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    Summary
    EudraCT Number:2010-021720-10
    Sponsor's Protocol Code Number:TMC-ORI-10-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-12-30
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2010-021720-10
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infection Study (SOLO II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effect of an investigational antibiotic (oritavancin) in the treatment of skin and skin structure infections compared to a commonly used antibiotic.
    A.3.2Name or abbreviated title of the trial where available
    SOLO II
    A.4.1Sponsor's protocol code numberTMC-ORI-10-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01252732
    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 SponsorThe Medicines Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Medicines Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Medicines Company UK Ltd
    B.5.2Functional name of contact pointJonathan Day
    B.5.3 Address:
    B.5.3.1Street Address115L Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4SA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441235 448504
    B.5.5Fax number00441235 835561
    B.5.6E-mailjonathan.day@themedco.com
    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 No
    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.3.1Product nameoritavancin diphosphate
    D.3.2Product code oritavancin
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOritavancin diphosphate
    D.3.9.1CAS number 192564-14-0
    D.3.9.2Current sponsor codeRamvocid
    D.3.9.3Other descriptive nameOritavancin, Oritavancin bis(phosphate), Oritavancin bisphosphate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-infective/antibiotic semi-synthetic lipoglycopeptide
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Vancomycin Hydrochloride 1 g Powder for Concentrate for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameVancomycin Hydrochloride 1 g Powder for Concentrate for Infusion
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVANCOMYCIN HYDROCHLORIDE
    D.3.9.1CAS number 1404-93-9
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeantibiotic
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Patients with acute bacterial skin and skin structure infections
    E.1.1.1Medical condition in easily understood language
    Treatment of Patients with acute bacterial skin and skin structure
    infections
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10065240
    E.1.2Term Wound infection bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10040872
    E.1.2Term Skin infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10042343
    E.1.2Term Subcutaneous abscess
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10066409
    E.1.2Term Staphylococcal skin infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007882
    E.1.2Term Cellulitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the non-inferiority (as defined by the cessation of spread or reduction in size of the baseline lesion at Early Clinical Evaluation (ECE) at 48 to 72 hours and no rescue medication with single-dose intravenous (IV) oritavancin diphosphate (oritavancin) compared with IV vancomycin for 7 to 10 days in the modified intent-to-treat (mITT) population.
    E.2.2Secondary objectives of the trial
    Clinical response [CR] (clinical cure [CC]) of single-dose IV oritavancin (ORI) vs 7-10 days IV vancomycin (VAN) treatment at End of Therapy (EOT) visit, sustained to Day 10 (D10) & post therapy evaluation (PTE) visit in mITT population
    CR (cessation of spread/reduction in size of the baseline lesion at 48-72h [CSBL]) of ORI vs VAN in clinically evaluable (CE) population
    CR (CC) of treatment with ORI vs VAN at EOT visit, D10 & PTE visit in CE population
    Efficacy: CR (CSBL & CC) endpoints by pathogen vs VAN treatment in the microbiologically ITT (MITT) & microbiologically evaluable (ME) populations
    Microbiological response [MR] of ORI vs VAN treatment in the MITT & ME populations
    Incidence of microbiological relapse or recurrence rates at PTE visit in MITT & ME populations
    CR & MR in patients in CE & ME populations meeting systemic inflammatory response syndrome
    criteria at screening/with +ve blood cultures
    Safety & tolerability
    PK & PK/PD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females ≥18 years old
    2. Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 7 days of IV therapy. A specimen for culture must be obtained whenever possible by an approved protocol method 24 hours before the first dose of study drug. Final culture results are not required prior to initiation of study drug.
    3. An ABSSSI which includes one of the following infections:
    a. Wound infections: that are either traumatic or surgical in origin defined as an infection characterized by purulent drainage from a wound with surrounding erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of erythema, oedema, and/or induration extending at least 5 cm from the peripheral margin of the wound), accompanied by signs and systemic inflammation symptoms as listed below. Onset of this infection must have occurred within 7 days prior to randomization and no later than 30 days following the trauma or surgical procedure.
    b. Cellulitis/erysipelas: a diffuse skin infection characterized by spreading areas of erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, minimum length of 10 cm and width of 7.5 cm), accompanied by signs and systemic inflammation symptoms as listed below. Onset of cellulitis must be within 7 days prior to randomization.
    c. Major cutaneous abscess: an infection characterized by a collection of pus within the dermis or deeper that is accompanied by erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of erythemia, oedema, and/or induration extending at least 5 cm from the peripheral margin of the abscess), accompanied by signs and systemic inflammation symptoms as listed below.
    4. ABSSSI must present with at least two of the following signs and symptoms:
    a. Purulent drainage or discharge
    b. Erythema
    c. Fluctuance
    d. Heat or localized warmth
    e. Oedema/induration
    f. Pain or tenderness to palpation

    AND At least one of the following signs of systemic inflammation*:
    a. Proximal lymph node swelling and tenderness
    b. Increased temperature (38.0°C [100.4°F]) (oral route; temperature should not be obtained by rectal, axillary or tympanic routes)
    c. Decreased temperature (<36.0°C or [<96.8°F]) (oral route; temperature should not be obtained by rectal, axillary or tympanic routes)
    d. Increased WBC (10,000/mm3)
    e. Bandemia > 10%
    f. C-reactive protein (CRP) > upper limit of normal (ULN)

    * If a patient does not have any of the noted signs of systemic inflammation, they may still be enrolled if they meet any of the following conditions:
    a. Age >70 years
    b. Diabetes mellitus requiring treatment with insulin and/or oral hypoglycaemic medications
    c. Treatment with immunosuppressive or chemotherapy in the prior 3 months
    5. Able to give informed consent and willing to comply with all required study procedures (if necessary informed consent may be obtained from the patient’s legal representative, with a witness present).
    E.4Principal exclusion criteria
    1. Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days unless:
    a. The causative Gram-positive pathogen(s) isolated from the ABSSSI site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or
    b. Documented failure to previous ABSSSI antibiotic therapy is available. Documentation of treatment failure must be recorded (eg, record in patient’s medical chart of wound size prior to initial treatment with demonstration of progression on therapy, discussion with prior treating physician, consultation of patient’s medical records, and/or consultation of available documentation of treatment (eg, prescription) before study randomization,
    c. Patient received a single dose of a short-acting antibacterial therapy (eg, surgical prophylaxis) three or more days before randomization (ie, patients cannot have received any antibiotic treatment within 72 hours of randomization).
    2. Infections associated with, or in close proximity to, a prosthetic device
    3. Severe sepsis or refractory shock
    4. Known or suspected bacteraemia at time of screening
    5. ABSSSI due to or associated with any of the following:
    a. Infections suspected or documented to be caused by Gram-negative pathogens (ie, human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis)
    b. Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
    c.Diabetic foot infections (infection extending distal to the malleoli in a patient with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or ulceration of their foot)
    d. Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
    e. Infected burns
    f. A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema or hidradenitis suppurativa
    g. Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)

    h. Any evolving necrotizing process (ie necrotizing fasciitis), gangrene or infection suspected or proven to be caused by Clostridium species (eg, crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection)
    i. Infections known to be caused by a Gram-positive organism with a vancomycin minimum inhibitory concentration (MIC) >2 mcg/mL or clinically failing prior therapy with glycopeptides
    j. Catheter site infections
    6. Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
    7. Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted)
    8. Last known cluster of differentiation 4 (CD4) count <200 cells/mm3 in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
    9. Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3
    10. Significant or life-threatening condition (eg, endocarditis) that would confound or interfere with the assessment of the ABSSSI
    11. Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control: (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are exempt from this exclusion
    12. History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: patients who have had histamine-like infusion reactions to a glycopeptide are not excluded
    13. Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
    14. Contraindication to vancomycin administration
    15. Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study drug
    16. Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
    17. Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
    18. Patients who the investigator considers unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study (eg, unlikely to survive 90 days from initiation of study drug)
    19. Liver function tests (LFTs) ≥3-times the ULN or total bilirubin ≥2-times ULN
    20. Presence or history of hyperuricemia and gouty arthritis
    21. Unwilling to refrain from chronic use of any medication with antipyretic properties
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy outcome is cessation of spread or reduction in size of baseline lesion, absence of fever, and no rescue antibiotic medication at ECE (48 to 72 hours).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Early Clinical Evaluation (ECE) at 48 to 72 hours (Hour 48 to Hour 72) from initiation of first study drug infusion
    E.5.2Secondary end point(s)
    Efficacy outcomes
    • Clinical cure determined by the investigator at the End of therapy (EOT), Day 10, and post-therapy evaluation (PTE) visits
    • Clinical cure, determined by the investigator, overall and by pathogen, at the EOT visit, Day 10, and at the (PTE) visit
    Microbiological outcomes:
    • The microbiological response, overall and by pathogen, at the EOT visit, at Day 10, and at the PTE visit
    • The microbiological relapse (or recurrence) at the PTE visit
    • The clinical response (cessation of spread or reduction in size ofbaseline lesion/absence of fever and no rescue antibiotic medication and clinical cure) and microbiological response within the CE population and
    MicroE population respectively meeting SIRS criteria at screening (defined as two of the following: temperature >38°C, pulse >90 bpm, respiratory rate >20 breaths per minute, WBC count >12,000 mm3 or <4,000 mm3 or >10% bandemia) OR with positive blood cultures
    E.5.2.1Timepoint(s) of evaluation of this end point
    - End of Therapy (EOT) at Day 7 to Day 10 or the day the patient stops study drug or changes to non–study drug therapy for primary ABSSSI
    - Day 10 Evaluation defined as 10 days from initiation of the first study drug infusion
    - Post therapy evaluation (PTE) at 7 to 14 days from EOT Safety follow up at 60 days (+ 7 days) post first administration of study drug
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Czech Republic
    France
    Germany
    India
    Israel
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit (Day 60) of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 815
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 960
    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)
    Please refer to protocol
    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 Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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