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    Clinical Trial Results:
    An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA)

    Summary
    EudraCT number
    		 2019-004478-24
    Trial protocol
    		 DE   NL  
    Global end of trial date
    30 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2022
    First version publication date
    12 May 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OV101-18-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03882918
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ovid Therapeutics Inc
    Sponsor organisation address
    1460 Broadway , New York, United States, 10036
    Public contact
    Todd F. Baumgartner, M.D., MPH, Ovid Therapeutics Inc., 1 8027525168, tbaumgartner@ovidrx.com
    Scientific contact
    Todd F. Baumgartner, M.D., MPH, Ovid Therapeutics Inc., 1 8027525168, tbaumgartner@ovidrx.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
    13 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in study participants who are at least 2 years old at the time of enrollment into this study
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Israel: 19
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    United States: 103
    Worldwide total number of subjects
    141
    EEA total number of subjects
    10
    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)
    83
    Adolescents (12-17 years)
    17
    Adults (18-64 years)
    41
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants in the study completed OV101-15-001 or OV101-16-001 and/or was a sibling of a participant who completed OV101-15-001, OV101-16-001, or OV101-19-001.

    Pre-assignment
    Screening details
    		 Subjects with Angelman Syndrome who completed the pharmacokinetic Study OV101-16-001 (NCT03109756) will also be permitted to participate, provided they meet all entry criteria.

    Period 1
    Period 1 title
    Baseline & Recruitment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 OV101
    Arm description
    		 gaboxadol
    Arm type
    		 Experimental

    Investigational medicinal product name
    gaboxadol
    Investigational medicinal product code
    OV101
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    OV101 was supplied in 5 mg, 2 mg, and/or 0.5 mg capsules. Capsules were swallowed or the contents could be sprinkled (1 capsule to ≤1 teaspoon) on a low-fat, semi-liquid food; if enacted, this approach must have been used throughout the study.

    Number of subjects in period 1
    		OV101
    Started
    141
    Completed
    1
    Not completed
    140
         Consent withdrawn by subject
    5
         Adverse event, non-fatal
    13
         Other
    9
         Study Terminated by Sponsor
    98
         Protocol deviation
    1
         Lack of efficacy
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OV101
    Reporting group description
    		 gaboxadol

    Reporting group values
    		 OV101 Total
    Number of subjects
    		 141 141
    Age categorical
    (NIH/OMB), there are subjects that chose multiple categories.
    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)
    		 83 83
        Adolescents (12-17 years)
    		 17 17
        Adults (18-64 years)
    		 41 41
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14 ± 9.30 -
    Gender categorical
    Sex
    Units: Subjects
        Female
    		 57 57
        Male
    		 84 84
    Subject analysis sets

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    gaboxadol

    Subject analysis sets values
    		 Treated patients
    Number of subjects
    141
    Age categorical
    (NIH/OMB), there are subjects that chose multiple categories.
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    83
        Adolescents (12-17 years)
    17
        Adults (18-64 years)
    41
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    7.8 ± 3.04
    Gender categorical
    Sex
    Units: Subjects
        Female
    57
        Male
    84

    End points

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    End points reporting groups
    Reporting group title
    OV101
    Reporting group description
    		 gaboxadol

    Subject analysis set title
    Treated patients
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    gaboxadol

    Primary: Incidence of adverse events in active treatment group

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    End point title
    		 Incidence of adverse events in active treatment group [1]
    End point description
    This study was prematurely terminated.
    End point type
    Primary
    End point timeframe
    Participants were to participate in the study for up to 166 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No Statistical Analyses was performed
    End point values
    		 OV101
    Number of subjects analysed
    141
    Units: patients
        Number of subjects analysed
    141
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs that occurred from the time written informed consent and/or assent were obtained to the End Of Study visit were recorded in the source documentation and reported in the CRF.
    Adverse event reporting additional description
    AEs were classified as “treatment-emergent” (i.e., TEAEs or serious TEAEs) if they occurred following the administration of IMP. All events reported in this database are treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    OV101
    Reporting group description
    		 gaboxadol

    Serious adverse events
    		 OV101
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 141 (2.13%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Partial seizures
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Seizure cluster
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 OV101
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    106 / 141 (75.18%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    11 / 141 (7.80%)
         occurrences all number
    11
    Fatigue
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Gait disturbance
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Crying
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Discomfort
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Influenza like illness
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Medical device site oedema
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Social circumstances
    Patient uncooperative
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Penis disorder
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Atelectasis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    8 / 141 (5.67%)
         occurrences all number
    8
    Irritability
         subjects affected / exposed
    8 / 141 (5.67%)
         occurrences all number
    8
    Middle insomnia
         subjects affected / exposed
    7 / 141 (4.96%)
         occurrences all number
    7
    Sleep disorder
         subjects affected / exposed
    7 / 141 (4.96%)
         occurrences all number
    7
    Aggression
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Insomnia
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Anxiety
         subjects affected / exposed
    5 / 141 (3.55%)
         occurrences all number
    5
    Abnormal behaviour
         subjects affected / exposed
    4 / 141 (2.84%)
         occurrences all number
    4
    Inappropriate affect
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Dermatillomania
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Enuresis
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Initial insomnia
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Decreased interest
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Disruptive mood dysregulation disorder
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Intentional self-injury
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Nail picking
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Stubbornness
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Terminal insomnia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tic
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Blood glucose decreased
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Amylase increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Blood creatine increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Blood insulin increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Mean cell volume increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Menstruation normal
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Weight increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    5 / 141 (3.55%)
         occurrences all number
    5
    Contusion
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    laceration
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Animal bite
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Ankle fracture
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Bite
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Concussion
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Foot fracture
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Joint injury
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Ligament rupture
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Skin abrasion
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tooth fracture
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Nervous system disorders
    Seizure
         subjects affected / exposed
    10 / 141 (7.09%)
         occurrences all number
    10
    Somnolence
         subjects affected / exposed
    8 / 141 (5.67%)
         occurrences all number
    8
    Generalised tonic-clonic seizure
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Petit mal epilepsy
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Tremor
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Headache
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Lethargy
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Myoclonus
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Partial seizures
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Clonic convulsion
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Dyskinesia
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Seizure cluster
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Status epilepticus
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Action tremor
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Altered state of consciousness
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Atonic seizures
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Cognitive disorder
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Hypertonia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Intention tremor
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tardive dyskinesia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tonic convulsion
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Increased tendency to bruise
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Photophobia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    13 / 141 (9.22%)
         occurrences all number
    13
    Constipation
         subjects affected / exposed
    9 / 141 (6.38%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    4 / 141 (2.84%)
         occurrences all number
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Dental caries
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Retching
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Anal incontinence
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Gastric ulcer
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Glossitis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Ileus
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Incarcerated hiatus hernia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tooth development disorder
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Tooth impacted
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 141 (3.55%)
         occurrences all number
    5
    Dermatitis allergic
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Dermatitis diaper
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Alopecia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Decubitus ulcer
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Urinary retention
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 141 (9.93%)
         occurrences all number
    14
    Nasopharyngitis
         subjects affected / exposed
    11 / 141 (7.80%)
         occurrences all number
    11
    corona virus infection
         subjects affected / exposed
    9 / 141 (6.38%)
         occurrences all number
    9
    Urinary tract infection
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Gastroenteritis
         subjects affected / exposed
    5 / 141 (3.55%)
         occurrences all number
    5
    Pneumonia
         subjects affected / exposed
    4 / 141 (2.84%)
         occurrences all number
    4
    Otitis media
         subjects affected / exposed
    4 / 141 (2.84%)
         occurrences all number
    4
    Conjunctivitis
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Enterobiasis
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Fungal infection
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Gastroenteritis viral
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    lung infection
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Viral infection
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    2 / 141 (1.42%)
         occurrences all number
    2
    Adenovirus infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Cellulitis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Device related infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Laryngitis viral
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Leishmaniasis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Oral infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Rhinovirus infection
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 141 (4.26%)
         occurrences all number
    6
    Abnormal loss of weight
         subjects affected / exposed
    5 / 141 (3.55%)
         occurrences all number
    5
    Dehydration
         subjects affected / exposed
    3 / 141 (2.13%)
         occurrences all number
    3
    Hypercalcaemia
         subjects affected / exposed
    1 / 141 (0.71%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33395098
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