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    Summary
    EudraCT Number:2015-005544-33
    Sponsor's Protocol Code Number:AUH-TFB-SR-ULMR
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2015-005544-33
    A.3Full title of the trial
    Shamrock – Ultrasound/MR image fusion guided lumbar plexus blocks
    Shamrock – Ultralyd/MR billedfusionsvejledt plexus lumbalis blokade
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Shamrock – Ultrasound/magnetic resonance image fusion guided block of the lumbar nervous plexus
    Shamrock – Ultrasound/magnetisk resonans billedfusionsvejledt blokade af lænderegionenes fletværk af nerver
    A.4.1Sponsor's protocol code numberAUH-TFB-SR-ULMR
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThomas Fichtner Bendtsen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportA.P. Møller and Wife Chastine Mc-Kinney Møller's Foundation for General Purposes
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThomas Fichtner Bendtsen
    B.5.2Functional name of contact pointClinical Trial Info: Shamrock UL/MR
    B.5.3 Address:
    B.5.3.1Street AddressDep. of Anaesthesiology, Aarhus University Hospital, Nørrebrogade 44
    B.5.3.2Town/ cityAarhus C
    B.5.3.3Post codeDK-8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4551542997
    B.5.6E-mailtfb@dadlnet.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lidokain-adrenalin SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Perineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpinpehrine
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameEPINEPHRINE
    D.3.9.4EV Substance CodeSUB06568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dotarem
    D.2.1.1.2Name of the Marketing Authorisation holderVicare Medicals A/S (represents GUERBET)
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Perineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGADOTERIC ACID
    D.3.9.1CAS number 72573-82-1
    D.3.9.4EV Substance CodeSUB07865MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hip surgery anaesthesia and perioperative analgesia
    Hoftekirurgisk anæstesi og perioperativ analgesi
    E.1.1.1Medical condition in easily understood language
    Anaesthesia for hip surgery and perioperative pain treatment
    Bedøvelse til hoftekirurgi og smertebehandling før og efter kirurgien
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036284
    E.1.2Term Post-operative hip pain
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10051060
    E.1.2Term Hip surgery
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A double blinded, randomized controlled trial of success for lumbar plexus block (L2-L4) of the femoral, obturator, and lateral femoral cutaneous nerves with ultrasound/MRI image fusion guided Shamrock method vs. ultrasound guided Shamrock method. Success is assessed as motor block of the femoral and obturator nerves and sensory block of the lateral femoral cutaneous nerve in healthy volunteers.
    Dobbeltblindet, randomiseret og kontrolleret undersøgelse af succes for plexus lumbalis blokade (L2-4) af nn. femoralis, obturatorius og cutaneus femoris lateralis med Shamrock metoden vejledt af ultralyd/MR billedfusion vs. vejledning af ultralyd alene. Succes vurderes i raske, frivillige forsøgspersoner som motorisk blokade af n. femoralis og n. obturatorius samt sensorisk blokade af n. cutaneus femoris lateralis.
    E.2.2Secondary objectives of the trial
    To estimate:
    • Time for preparation of block
    • Time for block procedure
    • Minimal electrical nerve stimulation for release of neuromuscular response
    • Type of neuromuscular response on electrical nervestimulation
    • Number of needle proceedings
    • Depth of block needle
    • Distance between injection site in skin to the sagittal midline
    • Discomfort during block procedure
    • Middlearterial bloodpressure
    • Perineural spread of local anaesthetics
    • Epidural spread of local anaesthetics
    • Motor block of the af femoral, obturator, superior gluteal and sciatic nerves
    • Sensory block of the dermatomes T8-S3 and the lateral femoral cutaneous nerve
    • Cost-effectiveness
    • Reproducibility of diffusion weighted MRI sequences
    for ultrasound/MRI image fusion guided Shamrock method vs ultrasound guided Shamrock method in healthy volunteers.
    • Forberedelsestid før blokaden
    • Anlæggelsestid for blokaden
    • Minimal elektrisk nervestimulation for udløsning af neuromuskulært respons
    • Type neuromuskulært respons på elektrisk nervestimulation
    • Antal nålefremføringer under blokadeanlæggelsen
    • Dybde af nåleindstik under blokadeanlæggelsen
    • Afstand fra indstik i huden til den sagittale midtlinje
    • Ubehag under blokadeanlæggelsen
    • Middelarterielt blodtryk (MAP)
    • Perineural spredning af lokalanalgetikum
    • Epidural spredning af lokalanalgetikum
    • Motorisk blokade af nn. femoralis, obturatorius, glutealis superior og ischiadicus
    • Sensorisk blokade af dermatomerne T8-S3 og n. cutaneus femoris lateralis
    • Cost-effectiveness
    • Reproducerbarhed af diffusionsvægtede MR-skanningssekvenser i den enkelte deltager
    for Shamrock metoden vejledt af ultralyd/MR billedfusion vs. vejledning af ultralyd alene
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 years
    • Body mass index (BMI): 18.5 ≤ BMI ≤30
    • Written and oral consent to participate
    • Normal healthy person (American Society of Anesthesiology [ASA] Classification I)
    • Alder ≥ 18 år
    • Body mass index: 18.5 ≤ BMI ≤30
    • Skriftligt og mundtligt samtykke til at deltage
    • Normal rask person (American Society of Anesthesiology [ASA] Classification I)
    E.4Principal exclusion criteria
    • Volunteers not abel to speak or understand Danish
    • Volunteers not able to cooperate
    • Allergy against the medicines used in the study
    • Daily use of analgesics
    • Drug abuse – according to the investigator's judgment
    • Alcohol consumption greater than the recommendations of the Danish National Board of Health
    • Contraindication for MRI scan (including pregnancy)
    • Volunteers in whom nerve blocks are impossible due to technical reasons or infection
    • Volunteers who are incompetent, eg. surrogate consent is unaccepted
    • Forsøgspersoner som ikke forstår og taler dansk
    • Forsøgspersoner som ikke kan samarbejde til undersøgelsen
    • Allergi overfor de i undersøgelsen nævnte stoffer
    • Dagligt forbrug af analgetikum
    • Medicinmisbrug – efter investigators skøn
    • Større alkoholforbrug end Sundhedsstyrelsens retningslinjer, det vil sige > 14 genstande ugentlige for mænd og > 7 genstande ugentligt for kvinder
    • Kontraindikation mod MR scanning inklusive graviditet
    • Forsøgspersoner hvor det på grund af tekniske forhold ikke er muligt at anlægge en lumbal nerveblokade
    • Inhabilitet, det vil sige at der ikke kan benyttes stedfortrædendes samtykke
    E.5 End points
    E.5.1Primary end point(s)
    Block success of the clinical relevant lumbar plexus nerves that innervate the hip joint capsule estimated as significant motor block of the femoral (L2-L4, knee extension) and obturator (L2-L3, hip adduction) nerves and significant sensory block of the lateral femoral cutaneous nerve (cold or pain). Motor block is a proxy marker for sensory block.
    Blok succes af de klinisk relevante lumbale pleksus nerver, der innerverer hofteledskapslen, estimeret som signifikant motorisk blokade af n. femoralis (L2-L4, knæekstension) og n. obturatorius (L2-L3, hofteadduktion) samt sensorisk blokade af n. cutaneus femoris lateralis (kulde eller smerte). Motorisk blokade er en proksy markør for sensorisk blokade.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Motor block is evaluated 60 minutes after completed block procedure and sensory block is evaluated 70 minutes after completed block procedure.
    Motorisk blokade er evalueret 60 minutter efter blokadeanlæggelsen og sensorisk blokade er evalueret 70 minutter efter blokadeanlæggelsen.
    E.5.2Secondary end point(s)
    • Time for preparation (seconds) from placement of study participant on the bed until end of pre-ultrasoundscanning
    • Time for block procedure (seconds) from placement of ultrasound transducer on the skin until block
    needle is pulled out after injection of local anesthetics
    • Minimal electrical nerve stimulation for release of neuromuscular response
    • Type of neuromuscular response on electrical nervestimulation
    • Number of needle proceedings (needle proceeding followed by retraction of block needle and new needle proceeding)
    • Depth of tip of block needle in reference to injection site in skin (cm)
    • Distance between injection site in skin to the sagittal midline (cm)
    • Discomfort during block procedure assessed as on numeric rating scale (NRS 0-10: 0 = no discomfort, 10 = worst possible discomfort)
    • Middlearterial bloodpressure (MAP) after block procedure in reference to pre-block
    • Perineural spread of local anaesthetics added contrast estimated on MRI scanning for the spinal nerves L1-S1, the femoral, obturator, lateral femoral cutaneous nerves, and the lumbosacral trunk
    • Epidural spread of local anaesthetics added contrast defined as confirmed circumferential spread estimated on MRI scanning and reduced or absent cold somatosensation in two consecutive dermatomes bilaterally
    • Motor block of the femoral, obturator, superior gluteal and sciatic nerves estimated with dynamometer and defined as decrease in muscle strength (mmHg) of knee extension, hip adduction, hip abduction, and knee flexion, respectively, in reference to pre-block test
    • Success of motor block of the femoral, obturator, superior gluteal and sciatic nerves estimated with dynamometer and defined as significant motor block of knee extension, hip adduction, hip abduction, and knee flexion, respectively, in reference to pre-block test
    • Sensory block (cold, warmth, touch, pain) of the dermatomes T8-S3 and the lateral femoral cutaneous nerve defined as reduced or absent somatosensation
    • Cost-effectiveness estimated as extra expense per extra successful nerve block (incremental cost-effectiveness ratio, ICER)
    • Reproducibility of diffusionweighted MRI scans evaluated for quantitive diffusion measures and evaluation of image quality
    • Forberedelsestid defineret som tiden (sekunder) fra lejring af forsøgsperson til præ-ultralydskanningens slut
    • Anlæggelsestid defineret som tiden (sekunder) fra placering af ultralydtransduceren på huden til blokadenålen er trukket ud fra huden efter injektion af lokalanalgetikum
    • Minimal elektrisk nervestimulation for udløsning af neuromuskulært respons angivet i mA
    • Type of neuromuskulært respons på elektrisk nervestimulation
    • Antal af nålefremføringer defineret som en nålefremføring efterfulgt af en tilbagetrækning og ny fremføring af blokadenålen
    • Dybde af nåleindstik defineret som afstanden (cm) fra blokadenålens spids til injektionsstedet i huden
    • Afstanden (cm) fra indstiksstedet i huden til den sagittale midtlinje
    • Ubehag under blokadeanlæggelsen estimeret på numeric rating scale (NRS 0-10: 0 = intet ubehag, 10 = værst tænkelige ubehag)
    • Middelarterielt blodtryk (MAP) after blokadeanlæggelsen sammenlignet med før blokadeanlæggelsen
    • Perineural spredning af lokalanalgetikum tilsat kontrast vurderet på MR skanning for spinal nerverne L1-S1, n. femoralis, n. obturatorius, n. cutanues femoris lateralis, og truncus lumbosacralis
    • Epidural spredning af lokalanalgetikum tilsat defineret som circumferentiel spredning på MR skanning og nedsat eller ingen bilateral sensorisk sans for kulde i to konsekutive dermatomer
    • Motorisk blokade af n. femoralis, n. obturatorius, n. glutealis superior og n. ischiadicus vurderet med dynamometer og defineret som nedsættelse af kraft (mmHg) af henholdsvis knæekstension, hofteadduktion, hofteabduktion, og knæfleksion i forhold til reference undersøgelse før blokade
    • Succes af motorisk blokade af n. femoralis, n. obturatorius, n. glutealis superior og n. ischiadicus vurderet med dynamometer og defineret som signifikant motorisk blokade af henholdsvis knæekstension, hofteadduktion, hofteabduktion, og knæfleksion i forhold til reference undersøgelse før blokade
    • Sensorisk blokade (kulde, varme, berøring, smerte) af dermatomerne T8-S3 og n. cutaneus femoris lateralis defineret som nedsat eller ingen sensorisk sans
    • Cost-effectiveness estimated as extra expense per extra successful nerve block (incremental cost-effectiveness ratio, ICER)
    • Reproducerbarhed af diffusionsvægtede MR skanning evalueret med kvantitative diffusionsmål og evaluering af billedkvalitet
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Time for preparation: 0 min after pre-ultrasoundscanning
    • Time for block procedure: 0 min after block
    • Minimal electrical nerve stimulation: before injection of local anesthetics
    • Type of neuromuscular response: before injection of local anesthetics
    • Number of needle proceedings: 0 min after block
    • Depth of block needle: 0 min after block
    • Distance between injection site and midline: 0 min after block
    • Discomfort: 0 min after block
    • MAP: 5 min after block
    • Perineural spread: 10-40 min after block
    • Epidural spread: 10-40 min and 70 min after block
    • Motor block: 60 min after block
    • Motor block success: 60 min after block
    • Sensory block: 70 min after block
    • Cost-effectiveness: 2 months after LVLS
    • MRI reproducibility: 40-55 min after block
    • Forberedelsestid: 0 min efter præ-ultralydscanning
    • Anlæggelsestid: 0 min efter blok
    • Minimal elektrisk nervestimulation: før injektion af lokalanalgetikum
    • Type of neuromuskulært respons: før injektion af lokalanalgetikum
    • Antal af nålefremføringer: 0 min efter blokade
    • Dybde af nåleindstik: 0 min efter blokade
    • Afstanden mellem indstikssted til midtlinje: 0 min efter blokade
    • Ubehag: 0 min efter blokadeanlæggelse
    • MAP: 5 min efter blokade
    • Perineural spredning: 10-40 min efter blokade
    • Epidural spredning: 10-40 min og 70 min efter blokade
    • Motorisk blokade: 60 min efter blokade
    • Succes af motorisk blokade: 60 min efter blokade
    • Sensorisk blokade: 70 min efter blokade
    • Cost-effectiveness: 2 måneder efter LVLS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Cost-effetiveness (ICER) of the ultrasound/MRI image fusion guided Shamrock method vs. the ultrasound guided Shamrock method.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    En anden teknik til at placere den samme medicin
    Another technique to place the same medical product
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. The volunteers will be invited to a voluntarily closing meeting after the last day of the trial.

    NB! We intend to include a total of 22 volunteers >= 18 years. That is why it says "22" of both adults (18-64 years) and elderly (>=65 years) beneath point. F.1. Age range.
    Ingen. Forsøgspersonerne vil blive tilbudt et opfølgende møde efter sidste forsøgsdag.

    NB! Vi vil inkludere 22 forsøgspersoner >= 18 år i alt. Derfor står det "22" mulige voksne (18-64 år) og 22 mulige ældre (>= 65 år) under punktet F.1. Age range.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-10
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