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    Clinical Trial Results:
    Prevention of paclitaxel-related neurological side effects with lithium – a randomized, double-blind, placebo-controlled, explorative proof-of-concept phase II clinical trial to counteract chemotherapy induced neurotoxicity

    Summary
    EudraCT number
    		 2015-004172-30
    Trial protocol
    		 DE  
    Global end of trial date
    18 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2026
    First version publication date
    06 Feb 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PREPARE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02753036
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00027165
    Sponsors
    Sponsor organisation name
    Charité Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Department of Neurology / NCRC, Charité – Universitätsmedizin Berlin, +49 30450 560 102, prepare-studie@charite.de
    Scientific contact
    Department of Neurology / NCRC, Charité – Universitätsmedizin Berlin, +49 30450 560 102, prepare-studie@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this proof-of-concept exploratory clinical trial is to test the hypothesis that a co-medication with lithium carbonate (Quilonum® retard) is able to reduce the burden of chemotherapy induced neuropathy (CIN) as measured by the “Total Neuropathy Score reduced” (TNSr) in breast cancer patients undergoing neurotoxic chemotherapy with weekly (q1w) or biweekly (q2w) paclitaxel infusions.
    Protection of trial subjects
    The study was conducted in accordance with the ICH E6 (R2) Guideline for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, German Medicinal Products Act (AMG)), and with the ethical principles that have their origins in the Declaration of Helsinki (version 2013). The Investigator also had to comply with all applicable privacy regulations (e.g., Regulation (EU) 2016/679 (General Data Protection Regulation, GDPR)).
    Background therapy
    		 Chemotherapy-induced polyneuropathy (CIPN) and postchemotherapy cognitive impairment (PCCI) are frequent side effects of paclitaxel treatment. CIPN/PCCI are potentially irreversible, reduce quality of life and often lead to treatment limitations, which affect patients’ outcome. We previously demonstrated that paclitaxel enhances an interaction of tthe Neuronal calcium sensor-1 protein (NCS-1) with the Inositol-1,4,5-trisphosphate receptor (InsP3R), which disrupts calcium homeostasis and triggers neuronal cell death via the calcium-dependent protease calpain in dorsal root ganglia neurons and neuronal precursor cells. Prophylactic treatment of rodents with lithium inhibits the NCS1-InsP3R interaction and ameliorates paclitaxel-induced polyneuropathy and cognitive impairment, which is in part supported by limited retrospective clinical data in patients treated with lithium carbonate at the time of chemotherapy. Currently no data are available from a prospective clinical trial to demonstrate its efficacy.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2022
    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
    Germany: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    79
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited between August 2, 2022 and July 8, 2024 in 8 study sites in Germany.

    Pre-assignment
    Screening details
    		 4952 were to bee assessed for eligibiilty in weekly tumor board meetings. The study included n=94 patients of which 86 patients were randomized divided into 2 groups.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lithium carbonate group
    Arm description
    		 IMP add-on to SMP
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lithium carbonate
    Investigational medicinal product code
    N05AN01
    Other name
    Quilonum
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Encapsulated lithium carbonate 225mg (Quilonum® retard), taken twice per day, starting 14 days prior to the first (nab-) paclitaxel infusion and ending 3 days after the last (nab-) paclitaxel infusion, respectively a maximum of 6 or 12 (nab-) paclitaxel infusions [approx. 9 (PTX q2w) or 14 (PTX q1w) weeks in total for each patient]

    Arm title
    		 Placebo control group
    Arm description
    		 Placebo add-on to SMP
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available placebo tablets (P-Tablets 8mm Lichtenstein) containing lactose-monohydrate, cellulose powder, magnesiumstearate (Ph. Eur.) and microcrystalline cellulose were provided and encapsulated identical to Lithium carbonate for blinding purposes by the trial pharmacy. Placebo were taken twice per day, starting 14 days prior to the first (nab-) paclitaxel infusion and ending 3 days after the last (nab-) paclitaxel infusion, respectively a maximum of 6 or 12 (nab-) paclitaxel infusions [approx. 9 (PTX q2w) or 14 (PTX q1w) weeks in total for each patient].

    Number of subjects in period 1
    		Lithium carbonate group Placebo control group
    Started
    43
    43
    Completed
    36
    42
    Not completed
    7
    1
         Consent withdrawn by subject
    3
    -
         Adverse event, non-fatal
    4
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lithium carbonate group
    Reporting group description
    		 IMP add-on to SMP

    Reporting group title
    Placebo control group
    Reporting group description
    		 Placebo add-on to SMP

    Reporting group values
    		 Lithium carbonate group Placebo control group Total
    Number of subjects
    		 43 43 86
    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)
    		 38 41 79
        From 65-84 years
    		 5 2 7
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 49.3 ( 10.5 ) 44.7 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 43 86
        Male
    		 0 0 0
    Comorbidies at screening
    Units: Subjects
        Diabetes
    		 4 0 4
        Arterial hypertension
    		 3 7 10
        none
    		 36 36 72
    Cumulative PTX dose
    Units: mg m-2
        median (inter-quartile range (Q1-Q3))
    		 720 (700 to 960) 960 (720 to 960) -

    End points

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    End points reporting groups
    Reporting group title
    Lithium carbonate group
    Reporting group description
    		 IMP add-on to SMP

    Reporting group title
    Placebo control group
    Reporting group description
    		 Placebo add-on to SMP

    Primary: Change TNSr

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    End point title
    		 Change TNSr
    End point description
    Analysis of the primary endpoint Total Neuropathy Score reduced (TNSr) after conclusion of chemotherapy
    End point type
    Primary
    End point timeframe
    from baseline up to 2 weeks after last paclitaxel infusion
    End point values
    		 Lithium carbonate group Placebo control group
    Number of subjects analysed
    36
    42
    Units: Score
    arithmetic mean (standard deviation)
        TNSr (baseline)
    0.83 ( 1.44 )
    0.76 ( 1.38 )
        TNSr (endpoint)
    3.97 ( 3.15 )
    4.66 ( 3.21 )
    Attachments
    		 secondary_endpoints_PREPARE
    Statistical analysis title
    		 efficacy results
    Statistical analysis description
    A linear mixed model was calculated to analyze the intervention effect, with the study centers as clusters. Adjustments were made for baseline TNSr values and cumulative chemotherapy doses as per the statistical analysis plan. Missing values were imputed using multiple imputation by chained equations. Thirty data sets were generated, and the results were pooled. On average, the lithium carbonate group had a TNSr value that was 0.5 points lower (90% CI: -0.6 to 1.6) than the placebo group at two
    Comparison groups
    Lithium carbonate group v Placebo control group
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Lithium carbonate group
    Reporting group description
    		 -

    Reporting group title
    Placebo control group
    Reporting group description
    		 -

    Serious adverse events
    		 Lithium carbonate group Placebo control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 43 (11.63%)
    6 / 43 (13.95%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    lithium intoxication
    Additional description: Hospitalization due to suspected lithium intoxication with dizziness/imbalance and muscle twitches subsequent to a urinary tract infection. Blinded laboratory report showed lithium level of 2.08mmol/l.
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac disorder, other
    Additional description: Especially cardiotoxicity of chemotherapy with epirubicin/cyclophosphamide
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
    Additional description: Pneumonitis as a result of therapy with the immune checkpoint inhibitor pembrolizumab, atypical pneumonia DD pneumonitis
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    Additional description: The patient presented with severe fatigue and dry cough and was admitted to hospital for further investigation.
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia with sepsis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Lithium carbonate group Placebo control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 43 (93.02%)
    41 / 43 (95.35%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Hot flashes
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 43 (13.95%)
    9 / 43 (20.93%)
         occurrences all number
    8
    10
    Edema
    Additional description: Edema limbs/face
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Fever
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    flu like symptoms
         subjects affected / exposed
    2 / 43 (4.65%)
    5 / 43 (11.63%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 43 (6.98%)
         occurrences all number
    3
    3
    Dyspnea
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Epistaxis
         subjects affected / exposed
    5 / 43 (11.63%)
    4 / 43 (9.30%)
         occurrences all number
    5
    4
    Rhinorrhea
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Depression
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    White blood cell decreased
         subjects affected / exposed
    15 / 43 (34.88%)
    20 / 43 (46.51%)
         occurrences all number
    15
    20
    Platelet count decreased
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Creatinine increased
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 43 (13.95%)
    4 / 43 (9.30%)
         occurrences all number
    8
    4
    Tremor
         subjects affected / exposed
    5 / 43 (11.63%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    15 / 43 (34.88%)
    16 / 43 (37.21%)
         occurrences all number
    18
    18
    Paresthesia
         subjects affected / exposed
    10 / 43 (23.26%)
    8 / 43 (18.60%)
         occurrences all number
    11
    11
    Dizziness
         subjects affected / exposed
    6 / 43 (13.95%)
    5 / 43 (11.63%)
         occurrences all number
    6
    5
    Dysgeusia
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Cognitive disturbance
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 43 (9.30%)
         occurrences all number
    4
    4
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    30 / 43 (69.77%)
    24 / 43 (55.81%)
         occurrences all number
    31
    26
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Eye disorders
    Blurred vision
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Watering eyes
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    4 / 43 (9.30%)
    4 / 43 (9.30%)
         occurrences all number
    4
    4
    Diarrhoe
         subjects affected / exposed
    14 / 43 (32.56%)
    11 / 43 (25.58%)
         occurrences all number
    17
    12
    Abdominal pain
         subjects affected / exposed
    5 / 43 (11.63%)
    1 / 43 (2.33%)
         occurrences all number
    5
    1
    Mucositis oral
         subjects affected / exposed
    4 / 43 (9.30%)
    7 / 43 (16.28%)
         occurrences all number
    4
    7
    Nausea
         subjects affected / exposed
    6 / 43 (13.95%)
    6 / 43 (13.95%)
         occurrences all number
    8
    6
    Dry mouth
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Dysphagia
         subjects affected / exposed
    2 / 43 (4.65%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    Flatulence
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Gastroesophageal reflux
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Vomiting
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    8 / 43 (18.60%)
    7 / 43 (16.28%)
         occurrences all number
    8
    8
    Alopecia
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Nail changes
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Pruritus
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    2
    2
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Endocrine disorders
    Hypothyreose
         subjects affected / exposed
    1 / 43 (2.33%)
    5 / 43 (11.63%)
         occurrences all number
    2
    6
    Adrenal insufficiency, Grad 4
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 43 (13.95%)
    6 / 43 (13.95%)
         occurrences all number
    6
    6
    Myalgia
         subjects affected / exposed
    10 / 43 (23.26%)
    9 / 43 (20.93%)
         occurrences all number
    11
    9
    Back Pain
         subjects affected / exposed
    4 / 43 (9.30%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Muscle cramp
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 43 (6.98%)
         occurrences all number
    2
    4
    Bone pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Neck pain
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 43 (2.33%)
         occurrences all number
    2
    1
    Enterocolitis infective
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 43 (6.98%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 43 (2.33%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    Shingles
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2022
    update protocol V1.2 (15/03/2022)
    10 Nov 2022
    update protocol V1.3 (31/08/2022)
    30 Jun 2023
    update protocol V1.4 (05/06/2023)

    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/3603542
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