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    Summary
    EudraCT Number:2018-003139-31
    Sponsor's Protocol Code Number:38RC18.103
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-10-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003139-31
    A.3Full title of the trial
    Efficacy and safety of levocetirizine alone or in combination with tranexamic acid in the treatment of spontaneous chronic urticaria. Multicentric controlled randomized study in cross-over, double-blind.
    Efficacité et tolérance de la Lévocétirizine seule ou en association avec l’acide tranexamique dans le traitement de l’urticaire chronique spontanée. Etude multicentrique contrôlée randomisée en cross-over, en double-aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of levocetirizine alone or in combination with tranexamic acid in the treatment of spontaneous chronic urticaria.
    Efficacité et tolérance de la Lévocétirizine seule ou en association avec l’acide tranexamique dans le traitement de l’urticaire chronique spontanée.
    A.3.2Name or abbreviated title of the trial where available
    TACUS
    A.4.1Sponsor's protocol code number38RC18.103
    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 SponsorCHU GRENOBLE ALPES
    B.1.3.4CountryFrance
    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 supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Grenoble-Alpes
    B.5.2Functional name of contact pointTiphaine Montagnon
    B.5.3 Address:
    B.5.3.1Street AddressDRCI-Pavillon Dauphiné - CS 10217
    B.5.3.2Town/ cityGrenoble Cedex 9
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.4Telephone number0033476766814
    B.5.5Fax number0033476765221
    B.5.6E-mailarcpromoteur@chu-grenoble.fr
    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 EXACYL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTranexamic Acid
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtranexamic acid
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 LEVOCETIRIZINE MYLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namelevocetirizine
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevocetirizine
    D.3.9.1CAS number 130018-87-0
    D.3.9.3Other descriptive nameLEVOCETIRIZINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20474
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronique Spontaneous urticaria
    Urticaire chronique spontanée
    E.1.1.1Medical condition in easily understood language
    Chronique Spontaneous urticaria
    Urticaire chronique spontanée
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks.
    Evaluer l’efficacité et la tolérance de l’association lévocétirizine 10mg/j + acide tranexamique 2g/j versus lévocetirizine seule 20mg/j en traitement de fond de l’urticaire chronique évaluées à 4 semaines.
    E.2.2Secondary objectives of the trial










    657/5000















    1 Demonstrate non-inferiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g versus levocetirizine alone 20mg / day in terms of efficacy on Angioedema activity score (AAS).
    2. Demonstrate the superiority of the association in terms of efficacy evaluated by a combined AAS + UAS7 (Urticaria activity score ) criterion
    3.Identify the clinical features of responders to the combination rather than antihistamines alone.
    4. Estimate the prognostic value, in terms of discrimination and calibration, of D-dimer for preaching the UCS response to tranexamic acid / antihistamine association.
    5.Compare the quality of life associated with each therapy.
    1 Démontrer la non infériorité de l’association lévocétirizine 10mg/j + acide tranexamique (AT) 2g versus lévocetirizine seule 20mg/j en terme d’efficacité sur l’AAS.
    2.Démontrer la supériorité de l’association en termes d’efficacité évaluée par un critère combiné AAS + UAS7
    3.Identifier les caractéristiques cliniques des patients répondeurs à l’association plutôt qu’aux anti-histaminiques seuls.
    4.Estimer la valeur pronostique, en termes de discrimination et de calibration, des D-dimères pour la prédication de la réponse de l’UCS à l’association acide tranexamique/anti-histaminique.
    5.Comparer la qualité de vie associée à chaque thérapeutique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years old
    - having spontaneous chronic urticaria, according to the criteria of the European Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an association of symptoms urticarial eruptions and / or recurrent angioedema for at least 6 weeks.
    - having given his written consent
    - affiliated to a social security scheme or beneficiary of such a scheme
    - Patient âgé de plus de 18 ans
    - ayant une urticaire chronique spontanée, selon les critères de l’European Academy of Allergology and Clinical Immunology (EAACI) en accord avec l’European Dermatology Forum (EDF), et la World Allergy Organization (WAO), correspondant à une association des symptômes suivants: éruptions urticariennes et/ou angioedèmes récidivants depuis au moins 6 semaines.
    - ayant donné son consentement écrit
    - affilié(e) à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    E.4Principal exclusion criteria
    - Urticaria associated with a specific systemic disease including cutaneous and systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with cryopyrin
    - Bradykinetic angioedema and isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria.
    - Presence of a contraindication to tranexamic acid: history of venous thromboembolic accident (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic stroke (angina, myocardial infarction, stroke); fibrinolytic states reactive to consumption coagulopathy; severe renal failure; antecedent of convulsions.
    - Presence of a contraindication to levocetirizine: known hypersensitivity to any of the components of the product, or to piperazine derivatives; severe renal insufficiency with creatinine clearance less than 10 ml / min. History of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (presence of lactose in the tablet).
    - Subject treated or having been treated with oral corticosteroids in the month preceding the selection
    - Topic treated or treated by Montelukast in the week before the selection
    - Subject treated or having been treated with H2 blockers in the week preceding the selection
    - Subject receiving anticoagulant or antiaggregant.
    - Subject treated or having been treated with immunosuppressants (eg methotrexate, ciclosporin, azathioprine, mycophenolate mofetil ...) in the month preceding the selection
    - Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not to be included in clinical trials)
    - Subject in exclusion period of another study
    - Subject can not be contacted in case of emergency
    - Urticaires associées à une maladie de système spécifique incluant les mastocytoses cutanées et systémiques, les vascularites urticariennes, les maladies autoinflammatoires associées à la cryopyrine
    - Angioedèmes bradykiniques et angioedèmes isolés dont l’origine n’est pas clairement attribuable à une urticaire chronique spontanée.
    - Présence d’une contre-indication à l’acide tranexamique : antécédents d'accident thrombo-embolique veineux (thrombose veineuse profonde, embolie pulmonaire) ou d'accident thrombo-embolique artériel (angor, infarctus du myocarde, accident vasculaire cérébral); états fibrinolytiques réactionnels à une coagulopathie de consommation; insuffisance rénale grave ; antécédent de convulsions.
    - Présence d’une contre-indication à la lévocétirizine : hypersensibilité connue à l'un des composants du produit, ou aux dérivés de la pipérazine ; insuffisance rénale sévère avec clairance de la créatinine inférieure à 10 ml/min. Antécédent de galactosémie congénitale, de syndrome de malabsorption du glucose et du galactose ou de déficit en lactase (présence de lactose dans le comprimé).
    - Sujet traité ou ayant été traité par corticoïdes oraux dans le mois précédant la sélection
    - Sujet traité ou ayant été traité par Montelukast dans la semaine précédant la sélection
    - Sujet traité ou ayant été traité par anti-H2 dans la semaine précédant la sélection
    - Sujet recevant un anticoagulant ou un antiagrégant.
    - Sujet traité ou ayant été traité par immunosuppresseurs (ex : methotrexate, ciclosporine, azathioprine, mycophenolate mofetil…) dans le mois précédant la sélection
    - Personnes visées aux articles L1121-5 à L1121-8 du CSP (femme enceinte, parturiente, mère qui allaite, personne privée de liberté par décision judiciaire ou administrative, personne faisant l’objet d’une mesure de protection légale, ne peuvent pas être inclues dans les essais cliniques)
    - Sujet en période d’exclusion d’une autre étude
    - Sujet ne pouvant être contacté en cas d’urgence
    E.5 End points
    E.5.1Primary end point(s)
    1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis.
    2. Collection of adverse effects
    3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period



    1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis.
    2. Collection of adverse effects
    3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period



    1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be conducted per protocol and intention to treat and non-inferiority will be retained if both analyzes are convergent (Le Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test only if non-inferiority is retained in per protocol analysis.
    2. Collection of adverse effects
    3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period


    1. Evolution of the UAS7 score between the beginning (J0) and the end (J28) of the treatment period. The analysis will be convergent (Henanff, A. et al., JAMA 2006; 295: 1147-1151). Then, a hierarchical analysis on the intention-to-treat population will be carried out with a superiority test.
    2. Collection of adverse effects
    3. Evolution of the UAS7 score between the beginning (D0) and the end (D28) of the treatment period

















    1. Evolution du score UAS7 entre le début (J0) et la fin (J28) de la période de traitement. L’analyse sera menée en per protocole et intention de traiter et la non infériorité sera retenue si les deux analyses sont convergentes (Le Henanff, A. et al. JAMA 2006;295:1147-1151). Ensuite, une analyse hiérarchique sur la population en intention de traiter sera réalisée avec un test de supériorité uniquement si la non infériorité est retenue en analyse per protocole.
    2. Recueil des effets indésirables
    3. Evolution du score UAS7 entre le début (J0) et la fin (J28) de la période de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 weeks
    E.5.2Secondary end point(s)
    1.Evolution of the AAS score between the beginning (J0) and the end (J28) of the treatment period.
    2. Combined improvement criterion of at least 50% of the UAS7 clinical score and the AAS score. These are 2 activity scores validated by the latest EAACI consensus:
    - UAS7 score: score assessing pruritus and number of urticaria plaques
    - AAS score: score evaluating the activity of seizures
    3. Differences in the clinical profiles of the responders to each of the therapies.
    4. Area under the ROC curve and D-dimer calibration for the prediction of therapeutic response to tranexamic acid.
    5. Improvement of the quality of life, evaluated by the 2 scores validated during the last international consensus:
    - CU-Q2oL score: assessing the impact of urticaria attacks
    - AE-QoL score: assessing the impact of episodes of angioedema associated with chronic urticaria








    1.Evolution of the AAS score between the beginning (J0) and the end (J28) of the treatment period.
    2. Combined improvement criterion of at least 50% of the UAS7 clinical score and the AAS score. These are 2 activity scores validated by the latest EAACI consensus:
    - UAS7 score: score assessing pruritus and number of urticaria plaques
    - AAS score: score evaluating the activity of seizures
    3. Differences in the clinical profiles of the responders to each of the therapies.
    4. Area under the ROC curve and D-dimer calibration for the prediction of therapeutic response to tranexamic acid.
    5. Improvement of the quality of life, evaluated by the 2 scores validated during the last international consensus:
    - CU-Q2oL score: assessing the impact of urticaria attacks
    - AE-QoL score: assessing the impact of episodes of angioedema associated with chronic urticaria





    1.Evolution du score AAS entre le début (J0) et la fin (J28) de la période de traitement.
    2.Critère combiné d’amélioration d’au moins 50% du score clinique UAS7 et du score AAS. Il s’agit de 2 scores d’activité validés par le dernier consensus de l’EAACI :
    - score UAS7 : score évaluant le prurit et le nombre de plaques d’urticaire
    - score AAS : score évaluant l’activité des crises
    3. Différences dans les profils cliniques des patients répondeurs à chacune des thérapeutiques.
    4. Aire sous la courbe ROC et calibration des D-dimères pour la prédiction de la réponse thérapeutique à l’acide tranexamique.
    5. Amélioration de la qualité de vie, évaluée par les 2 scores validés lors du dernier consensus international :
    - score CU-Q2oL : évaluant le retentissement lié aux crises d’urticaire
    - score AE-QoL : évaluant le retentissement lié au aux épisodes d’angioedème associés à l’urticaire chronique
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 weeks
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 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
    Levocetirizine alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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 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
    The end of study is the last visit of last patient, 15 days after the end of his treatment.
    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 months
    E.8.9.1In the Member State concerned days
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 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 state80
    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
    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 Decision2018-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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