{"ctNumber":"2024-517751-13-01","ctStatus":"Ended","startDateEU":"2024-12-26","endDateEU":"2026-03-16","decisionDate":"2024-11-26T14:35:56.488","publishDate":"2026-04-23T03:40:04.415565757","ctPublicStatusCode":8,"authorizedApplication":{"authorizedPartI":{"id":63018,"rowSubjectCount":0,"products":[{"id":256661,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"11398886","productPharmForm":"ORAL SOLUTION","euMpNumber":"PRD11398886","prodAuthStatus":1,"prodName":"Cannabidiol","pharmForm":"ORAL SOLUTION","sponsorProductCode":"CBD","activeSubstanceName":"CANNABIDIOL","euSubstNumber":"SUB26600","nameOrg":"CENTRE HOSPITALIER LE VINATIER","productSubstances":[{"productPk":"11398886","substancePk":"337822","nameOrg":"CENTRE HOSPITALIER LE VINATIER","substanceOrigin":"Chemical","actSubstOrigin":"Chemical","actSubstName":"CANNABIDIOL","substanceEvCode":"SUB26600","synonyms":["CBD"]}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"mg/ml milligram(s)/millilitre","maxDailyDoseAmount":"600","doseUomTotal":"g/ml gram(s)/millilitre","maxTotalDoseAmount":"67.2","maxTreatmentPeriod":16,"timeUnitCode":"2","evCode":"PRD11398886","sponsorProductCodeEdit":"CBD","miaNumber":"MM17/168","devices":[],"characteristics":["9"],"routes":["ORAL USE"],"allSubstancesChemicals":true,"productName":"Cannabidiol","jsonActiveSubstanceNames":"cannabidiol","pharmaceuticalFormDisplay":"ORAL SOLUTION"},{"id":256662,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo Cannabidiol 50 mg/g","pharmForm":"N/A","activeSubstanceName":"N/A","euSubstNumber":"N/A","productOtherName":"N/A","authorisationCountryCode":"IS","nameOrg":"N/A","sponsorSubstanceCode":"N/A","atcCode":"N/A","atcName":"N/A","atcTermLevel":"N/A","activeSubstanceOtherDescriptiveName":"N/A"},"isPaediatricFormulation":false,"mpRoleInTrial":"3","timeUnitCode":"2","evCode":"N/A","miaNumber":"2019-004740-30","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo Cannabidiol 50 mg/g","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Cannabidiol for reducing drinking in alcohol use disorder and modifying the effects of alcohol on the brain and the liver: a phase 2 clinical trial.- The CARAMEL Study","fullTitleTranslations":[{"id":4437611,"uuid":"8489326f-3ce7-4414-b6e9-7573c5a7b0d4","attributeTranslation":"Le cannabidiol dans la réduction de la consommation d'alcool chez les patients souffrant de troubles liés à l’usage d'alcool et dans la modification des effets de l'alcool sur le cerveau et le foie : un essai clinique de phase 2. (CARAMEL)","language":10,"languageDescription":"French"}],"publicTitle":"Cannabidiol for reducing drinking in alcohol use disorder and modifying the\neffects of alcohol on the brain and the liver","publicTitleTranslations":[{"id":4437619,"uuid":"0041b819-8aec-496c-9723-a3ef10d10dee","attributeTranslation":"Le cannabidiol dans la réduction de la consommation d'alcool chez les patients souffrant de troubles liés à l’usage d'alcool et dans la modification des effets de l'alcool sur le cerveau et le foie","language":10,"languageDescription":"French"}],"shortTitle":"PHRCN2018","secondaryIdentifyingNumbers":{"nctNumber":{"id":294917,"number":"NCT05159830"},"additionalRegistries":[{"id":294918,"number":"NCT05159830","otherRegistryName":"ClinicalTrials.gov Protocol Registration","ctRegistryCode":"6"}]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"4","trialCategory":"2","justificationForTrialCategory":"It is a phase II clinical trial","trialCategoryId":54929},"medicalCondition":{"partIMedicalConditions":[{"id":63186,"medicalCondition":"Psychiatric disorders","medicalConditionTranslations":[{"id":4437579,"uuid":"1f9e8c9b-60e2-4185-a26c-f18a527b314a","attributeTranslation":"Troubles psychiatriques","language":34,"languageDescription":"French (France)"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000036856,"version":"21.1","level":"LLT","termName":"Alcohol addiction","classificationCode":"10001590","organClass":10037175,"active":false}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":182024},{"code":"4","trialScopeId":182023},{"code":"3","trialScopeId":182025}],"mainObjective":"The primary objective of the CARAMEL study is to compare the reduction\nin alcohol drinking between CBD and placebo (PCB), in a population of\npatients with AUD and heavy drinking level at baseline (i.e., 12 standard\ndrinks (sd)/day or more).\nThe drinking reduction level will be defined by the total consumption in\nthe 28 days prior to inclusion, minus the total consumption of the 28 last\ndays of the study (weeks 8 to 12).","mainObjectiveTranslations":[{"id":4437618,"uuid":"a99ad3ed-651f-4487-868c-8729affb76b5","attributeTranslation":"L’objectif principal de l’étude CARAMEL est de comparer la réduction de la consommation d’alcool entre le CBD et un placebo (PCB) dans une population de patients souffrant d’un TUA et consommant à l’inclusion à minima 12 verres standards/jour.\nLe niveau de réduction de consommation sera défini par le différentiel entre la consommation totale au cours des 28 jours précédents l'inclusion et la consommation totale des 28 derniers jours de l'étude (semaines 8 à 12).","language":10,"languageDescription":"French"}],"secondaryObjectives":[{"id":204965,"number":1,"secondaryObjective":"Between-group comparison of other important drinking outcomes, i.e., total percentage of heavy drinking days, total percentage of days with no drinking, difference in craving scores between inclusion (V0) and end of treatment visit (V4).","secondaryObjectiveTranslations":[{"id":4437620,"uuid":"bf2b34b6-f43e-4fb5-a858-ed634a20b730","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : critères importants en matière de consommation d’alcool comme : le pourcentage total de jours de forte consommation, le pourcentage total de jours sans consommation d’alcool et la différence des scores de craving.","language":10,"languageDescription":"French"}]},{"id":204966,"number":2,"secondaryObjective":"Between-group comparison of the difference between inclusion (V0) and end of treatment visit (V4) observed in other clinical parameters (i.e., anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) score).","secondaryObjectiveTranslations":[{"id":4437621,"uuid":"8668d5df-cbd0-479c-a79d-e787c978fd09","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : paramètres cliniques comme par exemple l'anxiété et la dépression à l'aide du score de l’échelle HADS.","language":10,"languageDescription":"French"}]},{"id":204967,"number":3,"secondaryObjective":"Between-group comparison in the reduction of the Controlled Attenuation Parameter (CAP) which measures liver steatosis using transient ultra-sound elastography, between V0 and V4.","secondaryObjectiveTranslations":[{"id":4437622,"uuid":"2bf4825c-5f67-4f8a-8206-8503676f1149","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : réduction du paramètre d’atténuation contrôlée (CAP), qui mesure la stéatose hépatique par élastographie impulsionnelle à vibration contrôlée.","language":10,"languageDescription":"French"}]},{"id":204968,"number":4,"secondaryObjective":"Between-group comparison of alcohol-induced biological liver parameters (GGT, CDT, SGOT, SGPT, bilirubin) at V4.","secondaryObjectiveTranslations":[{"id":4437623,"uuid":"1cc79f57-8a06-4e4e-9309-e83536f6cdc0","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : paramètres biologiques hépatiques : GGT, CDT, ALAT, ASAT, bilirubine.","language":10,"languageDescription":"French"}]},{"id":204969,"number":5,"secondaryObjective":"Between-group comparison of alcohol-induced biological parameters (PEth) at V4.","secondaryObjectiveTranslations":[{"id":4437624,"uuid":"7427a7bc-e16c-4bdc-a40b-d17f49336682","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : Marqueur biologique de consommation d’alcool : PEth.","language":10,"languageDescription":"French"}]},{"id":204970,"number":6,"secondaryObjective":"Between-group comparison of the reduction in steatosis scores between V0 and V4, using Proton Density Fat Fraction (PDFF) estimated on the structural liver based on Chemical Shift Encoding-MRI (CSE-MRI) and MR Spectroscopy (MRS).","secondaryObjectiveTranslations":[{"id":4437625,"uuid":"938659d9-96a8-49b4-9bf7-c57fbdd00bbe","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : réduction des scores de stéatose à l'aide de la fraction de graisse en densité de proton (PDFF) estimée sur le foie structural via l'IRM codant l'effet chimique (CSE-MRI) et en spectroscopie à résonnance magnétique (MRS).","language":10,"languageDescription":"French"}]},{"id":204971,"number":7,"secondaryObjective":"Between-group comparison of recovery of grey matter integrity in corticostriatal-limbic circuits, between V0 and V4, using MRI Voxel Based Morphometry (VBM) and cortical thickness measures.","secondaryObjectiveTranslations":[{"id":4437626,"uuid":"31892922-a40e-42d1-adb5-d0c9f651aa7c","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : volume de matière grise dans les circuits corticostriataux-limbiques mesuré par voxel-based morphometry (VBM), ainsi que mesure de l'épaisseur corticale.","language":10,"languageDescription":"French"}]},{"id":204972,"number":8,"secondaryObjective":"Between-group comparison of the improvement in neuropsychological measures between V0 and V4.","secondaryObjectiveTranslations":[{"id":4437627,"uuid":"9d3618d3-aa7c-4443-bbae-735e0cf5aa69","attributeTranslation":"Comparaison des groupes entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : amélioration des mesures neuropsychologiques.","language":10,"languageDescription":"French"}]},{"id":204973,"number":9,"secondaryObjective":"Between-group comparison of the drinking level difference between last visit (V5) and end of treatment visit (V4).","secondaryObjectiveTranslations":[{"id":4437628,"uuid":"82fa9ad9-b3c6-4008-999d-4a0451d126ee","attributeTranslation":"Comparer la consommation d’alcool entre la dernière visite (V5) et V4.","language":10,"languageDescription":"French"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":397607,"number":1,"principalInclusionCriteria":"Being aged 18 years, or more","principalInclusionCriteriaTranslations":[{"id":4437612,"uuid":"027e87ab-786c-475a-9d99-a1042de2aa9c","attributeTranslation":"Etre majeur","language":34,"languageDescription":"French (France)"}]},{"id":397608,"number":2,"principalInclusionCriteria":"Comprendre le français","principalInclusionCriteriaTranslations":[{"id":4437613,"uuid":"c36bc1d6-85b2-4c1c-8a29-751bd172c7c6","attributeTranslation":"Being fluent in French","language":34,"languageDescription":"French (France)"}]},{"id":397609,"number":3,"principalInclusionCriteria":"Having read the information procedure and signed the informed consent sheet","principalInclusionCriteriaTranslations":[{"id":4437614,"uuid":"99d2a5d1-0b12-47b9-9606-ff2ad1794912","attributeTranslation":"Avoir lu la notice d’information et signé le consentement","language":34,"languageDescription":"French (France)"}]},{"id":397610,"number":4,"principalInclusionCriteria":"Being affiliated with health insurance","principalInclusionCriteriaTranslations":[{"id":4437615,"uuid":"bc1e5495-250d-4482-b34e-ef0aed48d33e","attributeTranslation":"Etre affilié à une assurance maladie","language":34,"languageDescription":"French (France)"}]},{"id":397611,"number":5,"principalInclusionCriteria":"DSM-5 criteria for AUD (all stages) (American Psychiatric Association, 2013)","principalInclusionCriteriaTranslations":[{"id":4437616,"uuid":"a5bf38c2-4453-495f-bfdc-21cd4e9240ec","attributeTranslation":"Avoir un TUA selon le DSM-5","language":34,"languageDescription":"French (France)"}]},{"id":397612,"number":6,"principalInclusionCriteria":"Average drinking level of at least 12 standard-drinks (120g of ethanol) per day over the month prior to inclusion (i.e., a total alcohol consumption of 336 standard-drinks during the 28-day assessment period prior to inclusion), using the A-TLFB","principalInclusionCriteriaTranslations":[{"id":4437617,"uuid":"d629000c-e8cb-4a23-b170-36a717dc0a59","attributeTranslation":"Niveau de consommation moyen d’au moins 12 verres standards (120 g d’éthanol) par jour sur le mois précédent l’inclusion (soit 336 verres standards sur les 28 jours précédant l’inclusion) en utilisant l’A-TLFB","language":34,"languageDescription":"French (France)"}]}],"principalExclusionCriteria":[{"id":685735,"number":1,"principalExclusionCriteria":"At least one day of abstinence (no alcohol drinking) during the month  prior to inclusion","principalExclusionCriteriaTranslations":[{"id":4437595,"uuid":"284a7eaa-4592-4518-b716-e7b22ee5e48f","attributeTranslation":"Avoir au moins un jour d’abstinence (sans alcool) dans les 28 jours précédents l’inclusion","language":34,"languageDescription":"French (France)"}]},{"id":685736,"number":10,"principalExclusionCriteria":"Pregnancy, lactation, or insufficient contraceptive measure (precautionary measure) (See 5.2 for acceptable birth control methods)","principalExclusionCriteriaTranslations":[{"id":4437596,"uuid":"8b196b17-fe3e-46d6-96d6-3018b991d8d7","attributeTranslation":"Grossesse ou allaitement, absence de contraception efficace pour les femmes en âge de procréer","language":34,"languageDescription":"French (France)"}]},{"id":685737,"number":11,"principalExclusionCriteria":"Patients with cancer, HIV, pulmonary arterial hypertension, epilepsy and with rifampicin, St. John’s wort, everolimus, tacrolimus or triazole antifungal agents like posaconazole, fluconazole.","principalExclusionCriteriaTranslations":[{"id":4437597,"uuid":"379446ef-9ffe-4280-b5bf-f89d0cfde897","attributeTranslation":"Patients atteints de cancer, de VIH, d’hypertension artérielle pulmonaire, d’épilepsie et prenant de la rifampicine, du millepertuis, de l’évérolimus, du tacrolimus ou des antifongiques triazoliques comme le posaconazole ou le fluconazole","language":34,"languageDescription":"French (France)"}]},{"id":685738,"number":12,"principalExclusionCriteria":"History of vascular accident and/or cardiac arrhythmias and/or myocardial infarction","principalExclusionCriteriaTranslations":[{"id":4437598,"uuid":"1ce1d006-ad5c-436d-8ecc-8a9f3058e4a9","attributeTranslation":"Antécédents d'accident vasculaire cérébral et/ou d'arythmies cardiaques et/ou d'infarctus du myocarde","language":34,"languageDescription":"French (France)"}]},{"id":685739,"number":13,"principalExclusionCriteria":"Patients receiving acamprosate, naltrexone, disulfiram, nalmefene, topiramate, baclofen for AUD within 30 days prior to screening.","principalExclusionCriteriaTranslations":[{"id":4437599,"uuid":"bae03df6-12ca-451d-a714-35ef63e0cdcb","attributeTranslation":"Patients recevant de l’acamprosate, de la naltrexone, du disulfirame, du nalméfène, du topiramate ou du baclofène pour trouble de consommation d’alcool dans les 30 jours précédant le dépistage","language":34,"languageDescription":"French (France)"}]},{"id":685740,"number":14,"principalExclusionCriteria":"MRI contraindication: pacemaker, insulin pump, heart metal valve, cochlear implant…","principalExclusionCriteriaTranslations":[{"id":4437600,"uuid":"80a14c47-1a39-45cd-8c55-b76001abbcd9","attributeTranslation":"Patients contre-indiqués aux IRM : pacemaker, pompe à insuline, valve cardiaque métallique, implant cochléaire…","language":34,"languageDescription":"French (France)"}]},{"id":685741,"number":15,"principalExclusionCriteria":"Known hypersensitivity to the active principle (cannabidiol) or excipients","principalExclusionCriteriaTranslations":[{"id":4437601,"uuid":"7ebf876a-1bca-4256-9994-8f09f9349111","attributeTranslation":"Hypersensibilité à la substance active (cannabidiol) ou aux excipients (sucralose, menthol, mannitol)","language":34,"languageDescription":"French (France)"}]},{"id":685742,"number":16,"principalExclusionCriteria":"Person under tutorship or curatorship","principalExclusionCriteriaTranslations":[{"id":4437602,"uuid":"593bdd5c-73b0-46a6-ba2a-5adcb2045597","attributeTranslation":"Personne sous tutelle ou curatelle","language":34,"languageDescription":"French (France)"}]},{"id":685743,"number":2,"principalExclusionCriteria":"Criteria for liver cirrhosis (Child-Pugh B or C)","principalExclusionCriteriaTranslations":[{"id":4437603,"uuid":"4d980bbf-edd7-4c48-a5d6-8514ef20313b","attributeTranslation":"Avoir des critères de cirrhose hépatique (Child-Pugh B ou C)","language":34,"languageDescription":"French (France)"}]},{"id":685744,"number":3,"principalExclusionCriteria":"DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder, using the MINI 7.0.2","principalExclusionCriteriaTranslations":[{"id":4437604,"uuid":"47f75c18-9161-41f5-b18e-99f48ecff59e","attributeTranslation":"Avoir des critères du DSM-5 de schizophrénie, trouble schizoaffectif, bipolarité identifié à l’aide du MINI 7.0.2","language":34,"languageDescription":"French (France)"}]},{"id":685745,"number":4,"principalExclusionCriteria":"Current suicidality, using the MNI 7.0.2","principalExclusionCriteriaTranslations":[{"id":4437605,"uuid":"265e1f07-c71a-4004-a130-f34922206a45","attributeTranslation":"Avoir des idées suicidaires","language":34,"languageDescription":"French (France)"}]},{"id":685746,"number":5,"principalExclusionCriteria":"Lifelong history of suicide attempts","principalExclusionCriteriaTranslations":[{"id":4437606,"uuid":"058aac5a-2a43-488a-9ff9-eee877fb25ba","attributeTranslation":"Antécédents de tentatives de suicide","language":34,"languageDescription":"French (France)"}]},{"id":685747,"number":6,"principalExclusionCriteria":"Lifelong history or current DSM-5 criteria for substance use disorder (other than alcohol or nicotine) using the MINI 7.0.2","principalExclusionCriteriaTranslations":[{"id":4437607,"uuid":"eb5d5e45-dddc-4ad6-ab04-7bfe0670996e","attributeTranslation":"Avoir un trouble d’usage de substance autre qu’alcool ou nicotine identifié à l’aide du MINI 7.0.2","language":34,"languageDescription":"French (France)"}]},{"id":685748,"number":7,"principalExclusionCriteria":"Any detected use of cannabis or any other cannabinoid within 60 days prior to screen","principalExclusionCriteriaTranslations":[{"id":4437608,"uuid":"1cc97a7e-3f65-4af3-92b6-f0ee99b5412b","attributeTranslation":"Toute utilisation rapportée ou détectée de cannabis ou de tout autre cannabinoïde dans les 60 jours précédents l’inclusion","language":34,"languageDescription":"French (France)"}]},{"id":685749,"number":8,"principalExclusionCriteria":"Patients with transaminase elevations greater than 3 times upper the limit of normal and bilirubin greater than 2 times upper the limit of normal","principalExclusionCriteriaTranslations":[{"id":4437609,"uuid":"1a301e4e-2422-46a9-b4f0-69540d3c29e3","attributeTranslation":"Les patients présentant des élévations de transaminases supérieures à 3 fois supérieures à la limite de la normale et la bilirubine supérieures à 2 fois supérieures à la limite de la normale","language":34,"languageDescription":"French (France)"}]},{"id":685750,"number":9,"principalExclusionCriteria":"Impaired medical condition (investigator's decision)","principalExclusionCriteriaTranslations":[{"id":4437610,"uuid":"680e59e8-c021-4f51-a2ee-688cedfd452f","attributeTranslation":"Etat de santé altéré (décision médicale de l’investigateur)","language":34,"languageDescription":"French (France)"}]}]},"endPoint":{"primaryEndPoints":[{"id":461001,"number":1,"endPoint":"The primary endpoint will be the total consumption of alcohol (in standard-drinks, sd) in the 28 last days (week 8 to week 12) of the study, using the A-TLFB daily self-report of alcohol drinking. The difference between the total alcohol consumption during 28 days preceding the study, and the 28 last days of the study, will be compared between the two groups.","isPrimary":true,"endPointTranslations":[{"id":4437580,"uuid":"4eb1f8d9-8a80-4ce0-8dfb-0d296a49eca2","attributeTranslation":"Le critère d'évaluation principal sera, entre les groupes, la différence de consommation totale d'alcool (exprimé en verre standard) au cours des 28 derniers jours (de la semaine 8 à la semaine 12) de l'étude moins celle des 28 jours précédant l’étude, en utilisant l'auto déclaration quotidienne de consommation d'alcool via l'A-TLFB.","language":10,"languageDescription":"French"}]}],"secondaryEndPoints":[{"id":461002,"number":1,"endPoint":"Percentages of heavy drinking days (i.e., 6 standard-drinks or more) during the study period.","isPrimary":false,"endPointTranslations":[{"id":4437581,"uuid":"8b778734-cbe5-4f26-96be-3cfd413f3d21","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : pourcentages de jours de forte consommation d'alcool (≥ 6 verres standards).","language":10,"languageDescription":"French"}]},{"id":461003,"number":2,"endPoint":"Difference (i.e., inclusion minus end of study) in alcohol craving scores using the OCDS.","isPrimary":false,"endPointTranslations":[{"id":4437582,"uuid":"a755e508-40fa-480d-bb9d-238fc3ede75e","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants : scores de craving en utilisant l’échelle OCDS.","language":10,"languageDescription":"French"}]},{"id":461004,"number":3,"endPoint":"Difference (i.e., inclusion minus end of study) in alcohol use disorder scores using the AUDIT-C.","isPrimary":false,"endPointTranslations":[{"id":4437583,"uuid":"e9e99c9c-a578-4a06-aee3-8a0438995247","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants: scores de consommation d’alcool en utilisant l’échelle AUDIT-C","language":10,"languageDescription":"French"}]},{"id":461005,"number":4,"endPoint":"Difference (i.e., inclusion minus end of study) in GGT levels.","isPrimary":false,"endPointTranslations":[{"id":4437584,"uuid":"3bfcb24e-221a-43db-b67c-a59c3ae786e8","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants: taux sanguins de GGT.","language":10,"languageDescription":"French"}]},{"id":461006,"number":5,"endPoint":"Difference (i.e., inclusion minus end of study) in CDT levels.","isPrimary":false,"endPointTranslations":[{"id":4437585,"uuid":"73c92a4c-1f4b-405e-80d4-3fa225de2e32","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants: taux sanguins de CDT.","language":10,"languageDescription":"French"}]},{"id":461007,"number":6,"endPoint":"Difference (i.e., inclusion minus end of study) in PEth levels.","isPrimary":false,"endPointTranslations":[{"id":4437586,"uuid":"b70a52c7-3b6c-48b7-9690-45ddbf1f3c89","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants: taux sanguins de PEth.","language":10,"languageDescription":"French"}]},{"id":461008,"number":7,"endPoint":"Difference (i.e., inclusion minus end of study) in anxiety and depression (HADS) scores.","isPrimary":false,"endPointTranslations":[{"id":4437587,"uuid":"f2319b91-093e-4fdf-bf1c-7e2ea4cad7c3","attributeTranslation":"Différence entre les visites d’inclusion (V0) et de fin de traitement (V4) des éléments suivants: scores d’anxiété et de dépression en utilisant l’échelle HADS.","language":10,"languageDescription":"French"}]},{"id":461009,"number":8,"endPoint":"Difference (i.e., inclusion minus end of study) in self-confidence to resist, quality of life (SF12v2), stigmatization, sleep quality (PSQI) 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