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    Clinical Trial Results:
    Combined Randomized, Double-Blind, Dose-Confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-Week Treatment With 1% GPB Cream vs Placebo and Open-Label Phase 3b Study to Assess Long-Term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream

    Summary
    EudraCT number
    		 2017-004534-28
    Trial protocol
    		 DE   SE   GB   AT   HU   DK   PL  
    Global end of trial date
    02 Feb 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Apr 2023
    First version publication date
    25 Dec 2022
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of Global end of trial date

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Hyp1-18/2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03658616
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. August Wolff GmbH & Co. KG Arzneimittel
    Sponsor organisation address
    Sudbrackstr. 56, Bielefeld, Germany, 33611
    Public contact
    Clinical Trial Disclosures Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
    Scientific contact
    Clinical Trial Disclosures Office, Dr. August Wolff GmbH & Co. KG Arzneimittel, ClinicalTrialDisclosures@drwolffgroup.com
    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
    17 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The assessment of efficacy and safety of topical administration of 1% GPB or placebo cream in patients with primary axillary hyperhidrosis, and the assessment of long-term efficacy and safety of topical administration of 1% GPB cream in patients with primary axillary hyperhidrosis.
    Protection of trial subjects
    This study was in compliance with the ethical principles of current applicable regulations, International Council for Harmonisation (ICH) of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements. All regulatory requirements relevant to the safety of the study participants were followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 17 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 72
    Country: Number of subjects enrolled
    Sweden: 116
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    Germany: 273
    Country: Number of subjects enrolled
    Hungary: 35
    Worldwide total number of subjects
    528
    EEA total number of subjects
    511
    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)
    526
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men and woman between 18 to 65 years with a body mass index of 18-32 kg/m2 that were diagnosed with severe primary axillary hyperhidrosis scoring a 3 or 4 in hyperhidrosis disease severity were recruited for the study. Recruitment took place for the dose-confirming part (3a) and subsequently for the long-term part (3b).

    Pre-assignment
    Screening details
    		 For part 3a, 171 out of 272 screened patients fulfilled the criteria of at least 50 mg sweat production in each axilla after a 14-day washout phase of previously used antiperspirants. For part 3b, 161 patients rolled over from part 3a and 357 out of 566 newly screened patients were also recruited fulfilling the selection critera.

    Period 1
    Period 1 title
    Dose-confirming part (Phase 3a)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Assessor, Subject
    Blinding implementation details
    To maintain the blind, GPB and placebo cream had identical appearance, texture, smell, as well as identical labeling and packaging. To minimize the potential for bias, treatment randomization information was kept confidential by the responsible sponsor personnel and was disclosed to the investigator, other study center personnel, the sponsor or its designee, and clinical research associate until after database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1% glycopyrronium bromide (GPB) cream
    Arm description
    		 In the dose-confirming Phase 3a part, 171 patients were randomized in a 1:1 ratio to once-daily treatment with 1% GPB cream (87 patients) or placebo cream (84 patients) for 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    1% GPB cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Topical administration to both axillae, once daily for 4 weeks starting on Day 1a. After Week 4 topical administration as needed (at least twice per week and at most once daily).

    Arm title
    		 Placebo cream
    Arm description
    		 The placebo cream was used in the Phase 3a part only and was identical to the GPB cream in terms of appearance, constitution of excipients, and packaging but was lacking active substance.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Topical administration to both axillae, once daily for 4 weeks starting on Day 1a.

    Number of subjects in period 1 [1]
    		1% glycopyrronium bromide (GPB) cream Placebo cream
    Started
    87
    84
    Completed
    84
    82
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    1
         Lack of efficacy
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The study consists of part 3a and 3b. Part 3a includes 171 patients and part 3b includes 357 newly recruited patients, for a total of 528 patients. Part 3a and 3b each has a baseline (Day 1a and Day 1b). For technical reasons, we only can report one baseline period.
    Period 2
    Period 2 title
    Long-term part (Phase 3b)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The long-term part of the study was open-label; thus, no randomization or blinding was done.

    Arms
    Arm title
    		 1% glycopyrronium bromide (GPB) cream
    Arm description
    		 During the Phase 3b part, patients were treated with 1% GPB cream for up to 72 weeks. Newly recruited patients applied 1% GPB cream once daily for the first 4 weeks (analogous to the treatment applied during Phase 3a). After the first 4 weeks of treatment (ie, after completion of Week 4), all patients (including those who rolled-over from the Phase 3a part) applied 1% GPB cream as needed (at least twice per week but at most once daily) up to Week 72/EOTb, followed by a 4-week safety follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    1% glycopyrronium bromide
    Investigational medicinal product code
    1% GPB cream
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Topical administration to both axillae. Newly recruited patients applied 1% GPB cream once daily for the first 4 weeks (analogous to the treatment applied during Phase 3a). After the first 4 weeks of treatment (ie, after completion of Week 4), all patients (including those who rolled-over from the Phase 3a part) applied 1% GPB cream as needed (at least twice a week, but at most once daily) up to Week 72.

    Number of subjects in period 2 [2]
    		1% glycopyrronium bromide (GPB) cream
    Started
    161
    Completed
    368
    Not completed
    150
         Adverse event, non-fatal
    15
         Death
    1
         Other reasons
    36
         Lost to follow-up
    43
         Consent withdrawn by subject
    55
    Joined
    357
         Late recruitment
         Late recruitment reason:
    357
             To achieve the planned total of 500 patients for the long-term 3b part of the study (including roll-over patients from Phase 3a), 357 additional patients were enrolled at Visit 3b (Baseline of long-term part).
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The study consists of part 3a and 3b. Part 3a includes 171 patients and part 3b includes 357 newly recruited patients, for a total of 528 patients. Part 3a and 3b each has a baseline (Day 1a and Day 1b). For technical reasons, we only can report one baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1% glycopyrronium bromide (GPB) cream
    Reporting group description
    		 In the dose-confirming Phase 3a part, 171 patients were randomized in a 1:1 ratio to once-daily treatment with 1% GPB cream (87 patients) or placebo cream (84 patients) for 4 weeks.

    Reporting group title
    Placebo cream
    Reporting group description
    		 The placebo cream was used in the Phase 3a part only and was identical to the GPB cream in terms of appearance, constitution of excipients, and packaging but was lacking active substance.

    Reporting group values
    		 1% glycopyrronium bromide (GPB) cream Placebo cream Total
    Number of subjects
    		 87 84 171
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Adults (18-65 years)
    		 87 84 171
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 11.9 ) 37.8 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 41 84
        Male
    		 44 43 87
    Subject analysis sets

    Subject analysis set title
    1% GPB (SAFa)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFa includes all patients who received at least 1 dose of IMP in Phase 3a. The assignment of patients to the treatment groups was as actually treated. The SAFa was used for all safety analyses of Phase 3a.

    Subject analysis set title
    1% GPB (FASa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASa includes all patients randomized and treated at least once with IMP in Phase 3a. As per the intention-to-treat principle, the assignment of patients to the treatment groups was as randomized. The FASa was used for the evaluation of all efficacy endpoints of Phase 3a.

    Subject analysis set title
    1% GPB (PPSa)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSa includes all patients of the FASa without any major protocol deviations in Phase 3a. The assignment of patients to the treatment groups was as actually treated. Protocol deviations were reviewed during a blind data review meeting (BDRM) held before the data base lock and unblinding of the Phase 3a part data to identify major deviations leading to the exclusion of patients from the PPSa.

    Subject analysis set title
    Placebo (SAFa)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFa includes all patients who received at least 1 dose of IMP in Phase 3a. The assignment of patients to the treatment groups was as actually treated. The SAFa was used for all safety analyses of Phase 3a.

    Subject analysis set title
    Placebo (FASa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASa includes all patients randomized and treated at least once with IMP in Phase 3a. As per the intention-to-treat principle, the assignment of patients to the treatment groups was as randomized. The FASa was used for the evaluation of all efficacy endpoints of Phase 3a.

    Subject analysis set title
    Placebo (PPSa)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSa includes all patients of the FASa without any major protocol deviations in Phase 3a. The assignment of patients to the treatment groups was as actually treated. Protocol deviations were reviewed during a blind data review meeting (BDRM) held before the data base lock and unblinding of the Phase 3a part data to identify major deviations leading to the exclusion of patients from the PPSa.

    Subject analysis set title
    1% GPB (SAFb)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFb includes all patients treated at least once with IMP in the Phase 3b part of the study (ie, roll-over patients from the Phase 3a and patients newly recruited to the Phase 3b part) and was used for all safety analyses of Phase 3b.

    Subject analysis set title
    1% GPB (FASb)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASb includes all patients of the SAFb

    Subject analysis set title
    1% GPB (FASnewb)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASnewb includes all patients newly recruited to the Phase 3b part who were treated at least once with IMP. This set is a subset of the FASb and was used for the evaluation of the primary and all secondary endpoints regarding only newly recruited patients. The FASb was used for all other secondary endpoint analyses.

    Subject analysis set title
    1% GPB (PPSb)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSb or PPSnewb includes all patients of the FASb or FASnewb who had no major protocol deviations until Week 28. No analyses using the PPSb or PPSnewb were planned after Week 28. Protocol deviations were reviewed during a DRM held before the final data base lock to identify major deviations leading to the exclusion of patients from the PPSb or PPSnewb.

    Subject analysis set title
    1% GPB (PPSnewb)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    1% GPB PPSnewb includes all patients of the FASb or FASnewb who had no major protocol deviations until Week 28

    Subject analysis sets values
    		 1% GPB (SAFa) 1% GPB (FASa) 1% GPB (PPSa) Placebo (SAFa) Placebo (FASa) Placebo (PPSa) 1% GPB (SAFb) 1% GPB (FASb) 1% GPB (FASnewb) 1% GPB (PPSb) 1% GPB (PPSnewb)
    Number of subjects
    87
    87
    69
    84
    84
    58
    518
    518
    357
    326
    205
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    0
    0
        Adults (18-65 years)
    87
    87
    69
    84
    84
    58
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    37.4 ( 11.9 )
    ( )
    ( )
    37.8 ( 12.3 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    43
    41
        Male
    44
    43

    End points

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    End points reporting groups
    Reporting group title
    1% glycopyrronium bromide (GPB) cream
    Reporting group description
    		 In the dose-confirming Phase 3a part, 171 patients were randomized in a 1:1 ratio to once-daily treatment with 1% GPB cream (87 patients) or placebo cream (84 patients) for 4 weeks.

    Reporting group title
    Placebo cream
    Reporting group description
    		 The placebo cream was used in the Phase 3a part only and was identical to the GPB cream in terms of appearance, constitution of excipients, and packaging but was lacking active substance.
    Reporting group title
    1% glycopyrronium bromide (GPB) cream
    Reporting group description
    		 During the Phase 3b part, patients were treated with 1% GPB cream for up to 72 weeks. Newly recruited patients applied 1% GPB cream once daily for the first 4 weeks (analogous to the treatment applied during Phase 3a). After the first 4 weeks of treatment (ie, after completion of Week 4), all patients (including those who rolled-over from the Phase 3a part) applied 1% GPB cream as needed (at least twice per week but at most once daily) up to Week 72/EOTb, followed by a 4-week safety follow-up.

    Subject analysis set title
    1% GPB (SAFa)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFa includes all patients who received at least 1 dose of IMP in Phase 3a. The assignment of patients to the treatment groups was as actually treated. The SAFa was used for all safety analyses of Phase 3a.

    Subject analysis set title
    1% GPB (FASa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASa includes all patients randomized and treated at least once with IMP in Phase 3a. As per the intention-to-treat principle, the assignment of patients to the treatment groups was as randomized. The FASa was used for the evaluation of all efficacy endpoints of Phase 3a.

    Subject analysis set title
    1% GPB (PPSa)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSa includes all patients of the FASa without any major protocol deviations in Phase 3a. The assignment of patients to the treatment groups was as actually treated. Protocol deviations were reviewed during a blind data review meeting (BDRM) held before the data base lock and unblinding of the Phase 3a part data to identify major deviations leading to the exclusion of patients from the PPSa.

    Subject analysis set title
    Placebo (SAFa)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFa includes all patients who received at least 1 dose of IMP in Phase 3a. The assignment of patients to the treatment groups was as actually treated. The SAFa was used for all safety analyses of Phase 3a.

    Subject analysis set title
    Placebo (FASa)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASa includes all patients randomized and treated at least once with IMP in Phase 3a. As per the intention-to-treat principle, the assignment of patients to the treatment groups was as randomized. The FASa was used for the evaluation of all efficacy endpoints of Phase 3a.

    Subject analysis set title
    Placebo (PPSa)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSa includes all patients of the FASa without any major protocol deviations in Phase 3a. The assignment of patients to the treatment groups was as actually treated. Protocol deviations were reviewed during a blind data review meeting (BDRM) held before the data base lock and unblinding of the Phase 3a part data to identify major deviations leading to the exclusion of patients from the PPSa.

    Subject analysis set title
    1% GPB (SAFb)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAFb includes all patients treated at least once with IMP in the Phase 3b part of the study (ie, roll-over patients from the Phase 3a and patients newly recruited to the Phase 3b part) and was used for all safety analyses of Phase 3b.

    Subject analysis set title
    1% GPB (FASb)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASb includes all patients of the SAFb

    Subject analysis set title
    1% GPB (FASnewb)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FASnewb includes all patients newly recruited to the Phase 3b part who were treated at least once with IMP. This set is a subset of the FASb and was used for the evaluation of the primary and all secondary endpoints regarding only newly recruited patients. The FASb was used for all other secondary endpoint analyses.

    Subject analysis set title
    1% GPB (PPSb)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PPSb or PPSnewb includes all patients of the FASb or FASnewb who had no major protocol deviations until Week 28. No analyses using the PPSb or PPSnewb were planned after Week 28. Protocol deviations were reviewed during a DRM held before the final data base lock to identify major deviations leading to the exclusion of patients from the PPSb or PPSnewb.

    Subject analysis set title
    1% GPB (PPSnewb)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    1% GPB PPSnewb includes all patients of the FASb or FASnewb who had no major protocol deviations until Week 28

    Primary: 3a: Primary efficacy endpoint: Absolute change in total sweat production from Baseline (Day 1a) to Day 29

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    End point title
    		 3a: Primary efficacy endpoint: Absolute change in total sweat production from Baseline (Day 1a) to Day 29
    End point description
    Absolute change in logarithmic values of total sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared to the placebo group. For the dose-confirming part (Phase 3a), the GM of sweat production was performed at the Screening Visit 2a, on Day 1a, and on Day 29/EOTa (Visit 5a).
    End point type
    Primary
    End point timeframe
    Baseline (Day 1a) to Day 29
    End point values
    		 1% GPB (FASa) 1% GPB (PPSa) Placebo (FASa) Placebo (PPSa)
    Number of subjects analysed
    77
    65
    78
    55
    Units: mg/ 5 min
        log mean (standard deviation)
    -1.58 ( 1.87 )
    -1.40 ( 1.57 )
    -0.72 ( 1.55 )
    -0.53 ( 1.21 )
    Statistical analysis title
    		 Absolute change in total sweat production from Bas
    Statistical analysis description
    A mixed effects model was used with treatment and logarithmic baseline values as fixed effects and center as random effect to test the primary hypothesis on a significance level of 5% (α=0.05; 2-sided).
    Comparison groups
    Placebo (FASa) v 1% GPB (FASa)
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: 3b: Primary efficacy endpoint: Absolute change in total sweat production from Baseline (Day 1b) to Week 12

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    End point title
    		 3b: Primary efficacy endpoint: Absolute change in total sweat production from Baseline (Day 1b) to Week 12
    End point description
    Absolute change in logarithmic values of total sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1b) to Day 29 in the 1% GPB group compared to the placebo group. For the long-term part of the study (Phase 3b), the GM was only performed for newly recruited patients, and was performed at Screening Visit 2b, Day 1b, Week 4, and Week 12.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1b) to Week 12
    End point values
    		 1% GPB (FASnewb) 1% GPB (PPSnewb)
    Number of subjects analysed
    316
    198
    Units: mg/ 5 min
        log mean (standard deviation)
    -1.529 ( 2.107 )
    -1.579 ( 2.112 )
    Statistical analysis title
    		 Titel Endpunkt
    Statistical analysis description
    A mixed effects model will be used with mean centered logarithmic baseline values as fixed effects and center as random effect to test the primary hypothesis on a significance level of 2.94% (α=0.0294; 2-sided).
    Comparison groups
    1% GPB (FASnewb) v 1% GPB (PPSnewb)
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.0294
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - Absolute change from Baseline was analysed

    Secondary: 3a: First key secondary endpoint: Percentage of HDSS responders at Day 29

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    End point title
    		 3a: First key secondary endpoint: Percentage of HDSS responders at Day 29
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 1% GPB (FASa) 1% GPB (PPSa) Placebo (FASa) Placebo (PPSa)
    Number of subjects analysed
    87
    69
    84
    58
    Units: percentage of patients
        number (not applicable)
    23.0
    27.5
    11.9
    12.1
    No statistical analyses for this end point

    Secondary: 3a: Second key secondary endpoint: Absolute change in the HidroQoL from Baseline (Day 1a) to Day 29

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    End point title
    		 3a: Second key secondary endpoint: Absolute change in the HidroQoL from Baseline (Day 1a) to Day 29
    End point description
    The Hyperhidrosis Quality of Life index [HidroQoL] consists of 18 items divided into 2 domains: a daily life activities domain (items 1 to 6) and a psychosocial domain (items 7 to 18). The answers are scored on a 3-point scale as follows: ‘no, not at all’ = 0, ‘a little’ = 1, and ‘very much’ = 2. A total score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 29
    End point values
    		 1% GPB (FASa) 1% GPB (PPSa) Placebo (FASa) Placebo (PPSa)
    Number of subjects analysed
    84
    69
    79
    56
    Units: Total score
    median (full range (min-max))
        Total score
    -6 (-36 to 6)
    -6 (-36 to 6)
    -1 (-35 to 4)
    -1 (-35 to 4)
    No statistical analyses for this end point

    Secondary: 3b: First key secondary endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 (>25%)

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    End point title
    		 3b: First key secondary endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 (>25%)
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 1% GPB (FASb) 1% GPB (PPSb)
    Number of subjects analysed
    518
    326
    Units: percentage of patients
        number (not applicable)
    28.0
    31.6
    No statistical analyses for this end point

    Secondary: 3b: Second key secondary endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 28 (>25%)

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    End point title
    		 3b: Second key secondary endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 28 (>25%)
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Week 28
    End point values
    		 1% GPB (FASb) 1% GPB (PPSb)
    Number of subjects analysed
    518
    326
    Units: percentage of patients
        number (not applicable)
    29.3
    35.6
    No statistical analyses for this end point

    Secondary: 3b: Third key secondary endpoint: Absolute change in the HidroQoL from Baseline (Day 1b) to Week 12

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    End point title
    		 3b: Third key secondary endpoint: Absolute change in the HidroQoL from Baseline (Day 1b) to Week 12
    End point description
    The Hyperhidrosis Quality of Life index [HidroQoL] consists of 18 items divided into 2 domains: a daily life activities domain (items 1 to 6) and a psychosocial domain (items 7 to 18). The answers are scored on a 3-point scale as follows: ‘no, not at all’ = 0, ‘a little’ = 1, and ‘very much’ = 2. A total score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1b) to Week 12
    End point values
    		 1% GPB (FASb) 1% GPB (PPSb)
    Number of subjects analysed
    468
    321
    Units: Total score
    median (confidence interval 95%)
        Total score
    -11 (-13 to -10)
    -12 (-13 to -10)
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Absolute change in sweat production assessed by GM from Baseline (Day 1a) to Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Absolute change in sweat production assessed by GM from Baseline (Day 1a) to Day 29
    End point description
    Absolute change in logarithmic values of total sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 by treatment group. For the dose-confirming part (Phase 3a), the GM of sweat production was performed at the Screening Visit 2a, on Day 1a, and on Day 29/EOTa (Visit 5a).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 29
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    77
    78
    Units: mg
        log mean (confidence interval 95%)
    -1.58 (-2.01 to -1.16)
    -0.72 (-1.07 to -0.37)
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Percentage change in sweat production assessed by GM from Baseline (Day 1a) to Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Percentage change in sweat production assessed by GM from Baseline (Day 1a) to Day 29
    End point description
    Percentage change of total sweat production from Baseline (Day 1a) to Day 29 by treatment group and in the 1% GPB group compared with the placebo group.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 29
    End point values
    		 1% GPB (FASa) 1% GPB (FASb)
    Number of subjects analysed
    77
    78
    Units: percent
        median (confidence interval 95%)
    -64.63 (-73.13 to -51.75)
    -34.32 (-49.71 to -2.67)
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Percentage of responders assessed by GM on Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Percentage of responders assessed by GM on Day 29
    End point description
    Responders are defined as patients with at least 50%, 75%, and 90% sweat reduction assessd by gravimetric measurement (GM) compared to Baseline. For this dose-confirming part, the GM of sweat production was performed at the Screening Visit 2a, on Day 1a, and on Day 29/EOTa (Visit 5a).
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    87
    84
    Units: percentage of patients
    number (not applicable)
        1. sweat reduction of ≥50%
    57.5
    34.5
        2. sweat reduction of ≥75%
    32.2
    16.7
        3. sweat reduction of ≥90%
    23.0
    9.5
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Absolute change in the HDSS from Baseline (Day 1a) to Day 15 and Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Absolute change in the HDSS from Baseline (Day 1a) to Day 15 and Day 29
    End point description
    Change of the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 15 and to Day 29
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    87 [2]
    84 [3]
    Units: score
    median (confidence interval 95%)
        Day 15
    -1 (-1 to 0)
    0 (0 to 0)
        Day 29
    0 (-1 to 0)
    0 (0 to 0)
    Notes
    [2] - Day 15: N=84 Day 29: N=83
    [3] - Day 15: N=79 Day 29: N=80
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS on Day 15

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    End point title
    		 3a: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS on Day 15
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Day 15
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    87
    84
    Units: percentage of patients
        number (not applicable)
    25.3
    9.5
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Absolute change in the HidroQoL from Baseline (Day 1a) to Day 15 and Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Absolute change in the HidroQoL from Baseline (Day 1a) to Day 15 and Day 29
    End point description
    The Hyperhidrosis Quality of Life index [HidroQoL] consists of 18 items divided into 2 domains: a daily life activities domain (items 1 to 6) and a psychosocial domain (items 7 to 18). The answers are scored on a 3-point scale as follows: ‘no, not at all’ = 0, ‘a little’ = 1, and ‘very much’ = 2. A total score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 15 and Day 29
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    87 [4]
    79
    Units: Total score
    median (confidence interval 95%)
        Day 15
    -5 (-8 to -2)
    -1 (-2 to -1)
        Day 29
    -6 (-9 to -4)
    -1 (-2 to -1)
    Notes
    [4] - Day 15: N=85 Day 29: N=84
    No statistical analyses for this end point

    Secondary: 3a: Secondary efficacy endpoint: Absolute change in the DLQI from Baseline (Day 1a) to Day 15 and Day 29

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    End point title
    		 3a: Secondary efficacy endpoint: Absolute change in the DLQI from Baseline (Day 1a) to Day 15 and Day 29
    End point description
    The Dermatology Life Quality Index [DLQI] is scored on a 4-point scale: ‘very much’ = 3, ‘a lot’ = 2, ‘a little’ = 1, ‘not at all’ or ‘question not relevant’ = 0. It is calculated as sum score of all questions resulting in a total score between 0 and 30. The higher the score, the more the quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1a) to Day 15 and Day 29
    End point values
    		 1% GPB (FASa) Placebo (FASa)
    Number of subjects analysed
    87 [5]
    79
    Units: score
    median (confidence interval 95%)
        Day 15
    -5 (-7 to -2)
    -2 (-3 to -1)
        Day 29
    -5 (-8 to -4)
    -3 (-4 to -1)
    Notes
    [5] - Day 15: N=85 Day 29: N=84
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage change in total sweat production assessed by GM from Baseline (Day 1b) to Week 4 and Week 12

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage change in total sweat production assessed by GM from Baseline (Day 1b) to Week 4 and Week 12
    End point description
    Percentage change in total sweat production assessed by gravimetric measuremt (GM) from Baseline (Day 1b) to Week 4 and Week 12 in the 1% GPB group. For the long-term part of the study (Phase 3b), the GM was only performed for newly recruited patients, and was performed at Screening Visit 2b, Day 1b, Week 4, and Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1b) to Week 4 and Week 12
    End point values
    		 1% GPB (FASnewb)
    Number of subjects analysed
    357 [6]
    Units: percent
    median (full range (min-max))
        Week 4
    -68.270 (-99.97 to 2100)
        Week 12
    -65.630 (-99.97 to 17050)
    Notes
    [6] - Week 4: N=313 Week 12: N= 316
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Absolute change in total sweat production assessed by GM from Baseline (Day 1b) to Week 4

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    End point title
    		 3b: Secondary efficacy endpoint: Absolute change in total sweat production assessed by GM from Baseline (Day 1b) to Week 4
    End point description
    Absolute change in logarithmic values of total sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1b) to Week 4 in the 1% GPB group. For the long-term part of the study (Phase 3b), the GM was only performed for newly recruited patients, and was performed at Screening Visit 2b, Day 1b, Week 4, and Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1b) to Week 4
    End point values
    		 1% GPB (FASnewb)
    Number of subjects analysed
    313
    Units: mg
        log mean (standard deviation)
    -1.642 ( 2.132 )
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage of responders assessed by GM at Week 4

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage of responders assessed by GM at Week 4
    End point description
    Responders are defined as patients with at least 50%, 75%, and 90% sweat reduction assessd by gravimetric measurement (GM) compared to Baseline. For the long-term part of the study (Phase 3b), the GM was only performed for newly recruited patients, and was performed at Screening Visit 2b, Day 1b, Week 4, and Week 12.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 1% GPB (FASnewb)
    Number of subjects analysed
    357
    Units: percentage of patients
    number (not applicable)
        ≥50%
    55.5
        ≥75%
    38.9
        ≥90%
    21.8
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage of responders assessed by GM at Week 12

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage of responders assessed by GM at Week 12
    End point description
    Responders are defined as patients with at least 50%, 75%, and 90% sweat reduction assessd by gravimetric measurement (GM) compared to Baseline. For the long-term part of the study (Phase 3b), the GM was only performed for newly recruited patients, and was performed at Screening Visit 2b, Day 1b, Week 4, and Week 12.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 1% GPB (FASnewb)
    Number of subjects analysed
    357
    Units: percentage of patients
    number (not applicable)
        ≥50%
    54.1
        ≥75%
    36.4
        ≥90%
    21.6
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Weeks 4, 8, 52, and 72 (unequal 25%)

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Weeks 4, 8, 52, and 72 (unequal 25%)
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 52, 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    518 [7]
    Units: percentage of patients
    number (not applicable)
        Week 4
    20.7
        Week 8
    26.6
        Week 52
    30.1
        Week 72
    32.0
    Notes
    [7] - Week 4: N=357 (newly recruited patients only) Week 8: N=518 Week 52: N=518 Week 72: N=518
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 (unequal 50%)

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 (unequal 50%)
    End point description
    Responders are defined as patients with at least 2-point improvement (= reduction) on the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 1% GPB (FASb) 1% GPB (PPSb)
    Number of subjects analysed
    518
    326
    Units: percentage of patients
        number (not applicable)
    28.0
    31.6
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Absolute change in the HDSS from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72

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    End point title
    		 3b: Secondary efficacy endpoint: Absolute change in the HDSS from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72
    End point description
    Change of the Hyperhidrosis Disease Severity Scale [HDSS] compared to Baseline. This 4-point scale was completed at each visit of both study parts (Phase 3a and 3b) starting with the Screening Visit, respectively.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 28, 52, and 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    Units: score
    median (full range (min-max))
        Week 4
    -1 (-3 to 1)
        Week 8
    -1 (-3 to 1)
        Week 12
    -1 (-3 to 1)
        Week 28
    -1 (-3 to 1)
        Week 52
    -1 (-3 to 1)
        Week 72
    -1 (-3 to 1)
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Absolute change in the HidroQoL from Baseline (Day 1b) to Weeks 4, 8, 28, 52, and 72

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    End point title
    		 3b: Secondary efficacy endpoint: Absolute change in the HidroQoL from Baseline (Day 1b) to Weeks 4, 8, 28, 52, and 72
    End point description
    The Hyperhidrosis Quality of Life index [HidroQoL] consists of 18 items divided into 2 domains: a daily life activities domain (items 1 to 6) and a psychosocial domain (items 7 to 18). The answers are scored on a 3-point scale as follows: ‘no, not at all’ = 0, ‘a little’ = 1, and ‘very much’ = 2. A total score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1 b) to Weeks 4, 8, 28, 52, and 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    518 [8]
    Units: Score
    median (full range (min-max))
        Week 4
    -7.0 (-36.0 to 6.0)
        Week 8
    -10.0 (-36.0 to 5.0)
        Week 28
    -13.0 (-36.0 to 6.0)
        Week 52
    -16.0 (-36.0 to 6.0)
        Week 72
    -17.0 (-36.0 to 9.0)
    Notes
    [8] - Week 4: N=332 Week 8: N=474 Week 28: N=430 Week 52: N=383 Week 72: N=369
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HidroQoL (≥4-point improvement from Baseline (Day 1b)) at Weeks 4, 8, 12, 28, 52, and 72

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    End point title
    		 3b: Secondary efficacy endpoint: Percentage of responders assessed by the HidroQoL (≥4-point improvement from Baseline (Day 1b)) at Weeks 4, 8, 12, 28, 52, and 72
    End point description
    The Hyperhidrosis Quality of Life index [HidroQoL] consists of 18 items divided into 2 domains: a daily life activities domain (items 1 to 6) and a psychosocial domain (items 7 to 18). The answers are scored on a 3-point scale as follows: ‘no, not at all’ = 0, ‘a little’ = 1, and ‘very much’ = 2. A total score was calculated.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 28, 52, and 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    518 [9]
    Units: percent
    number (not applicable)
        Week 4
    64.7
        Week 8
    72.4
        Week 12
    76.1
        Week 28
    72.2
        Week 52
    65.6
        Week 72
    64.9
    Notes
    [9] - Week 4: N=357 Week 8, 12, 28, 52 and 72: N=518
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Absolute change in the DLQI questionnaire from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72

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    End point title
    		 3b: Secondary efficacy endpoint: Absolute change in the DLQI questionnaire from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72
    End point description
    The Dermatology Life Quality Index [DLQI] is scored on a 4-point scale: ‘very much’ = 3, ‘a lot’ = 2, ‘a little’ = 1, ‘not at all’ or ‘question not relevant’ = 0. It is calculated as sum score of all questions resulting in a total score between 0 and 30. The higher the score, the more the quality of life is impaired.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    518 [10]
    Units: Score
    median (full range (min-max))
        Week 4
    -6 (-30 to 13)
        Week 8
    -7 (-30 to 19)
        Week 12
    -7 (-30 to 21)
        Week 28
    -8 (-28 to 21)
        Week 52
    -9 (-28 to 12)
        Week 72
    -10 (-27 to 8)
    Notes
    [10] - Week 4: N=331 Week 8: N=472 Week 12: N=468 Week 28: N=430 Week 52: N=383 Week 72: N=369
    No statistical analyses for this end point

    Secondary: 3b: Secondary efficacy endpoint: Absolute change in patient-rated hyperhidrosis severity from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72

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    End point title
    		 3b: Secondary efficacy endpoint: Absolute change in patient-rated hyperhidrosis severity from Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72
    End point description
    The patient-rated hyperhidrosis severity was assessed by asking the following question: “How did you perceive your underarm sweating in the past 24 hours?" and is rated on a scale from 0 (no sweating at all) to 10 (worst sweating that you ever had).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1b) to Weeks 4, 8, 12, 28, 52, and 72
    End point values
    		 1% GPB (FASb)
    Number of subjects analysed
    518 [11]
    Units: Score
    median (full range (min-max))
        Week 4
    -3 (-10 to 2)
        Week 8
    -3 (-10 to 3)
        Week 12
    -3 (-10 to 5)
        Week 28
    -3 (-10 to 3)
        Week 52
    -4 (-10 to 2)
        Week 72
    -4 (-10 to 3)
    Notes
    [11] - Week 4: N=217 Week 8: N=211 Week 12: N=210 Week 28: N=189 Week 52: N=169 Week 72: N=163
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (BL) to Week 72
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Phase 3a: 1% GPB (SAFa)
    Reporting group description
    		 Phase 3a: Treatment-emergent adverse events which started up to and including Day 29 or Week 4; patients self-administered the 1% GPB cream once daily in this period (SAFa, N=171)

    Reporting group title
    Phase 3a: Placebo (SAFa)
    Reporting group description
    		 Phase 3a: Treatment-emergent adverse events which started up to and including Day 29 or Week 4; patients self-administered the placebo cream once daily in this period (SAFa, N=171)

    Reporting group title
    Phase 3b: BL to Day 29/Week 4 - 1% GPB patients only (SAFb)
    Reporting group description
    		 Phase 3b: Treatment-emergent adverse events which started up to and including Day 29 or Week 4: Phase 3a (1% GPB only; N=81) PLUS Phase 3b (patients newly recruited to Phase 3b; N=357); patients self-administered the 1% GPB cream once daily in this period (SAFb, N=518)

    Reporting group title
    Phase 3b: After Day 29/Week 4 to Week 72 (SAFb)
    Reporting group description
    		 Phase 3b: Treatment-emergent adverse events which started after Day 29 or Week 4 until Weeek 72 (EOTb): patients administered the 1% GPB cream as needed (at least twice per week and at most once daily) in this period (SAFb, N=518)

    Reporting group title
    Phase 3b: BL to Week 72 - 1% GPB patients only (SAFb)
    Reporting group description
    		 Phase 3b: Treatment-emergent adverse events which started up to Week 72 (without AEs of Placebo patients during Phase 3a): all patients in the long-term part (SAFb, N=518)

    Reporting group title
    Phase 3b: BL to Week 72 - 1% GPB patients only (SAF)
    Reporting group description
    		 Phase 3b: Treatment-emergent adverse events which started up to Week 72 (without AEs of Placebo patients during Phase 3a): all patients in the safety analysis set who received GPB (SAF, N=528)

    Serious adverse events
    		 Phase 3a: 1% GPB (SAFa) Phase 3a: Placebo (SAFa) Phase 3b: BL to Day 29/Week 4 - 1% GPB patients only (SAFb) Phase 3b: After Day 29/Week 4 to Week 72 (SAFb) Phase 3b: BL to Week 72 - 1% GPB patients only (SAFb) Phase 3b: BL to Week 72 - 1% GPB patients only (SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 84 (0.00%)
    1 / 438 (0.23%)
    22 / 518 (4.25%)
    23 / 518 (4.44%)
    23 / 528 (4.36%)
         number of deaths (all causes)
    0
    0
    0
    1
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Ovarian operation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus operation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Gait disturbance
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Asthma
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Chronic idiopathic pain syndrome
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    2 / 518 (0.39%)
    2 / 518 (0.39%)
    2 / 528 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Electric shock
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 84 (0.00%)
    1 / 438 (0.23%)
    0 / 518 (0.00%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Micrognathia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Relapsing-remitting multiple sclerosis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Mydriasis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pupils unequal
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scleritis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    2 / 518 (0.39%)
    2 / 518 (0.39%)
    2 / 528 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    1 / 518 (0.19%)
    1 / 518 (0.19%)
    1 / 528 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Phase 3a: 1% GPB (SAFa) Phase 3a: Placebo (SAFa) Phase 3b: BL to Day 29/Week 4 - 1% GPB patients only (SAFb) Phase 3b: After Day 29/Week 4 to Week 72 (SAFb) Phase 3b: BL to Week 72 - 1% GPB patients only (SAFb) Phase 3b: BL to Week 72 - 1% GPB patients only (SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 87 (49.43%)
    37 / 84 (44.05%)
    179 / 438 (40.87%)
    346 / 518 (66.80%)
    378 / 518 (72.97%)
    379 / 528 (71.78%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 84 (2.38%)
    0 / 438 (0.00%)
    3 / 518 (0.58%)
    3 / 518 (0.58%)
    3 / 528 (0.57%)
         occurrences all number
    0
    2
    0
    3
    3
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 87 (10.34%)
    8 / 84 (9.52%)
    28 / 438 (6.39%)
    68 / 518 (13.13%)
    85 / 518 (16.41%)
    85 / 528 (16.10%)
         occurrences all number
    11
    10
    38
    168
    206
    206
    Migraine
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 84 (0.00%)
    1 / 438 (0.23%)
    13 / 518 (2.51%)
    14 / 518 (2.70%)
    14 / 528 (2.65%)
         occurrences all number
    1
    0
    1
    27
    28
    28
    Dizziness
         subjects affected / exposed
    1 / 87 (1.15%)
    2 / 84 (2.38%)
    1 / 438 (0.23%)
    1 / 518 (0.19%)
    2 / 518 (0.39%)
    2 / 528 (0.38%)
         occurrences all number
    1
    2
    1
    1
    2
    2
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    5 / 87 (5.75%)
    4 / 84 (4.76%)
    13 / 438 (2.97%)
    34 / 518 (6.56%)
    44 / 518 (8.49%)
    44 / 528 (8.33%)
         occurrences all number
    5
    4
    13
    67
    80
    80
    Application site irritation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    5 / 438 (1.14%)
    7 / 518 (1.35%)
    11 / 518 (2.12%)
    11 / 528 (2.08%)
         occurrences all number
    0
    0
    5
    21
    26
    26
    Application site pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 84 (1.19%)
    4 / 438 (0.91%)
    7 / 518 (1.35%)
    11 / 518 (2.12%)
    11 / 528 (2.08%)
         occurrences all number
    1
    1
    4
    19
    23
    23
    Application site papules
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 84 (0.00%)
    2 / 438 (0.46%)
    10 / 518 (1.93%)
    12 / 518 (2.32%)
    12 / 528 (2.27%)
         occurrences all number
    3
    0
    3
    20
    23
    23
    Application site pruritus
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 84 (1.19%)
    4 / 438 (0.91%)
    16 / 518 (3.09%)
    19 / 518 (3.67%)
    19 / 528 (3.60%)
         occurrences all number
    3
    1
    7
    32
    39
    39
    Pyrexia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    1 / 438 (0.23%)
    10 / 518 (1.93%)
    11 / 518 (2.12%)
    11 / 528 (2.08%)
         occurrences all number
    0
    0
    1
    11
    12
    12
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 84 (1.19%)
    6 / 438 (1.37%)
    19 / 518 (3.67%)
    25 / 518 (4.83%)
    25 / 528 (4.73%)
         occurrences all number
    1
    1
    6
    20
    26
    26
    Ocular hyperaemia
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 84 (0.00%)
    2 / 438 (0.46%)
    1 / 518 (0.19%)
    3 / 518 (0.58%)
    3 / 528 (0.57%)
         occurrences all number
    2
    0
    2
    1
    3
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 84 (0.00%)
    4 / 438 (0.91%)
    9 / 518 (1.74%)
    13 / 518 (2.51%)
    13 / 528 (2.46%)
         occurrences all number
    1
    0
    5
    15
    20
    20
    Diarrhoea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 84 (1.19%)
    2 / 438 (0.46%)
    9 / 518 (1.74%)
    11 / 518 (2.12%)
    11 / 528 (2.08%)
         occurrences all number
    0
    1
    2
    10
    12
    12
    Dry mouth
         subjects affected / exposed
    16 / 87 (18.39%)
    4 / 84 (4.76%)
    43 / 438 (9.82%)
    32 / 518 (6.18%)
    63 / 518 (12.16%)
    64 / 528 (12.12%)
         occurrences all number
    16
    4
    45
    54
    99
    100
    Nausea
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 84 (1.19%)
    4 / 438 (0.91%)
    8 / 518 (1.54%)
    12 / 518 (2.32%)
    12 / 528 (2.27%)
         occurrences all number
    0
    2
    4
    8
    12
    12
    Gastritis
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 84 (2.38%)
    0 / 438 (0.00%)
    9 / 518 (1.74%)
    9 / 518 (1.74%)
    9 / 528 (1.70%)
         occurrences all number
    0
    2
    0
    10
    10
    10
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 84 (2.38%)
    7 / 438 (1.60%)
    22 / 518 (4.25%)
    29 / 518 (5.60%)
    29 / 528 (5.49%)
         occurrences all number
    0
    2
    7
    25
    32
    32
    Nasal dryness
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 84 (0.00%)
    5 / 438 (1.14%)
    2 / 518 (0.39%)
    7 / 518 (1.35%)
    7 / 528 (1.33%)
         occurrences all number
    2
    0
    5
    2
    7
    7
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 84 (0.00%)
    3 / 438 (0.68%)
    12 / 518 (2.32%)
    15 / 518 (2.90%)
    15 / 528 (2.84%)
         occurrences all number
    1
    0
    3
    16
    19
    19
    Rash papular
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 84 (2.38%)
    0 / 438 (0.00%)
    0 / 518 (0.00%)
    0 / 518 (0.00%)
    0 / 528 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 84 (1.19%)
    4 / 438 (0.91%)
    20 / 518 (3.86%)
    23 / 518 (4.44%)
    23 / 528 (4.36%)
         occurrences all number
    1
    2
    4
    26
    30
    30
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 87 (11.49%)
    14 / 84 (16.67%)
    50 / 438 (11.42%)
    140 / 518 (27.03%)
    168 / 518 (32.43%)
    168 / 528 (31.82%)
         occurrences all number
    11
    14
    54
    202
    256
    256
    Corona virus infection
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 84 (0.00%)
    0 / 438 (0.00%)
    20 / 518 (3.86%)
    20 / 518 (3.86%)
    20 / 528 (3.79%)
         occurrences all number
    0
    0
    0
    20
    20
    20
    Urinary tract infection
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 84 (0.00%)
    2 / 438 (0.46%)
    4 / 518 (0.77%)
    6 / 518 (1.16%)
    6 / 528 (1.14%)
         occurrences all number
    2
    0
    2
    6
    8
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jul 2019
    Version 2.0 of the protocol, dated 26-Jul-2019: All changes implemented in country-specific amendments; Addition of assessment of patient-rated severity; Addition of documentation of previous hyperhidrosis treatment; Addition of option for re-screening; Update of the number of planned study centers; Clarification of anticholinergic side effects to be potentially related to the IMP; Clarification of 2 exclusion criteria (Exclusion Criteria 12 and 14); Deletion of 1 exclusion criterion (Exclusion Criterion 13); Addition of 1 exclusion criterion (Exclusion Criterion 30); Update on use of aluminum-free deodorants and recording of deodorant use in patient diary; Update of general restrictions and precautions; Update of handling of missing data; Removal of time window for Visits 3a and 3b; Change of reporting of immediately reportable events to reporting via the eCRF.
    08 Apr 2020
    Amendment 1.0 to protocol Version 2.0, dated 08-Apr-2020: Addition of a DMC to ensure the preservation of trial integrity during the time of the COVID-19 pandemic restrictions; Change in IMP dispensing during the COVID-19 pandemic; Change of some center visits to telephone visits during the COVID-19 pandemic; Temporary change of consent procedure to this amendment during the COVID 19 pandemic.

    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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