primary: Pain comparison V1

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    End point title
    		 Pain comparison V1
    End point description
    End point type
    Primary
    End point timeframe
    V1
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 1
    Number of subjects analysed
    100
    100
    200
    Units: VAS Scale
        number (not applicable)
    100
    100
    200
    Statistical analysis title
    		 Pain Statistical significant difference V1
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.855
         upper limit
    		 0.795
    Variability estimate
    Standard error of the mean

    Primary: Pain comparison V2

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    End point title
    		 Pain comparison V2
    End point description
    End point type
    Primary
    End point timeframe
    V2
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    99
    99
    198
    Units: VAS Scale
        number (not applicable)
    99
    99
    198
    Statistical analysis title
    		 Pain Statistical significant difference V2
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7865
         upper limit
    		 0.1401
    Variability estimate
    Standard error of the mean

    Primary: Pain comparison V3

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    End point title
    		 Pain comparison V3
    End point description
    End point type
    Primary
    End point timeframe
    V3
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 3
    Number of subjects analysed
    73
    79
    152
    Units: VAS Scale
        number (not applicable)
    73
    79
    152
    Statistical analysis title
    		 Pain Statistical significant difference V3
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1669
         upper limit
    		 0.7814
    Variability estimate
    Standard error of the mean

    Primary: Pain comparison V4

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    End point title
    		 Pain comparison V4
    End point description
    End point type
    Primary
    End point timeframe
    V4
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 4
    Number of subjects analysed
    97
    99
    196
    Units: VAS scale
        number (not applicable)
    97
    99
    196
    Statistical analysis title
    		 Pain Statistical significant difference V4
    Comparison groups
    Experimental arm Test v Experimental arm Reference
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3912
         upper limit
    		 0.1024
    Variability estimate
    Standard error of the mean

    Primary: Dryness comparison V1

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    End point title
    		 Dryness comparison V1
    End point description
    End point type
    Primary
    End point timeframe
    V1
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 1
    Number of subjects analysed
    100
    100
    200
    Units: VAS Scale
        number (not applicable)
    100
    100
    200
    Statistical analysis title
    		 Dryness Statistical significant difference V1
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5895
         upper limit
    		 1.35
    Variability estimate
    Standard error of the mean

    Primary: Dryness comparison V2

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    End point title
    		 Dryness comparison V2
    End point description
    End point type
    Primary
    End point timeframe
    V2
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    99
    99
    198
    Units: VAS Scale
        number (not applicable)
    99
    99
    198
    Statistical analysis title
    		 Dryness Statistical significant difference V2
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    198
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5992
         upper limit
    		 0.3567
    Variability estimate
    Standard error of the mean

    Primary: Dryness comparison V3

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    End point title
    		 Dryness comparison V3
    End point description
    End point type
    Primary
    End point timeframe
    V3
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 3
    Number of subjects analysed
    73
    79
    152
    Units: VAS Scale
        number (not applicable)
    73
    79
    152
    Statistical analysis title
    		 Dryness Statistical significant difference V3
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2207
         upper limit
    		 0.0959
    Variability estimate
    Standard error of the mean

    Primary: Dryness comparison V4

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    End point title
    		 Dryness comparison V4
    End point description
    End point type
    Primary
    End point timeframe
    V4
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 4
    Number of subjects analysed
    97
    99
    198
    Units: VAS Scale
        number (not applicable)
    97
    99
    198
    Statistical analysis title
    		 Dryness Statistical significant difference V4
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.327
         upper limit
    		 0.0063
    Variability estimate
    Standard error of the mean

    Secondary: Interleukin IL6 comparison V1

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    End point title
    		 Interleukin IL6 comparison V1
    End point description
    End point type
    Secondary
    End point timeframe
    V1
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 1
    Number of subjects analysed
    99
    100
    199
    Units: pg/mL
    99
    100
    199
    Statistical analysis title
    		 IL6 Statistical significant difference V1
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.38
         upper limit
    		 17.05
    Variability estimate
    Standard error of the mean

    Secondary: Interleukin IL6 comparison V2

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    End point title
    		 Interleukin IL6 comparison V2
    End point description
    End point type
    Secondary
    End point timeframe
    V2
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 2
    Number of subjects analysed
    96
    90
    186
    Units: pg/mL
    96
    90
    186
    Statistical analysis title
    		 IL6 Statistical significant difference V2
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.825
         upper limit
    		 6.281
    Variability estimate
    Standard error of the mean

    Secondary: Interleukin IL6 comparison V3

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    End point title
    		 Interleukin IL6 comparison V3
    End point description
    End point type
    Secondary
    End point timeframe
    V3
    End point values
    		 Experimental arm Reference Experimental arm Test Visit 3
    Number of subjects analysed
    68
    70
    138
    Units: pg/mL
    68
    70
    138
    Statistical analysis title
    		 IL6 Statistical significant difference V3
    Comparison groups
    Experimental arm Reference v Experimental arm Test
    Number of subjects included in analysis
    138
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.386
         upper limit
    		 3.17
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were evaluated on Visit 1, Visit2, Visit 3 and Follow-up.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious and/or serious adverse events were recorded through the entire study period neither by the investigator neither by the patients.

    More information

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