{"ctNumber":"2025-522310-24-00","ctStatus":"Authorised","startDateEU":"2026-09-18","decisionDate":"2026-08-19T13:16:43.48","publishDate":"2026-09-29T03:40:47.426914456","ctPublicStatusCode":3,"authorizedApplication":{"authorizedPartI":{"id":130155,"rowSubjectCount":776,"rowCountriesInfo":[{"eutctId":100000000557,"name":"United States","isoNumber":840,"isoAlpha2Code":"US","isoAlpha3Code":"USA","current":true},{"eutctId":100000000538,"name":"Taiwan","isoNumber":158,"isoAlpha2Code":"TW","isoAlpha3Code":"TWN","current":true},{"eutctId":100000000465,"name":"Mexico","isoNumber":484,"isoAlpha2Code":"MX","isoAlpha3Code":"MEX","current":true},{"eutctId":100000000556,"name":"United Kingdom","isoNumber":826,"isoAlpha2Code":"GB","isoAlpha3Code":"GBR","current":true},{"eutctId":100000000329,"name":"Australia","isoNumber":36,"isoAlpha2Code":"AU","isoAlpha3Code":"AUS","current":true},{"eutctId":100000000354,"name":"Canada","isoNumber":124,"isoAlpha2Code":"CA","isoAlpha3Code":"CAN","current":true},{"eutctId":100000000346,"name":"Brazil","isoNumber":76,"isoAlpha2Code":"BR","isoAlpha3Code":"BRA","current":true},{"eutctId":100000000362,"name":"China","isoNumber":156,"isoAlpha2Code":"CN","isoAlpha3Code":"CHN","current":true},{"eutctId":100000000432,"name":"Japan","isoNumber":392,"isoAlpha2Code":"JP","isoAlpha3Code":"JPN","current":true},{"eutctId":100000000439,"name":"Korea, Republic of","isoNumber":410,"isoAlpha2Code":"KR","isoAlpha3Code":"KOR","current":true}],"products":[{"id":540586,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713220","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713220","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713220","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713220","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21392,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":540587,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo to match LY","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","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo to match LY","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"},{"id":540584,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713221","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713221","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713221","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713221","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21390,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":540585,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713219","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713219","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713219","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713219","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21391,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)","fullTitleTranslations":[{"id":10860959,"uuid":"23df7aab-3906-4cf3-a2de-4ad5d84e32f4","attributeTranslation":"Estudio de fase III, multicéntrico, aleatorizado, doble ciego y de grupos paralelos para investigar la eficacia y la seguridad del tratamiento complementario con brenipatida para retrasar el tiempo transcurrido hasta la recidiva en comparación con el placebo en participantes adultos con trastorno depresivo mayor (RENEW-MDD-2)","language":7,"languageDescription":"Spanish"},{"id":10860957,"uuid":"23df7aab-3906-4cf3-a2de-4ad5d84e32f4","attributeTranslation":"Μια Πολυκεντρική, Τυχαιοποιημένη, Διπλά Τυφλή, Παράλληλων Σκελών Δοκιμή Φάσης 3 για τη Διερεύνηση της Αποτελεσματικότητας και της Ασφάλειας της Συμπληρωματικής Θεραπείας με Brenipatide στην Καθυστέρηση του Χρόνου έως την Υποτροπή σε Σύγκριση με το Εικονικό Φάρμακο σε Ενήλικους Συμμετέχοντες με Μείζονα Καταθλιπτική Διαταραχή (RENEW-MDD-2)","language":32,"languageDescription":"Greek (Greece)"},{"id":10860958,"uuid":"23df7aab-3906-4cf3-a2de-4ad5d84e32f4","attributeTranslation":"Randomizowane, wieloośrodkowe badanie III fazy, prowadzone metodą podwójnie ślepej próby w grupach równoległych, mające na celu ocenę skuteczności i bezpieczeństwa stosowania leczenia wspomagającego preparatem Brenipatide w porównaniu z placebo w celu opóźnienia nawrotu objawów u dorosłych pacjentów z zaburzeniami depresyjnymi (RENEW-MDD-2)","language":19,"languageDescription":"Polish"}],"publicTitle":"A Study of Brenipatide (LY3537031) in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)","publicTitleTranslations":[{"id":10860969,"uuid":"c3c86da2-2591-4b86-9e55-86ff65375f8e","attributeTranslation":"Μια Δοκιμή του Brenipatide (LY3537031) σε Ενήλικους Συμμετέχοντες με Μείζονα Καταθλιπτική Διαταραχή (RENEW-MDD-2)","language":32,"languageDescription":"Greek (Greece)"},{"id":10860970,"uuid":"c3c86da2-2591-4b86-9e55-86ff65375f8e","attributeTranslation":"Badanie preparatu Brenipatide (LY3537031) u dorosłych pacjentów z zaburzeniami depresyjnymi (RENEW-MDD-2)","language":19,"languageDescription":"Polish"},{"id":10860971,"uuid":"c3c86da2-2591-4b86-9e55-86ff65375f8e","attributeTranslation":"Estudio para evaluar la brenipatida (LY3537031) en participantes adultos con trastorno depresivo mayor (RENEW-MDD-2)","language":7,"languageDescription":"Spanish"}],"shortTitle":"J2S-MC-GZMI","secondaryIdentifyingNumbers":{"whoUniversalTrialNumber":{"id":530517,"number":"U1111-1337-0079"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"In line with the EMA Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database to be audited- EMA/42176/2014”, the trial meets the definition of category 2 trial since it is a Phase III trial assessing a non-authorised investigational medicinal product  to investigate safety and efficacy.","trialCategoryId":119769},"medicalCondition":{"partIMedicalConditions":[{"id":135782,"medicalCondition":"Depressive Disorder, Major","medicalConditionTranslations":[{"id":10860937,"uuid":"7713177e-d1dc-45ed-bf40-2177a60c2a29","attributeTranslation":"Zaburzenia depresyjne","language":19,"languageDescription":"Polish"},{"id":10860938,"uuid":"7713177e-d1dc-45ed-bf40-2177a60c2a29","attributeTranslation":"Trastorno depresivo mayor","language":7,"languageDescription":"Spanish"},{"id":10860936,"uuid":"7713177e-d1dc-45ed-bf40-2177a60c2a29","attributeTranslation":"Καταθλιπτική Διαταραχή, Μείζονα","language":32,"languageDescription":"Greek (Greece)"}],"isConditionRareDisease":false}]},"trialObjective":{"trialScopes":[{"code":"4","trialScopeId":394804},{"code":"6","trialScopeId":394802},{"code":"5","trialScopeId":394803}],"mainObjective":"To demonstrate that at least 1 dose level of brenipatide, given as an adjunctive treatment to a stable SoC medication regimen, is superior to placebo in the treatment of participants with MDD.","mainObjectiveTranslations":[{"id":10860967,"uuid":"e1b1ddff-6571-4fb9-99b7-02bbac1a2994","attributeTranslation":"Wykazanie, że co najmniej jeden poziom dawki preparatu Brenipatide podawanego jako leczenie wspomagające do stabilnego schematu leków w ramach standardowej opieki (ang. standard of care, SoC) jest skuteczniejszy niż placebo w leczeniu uczestników z MDD.","language":19,"languageDescription":"Polish"},{"id":10860968,"uuid":"e1b1ddff-6571-4fb9-99b7-02bbac1a2994","attributeTranslation":"Demostrar que al menos 1 dosis de brenipatida, administrada como tratamiento complementario a una pauta posológica estable de la medicación del TR, es superior al placebo en el tratamiento de participantes con TDM.","language":7,"languageDescription":"Spanish"},{"id":10860966,"uuid":"e1b1ddff-6571-4fb9-99b7-02bbac1a2994","attributeTranslation":"Να καταδειχθεί ότι τουλάχιστον 1 δοσολογικό επίπεδο brenipatide επιπλέον ενός σταθερού θεραπευτικού σχήματος SoC είναι ανώτερο από το εικονικό φάρμακο στη θεραπεία συμμετεχόντων με ΜΚΔ.","language":32,"languageDescription":"Greek (Greece)"}],"secondaryObjectives":[]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":881133,"number":1,"principalInclusionCriteria":"Are on stable standard of care medication for major depressive disorder","principalInclusionCriteriaTranslations":[{"id":10860960,"uuid":"c34c6e91-06be-4ef9-8c0b-8a071d5efe07","attributeTranslation":"Λαμβάνουν σταθερό φαρμακευτικό σχήμα SoC για τη μείζονα καταθλιπτική διαταραχή","language":32,"languageDescription":"Greek (Greece)"},{"id":10860962,"uuid":"c34c6e91-06be-4ef9-8c0b-8a071d5efe07","attributeTranslation":"Cumplir los criterios diagnósticos de trastorno depresivo mayor.","language":7,"languageDescription":"Spanish"},{"id":10860961,"uuid":"c34c6e91-06be-4ef9-8c0b-8a071d5efe07","attributeTranslation":"przyjmowanie stabilnych dawek leków stosowanych w leczeniu zaburzeń depresyjnych w ramach standardowej opieki","language":19,"languageDescription":"Polish"}]},{"id":881134,"number":2,"principalInclusionCriteria":"Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as   •  self-inject study intervention   •  store and use the provided blinded study intervention, as directed   •  maintain electronic and paper study diaries, as applicable, and   •  complete the required questionnaires","principalInclusionCriteriaTranslations":[{"id":10860963,"uuid":"b6187de7-a29c-42aa-ba2b-86a4c4700aea","attributeTranslation":"Είναι αξιόπιστοι και πρόθυμοι να είναι διαθέσιμοι για όλη τη διάρκεια της δοκιμής και να προσέρχονται στις απαιτούμενες επισκέψεις της δοκιμής, καθώς και είναι πρόθυμοι και ικανοί να ακολουθούν τις διαδικασίες της δοκιμής όπως απαιτείται, όπως π.χ. \n •  αυτοχορήγηση με ένεση της παρέμβασης της δοκιμής\n•  να αποθηκεύουν και να χρησιμοποιούν την παρεχόμενη τυφλοποιημένη παρέμβαση της δοκιμής, σύμφωνα με τις οδηγίες \n •  να τηρούν ηλεκτρονικά και έντυπα ημερολόγια της δοκιμής, όπου εφαρμόζεται, και\n•  να συμπληρώνουν τα απαιτούμενα ερωτηματολόγια","language":32,"languageDescription":"Greek (Greece)"},{"id":10860965,"uuid":"b6187de7-a29c-42aa-ba2b-86a4c4700aea","attributeTranslation":"• Recibir medicación del tratamiento de referencia para el trastorno depresivo mayor de manera estable. \n• Ser responsables y estar dispuestos a tener disponibilidad durante todo el estudio y a asistir a las visitas obligatorias, así como estar dispuestos y ser capaces de seguir los procedimientos del estudio según sea necesario, como los siguientes: \n     • Autoinyectarse la intervención del estudio.\n     • Almacenar y utilizar la intervención del estudio enmascarada que se ha proporcionado, según las indicaciones.\n     • Mantener actualizados los diarios electrónicos y en papel del estudio, según corresponda.\n     • Cumplimentar los cuestionarios obligatorios.","language":7,"languageDescription":"Spanish"},{"id":10860964,"uuid":"b6187de7-a29c-42aa-ba2b-86a4c4700aea","attributeTranslation":"wiarygodność i gotowość do pozostania do dyspozycji przez cały czas trwania badania, stawiania się na wymaganych wizytach w ramach badania oraz gotowość i zdolność do przestrzegania procedur w ramach badania takich jak: \n     • samodzielne wstrzykiwanie produktu stosowanego w badaniu;\n     • przechowywanie i wykorzystywanie zaślepionego produktu stosowanego w badaniu zgodnie z zaleceniami;\n     • prowadzenie elektronicznych i papierowych dzienniczków badania, w zależności od sytuacji, oraz\n     • wypełnianie wymaganych kwestionariuszy.","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":1506673,"number":1,"principalExclusionCriteria":"Have a lifetime history or current diagnosis of the following:   •  schizophrenia spectrum or other psychotic disorder   •  bipolar disorder   •  borderline personality disorder, or   •  any eating disorder","principalExclusionCriteriaTranslations":[{"id":10860944,"uuid":"8d1f4a5d-1459-425f-8af5-4243431d82f3","attributeTranslation":"•\tTener antecedentes a lo largo de la vida o un diagnóstico actual de lo siguiente: \n               • Espectro de la esquizofrenia u otro trastorno psicótico. \n               • Trastorno bipolar. \n               • Trastorno limítrofe de la personalidad. \n               • Cualquier trastorno de la conducta alimentaria.","language":7,"languageDescription":"Spanish"},{"id":10860943,"uuid":"8d1f4a5d-1459-425f-8af5-4243431d82f3","attributeTranslation":"•\tStwierdzone w wywiadzie lub aktualne rozpoznanie następujących schorzeń: \n               • spektrum schizofrenii lub innych zaburzeń psychotycznych; \n               • choroby afektywnej dwubiegunowej; \n               • osobowości chwiejnej emocjonalnie podtypu granicznego (borderline) lub \n               • jakiegokolwiek zaburzenia jedzenia.","language":19,"languageDescription":"Polish"},{"id":10860942,"uuid":"8d1f4a5d-1459-425f-8af5-4243431d82f3","attributeTranslation":"Έχουν ισόβιο ιστορικό ή τρέχουσα διάγνωση των ακόλουθων:\n● \tδιαταραχή του φάσματος της σχιζοφρένειας ή άλλη ψυχωτική διαταραχή\n● \tδιπολική διαταραχή\n● \tοριακή διαταραχή προσωπικότητας, ή \n●      οποιαδήποτε διατροφική διαταραχή","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1506674,"number":2,"principalExclusionCriteria":"Have type 1 diabetes mellitus, or a history of: • ketoacidosis, or • hyperosmolar state or coma.","principalExclusionCriteriaTranslations":[{"id":10860946,"uuid":"56f36eec-e8dd-432e-b02f-c593b96fd487","attributeTranslation":"•\tCukrzyca typu 1 lub stwierdzone w wywiadzie: \n              • kwasica ketonowa lub \n              • stan hiperosmolarny lub śpiączka.","language":19,"languageDescription":"Polish"},{"id":10860945,"uuid":"56f36eec-e8dd-432e-b02f-c593b96fd487","attributeTranslation":"Έχουν σακχαρώδη διαβήτη τύπου 1 ή ιστορικό:\n●\tκετοξέωσης, ή\n●\tυπερωσμωτικής κατάστασης ή κώματος","language":32,"languageDescription":"Greek (Greece)"},{"id":10860947,"uuid":"56f36eec-e8dd-432e-b02f-c593b96fd487","attributeTranslation":"•\tTener diabetes de tipo 1 o antecedentes de lo siguiente: \n              • Cetoacidosis. \n              • Estado hiperosmolar o coma.","language":7,"languageDescription":"Spanish"}]},{"id":1506675,"number":3,"principalExclusionCriteria":"Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening","principalExclusionCriteriaTranslations":[{"id":10860948,"uuid":"bc400e58-2b70-477b-8ea8-9ade251f1f43","attributeTranslation":"Έχουν ένδειξη μέτριας ή σοβαρής διαταραχής χρήσης ουσιών ή αλκοόλ εντός 180 ημερών πριν από την αρχική εκτίμηση","language":32,"languageDescription":"Greek (Greece)"},{"id":10860949,"uuid":"bc400e58-2b70-477b-8ea8-9ade251f1f43","attributeTranslation":"•\tPotwierdzone umiarkowane albo ciężkie zaburzenia związane z używaniem substancji psychoaktywnych albo alkoholu w ciągu 180 dni poprzedzających badania przesiewowe.","language":19,"languageDescription":"Polish"},{"id":10860950,"uuid":"bc400e58-2b70-477b-8ea8-9ade251f1f43","attributeTranslation":"Indicios de trastorno moderado o grave por consumo de sustancias o alcohol en los 180 días anteriores a la selección.","language":7,"languageDescription":"Spanish"}]},{"id":1506676,"number":4,"principalExclusionCriteria":"Are actively suicidal or deemed a significant risk for suicide","principalExclusionCriteriaTranslations":[{"id":10860953,"uuid":"094d40ea-a5e5-4d5a-8e21-4be2d9b008f8","attributeTranslation":"Presentar ideas de suicidio de manera activa o considerarse en riesgo significativo de suicidio.","language":7,"languageDescription":"Spanish"},{"id":10860952,"uuid":"094d40ea-a5e5-4d5a-8e21-4be2d9b008f8","attributeTranslation":"•\tWykazywanie aktywnych myśli samobójczych lub bycie uznanym za osobę narażoną na istotne ryzyko popełnienia samobójstwa.","language":19,"languageDescription":"Polish"},{"id":10860951,"uuid":"094d40ea-a5e5-4d5a-8e21-4be2d9b008f8","attributeTranslation":"Είναι σε ενεργό αυτοκτονικό ιδεασμό ή θεωρείται ότι διατρέχουν σημαντικό κίνδυνο αυτοκτονίας","language":32,"languageDescription":"Greek (Greece)"}]},{"id":1506677,"number":5,"principalExclusionCriteria":"Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening","principalExclusionCriteriaTranslations":[{"id":10860956,"uuid":"f9689476-cf42-4332-aa66-05db2a40db8b","attributeTranslation":"Haber participado en un estudio clínico y haber recibido tratamiento activo, o desconocerse si han recibido tratamiento activo, en los 90 días o 5 semividas (lo que sea más largo) previos a la selección.","language":7,"languageDescription":"Spanish"},{"id":10860955,"uuid":"f9689476-cf42-4332-aa66-05db2a40db8b","attributeTranslation":"•\tUdział w badaniu klinicznym i otrzymywanie aktywnego leczenia lub brak wiedzy na temat tego, czy osoba otrzymywała aktywne leczenie w ciągu 90 dni lub 5 okresów półtrwania (zależnie od tego, który okres jest dłuższy) przed badaniem przesiewowym.","language":19,"languageDescription":"Polish"},{"id":10860954,"uuid":"f9689476-cf42-4332-aa66-05db2a40db8b","attributeTranslation":"Έχουν συμμετάσχει σε κλινική δοκιμή και έλαβαν δραστική θεραπεία, ή είναι άγνωστο εάν έλαβαν δραστική θεραπεία, εντός 90 ημερών ή 5 χρόνων ημίσειας ζωής (όποιο είναι μεγαλύτερο) πριν από την αρχική εκτίμηση.","language":32,"languageDescription":"Greek (Greece)"}]}]},"endPoint":{"primaryEndPoints":[{"id":1031420,"number":1,"endPoint":"Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD)","isPrimary":true,"endPointTranslations":[{"id":10860941,"uuid":"3c51e9c0-6ee1-4f85-a401-0f4aff12af52","attributeTranslation":"Tiempo transcurrido hasta la recidiva, definido como el número de días transcurrido desde la aleatorización hasta la fecha en la que el participante cumple cualquier criterio de recidiva de trastorno depresivo mayor (TDM).","language":7,"languageDescription":"Spanish"},{"id":10860940,"uuid":"3c51e9c0-6ee1-4f85-a401-0f4aff12af52","attributeTranslation":"Czas do wystąpienia nawrotu zdefiniowany jako liczba dni od randomizacji do daty spełnienia przez uczestnika dowolnego z kryteriów nawrotu zaburzeń depresyjnych (ang. Major Depressive Disorder, MDD).","language":19,"languageDescription":"Polish"},{"id":10860939,"uuid":"3c51e9c0-6ee1-4f85-a401-0f4aff12af52","attributeTranslation":"Χρόνος έως την υποτροπή, ο οποίος ορίζεται ως ο αριθμός ημερών από την ημερομηνία τυχαιοποίησης έως την ημερομηνία κατά την οποία ο συμμετέχων πληροί οποιοδήποτε κριτήριο υποτροπής της Μείζονος Καταθλιπτικής Διαταραχής (ΜΚΔ)","language":32,"languageDescription":"Greek (Greece)"}]}],"secondaryEndPoints":[]},"trialDuration":{"estimatedGlobalEndDate":"2028-05-28","estimatedEndDate":"2028-05-28","estimatedRecruitmentStartDate":"2026-07-15"},"sourceOfMonetarySupport":[],"populationOfTrialSubjects":{"ageRanges":[{"id":357429,"ageRangeCategoryCode":"3","ageRangeCategory":"3"},{"id":357430,"ageRangeCategoryCode":"4","ageRangeCategory":"4"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"1"}},"protocolInformation":{"studyDesign":{"periodDetails":[]}},"scientificAdviceAndPip":{"scientificAdvices":[{"id":55781,"competentAuthority":{"id":947786,"organisation":{"id":991121,"type":"EU Institution/Body/Agency","typeCode":"14","name":"European Medicines Agency","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100013412","organisationLocationStatus":"Active"},"address":{"addressId":1064708,"oneLine":"Domenico Scarlattilaan 6","addressLine1":"Domenico Scarlattilaan 6","addressLine2":"","addressLine3":"","addressLine4":"","city":"Amsterdam","postcode":"1083 HS","country":2029,"countryName":"Netherlands"},"isBusinessKeyValidated":true,"businessKey":"ORG-100013412"}}],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[{"id":34048,"ctNumber":"2025-522308-25-00","sponsorName":"Eli Lilly &amp; Co.","fullTitle":"J2S-MC-GZMH: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)","sponsorAgreementOption":"NON_APPLICABLE","sponsorAgreementOptionName":"NON_APPLICABLE","parentClinicalTrialId":23908,"hasDocument":false,"associatedCtDocs":[]}],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-08-19","conclusionDate":"2026-08-19","therapeuticAreas":[{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}],"medicalConditions":[{"id":135782,"medicalCondition":"Depressive Disorder, Major","isConditionRareDisease":false}],"sponsors":[{"id":147708,"primary":true,"publicContacts":[{"id":435811,"type":"Public","functionalName":"Lilly Clinical Trials information desk","functionalEmailAddress":"EU_lilly_clinical_trials@lilly.com","telephone":"00353214232400","organisation":{"id":794883,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":435812,"type":"Scientific","functionalName":"Lilly Clinical Trials information desk","functionalEmailAddress":"EU_lilly_clinical_trials@lilly.com","telephone":"00353214232400","organisation":{"id":794883,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":668062,"organisationAddress":{"id":948670,"organisation":{"id":992011,"type":"Health care","typeCode":"2","name":"IQVIA","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000018673","organisationLocationStatus":"Active"},"address":{"addressId":1065757,"oneLine":"2400 Ellis Road","addressLine1":"2400 Ellis Road","addressLine2":"","addressLine3":"","addressLine4":"","city":"Durham","postcode":"NC 27703","country":840,"countryName":"United States"},"phone":"+48662036936","email":"aleksandra.balacka@iqvia.com","isBusinessKeyValidated":false,"businessKey":"ORL-000018673"},"sponsorDuties":[{"id":1037090,"code":"1"}],"phoneNumber":"+48662036936","email":"aleksandra.balacka@iqvia.com"},{"id":668073,"organisationAddress":{"id":948664,"organisation":{"id":992005,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Cleveland Clinic Foundation","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028017","organisationLocationStatus":"Active"},"address":{"addressId":1065751,"oneLine":"9500 Euclid Avenue","addressLine1":"9500 Euclid Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Cleveland","postcode":"44195-0001","country":840,"countryName":"United States"},"phone":"2164456439","email":"brennat@ccf.org","isBusinessKeyValidated":true,"businessKey":"ORG-100028017"},"sponsorDuties":[{"id":1037101,"code":"15","value":"Adjudication"}],"phoneNumber":"2164456439","email":"brennat@ccf.org"},{"id":668072,"organisationAddress":{"id":948652,"organisation":{"id":991993,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Veeva Systems Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006053","organisationLocationStatus":"Active"},"address":{"addressId":1065739,"oneLine":"4280 Hacienda Drive","addressLine1":"4280 Hacienda Drive","addressLine2":"","addressLine3":"","addressLine4":"","city":"Pleasanton","postcode":"94588-2719","country":840,"countryName":"United States"},"phone":"9252719807","email":"audits@veeva.com","isBusinessKeyValidated":true,"businessKey":"ORG-100006053"},"sponsorDuties":[{"id":1037100,"code":"6"}],"phoneNumber":"9252719807","email":"audits@veeva.com"},{"id":668068,"organisationAddress":{"id":948650,"organisation":{"id":991991,"type":"Pharmaceutical company","typeCode":"10","name":"Trialbee AB","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100051369","organisationLocationStatus":"Active"},"address":{"addressId":1065737,"oneLine":"Sodra Tullgatan 3, Malmo S T Petri","addressLine1":"Sodra Tullgatan 3","addressLine2":"Malmo S T Petri","addressLine3":"","addressLine4":"","city":"Malmo","postcode":"211 40","country":2028,"countryName":"Sweden"},"phone":"2679665311","email":"bill.abbott@trialbee.com","isBusinessKeyValidated":true,"businessKey":"ORG-100051369"},"sponsorDuties":[{"id":1037096,"code":"15","value":"Patient Referral, Recruitment, Screening, and Retention"}],"phoneNumber":"2679665311","email":"bill.abbott@trialbee.com"},{"id":668066,"organisationAddress":{"id":948660,"organisation":{"id":992001,"type":"Non-Pharmaceutical company","typeCode":"11","name":"Greenphire LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100041621","organisationLocationStatus":"Active"},"address":{"addressId":1065747,"oneLine":"1018 West 9th Avenue Suite 200","addressLine1":"1018 West 9th Avenue Suite 200","addressLine2":"","addressLine3":"","addressLine4":"","city":"King Of Prussia","postcode":"19406-1225","country":840,"countryName":"United States"},"phone":"2156094729","email":"jon.silberg@greenphire.com","isBusinessKeyValidated":true,"businessKey":"ORG-100041621"},"sponsorDuties":[{"id":1037094,"code":"15","value":"Patient Recruitment, Screening, and Retention"}],"phoneNumber":"2156094729","email":"jon.silberg@greenphire.com"},{"id":668067,"organisationAddress":{"id":948654,"organisation":{"id":991995,"type":"Pharmaceutical company","typeCode":"10","name":"Bioagilytix Labs LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100013030","organisationLocationStatus":"Active"},"address":{"addressId":1065741,"oneLine":"2300 Englert Drive Suite G","addressLine1":"2300 Englert Drive Suite G","addressLine2":"","addressLine3":"","addressLine4":"","city":"Durham","postcode":"27713-4450","country":840,"countryName":"United States"},"phone":"9192871555","email":"Jennifer.zemo@bioagilytix.com","isBusinessKeyValidated":true,"businessKey":"ORG-100013030"},"sponsorDuties":[{"id":1037095,"code":"4"}],"phoneNumber":"9192871555","email":"Jennifer.zemo@bioagilytix.com"},{"id":668069,"organisationAddress":{"id":948665,"organisation":{"id":992006,"type":"Pharmaceutical company","typeCode":"10","name":"Cogstate Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100045256","organisationLocationStatus":"Active"},"address":{"addressId":1065752,"oneLine":"195 Church Street Fl 4","addressLine1":"195 Church Street Fl 4","addressLine2":"","addressLine3":"","addressLine4":"","city":"New Haven","postcode":"06510-2009","country":840,"countryName":"United States"},"phone":"14752731924","email":"dwhitaker@cogstate.com","isBusinessKeyValidated":true,"businessKey":"ORG-100045256"},"sponsorDuties":[{"id":1037097,"code":"15","value":"Site training"}],"phoneNumber":"14752731924","email":"dwhitaker@cogstate.com"},{"id":668061,"organisationAddress":{"id":949165,"organisation":{"id":992510,"type":"Pharmaceutical company","typeCode":"10","name":"Pharmaserve Lilly S.A.C.I.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100005347","organisationLocationStatus":"Active"},"address":{"addressId":1066350,"oneLine":"15 Km Athens-Lamias 0","addressLine1":"15 Km Athens-Lamias 0","addressLine2":"","addressLine3":"","addressLine4":"","city":"Kifisia","postcode":"145 64","country":2014,"countryName":"Greece"},"phone":"00302106294733","email":"clinops@lilly.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100005347"},"sponsorDuties":[{"id":1037085,"code":"1"},{"id":1037086,"code":"12"},{"id":1037087,"code":"15","value":"Negotiation and Execution of Clinical Trial Agreements with the participating sites, make study payments based on invoices"},{"id":1037088,"code":"2"},{"id":1037089,"code":"5"}],"phoneNumber":"00302106294733","email":"clinops@lilly.gr"},{"id":668063,"organisationAddress":{"id":948663,"organisation":{"id":992004,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Q2 Solutions LLC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100017000","organisationLocationStatus":"Active"},"address":{"addressId":1065750,"oneLine":"26081 Avenue Hall Suite 150","addressLine1":"26081 Avenue Hall Suite 150","addressLine2":"","addressLine3":"","addressLine4":"","city":"Valencia","postcode":"91355-1241","country":840,"countryName":"United States"},"phone":"4401506818241","email":"Nicola.McDonagh@iqvia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100017000"},"sponsorDuties":[{"id":1037091,"code":"4"}],"phoneNumber":"4401506818241","email":"Nicola.McDonagh@iqvia.com"},{"id":668071,"organisationAddress":{"id":948667,"organisation":{"id":992008,"type":"Health care","typeCode":"2","name":"Q2 Solutions LLC","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000018672","organisationLocationStatus":"Active"},"address":{"addressId":1065754,"oneLine":"The Alba Campus Rosebank, West Lothian","addressLine1":"The Alba Campus Rosebank","addressLine2":"West Lothian","addressLine3":"","addressLine4":"","postcode":"EH54 7EG","country":826,"countryName":"United Kingdom"},"phone":"4401506818241","email":"Nicola.McDonagh@iqvia.com","isBusinessKeyValidated":false,"businessKey":"ORL-000018672"},"sponsorDuties":[{"id":1037099,"code":"4"}],"phoneNumber":"4401506818241","email":"Nicola.McDonagh@iqvia.com"},{"id":668064,"organisationAddress":{"id":948661,"organisation":{"id":992002,"type":"Non-Pharmaceutical company","typeCode":"11","name":"The Hibbert Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100047639","organisationLocationStatus":"Active"},"address":{"addressId":1065748,"oneLine":"400 Pennington Avenue","addressLine1":"400 Pennington Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Trenton","postcode":"08618-3105","country":840,"countryName":"United States"},"phone":"6092226000","email":"poynter_leah@network.lilly.com","isBusinessKeyValidated":true,"businessKey":"ORG-100047639"},"sponsorDuties":[{"id":1037092,"code":"15","value":"Patient Recruitment, Screening, and Retention"}],"phoneNumber":"6092226000","email":"poynter_leah@network.lilly.com"},{"id":668065,"organisationAddress":{"id":948666,"organisation":{"id":992007,"type":"Health care","typeCode":"2","name":"Clinical Ink","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000018671","organisationLocationStatus":"Active"},"address":{"addressId":1065753,"oneLine":"110 Gibraltar Road Suite 150","addressLine1":"110 Gibraltar Road Suite 150","addressLine2":"","addressLine3":"","addressLine4":"","city":"Horsham","postcode":"PA 19044 - 2302","country":840,"countryName":"United States"},"phone":"13367147402","email":"Rita.Moritz@clinicalink.com","isBusinessKeyValidated":false,"businessKey":"ORL-000018671"},"sponsorDuties":[{"id":1037093,"code":"7"}],"phoneNumber":"13367147402","email":"Rita.Moritz@clinicalink.com"},{"id":668070,"organisationAddress":{"id":948653,"organisation":{"id":991994,"type":"Pharmaceutical company","typeCode":"10","name":"RWS Life Sciences Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042348","organisationLocationStatus":"Active"},"address":{"addressId":1065740,"oneLine":"101 East River Drive","addressLine1":"101 East River Drive","addressLine2":"","addressLine3":"","addressLine4":"","city":"East Hartford","postcode":"06108-3285","country":840,"countryName":"United States"},"phone":"+18607276000","email":"Shawn.McKown@rws.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042348"},"sponsorDuties":[{"id":1037098,"code":"15","value":"eCOA translations"}],"phoneNumber":"+18607276000","email":"Shawn.McKown@rws.com"},{"id":668074,"organisationAddress":{"id":948656,"organisation":{"id":991997,"type":"Pharmaceutical company","typeCode":"10","name":"Labcorp Early Development Laboratories Inc.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100012865","organisationLocationStatus":"Active"},"address":{"addressId":1065743,"oneLine":"3301 Kinsman Boulevard","addressLine1":"3301 Kinsman Boulevard","addressLine2":"","addressLine3":"","addressLine4":"","city":"Madison","postcode":"53704-2523","country":840,"countryName":"United States"},"phone":"6082105459","email":"Jennifer.Tournear@labcorp.com","isBusinessKeyValidated":true,"businessKey":"ORG-100012865"},"sponsorDuties":[{"id":1037102,"code":"4"}],"phoneNumber":"6082105459","email":"Jennifer.Tournear@labcorp.com"}],"organisation":{"id":794883,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"},"addresses":[{"id":756231,"organisation":{"id":794883,"type":"Pharmaceutical company","typeCode":"10","name":"Eli Lilly & Co.","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000156","organisationLocationStatus":"Active"},"address":{"addressId":833020,"oneLine":"1 Lilly Corporate Center","addressLine1":"1 Lilly Corporate Center","addressLine2":"","addressLine3":"","addressLine4":"","city":"Indianapolis","postcode":"46285-0001","country":840,"countryName":"United States"},"isBusinessKeyValidated":true,"businessKey":"ORG-100000156"}],"isCommercial":true,"commercial":"Commercial"}],"trialCategoryCode":"2","trialCategoryJustificationComment":"In line with the EMA Appendix on disclosure rules to the “Functional specifications for the EU portal and EU database to be audited- EMA/42176/2014”, the trial meets the definition of category 2 trial since it is a Phase III trial assessing a non-authorised investigational medicinal product  to investigate safety and efficacy.","partOneTherapeuticAreas":[{"id":1161288,"therapeuticArea":{"code":"33","name":"Psychiatry and Psychology [F] - Mental Disorders [F03]"}}],"productRoleGroupInfos":[{"id":402921,"comments":"Brenipatide, Brenipatide, Brenipatide","productRoleCode":"1","productRoleName":"Test","products":[{"id":540584,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713221","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713221","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713221","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713221","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21390,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":540585,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713219","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713219","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713219","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713219","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21391,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"},{"id":540586,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"12713220","productPharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","euMpNumber":"PRD12713220","prodAuthStatus":1,"prodName":"Brenipatide","pharmForm":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE","sponsorProductCode":"LY3537031","activeSubstanceName":"LY3537031","euSubstNumber":"SUB418174","nameOrg":"ELI LILLY AND COMPANY LIMITED","productSubstances":[{"productPk":"12713220","substancePk":"418177","nameOrg":"ELI LILLY AND COMPANY LIMITED","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"LY3537031","substanceEvCode":"SUB418174"}],"activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"Other","maxDailyDoseAmount":"0","doseUomTotal":"Other","maxTotalDoseAmount":"0","maxTreatmentPeriod":1,"timeUnitCode":"1","otherMedicinalProduct":"Chemical","evCode":"PRD12713220","sponsorProductCodeEdit":"LY3537031","devices":[{"id":21392,"productUseDeviceCode":"1","productUseDeviceUsage":[],"hasCeMark":false}],"characteristics":["11"],"routes":["SUBCUTANEOUS USE"],"allSubstancesChemicals":false,"productName":"Brenipatide","jsonActiveSubstanceNames":"ly3537031","pharmaceuticalFormDisplay":"SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE"}]},{"id":402922,"comments":"Placebo to match LY","productRoleCode":"3","productRoleName":"Placebo","products":[{"id":540587,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPharmForm":"N/A","euMpNumber":"N/A","marketingAuthNumber":"N/A","prodName":"Placebo to match LY","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","devices":[],"characteristics":[],"routes":[],"allSubstancesChemicals":false,"productName":"Placebo to match LY","jsonActiveSubstanceNames":"n/a","pharmaceuticalFormDisplay":"N/A"}]}],"isLowIntervention":false},"authorizedPartsII":[{"id":332783,"mscId":59565,"mscInfo":{"id":59565,"clinicalTrialId":23910,"countryOrganisationId":2013,"reportingStatusCode":"Authorised","fromDate":"2026-08-20","toDate":"2026-08-20","isProposedRms":true,"expressDecision":"willing","countryName":"Germany","organisationInfo":{},"firstDecisionDate":"2026-08-24","trialStatus":"Authorised","trialPeriod":[{"id":91045,"trialStartDate":"2026-09-18","fromDate":"2026-09-28"},{"id":91046,"trialStartDate":"2026-09-18","fromDate":"2026-09-28"}],"trialRecruitmentPeriod":[],"hasRecruitmentStarted":false,"activeTrialPeriod":{"id":154222,"trialStartDate":"2026-09-18","fromDate":"2026-09-28"},"activeTrialRecruitmentPeriod":{},"isWillingAtDayThreeView":true,"clinicalTrialStatusHistory":[{"id":382989,"mscId":59565,"trialStatus":"Under evaluation","trialStatusDate":"2026-05-06T21:06:11.891"},{"id":461065,"mscId":59565,"trialStatus":"Authorised","trialStatusDate":"2026-08-24T13:58:19.922"}],"applicationTypeMsc":"1","mscName":"Germany","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-21","decision":"authorized_conditions","decisionDate":"2026-08-24"},"decisionDate":"2026-08-24","recruitmentSubjectCount":53,"trialSites":[{"id":2337751,"organisationAddressInfo":{"id":949473,"organisation":{"id":992820,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Klinische Forschung Hamburg GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100042069","organisationLocationStatus":"Active"},"address":{"addressId":1066726,"oneLine":"Hoheluftchaussee 18, Hoheluft-Ost","addressLine1":"Hoheluftchaussee 18","addressLine2":"Hoheluft-Ost","addressLine3":"","addressLine4":"","city":"Hamburg","postcode":"20253","country":2013,"countryName":"Germany"},"phone":"+49404607630","email":"christian.deckert@pratia.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042069"},"personInfo":{"id":2591253,"firstName":"Christian","lastName":"Deckert","telephone":"+49404607630","email":"christian.deckert@pratia.com","title":"1"},"departmentName":"N/A"},{"id":2337750,"organisationAddressInfo":{"id":949463,"organisation":{"id":992810,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Charite Universitaetsmedizin Berlin KöR","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100008480","organisationLocationStatus":"Active"},"address":{"addressId":1066716,"oneLine":"Hindenburgdamm 30, Lichterfelde","addressLine1":"Hindenburgdamm 30","addressLine2":"Lichterfelde","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"12203","country":2013,"countryName":"Germany"},"phone":"004930450517531","email":"christian.otte@charite.de","isBusinessKeyValidated":true,"businessKey":"ORG-100008480"},"personInfo":{"id":2591252,"firstName":"Christian","lastName":"Otte","telephone":"004930450517531","email":"christian.otte@charite.de","title":"2"},"departmentName":"Klinik für Psychiatrie und Psychotherapie"},{"id":2337752,"organisationAddressInfo":{"id":949486,"organisation":{"id":992833,"type":"Educational Institution","typeCode":"1","name":"Universitaet Leipzig","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100000273","organisationLocationStatus":"Active"},"address":{"addressId":1066741,"oneLine":"Semmelweisstrasse 10, Zentrum-Suedost","addressLine1":"Semmelweisstrasse 10","addressLine2":"Zentrum-Suedost","addressLine3":"","addressLine4":"","city":"Leipzig","postcode":"04103","country":2013,"countryName":"Germany"},"phone":"00493419724430","email":"maria.strauss@medizin.uni-leipzig.de","isBusinessKeyValidated":true,"businessKey":"ORG-100000273"},"personInfo":{"id":2591254,"firstName":"Maria","lastName":"Strauss","telephone":"00493419724430","email":"maria.strauss@medizin.uni-leipzig.de","title":"2"},"departmentName":"Department für Psychische Gesundheit, Klinik und Poliklinik für Psychiatrie und Psychotherapie"},{"id":2337748,"organisationAddressInfo":{"id":949480,"organisation":{"id":992827,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"FutureMeds GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100039142","organisationLocationStatus":"Active"},"address":{"addressId":1066735,"oneLine":"Wilmersdorfer Strasse 79, Charlottenburg","addressLine1":"Wilmersdorfer Strasse 79","addressLine2":"Charlottenburg","addressLine3":"","addressLine4":"","city":"Berlin","postcode":"10629","country":2013,"countryName":"Germany"},"phone":"004915785526789","email":"sascha.oehm@futuremeds.com","isBusinessKeyValidated":true,"businessKey":"ORG-100039142"},"personInfo":{"id":2591250,"firstName":"Sascha","lastName":"Oehm","telephone":"004915785526789","email":"sascha.oehm@futuremeds.com","title":"1"},"departmentName":"N/A"},{"id":2337749,"organisationAddressInfo":{"id":949476,"organisation":{"id":992823,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100033245","organisationLocationStatus":"Active"},"address":{"addressId":1066730,"oneLine":"Goethestrasse 1, Feldstadt","addressLine1":"Goethestrasse 1","addressLine2":"Feldstadt","addressLine3":"","addressLine4":"","city":"Schwerin","postcode":"19053","country":2013,"countryName":"Germany"},"phone":"0049385207980","email":"heike.benes@somnibene.de","isBusinessKeyValidated":true,"businessKey":"ORG-100033245"},"personInfo":{"id":2591251,"firstName":"Heike","lastName":"Benes","telephone":"0049385207980","email":"heike.benes@somnibene.de","title":"1"},"departmentName":"N/A"},{"id":2337747,"organisationAddressInfo":{"id":949460,"organisation":{"id":992807,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"Pharmakologisches Studienzentrum Chemnitz GmbH","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100043385","organisationLocationStatus":"Active"},"address":{"addressId":1066713,"oneLine":"Carolastrasse 2, Zentrum","addressLine1":"Carolastrasse 2","addressLine2":"Zentrum","addressLine3":"","addressLine4":"","city":"Chemnitz","postcode":"09111","country":2013,"countryName":"Germany"},"phone":"004937124080150","email":"ralf.bodenschatz.sz@studienzentrum-chemnitz.de","isBusinessKeyValidated":true,"businessKey":"ORG-100043385"},"personInfo":{"id":2591249,"firstName":"Ralf","lastName":"Bodenschatz","telephone":"004937124080150","email":"ralf.bodenschatz.sz@studienzentrum-chemnitz.de","title":"3"},"departmentName":"N/A"}],"applicationStatusCode":"Authorised"},{"id":316449,"mscId":59566,"mscInfo":{"id":59566,"clinicalTrialId":23910,"countryOrganisationId":2014,"reportingStatusCode":"Authorised","fromDate":"2026-06-22","toDate":"2026-06-22","isProposedRms":false,"expressDecision":"unwilling","countryName":"Greece","organisationInfo":{},"firstDecisionDate":"2026-08-19","trialStatus":"Authorised","trialPeriod":[],"trialRecruitmentPeriod":[],"hasRecruitmentStarted":false,"activeTrialPeriod":{},"activeTrialRecruitmentPeriod":{},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":382990,"mscId":59566,"trialStatus":"Under evaluation","trialStatusDate":"2026-05-06T21:06:11.934"},{"id":458505,"mscId":59566,"trialStatus":"Authorised","trialStatusDate":"2026-08-19T13:16:42.834"}],"applicationTypeMsc":"1","mscName":"Greece","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-06-29","decision":"authorized_conditions","decisionDate":"2026-08-19"},"decisionDate":"2026-08-19","recruitmentSubjectCount":46,"trialSites":[{"id":2211047,"organisationAddressInfo":{"id":957476,"organisation":{"id":1000854,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University General Hospital Attikon General Hospital Of West Attica H Agia Varvara","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100030696","organisationLocationStatus":"Active"},"address":{"addressId":1076393,"oneLine":"Rimini 1","addressLine1":"Rimini 1","addressLine2":"","addressLine3":"","addressLine4":"","city":"Chaidari","postcode":"124 61","country":2014,"countryName":"Greece"},"phone":"+302105832434","email":"smyrnis@med.uoa.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100030696"},"personInfo":{"id":2452470,"firstName":"Nikolaos","lastName":"Smyrnis","telephone":"+302105832434","email":"smyrnis@med.uoa.gr","title":"2"},"departmentName":"2nd Department of Psychiatry"},{"id":2211044,"organisationAddressInfo":{"id":957470,"organisation":{"id":1000848,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Pan-Arcadian General Hospital Of Tripoli Evangelistria","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100054374","organisationLocationStatus":"Active"},"address":{"addressId":1076387,"oneLine":"Terma Erythrou Staurou","addressLine1":"Terma Erythrou Staurou","addressLine2":"","addressLine3":"","addressLine4":"","city":"Tripolis","postcode":"221 31","country":2014,"countryName":"Greece"},"phone":"+306947826453","email":"kgeorgopoulou@yahoo.com","isBusinessKeyValidated":true,"businessKey":"ORG-100054374"},"personInfo":{"id":2452467,"firstName":"Aikaterini","lastName":"Georgopoulou","telephone":"+306947826453","email":"kgeorgopoulou@yahoo.com","title":"1"},"departmentName":"Adult Psychiatric Clinic"},{"id":2211049,"organisationAddressInfo":{"id":957466,"organisation":{"id":1000844,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Argolida General Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100049960","organisationLocationStatus":"Active"},"address":{"addressId":1076383,"oneLine":"Korinthou 191","addressLine1":"Korinthou 191","addressLine2":"","addressLine3":"","addressLine4":"","city":"Argos-Mykines","postcode":"212 31","country":2014,"countryName":"Greece"},"phone":"+302751360350","email":"gamvroulak@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100049960"},"personInfo":{"id":2452472,"firstName":"Aikaterini","lastName":"Gamvroula","telephone":"+302751360350","email":"gamvroulak@gmail.com","title":"1"},"departmentName":"Psychiatric Department"},{"id":2211045,"organisationAddressInfo":{"id":957479,"organisation":{"id":1000857,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"General Hospital Of Thessaloniki Papageorgiou","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042242","organisationLocationStatus":"Active"},"address":{"addressId":1076397,"oneLine":"Ring Road Of Thessaloniki, Ministry Of Pavlos Melas","addressLine1":"Ring Road Of Thessaloniki","addressLine2":"Ministry Of Pavlos Melas","addressLine3":"","addressLine4":"","city":"Efkarpia","postcode":"564 29","country":2014,"countryName":"Greece"},"phone":"+302313323911","email":"mondoloukas@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100042242"},"personInfo":{"id":2452468,"firstName":"Loukas","lastName":"Athanasiadis","telephone":"+302313323911","email":"mondoloukas@gmail.com","title":"2"},"departmentName":"1st Psychiatric Clinic"},{"id":2211046,"organisationAddressInfo":{"id":912510,"organisation":{"id":954655,"type":"Health care","typeCode":"2","name":"Multidisciplinary Mental Health Hospital of Attiki","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000017840","organisationLocationStatus":"Active"},"address":{"addressId":1021432,"oneLine":"374 Athinon Avenue","addressLine1":"374 Athinon Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Chaidari, Athens","postcode":"12462","country":2014,"countryName":"Greece"},"phone":"+302112054278","email":"tsopelas@gmail.com","isBusinessKeyValidated":false,"businessKey":"ORL-000017840"},"personInfo":{"id":2452469,"firstName":"Christos","lastName":"Tsopelas","telephone":"+302112054278","email":"tsopelas@gmail.com","title":"1"},"departmentName":"2nd Adult Psychiatric Clinic"},{"id":2211048,"organisationAddressInfo":{"id":957488,"organisation":{"id":1000866,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Sismanogleio General Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100031833","organisationLocationStatus":"Active"},"address":{"addressId":1076409,"oneLine":"Sismanogliou 37","addressLine1":"Sismanogliou 37","addressLine2":"","addressLine3":"","addressLine4":"","city":"Maroussi","postcode":"151 26","country":2014,"countryName":"Greece"},"phone":"+302132058302","email":"tsakdo@yahoo.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100031833"},"personInfo":{"id":2452471,"firstName":"Domna","lastName":"Tsaklakidou","telephone":"+302132058302","email":"tsakdo@yahoo.gr","title":"1"},"departmentName":"Adult Psychiatric Department"},{"id":2211050,"organisationAddressInfo":{"id":957495,"organisation":{"id":1000873,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University General Hospital Of Ioannina","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043604","organisationLocationStatus":"Active"},"address":{"addressId":1076416,"oneLine":"Niarchou Stavrou Avenue","addressLine1":"Niarchou Stavrou Avenue","addressLine2":"","addressLine3":"","addressLine4":"","city":"Ioannina","postcode":"455 00","country":2014,"countryName":"Greece"},"phone":"+302651099667","email":"ppetrikis@hotmail.gr","isBusinessKeyValidated":true,"businessKey":"ORG-100043604"},"personInfo":{"id":2452473,"firstName":"Petros","lastName":"Petrikis","telephone":"+302651099667","email":"ppetrikis@hotmail.gr","title":"2"},"departmentName":"Psychiatric Department"}],"applicationStatusCode":"Authorised"},{"id":328882,"mscId":59567,"mscInfo":{"id":59567,"clinicalTrialId":23910,"countryOrganisationId":2027,"reportingStatusCode":"Authorised","fromDate":"2026-08-05","toDate":"2026-08-05","isProposedRms":false,"expressDecision":"unwilling","countryName":"Spain","organisationInfo":{},"firstDecisionDate":"2026-08-24","trialStatus":"Authorised","trialPeriod":[],"trialRecruitmentPeriod":[],"hasRecruitmentStarted":false,"activeTrialPeriod":{},"activeTrialRecruitmentPeriod":{},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":382991,"mscId":59567,"trialStatus":"Under evaluation","trialStatusDate":"2026-05-06T21:06:11.949"},{"id":461030,"mscId":59567,"trialStatus":"Authorised","trialStatusDate":"2026-08-24T08:28:54.331"}],"applicationTypeMsc":"1","mscName":"Spain","assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-18","decision":"authorized_conditions","decisionDate":"2026-08-24"},"decisionDate":"2026-08-24","recruitmentSubjectCount":30,"trialSites":[{"id":2309845,"organisationAddressInfo":{"id":955628,"organisation":{"id":999001,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Complejo Asistencial Universitario De Salamanca","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028551","organisationLocationStatus":"Active"},"address":{"addressId":1074195,"oneLine":"Avenida De Portugal 83","addressLine1":"Avenida De Portugal 83","addressLine2":"","addressLine3":"","addressLine4":"","city":"Salamanca","postcode":"37005","country":2027,"countryName":"Spain"},"phone":"34639754620","email":"amontejo@usal.es","isBusinessKeyValidated":true,"businessKey":"ORG-100028551"},"personInfo":{"id":2560573,"firstName":"Angel","lastName":"Montejo","telephone":"34639754620","email":"amontejo@usal.es","title":"1"},"departmentName":"Psiquiatry"},{"id":2309838,"organisationAddressInfo":{"id":955651,"organisation":{"id":999024,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Eap Osona Sud Alt Congost S.L.P.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042732","organisationLocationStatus":"Active"},"address":{"addressId":1074220,"oneLine":"Placa Del Pla Del Mestre 7","addressLine1":"Placa Del Pla Del Mestre 7","addressLine2":"","addressLine3":"","addressLine4":"","city":"Centelles","postcode":"08540","country":2027,"countryName":"Spain"},"phone":"34938810485","email":"snarejos@ebacentelles.cat","isBusinessKeyValidated":true,"businessKey":"ORG-100042732"},"personInfo":{"id":2560566,"firstName":"Silvia","lastName":"Narejos Pérez","telephone":"34938810485","email":"snarejos@ebacentelles.cat","title":"1"},"departmentName":"General Medicine"},{"id":2309837,"organisationAddressInfo":{"id":955648,"organisation":{"id":999021,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"University Hospital Virgen Del Rocio S.L.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100030783","organisationLocationStatus":"Active"},"address":{"addressId":1074217,"oneLine":"Avenida De Manuel Siurot S/n","addressLine1":"Avenida De Manuel Siurot S/n","addressLine2":"","addressLine3":"","addressLine4":"","city":"Sevilla","postcode":"41013","country":2027,"countryName":"Spain"},"phone":"34955055747","email":"benedicto.crespo.sspa@juntadeandalucia.es","isBusinessKeyValidated":true,"businessKey":"ORG-100030783"},"personInfo":{"id":2560565,"firstName":"Benedicto","lastName":"Crespo","telephone":"34955055747","email":"benedicto.crespo.sspa@juntadeandalucia.es","title":"1"},"departmentName":"Psiquiatry"},{"id":2309843,"organisationAddressInfo":{"id":955641,"organisation":{"id":999014,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Parc Sanitari Sant Joan De Deu","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042235","organisationLocationStatus":"Active"},"address":{"addressId":1074208,"oneLine":"Calle Del Doctor Antoni Pujadas 42","addressLine1":"Calle Del Doctor Antoni Pujadas 42","addressLine2":"","addressLine3":"","addressLine4":"","city":"Sant Boi De Llobregat","postcode":"08830","country":2027,"countryName":"Spain"},"phone":"34936406350","email":"oscar.soto@sjd.es","isBusinessKeyValidated":true,"businessKey":"ORG-100042235"},"personInfo":{"id":2560571,"firstName":"Oscar","lastName":"Soto Angona","telephone":"34936406350","email":"oscar.soto@sjd.es","title":"1"},"departmentName":"Psiquiatry"},{"id":2309842,"organisationAddressInfo":{"id":910785,"organisation":{"id":952920,"type":"Health care","typeCode":"2","name":"Servicio de Salud Mental del Área IV CSM La Corredoría Oviedo","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000017800","organisationLocationStatus":"Active"},"address":{"addressId":1019318,"oneLine":"calle Alfredo Blanco, s/n, 33011, Oviedo, Principado de Asturias","addressLine1":"calle Alfredo Blanco, s/n","addressLine2":"33011, Oviedo, Principado de Asturias","addressLine3":"","addressLine4":"","postcode":"33011","country":2027,"countryName":"Spain"},"phone":"985103552","email":"pilaralejandra.saiz@gmail.com","isBusinessKeyValidated":false,"businessKey":"ORL-000017800"},"personInfo":{"id":2560570,"firstName":"Pilar Alejandra","lastName":"Saiz Martínez","telephone":"34985103552","email":"pilaralejandra.saiz@gmail.com","title":"1"},"departmentName":"Psiquiatry"},{"id":2309835,"organisationAddressInfo":{"id":844499,"organisation":{"id":886116,"type":"Health care","typeCode":"2","name":"Hospital Provincial de Zamora","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000016242","organisationLocationStatus":"Active"},"address":{"addressId":938916,"oneLine":"C/ Hernán Cortés, s/n C.P.","addressLine1":"C/ Hernán Cortés, s/n C.P.","addressLine2":"","addressLine3":"","addressLine4":"","city":"Zamora","postcode":"49020","country":2027,"countryName":"Spain"},"phone":"669462622","email":"mfrancom@saludcastillayleon.es","isBusinessKeyValidated":false,"businessKey":"ORL-000016242"},"personInfo":{"id":2560563,"firstName":"Juan Antonio","lastName":"Garcia Mellado","telephone":"34669462622","email":"jgarciame@saludcastillayleon.es","title":"1"},"departmentName":"Psiquiatry"},{"id":2309840,"organisationAddressInfo":{"id":955634,"organisation":{"id":999007,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Del Mar","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028631","organisationLocationStatus":"Active"},"address":{"addressId":1074201,"oneLine":"Passeig Maritim De La Barceloneta 25-29","addressLine1":"Passeig Maritim De La Barceloneta 25-29","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08003","country":2027,"countryName":"Spain"},"phone":"34932483175","email":"vperezv@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100028631"},"personInfo":{"id":2560568,"firstName":"Victor","lastName":"Pérez -Sola","telephone":"34932483175","email":"vperezv@gmail.com","title":"1"},"departmentName":"Psiquiatry"},{"id":2309839,"organisationAddressInfo":{"id":844486,"organisation":{"id":886103,"type":"Health care","typeCode":"2","name":"Hospital Clinic de Barcelona","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000016241","organisationLocationStatus":"Active"},"address":{"addressId":938902,"oneLine":"Carrer de Còrsega, 188, L'Eixample","addressLine1":"Carrer de Còrsega, 188, L'Eixample","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08036","country":2027,"countryName":"Spain"},"phone":"932275400","email":"macarulla@clinic.cat","isBusinessKeyValidated":false,"businessKey":"ORL-000016241"},"personInfo":{"id":2560567,"firstName":"Eduard","lastName":"Vieta","telephone":"34932275400","email":"EVIETA@clinic.cat","title":"1"},"departmentName":"Psiquiatry"},{"id":2309841,"organisationAddressInfo":{"id":955639,"organisation":{"id":999012,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital Universitario Infanta Leonor","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100041540","organisationLocationStatus":"Active"},"address":{"addressId":1074206,"oneLine":"Avenida Gran Via Del Este 80","addressLine1":"Avenida Gran Via Del Este 80","addressLine2":"","addressLine3":"","addressLine4":"","city":"Madrid","postcode":"28031","country":2027,"countryName":"Spain"},"phone":"34670887653","email":"fjquinterog@yahoo.es","isBusinessKeyValidated":true,"businessKey":"ORG-100041540"},"personInfo":{"id":2560569,"firstName":"Javier","lastName":"Quintero","telephone":"34670887653","email":"fjquinterog@yahoo.es","title":"1"},"departmentName":"Psiquiatry"},{"id":2309836,"organisationAddressInfo":{"id":955646,"organisation":{"id":999019,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100043773","organisationLocationStatus":"Active"},"address":{"addressId":1074215,"oneLine":"Calle Alejo Fernandez 9","addressLine1":"Calle Alejo Fernandez 9","addressLine2":"","addressLine3":"","addressLine4":"","city":"Sevilla","postcode":"41003","country":2027,"countryName":"Spain"},"phone":"34954709183","email":"aliaga.verdugo@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100043773"},"personInfo":{"id":2560564,"firstName":"Alberto","lastName":"Aliaga Verdugo","telephone":"34954709183","email":"aliaga.verdugo@gmail.com","title":"1"},"departmentName":"Endocrinology"},{"id":2309834,"organisationAddressInfo":{"id":959287,"organisation":{"id":1002670,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hospital De La Santa Creu I Sant Pau","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100028622","organisationLocationStatus":"Active"},"address":{"addressId":1078574,"oneLine":"Calle De San Antonio Maria Claret 167","addressLine1":"Calle De San Antonio Maria Claret 167","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08025","country":2027,"countryName":"Spain"},"phone":"34616669072","email":"ncardoner@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100028622"},"personInfo":{"id":2560562,"firstName":"Narcis","lastName":"Cardoner","telephone":"34616669072","email":"ncardoner@gmail.com","title":"1"},"departmentName":"Psiquiatry"},{"id":2309844,"organisationAddressInfo":{"id":955359,"organisation":{"id":998731,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Hestia Palau S.L.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100051788","organisationLocationStatus":"Active"},"address":{"addressId":1073873,"oneLine":"Calle De San Antonio Maria Claret 135","addressLine1":"Calle De San Antonio Maria Claret 135","addressLine2":"","addressLine3":"","addressLine4":"","city":"Barcelona","postcode":"08025","country":2027,"countryName":"Spain"},"phone":"34934894294","email":"elenaroscucurull@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100051788"},"personInfo":{"id":2560572,"firstName":"Elena","lastName":"Ros Cucurull","telephone":"34934894294","email":"elenaroscucurull@gmail.com"},"departmentName":"Psiquiatry"}],"applicationStatusCode":"Authorised"},{"id":325071,"mscId":59568,"mscInfo":{"id":59568,"clinicalTrialId":23910,"countryOrganisationId":2031,"reportingStatusCode":"Authorised","fromDate":"2026-07-22","toDate":"2026-07-22","isProposedRms":false,"expressDecision":"unwilling","countryName":"Poland","organisationInfo":{},"firstDecisionDate":"2026-08-25","trialStatus":"Authorised","trialPeriod":[{"id":91050,"trialStartDate":"2026-09-24","fromDate":"2026-09-28"},{"id":91051,"trialStartDate":"2026-09-24","fromDate":"2026-09-28"}],"trialRecruitmentPeriod":[],"hasRecruitmentStarted":false,"activeTrialPeriod":{"id":154227,"trialStartDate":"2026-09-24","fromDate":"2026-09-28"},"activeTrialRecruitmentPeriod":{},"isWillingAtDayThreeView":false,"clinicalTrialStatusHistory":[{"id":382992,"mscId":59568,"trialStatus":"Under evaluation","trialStatusDate":"2026-05-06T21:06:11.964"},{"id":461187,"mscId":59568,"trialStatus":"Authorised","trialStatusDate":"2026-08-25T09:26:12.377"}],"applicationTypeMsc":"1","mscName":"Poland","assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-08-21","decision":"authorized_conditions","decisionDate":"2026-08-25"},"decisionDate":"2026-08-25","recruitmentSubjectCount":99,"trialSites":[{"id":2279873,"organisationAddressInfo":{"id":1009390,"organisation":{"id":1055728,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Penta Hospitals Badania Kliniczne Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040967","organisationLocationStatus":"Active"},"address":{"addressId":1138173,"oneLine":"Ul. Na Zaspe 3","addressLine1":"Ul. Na Zaspe 3","addressLine2":"","addressLine3":"","addressLine4":"","city":"Gdansk","postcode":"80-546","country":2031,"countryName":"Poland"},"phone":"+48730201221","email":"grzegorz.kuczynski@pentahospitals.pl","isBusinessKeyValidated":true,"businessKey":"LOC-100067457"},"personInfo":{"id":2527789,"firstName":"Grzegorz","lastName":"Kuczyński","telephone":"+48730201221","email":"grzegorz.kuczynski@pentahospitals.pl","title":"1"},"departmentName":"NA"},{"id":2279832,"organisationAddressInfo":{"id":951727,"organisation":{"id":995089,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Clinhouse Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042944","organisationLocationStatus":"Active"},"address":{"addressId":1069431,"oneLine":"Ul. Tarnopolska 77","addressLine1":"Ul. Tarnopolska 77","addressLine2":"","addressLine3":"","addressLine4":"","city":"Zabrze","postcode":"41-807","country":2031,"countryName":"Poland"},"phone":"48881209969","email":"jmoszant@wp.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100042944"},"personInfo":{"id":2527744,"firstName":"Joanna","lastName":"Moszant","telephone":"48881209969","email":"jmoszant@wp.pl","title":"1"},"departmentName":"N/A"},{"id":2279829,"organisationAddressInfo":{"id":948597,"organisation":{"id":991938,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Ginemedica Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100049271","organisationLocationStatus":"Active"},"address":{"addressId":1065675,"oneLine":"Ul. Podwale 83/3","addressLine1":"Ul. Podwale 83/3","addressLine2":"","addressLine3":"","addressLine4":"","city":"Wroclaw","postcode":"50-414","country":2031,"countryName":"Poland"},"phone":"48574386425","email":"katarzyna.okopien@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100049271"},"personInfo":{"id":2527741,"firstName":"Katarzyna","lastName":"Okopien","telephone":"48574386425","email":"katarzyna.okopien@gmail.com","title":"1"},"departmentName":"N/A"},{"id":2279827,"organisationAddressInfo":{"id":948603,"organisation":{"id":991944,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Santa Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100040835","organisationLocationStatus":"Active"},"address":{"addressId":1065681,"oneLine":"Ul. Pilota Stanislawa Wigury 19","addressLine1":"Ul. Pilota Stanislawa Wigury 19","addressLine2":"","addressLine3":"","addressLine4":"","city":"Lodz","postcode":"90-302","country":2031,"countryName":"Poland"},"phone":"48508489097","email":"elzbieta.wagenknecht@ptg-network.com","isBusinessKeyValidated":true,"businessKey":"ORG-100040835"},"personInfo":{"id":2527739,"firstName":"Elżbieta","lastName":"Wagenknecht","telephone":"48508489097","email":"elzbieta.wagenknecht@ptg-network.com","title":"1"},"departmentName":"N/A"},{"id":2279825,"organisationAddressInfo":{"id":948579,"organisation":{"id":991920,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Diamond Clinic Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042453","organisationLocationStatus":"Active"},"address":{"addressId":1065654,"oneLine":"Ul. Stefana Rogozinskiego 6/U3","addressLine1":"Ul. Stefana Rogozinskiego 6/U3","addressLine2":"","addressLine3":"","addressLine4":"","city":"Cracow","postcode":"31-559","country":2031,"countryName":"Poland"},"phone":"+48696049029","email":"barbara@diamondclinic.eu","isBusinessKeyValidated":true,"businessKey":"ORG-100042453"},"personInfo":{"id":2527737,"firstName":"Barbara","lastName":"REWERSKA","telephone":"+48696049029","email":"barbara@diamondclinic.eu","title":"1"},"departmentName":"NA"},{"id":2279830,"organisationAddressInfo":{"id":948583,"organisation":{"id":991924,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"In Vivo Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100042782","organisationLocationStatus":"Active"},"address":{"addressId":1065660,"oneLine":"Ul. Kaszubska 17h","addressLine1":"Ul. Kaszubska 17h","addressLine2":"","addressLine3":"","addressLine4":"","city":"Bydgoszcz","postcode":"85-048","country":2031,"countryName":"Poland"},"phone":"48888455614","email":"annaskimina@onet.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100042782"},"personInfo":{"id":2527742,"firstName":"Anna","lastName":"Kowal-Skimina","telephone":"48888455614","email":"annaskimina@onet.pl","title":"1"},"departmentName":"N/A"},{"id":2279833,"organisationAddressInfo":{"id":955100,"organisation":{"id":998469,"type":"Health care","typeCode":"2","name":"NZOP Mentis","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000018783","organisationLocationStatus":"Active"},"address":{"addressId":1073460,"oneLine":"ul. Kazimierza Karasia 20","addressLine1":"ul. Kazimierza Karasia 20","addressLine2":"","addressLine3":"","addressLine4":"","city":"Leszno","postcode":"64-100","country":2031,"countryName":"Poland"},"phone":"48609205888","email":"krzevo@poczta.onet.pl","isBusinessKeyValidated":false,"businessKey":"ORL-000018783"},"personInfo":{"id":2527745,"firstName":"Bartłomiej","lastName":"Krzewiński","telephone":"48609205888","email":"krzevo@poczta.onet.pl","title":"1"},"departmentName":"N/A"},{"id":2279828,"organisationAddressInfo":{"id":952472,"organisation":{"id":995838,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Nowy Szpital W Olkuszu Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100056432","organisationLocationStatus":"Active"},"address":{"addressId":1070336,"oneLine":"Al. 1000-Lecia Nr. 13","addressLine1":"Al. 1000-Lecia Nr. 13","addressLine2":"","addressLine3":"","addressLine4":"","city":"Olkusz","postcode":"32-300","country":2031,"countryName":"Poland"},"phone":"48727600366","email":"badania.kliniczne@pentahospitals.pl","isBusinessKeyValidated":true,"businessKey":"ORG-100056432"},"personInfo":{"id":2527740,"firstName":"Katarzyna","lastName":"Urbanczyk-Losien","telephone":"48727600366","email":"badania.kliniczne@pentahospitals.pl","title":"1"},"departmentName":"N/A"},{"id":2279831,"organisationAddressInfo":{"id":948592,"organisation":{"id":991933,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Revit Sp. z o.o.","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100044322","organisationLocationStatus":"Active"},"address":{"addressId":1065670,"oneLine":"Ul. Swobodna 38","addressLine1":"Ul. Swobodna 38","addressLine2":"","addressLine3":"","addressLine4":"","city":"Bialystok","postcode":"15-756","country":2031,"countryName":"Poland"},"phone":"48667980448","email":"jacekdobryniewski@gmail.com","isBusinessKeyValidated":true,"businessKey":"ORG-100044322"},"personInfo":{"id":2527743,"firstName":"Jacek","lastName":"Dobryniewski","telephone":"48667980448","email":"jacekdobryniewski@gmail.com","title":"1"},"departmentName":"N/A"},{"id":2279823,"organisationAddressInfo":{"id":194091,"organisation":{"id":197615,"type":"Health care","typeCode":"2","name":"Praktyka Lekarska Małgorzata Wojtanowska-Bogacka","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000002392","organisationLocationStatus":"Active"},"address":{"addressId":206053,"oneLine":"ul. Barwicka 14 h/4","addressLine1":"ul. Barwicka 14 h/4","addressLine2":"","addressLine3":"","addressLine4":"","city":"Poznań","postcode":"60-192","country":2031,"countryName":"Poland"},"phone":"+48604900927","email":"szymkowiaksylwia@gmail.com","isBusinessKeyValidated":false,"businessKey":"ORL-000002392"},"personInfo":{"id":2527735,"firstName":"Malgorzata","lastName":"Wojtanowska-Bogacka","telephone":"48502265707","email":"bogacka@onet.eu","title":"1"},"departmentName":"N/A"},{"id":2279826,"organisationAddressInfo":{"id":950054,"organisation":{"id":993408,"type":"Health care","typeCode":"2","name":"MentalMEDIC Grzegorz Giemza, Gliwickie Centrum Psychiatrii i Psychoterapii","commercial":false,"isBusinessKeyValidated":false,"businessKey":"ORL-000018692","organisationLocationStatus":"Active"},"address":{"addressId":1067414,"oneLine":"ul. Żółkiewskiego 38","addressLine1":"ul. Żółkiewskiego 38","addressLine2":"","addressLine3":"","addressLine4":"","city":"Bielsko-Biała","postcode":"43-300","country":2031,"countryName":"Poland"},"phone":"48784269898","email":"grzegorz.giemza@cbkmentalmedic.pl","isBusinessKeyValidated":false,"businessKey":"ORL-000018692"},"personInfo":{"id":2527738,"firstName":"Grzegorz","lastName":"Giemza","telephone":"48784269898","email":"grzegorz.giemza@cbkmentalmedic.pl","title":"1"},"departmentName":"N/A"}],"applicationStatusCode":"Authorised"}],"applicationInfo":[{"id":55131,"type":"INITIAL","status":"Authorised","ctNumber":"2025-522310-24-00","trialStatus":"Authorised","submissionDate":"2026-05-06","partI":{"assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-08-19"},"partIIInfo":[{"id":332783,"mscId":59565,"mscInfo":{"id":59565,"mscName":"Germany","countryOrganisationId":2013,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-21","decision":"authorized_conditions","decisionDate":"2026-08-24","reportingStatusCode":"Authorised","countryName":"Germany","trialStatus":"Authorised","firstDecisionDate":"2026-08-24"},"applicationStatusCode":"Authorised"},{"id":316449,"mscId":59566,"mscInfo":{"id":59566,"mscName":"Greece","countryOrganisationId":2014,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-06-29","decision":"authorized_conditions","decisionDate":"2026-08-19","reportingStatusCode":"Authorised","countryName":"Greece","trialStatus":"Authorised","firstDecisionDate":"2026-08-19"},"applicationStatusCode":"Authorised"},{"id":328882,"mscId":59567,"mscInfo":{"id":59567,"mscName":"Spain","countryOrganisationId":2027,"assessmentOutcome":"acceptable","assessmentOutcomeDate":"2026-08-18","decision":"authorized_conditions","decisionDate":"2026-08-24","reportingStatusCode":"Authorised","countryName":"Spain","trialStatus":"Authorised","firstDecisionDate":"2026-08-24"},"applicationStatusCode":"Authorised"},{"id":325071,"mscId":59568,"mscInfo":{"id":59568,"mscName":"Poland","countryOrganisationId":2031,"assessmentOutcome":"acceptable_conditions","assessmentOutcomeDate":"2026-08-21","decision":"authorized_conditions","decisionDate":"2026-08-25","reportingStatusCode":"Authorised","countryName":"Poland","trialStatus":"Authorised","firstDecisionDate":"2026-08-25"},"applicationStatusCode":"Authorised"}],"decisionDate":"2026-08-19","ctMSCsByApplication":[{"id":59565,"mscName":"Germany","reportingStatusCode":"Authorised"},{"id":59566,"mscName":"Greece","reportingStatusCode":"Authorised"},{"id":59567,"mscName":"Spain","reportingStatusCode":"Authorised"},{"id":59568,"mscName":"Poland","reportingStatusCode":"Authorised"}],"businessKey":"IN","allPartTwosOutOfScope":false,"applicationTrialDecisionByMsc":{},"decisions":[{"id":139088,"applicationId":55131,"mscId":59568,"mscName":"Poland","decisionDate":"2026-08-25T09:26:13.51","decision":"authorized_conditions","assessmentOutcome":"acceptable_conditions","eventType":"decision","part2Id":325071,"part1Id":130155,"applicationType":"INITIAL","isRMS":false},{"id":138453,"applicationId":55131,"mscId":59566,"mscName":"Greece","decisionDate":"2026-08-19T13:16:43.48","decision":"authorized_conditions","assessmentOutcome":"acceptable","eventType":"decision","part2Id":316449,"part1Id":130155,"applicationType":"INITIAL","isRMS":false},{"id":138832,"applicationId":55131,"mscId":59567,"mscName":"Spain","decisionDate":"2026-08-24T08:28:55.045","decision":"authorized_conditions","assessmentOutcome":"acceptable","eventType":"decision","part2Id":328882,"part1Id":130155,"applicationType":"INITIAL","isRMS":false},{"id":138955,"applicationId":55131,"mscId":59565,"mscName":"Germany","decisionDate":"2026-08-24T13:58:20.537","decision":"authorized_conditions","assessmentOutcome":"acceptable","eventType":"decision","part2Id":332783,"part1Id":130155,"applicationType":"INITIAL","isRMS":true}]}],"trialGlobalEnd":[],"memberStatesConcerned":[{"mscName":"Poland","mscId":59568,"firstDecisionDate":"2026-08-25T09:26:13.51","lastDecisionDate":"2026-08-25T09:26:13.51","mscPublicStatusCode":3},{"mscName":"Greece","mscId":59566,"firstDecisionDate":"2026-08-19T13:16:43.48","lastDecisionDate":"2026-08-19T13:16:43.48","mscPublicStatusCode":2},{"mscName":"Spain","mscId":59567,"firstDecisionDate":"2026-08-24T08:28:55.045","lastDecisionDate":"2026-08-24T08:28:55.045","mscPublicStatusCode":2},{"mscName":"Germany","mscId":59565,"firstDecisionDate":"2026-08-24T13:58:20.537","lastDecisionDate":"2026-08-24T13:58:20.537","mscPublicStatusCode":3}],"eudraCt":{"isTransitioned":false}},"events":{"temporaryHaltList":[],"trialEvents":[{"mscId":59565,"mscName":"Germany","events":[{"notificationType":"START_OF_TRIAL","date":"2026-09-18"}]},{"mscId":59566,"mscName":"Greece","events":[]},{"mscId":59567,"mscName":"Spain","events":[]},{"mscId":59568,"mscName":"Poland","events":[{"notificationType":"START_OF_TRIAL","date":"2026-09-24"}]}],"unexpectedEvents":[],"seriousBreaches":[],"urgentSafetyMeasures":[]},"results":{},"documents":[{"title":"D4_Patient Facing Document_Copyright Statement","uuid":"020ba8bf-ed28-415a-bc8d-bff0efa905cb","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_Protocol 2025-522310-24-00 for publication","uuid":"0dcbf388-d8f3-4154-b2c1-64ca35e74269","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"initial","systemVersion":"1"},{"title":"D1_Protocol_2025-522310-24-00_GR_Redacted","uuid":"e86ba4b7-f82b-4b1b-a750-ab94c08779c4","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"Initial","systemVersion":"1"},{"title":"D4_Study Participant Contact Card_GR","uuid":"481327b9-4795-41ce-8f88-c0055984e400","documentType":"104","documentTypeLabel":"Protocol (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"2","systemVersion":"1"},{"title":"D1_Protocol synopsis_2025-522310-24-00_Redacted","uuid":"7b59a031-b2e0-4d38-b7c5-67453b5f6eba","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"1","systemVersion":"1"},{"title":"D1_Protocol Synopsis_2025-522310-24-00_Redacted_ENG","uuid":"8539de42-15de-428d-afb1-9c683266a246","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"1.0","systemVersion":"1"},{"title":"D1_Protocol Synopsis_2025-522310-24-00_GR_Redacted","uuid":"b81003bc-3ddb-4013-888d-5d10119e9155","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"Initial","systemVersion":"1"},{"title":"D1_Protocol Synopsis_2025-522310-24-00_Redacted","uuid":"633c1e31-3c1a-4a30-a356-fb9ba76f4e35","documentType":"7","documentTypeLabel":"Synopsis of the protocol (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":130155,"manualVersion":"1.0","systemVersion":"1"},{"title":"K1_recruitment arrangements statement","uuid":"56e05a19-9331-4d75-add2-1cbcbb82b294","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Poster_DIGITAL_Master","uuid":"f0e2780d-bd3d-4e6b-aad4-8832e482ad9d","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Poster_PRINT_Master","uuid":"547e884b-0c8a-4691-8e5c-11b79e372880","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Neuro MDD Info_Master","uuid":"22c88f78-9699-48f1-9704-bfd81230bdf6","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K3_ZoomHealth_PrivacyStatement","uuid":"49698b90-98d7-43c2-bbe8-c32f1eb0974f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K3_ZoomHealth Screenshots","uuid":"21a6473b-7c35-4a4c-93fb-08b166907eee","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K3_ZoomHealth_TermsofService","uuid":"91d1425c-cfca-450b-b8f9-7850808aa7be","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K1_Informed consent and patient recruitment procedure_DE","uuid":"ef6e03d4-469b-4e81-89ae-c7c4c6d70e79","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment Material_Trialbee_SelfAssessment_Redacted","uuid":"e54347f2-847e-46a7-ad61-01f4a2c15c36","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment Material_Trialbee_SecondaryAssessment_Redacted","uuid":"48e92415-4c81-4cd3-aa62-c3b0ff8d55a7","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"2"},{"title":"K2_Recruitment Material_Trialbee_AnimatedVideoStoryboard_Redacted","uuid":"6f281692-88dd-4ec8-8b2b-53ba6cb5d473","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment Material_Trialbee_Global Privacy Policy","uuid":"0ff4e05a-c7a6-41f6-a219-78b2adf0dd9e","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Trialbee_DigitalMarketingContent","uuid":"0bc993ae-2d1b-4c4b-a17e-e63857e22e7c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"1"},{"title":"K2_Recruitment Material_Brochure_DIGITAL_Master_Redacted","uuid":"ce14c9a6-99b4-4a18-b12d-fc4684f9019f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_Brochure_PRINT_Master_Redacted","uuid":"100f6f9d-96b9-439b-8ed3-c8ea3be911b4","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment Material_LT Trial Page_Master_Redacted","uuid":"d0e8e76a-834a-4b81-952f-e2e664382d01","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"L3_patient contact card","uuid":"6d83404b-fd97-441e-b718-b9ae826ecc85","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main ICF_Redacted","uuid":"c5bd250a-0354-47df-9484-cd9668c2bb22","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.2","systemVersion":"3"},{"title":"L1_SIS and ICF_Addendum Pregnant Partner","uuid":"c5d5558d-824f-4c93-a1e6-330e8697dc06","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":29,"fileType":"PDF","associatedEntityId":332783,"manualVersion":"1.0","systemVersion":"1"},{"title":"K1_recruitment arrangements statement","uuid":"981ad752-7fa6-4f48-a960-3ac761639eb5","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_DigitalMarketingContent_GR","uuid":"803aa13f-8e3b-4f68-b378-97a6c9399a39","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Poster_Digital_GR","uuid":"3a1100cd-208e-43a6-83e4-cc4d23d1c141","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Poster_GR","uuid":"f5d6b24a-c903-4359-ad00-f8c42c1faf04","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_LT-Trial-Page_GR_Redacted","uuid":"7eb72069-4907-4333-a9cc-14945766785d","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_AnimatedVideoStoryboard_GR_Redacted","uuid":"9d75c6d9-01ea-49fa-b60a-e1262fcc594d","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_SelfAssessment_GR_Redacted","uuid":"40701da1-c44b-4768-abe2-6fda7fe2150f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee_SecondaryAssessment_GR_Redacted","uuid":"b06dde24-7df7-4893-a910-6457b19db2e9","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee Global Privacy Policy_GR","uuid":"80b2a891-474d-4884-b673-fa23dd879624","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":5,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Trialbee Overview Supplementary Information_GR","uuid":"c32124c2-eaaf-457b-80d1-3d495b5d37d1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Study Participant Contact Card_GR","uuid":"2ed856ea-2e7f-46ad-9531-2158f5eed8f9","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"2","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Postcard_TY-Video-Dropout_GR","uuid":"db5fb9fa-4852-4052-95ed-4947f577b7c3","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"3.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Postcard_TY-Video-End-of-Study_GR","uuid":"4a252cdd-4d24-4a4e-8028-979969715898","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"3.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Postcard_TY-Video-Screening_GR","uuid":"c3eb3a69-47d4-4b1c-bbf7-d9c218bf908a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"3.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Supportive-Partner-Guide_GR","uuid":"02378eb7-80cb-4bb1-b07c-369b3602f96b","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"2.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Video-Storyboard-Thank-You-Dropout_GR","uuid":"075f2f80-6e8d-4b83-92e6-bdd55e8b8f6a","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Video-Storyboard-Thank-You-End-Of-Study_GR","uuid":"6579350b-e04d-4faf-8e4c-2fbe72b9d7cf","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_CT_Video-Storyboard-Thank-You-Screening_GR","uuid":"497a747e-921d-44b5-a5b5-97a15eeeebf8","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1.1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_End-of-Study-Letter_GR","uuid":"ad292093-e321-4655-a147-57b105d9e7d5","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Other Subject Information Material_Subject Instructions for Use of IP_GR_Redacted","uuid":"d17fd6a1-28f0-4a35-abb2-18bb61230310","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"L1_Recruitment and Informed consent procedure","uuid":"19db3ebf-be63-4320-8308-b81b8788f5df","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1","systemVersion":"1"},{"title":"L1_ICF_Main_GR_Redacted","uuid":"e4ae3c3f-c1db-4908-988e-394836b530ff","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":32,"fileType":"PDF","associatedEntityId":316449,"manualVersion":"1.1","systemVersion":"2"},{"title":"K2_Recruitment material_Brochure_Print_Redacted","uuid":"c61bc9cf-e5a1-415f-84d4-6e84c502b6b5","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.1","systemVersion":"3"},{"title":"K2_Recruitment material_Brochure_Digital_Redacted","uuid":"24e2c48e-7597-4827-a55f-25f409c8672b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.1","systemVersion":"3"},{"title":"K2_Recruitment Material_Neuro_MDD-Info_ES","uuid":"40266e94-daf4-4b5d-8649-b775bc06f96b","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Poster_Digital","uuid":"a063d8a0-eebc-4dc2-be9e-6e36a1e4e6a0","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.1","systemVersion":"3"},{"title":"K2_Recruitment material_Poster_Print","uuid":"ddd0713b-1273-4f1f-987d-73fb1c53f248","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.1","systemVersion":"3"},{"title":"K3_Trialbee_OverviewSupplementaryInformation","uuid":"5533f90b-91b1-45f5-9123-2dd0d679b7f9","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Trialbee_Global Privacy Policy","uuid":"dda00f17-ce32-44dc-8840-a1d35d35968e","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.0","systemVersion":"1"},{"title":"K1_recruitment arrangements statement","uuid":"c35ee8ff-f329-487f-9911-4fc3bdb51b8f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":6,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Trialbee_DigitalMarketingContent","uuid":"3c9dfe40-7c10-4473-97de-100accc00bcd","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1.0","systemVersion":"1"},{"title":"K3_Trialbee_SecondaryAssessment_Redacted","uuid":"8c42573c-f316-45c8-a7eb-64ac5efa6f34","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"1"},{"title":"K3_Trialbee_SelfAssessment_Redacted","uuid":"4fd33828-b7b2-4751-85b3-5b3b0d2c2538","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"1"},{"title":"K3_Trialbee_AnimatedVideoStoryboard_Redacted","uuid":"afdc6541-2601-44be-baa2-769f8763d7b1","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"1"},{"title":"L1_SIS and ICF_Main_Redacted","uuid":"a9290a4f-904e-41e0-b008-a5d6f5553498","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"4"},{"title":"L2_Other subject information material_Patient Emergency Card","uuid":"0438dce5-bd02-47d7-8a38-630a9406fc5e","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"1"},{"title":"L1_SIS and ICF_Pregnant Partner Consent_Redacted","uuid":"d11ebb17-097c-4632-8b2a-be21f138158f","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":7,"fileType":"PDF","associatedEntityId":328882,"manualVersion":"1","systemVersion":"3"},{"title":"K1_Recruitment arrangements_PL","uuid":"f3bb3a14-72ce-4e3c-9720-e17fe702845f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Poster_DIGITAL_Master","uuid":"b327f3d4-f7f4-44bd-8e88-141b8188b656","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_Neuro_MDD-Info_Master","uuid":"f7999146-492d-4ff8-b02f-8869dbe74f06","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Brochure_DIGITAL_Master_Redacted","uuid":"4d22d3a3-65d4-4c9e-a327-0641c9369e0a","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Brochure_PRINT_Master_Redacted","uuid":"b607e71e-9065-415a-8cdb-8de4ace4738a","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Poster_PRINT_Master","uuid":"1cabbdda-1c22-441e-bc17-707e003fc62f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_LT Trial Page_Master_Redacted","uuid":"cebc0d15-1742-47cf-94fa-a36277b715da","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Trialbee_SecondaryAssessment_Redacted","uuid":"62af08a6-2c8a-4b86-b911-6043a6f3d71f","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"2"},{"title":"K2_Recruitment material_Trialbee_Global Privacy Policy","uuid":"21aeffeb-2046-4f15-b856-c572781b52c3","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Trialbee_AnimatedVideoStoryboard_redacted","uuid":"484c5afd-f9cd-428d-a95d-bb856729fdd8","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Trialbee_SelfAssessment_Redacted","uuid":"3251161c-a5b8-4830-b8de-39aadb8c5bbf","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"K2_Recruitment material_GZMI_Trialbee_DigitalMarketingContent","uuid":"46c0a371-369d-4800-9a33-972f7838244c","documentType":"14","documentTypeLabel":"Recruitment arrangements (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L3_Info Re insurance Conditions for Patients","uuid":"9ab23869-5829-442a-87ea-c4a43df7a231","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Other subject information material_Polish_ZoomHealth_Screenshots","uuid":"8ad1ea82-57f3-4355-ac4f-daaae4bc47fa","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Other subject information material_Polish_ZoomHealth_PrivacyStatement","uuid":"47f4a693-6a5a-46a8-bd73-707a84f0bfb6","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Other subject information material_Polish_ZoomHealth_TermsofService","uuid":"4d645437-5b2c-4753-a578-e835e9f31696","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L2_Informed consent and patient recruitment procedure","uuid":"bfeabe92-fd2a-4501-8e0a-a509ee136b94","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1","systemVersion":"1"},{"title":"L1_SIS and ICF_PL_Main ICF_Redacted","uuid":"213f644b-27b1-4939-9001-3527f0e8d020","documentType":"15","documentTypeLabel":"Subject information and informed consent form (for publication)","languageCode":19,"fileType":"PDF","associatedEntityId":325071,"manualVersion":"1.1","systemVersion":"3"}],"trialRegion":"Both","trialRegionCode":3,"correctiveMeasures":[]}