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    Clinical Trial Results:
    A randomized, controlled, multi-center study on the effectiveness of Traumeel® S (both ointment and gel) in Terms of pain and function compared with a topical NSAID in athletes with acute ankle sprain.

    Summary
    EudraCT number
    		 2008-007939-41
    Trial protocol
    		 ES  
    Global end of trial date
    12 Sep 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Sep 2016
    First version publication date
    14 Sep 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TRS-ESP 2008-007939-41
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01066520
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biologische Heilmittel Heel GmbH
    Sponsor organisation address
    Dr-Reckeweg-Strasse 2-4, Baden-Baden, Germany, 76532
    Public contact
    Dr. Gabriele Niemann, Biologische Heilmittel Heel GmbH, +49 7221 501-290, gabriele.niemann@heel.com
    Scientific contact
    Dr. Gabriele Niemann, Biologische Heilmittel Heel GmbH, +49 7221 501-290, gabriele.niemann@heel.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
    12 Mar 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Sep 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Confirmatory proof of efficacy in terms of pain and function using a test for noninferiority (‘at least as good’) for Traumeel® S topical treatment as compared to diclofenac topical treatment for patients with ankle sprain.
    Protection of trial subjects
    Standard protection of trial subjects according to ICH GCP requirements was applied.
    Background therapy
    		 Rescue medication for pain control (paracetamol 500-mg tablets, up to four tablets daily) was recorded by the patients on the patient diary Cards.
    Evidence for comparator
    		 Topical application of diclofenac significantly reduces pain and inflammation in acute and chronic conditions including ankle sprain. Moreover it is well tolerated, resulting mostly in mild, easily resolved local Skin irritation, and is associated with fewer side-effects than other topical NSAIDs.
    Actual start date of recruitment
    24 Aug 2009
    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
    Spain: 449
    Worldwide total number of subjects
    449
    EEA total number of subjects
    449
    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)
    3
    Adults (18-64 years)
    446
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 15 centers enrolled 299 subjects (stage I) starting 24 August 2009. 150 patients were randomized in 10 study centers in stage II (combined stages: 449 patients in 15 study centers). The study was conducted as a randomized, double-blinded, controlled two-stage study of athletes having an acute unilateral ankle sprain of the lateral ankle joint.

    Pre-assignment
    Screening details
    		 Subjects were selected among athletes who were in training (professional or as amateur) and had experienced an acute unilateral ankle sprain of the lateral ankle joint. Eligible patients were randomized to receive one of the following treatments of the ankle for 2 weeks: • Traumeel® S ointment • Traumeel® S gel • Diclofenac gel

    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, Data analyst, Carer, Assessor
    Blinding implementation details
    Subjects were assigned in a 1:1:1 randomization (Traumeel® S ointment: Traumeel® S gel: Diclofenac) according to a randomization schedule generated by idv Datenanalyse und Versuchsplanung (Krailling, Germany). The study was partially double blind. The 3 IMPs were packed in identical containers. In the setting of a 3-arm randomization it was double-blind for Traumeel® S gel + diclofenac gel (subject and investigator) and single-blind for Traumeel® S ointment (investigator).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Analysed Safety Combined Stages Traumeel S Gel
    Arm description
    		 150 Patients were randomized in both stages to this Group but 2 of them were not treated. Tthus, 148 were included to the analysed safety Group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Traumeel S Gel
    Investigational medicinal product code
    none
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    IMP was applied three times daily, 2 g of gel (strand of ca. 6 cm, as measured onto the provided dosing cards), to sufficiently cover the area of the lesion, gently rubbing, wait 15 minutes before covering the treated Skin with clothing. No shower or bath was allowed for at least one hour after applying the ointment or gel. IMP was applied by the patient himself at each day of the study, in the morning, around noon and at late afternoon, until termination.

    Investigational medicinal product name
    Traumeel S Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    IMP was applied three times daily, 2 g of gel (strand of ca. 6 cm, as measured onto the provided dosing cards), to sufficiently cover the area of the lesion, gently rubbing, wait 15 minutes before covering the treated Skin with clothing. No shower or bath was allowed for at least one hour after applying the ointment or gel. IMP was applied by the patient himself at each day of the study, in the morning, around noon and at late afternoon, until termination.

    Arm title
    		 Safety Combined Stages Traumeel S ointment
    Arm description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 152 Patients were randomized in both stages to this Group and completed the Trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Traumeel S ointment
    Investigational medicinal product code
    none
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    IMP was applied three times daily, 2 g of ointment (strand of ca. 6 cm, as measured onto the provided dosing cards), to sufficiently cover the area of the lesion, gently rubbing, wait 15 minutes before covering the treated Skin with clothing. No shower or bath was allowed for at least one hour after applying the ointment or gel. IMP was applied by the patient himself at each day of the study, in the morning, around noon and at late afternoon, until termination.

    Arm title
    		 Safety combined stages Diclofenac gel
    Arm description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 147 Patients were randomized in both stages to this Group and completed the Trial.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diclofenac gel
    Investigational medicinal product code
    none
    Other name
    NSAID
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    2 g of gel three times daily, to sufficiently cover the area of the lesion, gently rubbing.

    Number of subjects in period 1 [1]
    		Analysed Safety Combined Stages Traumeel S Gel Safety Combined Stages Traumeel S ointment Safety combined stages Diclofenac gel
    Started
    148
    152
    147
    Completed
    148
    152
    147
    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: 150 Patients were randomized in both stages to this group, however 2 patients were not treated. Thus, only 148 patients were analysed in the Traumeel S Gel safety Group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Analysed Safety Combined Stages Traumeel S Gel
    Reporting group description
    		 150 Patients were randomized in both stages to this Group but 2 of them were not treated. Tthus, 148 were included to the analysed safety Group.

    Reporting group title
    Safety Combined Stages Traumeel S ointment
    Reporting group description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 152 Patients were randomized in both stages to this Group and completed the Trial.

    Reporting group title
    Safety combined stages Diclofenac gel
    Reporting group description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 147 Patients were randomized in both stages to this Group and completed the Trial.

    Reporting group values
    		 Analysed Safety Combined Stages Traumeel S Gel Safety Combined Stages Traumeel S ointment Safety combined stages Diclofenac gel Total
    Number of subjects
    		 148 152 147 447
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 1 2 0 3
        Adults (18-64 years)
    		 147 150 147 444
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Data are available from the ITT Groups only
    Units: years
        arithmetic mean (standard deviation)
    		 27.9 ( 6.68 ) 28.3 ( 6.63 ) 27.2 ( 6.5 ) -
    Gender categorical
    Data are available on the ITT subgroup only.
    Units: Subjects
        Female
    		 106 113 109 328
        Male
    		 42 39 38 119
    Race
    Data are available from the ITT subgroup only.
    Units: Subjects
        Caucasian
    		 141 147 142 430
        Asian
    		 0
        African
    		 1 2 1 4
        Latin American
    		 6 3 4 13
    Smoker
    Data are available on the ITT subgroup only.
    Units: Subjects
        YES
    		 26 36 19 81
        NO
    		 122 116 128 366
    Location
    Data are available on the ITT subgroup only.
    Units: Subjects
        LEFT
    		 66 69 69 204
        RIGHT
    		 82 83 78 243
    Location
    Data are available on the ITT subgroup only.
    Units: Subjects
        LEFT
    		 66 69 69 204
        RIGHT
    		 82 83 78 243
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 ( ) ( ) ( ) -
    Subject analysis sets

    Subject analysis set title
    ITT Combined Stages Traumeel Gel
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Traumeel Gel Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Subject analysis set title
    ITT combined stages Traumeel ointment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Traumeel Ointment Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Subject analysis set title
    ITT combined stages Diclofenac Gel
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Diclofenac Gel Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Subject analysis sets values
    		 ITT Combined Stages Traumeel Gel ITT combined stages Traumeel ointment ITT combined stages Diclofenac Gel
    Number of subjects
    140
    143
    137
    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)
    140
    143
    137
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    Age continuous
    Data are available from the ITT Groups only
    Units: years
        arithmetic mean (standard deviation)
    27.7 ( 6.62 )
    28.3 ( 6.58 )
    27.1 ( 6.05 )
    Gender categorical
    Data are available on the ITT subgroup only.
    Units: Subjects
        Female
    39
    39
    34
        Male
    101
    104
    103
    Race
    Data are available from the ITT subgroup only.
    Units: Subjects
        Caucasian
    133
    138
    132
        Asian
    0
    0
    0
        African
    1
    2
    1
        Latin American
    6
    3
    4
    Smoker
    Data are available on the ITT subgroup only.
    Units: Subjects
        YES
    22
    35
    18
        NO
    118
    108
    119
    Location
    Data are available on the ITT subgroup only.
    Units: Subjects
        LEFT
    28
    35
    42
        RIGHT
    112
    108
    95
    Location
    Data are available on the ITT subgroup only.
    Units: Subjects
        LEFT
    66
    64
    66
        RIGHT
    74
    79
    71
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    23.6 ( 2.9 )
    24.1 ( 3 )
    23.5 ( 2.8 )

    End points

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    End points reporting groups
    Reporting group title
    Analysed Safety Combined Stages Traumeel S Gel
    Reporting group description
    		 150 Patients were randomized in both stages to this Group but 2 of them were not treated. Tthus, 148 were included to the analysed safety Group.

    Reporting group title
    Safety Combined Stages Traumeel S ointment
    Reporting group description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 152 Patients were randomized in both stages to this Group and completed the Trial.

    Reporting group title
    Safety combined stages Diclofenac gel
    Reporting group description
    		 All patients who have had at least one dose of medication and one contact with the investigator afterwards are analyzed for safety. 147 Patients were randomized in both stages to this Group and completed the Trial.

    Subject analysis set title
    ITT Combined Stages Traumeel Gel
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Traumeel Gel Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Subject analysis set title
    ITT combined stages Traumeel ointment
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Traumeel Ointment Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Subject analysis set title
    ITT combined stages Diclofenac Gel
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Group is a subgroup of the Safety combined stages Diclofenac Gel Group and includes all patients who have had at least one dose of medication, at least one efficacy evaluation under medication, and are without severe protocol deviations (full Analysis set). The ITT analysis is defined as the first line efficacy analysis, being in the line of a pragmatic approach (i.e. the test Treatment should demonstrate its efficacy under conditions that are to be expected in everyday life).

    Primary: Percent Change from baseline VAS scale on Day 7

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    End point title
    		 Percent Change from baseline VAS scale on Day 7
    End point description
    End point type
    Primary
    End point timeframe
    The 100 mm VAS score was recorded at Baseline and on Days 4, 7, 14 and 42.
    End point values
    		 ITT Combined Stages Traumeel Gel ITT combined stages Traumeel ointment ITT combined stages Diclofenac Gel
    Number of subjects analysed
    140
    142
    136
    Units: mm
        arithmetic mean (standard deviation)
    -65.63 ( 26.136 )
    -60.88 ( 29.633 )
    -64.54 ( 26.094 )
    Statistical analysis title
    		 Percent change in VAS scale Day 7
    Comparison groups
    ITT Combined Stages Traumeel Gel v ITT combined stages Traumeel ointment v ITT combined stages Diclofenac Gel
    Number of subjects included in analysis
    418
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.8205
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mann-Whitney effect size
    Point estimate
    0.5142
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 0.4
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - The Mann-Whitney measure gives the probability that a randomly chosen patient from the test group is better off than a randomly chosen patient from the reference group. The lower inferiority margin is stipulated as 0.4, because this is halfway between a ‘relevant’ and a ‘small’ difference (0.36 and 0.44). If (at least as good) is proven for the lower equivalence bound 0.4 then the lower bound of the one-sided confidence interval could define post hoc even a tighter margin for than the value 0.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Informatiomn on adverse events was assessed during the complete study period of 14 days at each visit as follows: visit 2 (Day 4), visit 3 (Day 7) and visit 4 (Day 14). and during follow up on visit 5, 6 weeks after visit 1 (Day0).
    Adverse event reporting additional description
    Findings of physical examination and vital criteria were presented by descriptive statistics. Adverse events (AEs) were categorized by primary system organ class (SOC) and MedDRA preferred terms coded using the MedDRA dictionary. The number, intensity, relation to study medication, and action taken was described by frequency tables. Serious
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Safety Combined Stages Traumeel S Gel
    Reporting group description
    		 150 Patients were randomized in both stages to this group. 148 were included to the safety Group.

    Reporting group title
    Safety Combined Stages Traumeel S ointment
    Reporting group description
    		 152 Patients were randomized in both stages to this Group and completed the Trial.

    Reporting group title
    Safety combined stages Diclofenac gel
    Reporting group description
    		 147 Patients were randomized in both stages to this Group and completed the Trial.

    Serious adverse events
    		 Safety Combined Stages Traumeel S Gel Safety Combined Stages Traumeel S ointment Safety combined stages Diclofenac gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 152 (0.00%)
    0 / 147 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Combined Stages Traumeel S Gel Safety Combined Stages Traumeel S ointment Safety combined stages Diclofenac gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 148 (9.46%)
    11 / 152 (7.24%)
    8 / 147 (5.44%)
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 152 (0.66%)
    0 / 147 (0.00%)
         occurrences all number
    0
    1
    0
    Joint sprain
         subjects affected / exposed
    1 / 148 (0.68%)
    1 / 152 (0.66%)
    1 / 147 (0.68%)
         occurrences all number
    1
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 148 (3.38%)
    3 / 152 (1.97%)
    1 / 147 (0.68%)
         occurrences all number
    5
    7
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 152 (0.66%)
    0 / 147 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 148 (0.00%)
    1 / 152 (0.66%)
    0 / 147 (0.00%)
         occurrences all number
    0
    2
    0
    Swelling
         subjects affected / exposed
    0 / 148 (0.00%)
    0 / 152 (0.00%)
    2 / 147 (1.36%)
         occurrences all number
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 148 (0.68%)
    1 / 152 (0.66%)
    1 / 147 (0.68%)
         occurrences all number
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 152 (0.00%)
    0 / 147 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 148 (0.00%)
    3 / 152 (1.97%)
    1 / 147 (0.68%)
         occurrences all number
    0
    4
    1
    Pruritus
         subjects affected / exposed
    2 / 148 (1.35%)
    2 / 152 (1.32%)
    1 / 147 (0.68%)
         occurrences all number
    2
    2
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 148 (1.35%)
    0 / 152 (0.00%)
    0 / 147 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    influenza
         subjects affected / exposed
    1 / 148 (0.68%)
    0 / 152 (0.00%)
    0 / 147 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 148 (1.35%)
    0 / 152 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    2
    0
    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.
    not applicable

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/11273971
    http://www.ncbi.nlm.nih.gov/pubmed/14751943
    http://www.ncbi.nlm.nih.gov/pubmed/9475896
    http://www.ncbi.nlm.nih.gov/pubmed/11195774
    http://www.ncbi.nlm.nih.gov/pubmed/17137000
    http://www.ncbi.nlm.nih.gov/pubmed/23543522
    http://www.ncbi.nlm.nih.gov/pubmed/11550833
    http://www.ncbi.nlm.nih.gov/pubmed/23543517
    http://www.ncbi.nlm.nih.gov/pubmed/15286056
    http://www.ncbi.nlm.nih.gov/pubmed/15317652
    http://www.ncbi.nlm.nih.gov/pubmed/15147585
    http://www.ncbi.nlm.nih.gov/pubmed/15155436
    http://www.ncbi.nlm.nih.gov/pubmed/11505416
    http://www.ncbi.nlm.nih.gov/pubmed/3283007
    http://www.ncbi.nlm.nih.gov/pubmed/10709306
    http://www.ncbi.nlm.nih.gov/pubmed/15330450
    http://www.ncbi.nlm.nih.gov/pubmed/16309613
    http://www.ncbi.nlm.nih.gov/pubmed/21231861
    http://www.ncbi.nlm.nih.gov/pubmed/19546098
    http://www.ncbi.nlm.nih.gov/pubmed/21422934
    http://www.ncbi.nlm.nih.gov/pubmed/11276181
    http://www.ncbi.nlm.nih.gov/pubmed/20457737
    http://www.ncbi.nlm.nih.gov/pubmed/14754753
    http://www.ncbi.nlm.nih.gov/pubmed/18810189
    http://www.ncbi.nlm.nih.gov/pubmed/10291102
    http://www.ncbi.nlm.nih.gov/pubmed/16972714
    http://www.ncbi.nlm.nih.gov/pubmed/16972715
    http://www.ncbi.nlm.nih.gov/pubmed/16395993
    http://www.ncbi.nlm.nih.gov/pubmed/7786985
    http://www.ncbi.nlm.nih.gov/pubmed/15969304
    http://www.ncbi.nlm.nih.gov/pubmed/1509217
    http://www.ncbi.nlm.nih.gov/pubmed/2197679
    http://www.ncbi.nlm.nih.gov/pubmed/16781589
    http://www.ncbi.nlm.nih.gov/pubmed/18346625
    http://www.ncbi.nlm.nih.gov/pubmed/18937623
    http://www.ncbi.nlm.nih.gov/pubmed/18279583
    http://www.ncbi.nlm.nih.gov/pubmed/19380203
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