Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
10,000
Countries
14
Sites
260
Overweight
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function and kidney outcomes.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 28 May 2024 → ongoing
- Decision date (initial)
- 2024-05-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508630-34-00
- WHO UTN
- U1111-1297-5097
- ClinicalTrials.gov
- NCT05882045
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function and kidney outcomes.
Conditions and MedDRA coding
Overweight
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Must be 45 years old or older
- Have BMI of >27.0 kg/m2
- Have established ASCVD and/or CKD
- With or without T2D as long as HbA1c<10%
Exclusion criteria 7
- Have Type 1 Diabetes
- Have had or plan to have a surgical treatment for obesity
- Have an eGFR <20 mL/min/1.73 m2 at screening
- Have any of the following cardiovascular conditions ≤ 90 days prior to randomization: Myocardial infarction, Acute coronary syndrome, Stroke, or coronary, peripheral, or carotid artery arterial revascularization procedure
- Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
- Have acute decompensated heart failure requiring hospitalization
- Have New York Heart Association (NYHA) Classification Class IV heart failure at screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Time to First Occurrence of Composite Endpoints A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF)
- Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10345188 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345508 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345551 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345489 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345209 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 5 |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| Indiana University ORL-000004548
|
Bloomington, IN, United States | Code 10 |
| Brightech International, LLC ORL-000001391
|
Somerset, NJ, United States | Code 10 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| R&G US Inc. ORL-000004546
|
Somerset, NJ, United States | Code 10 |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other |
Locations
14 EU/EEA countries · 260 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 96 | 13 |
| Belgium | Ongoing, recruitment ended | 81 | 20 |
| Czechia | Ongoing, recruitment ended | 251 | 33 |
| Denmark | Ongoing, recruitment ended | 155 | 6 |
| France | Ongoing, recruitment ended | 58 | 17 |
| Germany | Ongoing, recruitment ended | 382 | 24 |
| Greece | Ongoing, recruitment ended | 128 | 11 |
| Hungary | Ongoing, recruitment ended | 159 | 14 |
| Italy | Ongoing, recruitment ended | 139 | 15 |
| Netherlands | Ongoing, recruitment ended | 365 | 30 |
| Poland | Ongoing, recruitment ended | 304 | 20 |
| Romania | Ongoing, recruitment ended | 247 | 21 |
| Slovakia | Ongoing, recruitment ended | 240 | 22 |
| Spain | Ongoing, recruitment ended | 111 | 14 |
| Rest of world
Israel, Argentina, United States, United Kingdom, Mexico, Brazil, Ukraine, India, Australia, Canada, Turkey
|
— | 7,284 | — |
Investigational sites
Vivit Institute
VIVIT - Vorarlberg Institute for Vascular Investigation and Treatment, Carinagasse 47, 6800, Feldkirch
A.O. Krankenhaus St. Josef Braunau GmbH
Internal Medicine I, Ringstrasse 60, 5280, Braunau Am Inn
Imed19-Privat
Imed19-privat, Chimanistrasse 1, Doebling, Vienna
Ordensklinikum Linz GmbH
Nephrologie, Fadingerstrasse 1, 4020, Linz
Private Practice - Dr. Evelyn Fließer-Görzer
Private Practice - Dr. Evelyn Fließer-Görzer, Kastaniensiedlung 1, 8511, Sankt Stefan ob Stainz
Klinik Landstrabe
1st Medical Department, Juchgasse 25, Landstrasse, Vienna
Medizinische Universitaet Innsbruck
Internal Medicine 1, Anichstrasse 35, 6020, Innsbruck
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Medicine III, Division of Endocrinology and Metabolism, Waehringer Guertel 18-20, Alsergrund, Vienna
Cardio Metabolic Centre
N/A, Hauptplatz 3/1/1.10, 7210, Mattersburg
Medical University Of Graz
Department of Internal Medicine, Division of Endocrinology and Diabetology, Auenbruggerplatz 15, 8036, Graz
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstrasse 1, Hietzing, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Zentrum Fur Klinische Studien Dr. Hanusch GmbH, Gumpendorfer Strasse 95/9, Mariahilf, Vienna
Konvent Der Barmherzigen Brueder
Internal Medicine, Seilerstaette 2, 4020, Linz
Cliniques Universitaires Saint-Luc
Nephrology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Jan Yperman Ziekenhuis
Endocrinology, Briekestraat 12, 8900, Ieper
UZ Leuven
Nephrology, Herestraat 49, 3000, Leuven
Jessa Ziekenhuis
Cardiology, Stadsomvaart 11, 3500, Hasselt
Centre hospitalier universitaire de Liege
Diabetes, Nutrition and Metabolics disorders, Avenue De L'hopital 1, 4000, Liege
Algemeen Ziekenhuis Groeninge
Endocrinology, President Kennedylaan 4, 8500, Kortrijk
Imelda
Associatie Dialyse Endocrinologie, Imeldalaan 9, 2820, Bonheiden
Algemeen Ziekenhuis Delta
Nephrology, Deltalaan 1, 8800, Roeselare
Hopital Erasme
Endocrinologie, Lennikse Baan 808, 1070, Anderlecht
Anima
NA, Alkerstraat 28, 3570, Alken
Het Ziekenhuisnetwerk Antwerpen
Endocrinologie, Lange Bremstraat 70, 2170, Antwerp
Algemeen Ziekenhuis Klina
Cardiologie, Augustijnslei 100, 2930, Brasschaat
Onze-Lieve-Vrouwziekenhuis
Endocrinologie, Moorselbaan 164, 9300, Aalst
UZ Brussel
Diabeteskliniek, Laarbeeklaan 101, 1090, Jette
Kormont
Cardiology, Kwaremontplein 45, 9690, Kluisbergen
AZ Oostende vzw
Endocrinology, Gouwelozestraat 100, route 10, Oostende
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Cardiology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Universitair Ziekenhuis Gent
Nephrology, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Oost Limburg
Nephrology, Synaps Park 1, 3600, Genk
Antwerp University Hospital
Endocrinology-Diabetology-Metabolism, Drie Eikenstraat 655, 2650, Edegem
Edumed s.r.o.
Diabetologická ambulance, Mlynska 189, 547 01, Nachod
Centrum kardiovaskulární medicíny s.r.o
N/A, Poliklinika Pod Marjánkou, Pod Marjánkou 1906/12, Praha 6
Diabetologicke centrum s.r.o.
N/A, Krapkova 5, 779 00, Olomouc
Kardiologie Stribrny s.r.o.
NA, Koliste 141/47, Zabrdovice, Brno
Medicus Services s.r.o.
Kardiologicka ambulance, Nadrazni 1317/5, 250 01, Brandys Nad Labem
Synexus Czech s.r.o.
N/A, Karlovo Namesti 2097/10, Nove Mesto, Prague
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Kardiologicka ambulance, Palackeho 201, 541 01, Horni Predmesti
MUDr. Miroslav Koliba s.r.o.
N/A, Bieblova 410/2, Moravska Ostrava, Ostrava
ResTrial s.r.o.
N/A, Zhorelecka 514/2, Bohnice, Prague 8
Diahaza s.r.o.
Interní a diabetologická ambulance, Palackeho 492/62, 769 01, Holesov
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Fledip s.r.o.
Endokrinologie a diabetologie, Na dlouhem lanu, 160 00, Prague 6
MaderMED s.r.o.
Interní, diabetologická a cévní ambulance, Chittussiho 1001/9, 710 00, Slezska Ostrava
Agentura Science Pro spol. s r.o.
N/A, Dlouha 521/34, 779 00, Lazce
Fakultni Nemocnice U Sv Anny V Brne
I. interni kardioangiologicka klinika, Pekarska 53, Stare Brno, Brno-Stred
Kardiologicka ambulance
Kardiologicka ambulance, Vítězná 173/1A, Litovel, Olomoucký kraj
PreventaMed s.r.o.
N/A, Domovina 774/2, 779 00, Olomouc
Kardio Chlumec s.r.o.
N/A, Nadrazni 783, 503 51, Chlumec Nad Cidlinou Iv
Diakom s.r.o.
N/A, Husova 760, 33401, Přeštice
Pedicor Trial s.r.o.
Kardiologicka a Angiologicka Ambulance, Horni 266/73, Dubina, Ostrava
MUDr. Jana Parkanyiova
N/A, Revoluční 765/19, 110 00, Praha 1
Cardio Research s.r.o.
Kardiologicka ambulance, J. A. Bati 5645, 760 01, Zlin
Fakultni Thomayerova nemocnice
N/A, Videnska 800, Krc, Prague 4
Fakultni Nemocnice U Sv Anny V Brne
I. interni kardioangiologicka klinika, Pekarska 53, 656 91, Brno
MEDICON a.s.
N/A, Antala Staska 1670/80, Krc, Prague 4
Nefrologie s.r.o.
N/A, Hviezdoslavova 1600, 149 00, Praha 4
Clinical Trials Service s.r.o.
N/A, Masarykovo Namesti 155, 686 01, Uherske Hradiste
Diabetologie a endokrinologie J. Venerova s.r.o.
N/A, Pod Marjánkou 1906/12, 169 00, Praha 6
MUDr. Barbora Diepoltova
Diabetologicka ambulance, Axmanova 131, Klanovice, Praha 9
Univmed s.r.o.
N/A, Žerotínovo nám. 533/6, 602 00, Brno
Nemocnice Cesky Krumlov a.s.
Interní oddělení, Nemocnicni 429, 381 01, Horni Brana
Corintez s.r.o.
Internal Medicine and Cardiology, Seydlerova 2451/8, Stodulky, Prague 13
Kardioma s.r.o.
Kardiologická a interní ambulance, Jana Vostrcila 1531, 280 02, Kolin V
Sanos A/S
N/A, Boulevarden 19g, 7100, Vejle
Sanos A/S
Sanos Clinic, Herlev Hovedgade 82, 2730, Herlev
Sanos A/S
N/A, Borgergade 39, 9362, Gandrup
Herlev and Gentofte Hospital
N/A, Borgmester Ib Juhls Vej 17, 3. sal, Herlev
Sygehus Soenderjylland Soenderborg
N/A, Kresten Philipsens Vej 15, 6200, Aabenraa
Region Midtjylland
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Centre Hospitalier Universitaire De Nice
Cardiology, 30 Voie Romaine, 06000, Nice
Les Hopitaux De Chartres
Cardiology-Diabetology-Nephrology, 4 Rue Claude Bernard, 28630, Le Coudray
Assistance Publique Hopitaux De Paris
Nutrition, 20 Rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire De Montpellier
Nutrition-diabetes, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Pellegrin Hospital
Nephrology, Place Amelie Raba Leon, 33000, Bordeaux
Polyclinique Vauban
Cardiology, 10 Avenue Vauban, 59300, Valenciennes
Centre Hospitalier Universitaire De Toulouse
Diabetology-Metabolic diseases-Nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Endocrinology-Diabetology-Nutrition, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre Hospitalier Sud Francilien
Endocrinology-Diabetology, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
CHU Gabriel-Montpied
Nutrition, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Universitaire De Nantes
Endocrinology-Diabetology-Nutrition, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire Rouen
Néphrologie, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Centre Hospitalier Regional Universitaire De Tours
Nephrology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire Grenoble Alpes
Nephrology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Endocrinology-Diabetology-Nutrition, Avenue De Magellan, 33600, Pessac
Hopital Universitaire Pitie Salpetriere
Cardiovascular Prevention Unit, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Les Hopitaux Universitaires De Strasbourg
Medecine Interne, Endocrinologie et Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
FutureMeds GmbH
N/A, Wilmersdorfer Strasse 79, Charlottenburg, Berlin
Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
N/A, Wandsbeker Marktstrasse 73, Wandsbek, Hamburg
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
Kardiologisch-Angiologische Praxis Herzzentrum Bremen
N/A, Senator-Wessling-Strasse 1A, 28277, Bremen
Zentrum fuer klinische Studien Suedbrandenburg GmbH
N/A, Bahnhofstrasse 22, 04910, Elsterwerda
Nephrologisches Zentrum Villingen-Schwenningen
N/A, Albert-Schweitzer-Strasse 6, 78052, Villingen-Schwenningen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
1. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
N/A, Heidering 31, Heideviertel, Hanover
Uhz Klinische Forschung
N/A, Unterstrasse 75, Frintrop, Essen
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik III, Kardiologie, Nephrologie, Angiologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Dr. med. Andreas Wilke Dr. med. Andrej Malazhavy und Detelin Lalev Denchev Fachaerzte Innere Medizin und Kardiologie Partnerschaft
N/A, Hauptkanal Links 100, Papenburg-Untenende, Papenburg
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
CRS Clinical Research Services Management GmbH
N/A, Grenadierstrasse 1, Neckarstadt, Mannheim
Ambenet GmbH Das Ambulante Behandlungsnetz
AmBeNet GmbH, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Universitaetsklinikum Schleswig-Holstein AöR
Universität zu Lübeck. Institut für Endokrinologie und Diabetes, Ratzeburger Allee 160, 23538, Luebeck
Zentrum für klinische Studien Allgäu Oberschwaben. Praxis Sauter & Sauter & Dr. Vorbach
Zentrum für klinische Studien Allgäu Oberschwaben. Praxis Sauter & Sauter & Dr. Vorbach, Herrenstraße 22-24, 88239, Wangen
St. Johannes Hospital Dortmund
Clinic of Internal medicine I, Johannesstraße 9-17, 44137, Dortmund
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
N/A, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Zentrum für klinische Studien
N/A, Hauptstraße 98, 66386, St. Ingbert
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
Studienzentrum, Haus A, Enderstrasse 59, Dresden
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medical Clinic III, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitat Heidelberg
N/A, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Athens Medical Center S.A.
Diabetes Department, Areos 36, 175 62, Paleo Faliro
University General Hospital Of Ioannina
Endocrinology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Euromedica General Clinic Of Thessaloniki
Endocrinology, Diabetes and Metabolism Department, Kallas Marias 11, Gravias 2, Thessaloniki
Athens Medical Center S.A.
Internal Medicine Clinic, Adersen 1, 115 25, Athens
General University Hospital Of Larissa
Endocrinology Clinic and Metabolic Diseases, P. O. Box 1425, 411 10, Larissa
General Hospital Of Thessaloniki Papageorgiou
1st Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Laiko General Hospital Of Athens
Diabetes Center, 1st Propaedeutic Internal Medicine Department, Agiou Thoma (goudi) 17, 115 27, Athens
Athens Medical Center S.A.
Department of Internal Medicine, Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi
General Hospital Of Athens G Gennimatas
Endocrinology Department, Messogion Avenue 154, 115 27, Athens
424 Military General Training Hospital
2nd Internal Medicine Clinic, Ring Road, N. Efkarpia, Thessaloniki
General Hospital Of Thessloniki G Gennimatas
Internal Medicine Clinic, Ethnikis Aminis 41, 546 35, Thessaloniki
University Of Debrecen
Belgyogyaszati Intezet, Nagyerdei Korut 98, 4032, Debrecen
Allergo-Derm Bakos Kft.
N/A, Baross Utca 20, 5000, Szolnok
CRU Hungary Kft.
N/A, Semmelweis Ter 1, 2143, Kistarcsa
Ujpesti Egeszsegugyi Nonprofit Kft.
N/A, Gorgey Artur Ut 30, 1046, Budapest IV
Semmelweis University
Varosmajori Sziv-és Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Komaromi Selye Janos Korhaz
Diabetologia, Beothy Zsolt Utca 4, 2900, Komarom
Privat Doktor Egeszseguegyi Szolgaltato Zrt.
N/A, Visegradi Utca 40, 1132, Budapest XVIII
University Of Szeged
Szent-Gyorgyi Albert Klinikai Kozpont, Kalvaria Sugarut 57, 6725, Szeged
Central Hospital Of Northern Pest Military Hospital
N/A, Podmaniczky Utca 109, 1062, Budapest VI
Obudai Egeszsegugyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Central Hospital Of Northern Pest Military Hospital
II. Belgyógyászat, Robert Karoly Korut 44, 1134, Budapest XIII
Zala Varmegyei Szent Rafael Korhaz
Diabetologia, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Szent Margit Rendelointezet
N/A, Vorosvari Ut 88-96/III, III Kerulet, Budapest III
DRC Kft.
N/A, Dozsa Gyorgy Utca 22, 8313, Balatongyorok
Fondazione Policlinico Universitario Campus Bio-Medico
Research Unit of Endocrinology and Diabetes, Department of Medicine and Surgery, Via Alvaro Del Portillo N 200, 00128, Rome
Centro Cardiologico Monzino S.p.A.
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, Via Carlo Parea 4, 20138, Milan
Ospedale San Raffaele S.r.l.
Unità Cardio-Metabolica e Trials Clinici, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Pisana
Department of Clinical and Experimental Medicine - Endocrine Unit, Via Paradisa 2, 56124, Pisa
Policlinico San Donato S.p.A.
Endocrinologia, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Ospedaliero Universitaria Pisana
Dipartimento di Medicina Clinica e Sperimentale, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UO Nefrologia, Dialisi e Trapianto, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Ospedale Policlinico San Martino
" Dept. of Internal Medicine (DIMI)", Viale Benedetto XV 6, 16132, Genoa
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Dipartimento Assistenziale Integrato Medico, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dept. of Medical and Surgical sciences - UOC Endocrinologia e Prevenzione e Cura del Diabete, Via Pietro Albertoni 15, 40138, Bologna
Hospital Santa Maria Della Misericordia
Struttura Complessa di endocrinologia e malattie metaboliche, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
SC Malattie Endocrine-Diabetologia, Piazza Oms 1, 24127, Bergamo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento Scienze Mediche e Chirurgiche -Obesità, Largo Francesco Vito 1, 00168, Rome
University Hospital Of Ferrara
Centro dello Scompenso, Cona, Via Aldo Moro 8, Ferrara
Azienda Ospedaliero-Universitaria Policlinico Umberto I
UOD Diabetologia, Viale Del Policlinico 155, 00161, Rome
Medisch Centrum Thomsonplein
General Practice, Thomsonplein 23, 2565 KV, The Hague
Amsterdam UMC, location AMC
Internal Medicine, Meibergdreef 9, A01-113, Amsterdam
Medisch Spectrum Twente
Cardiology, Koningsplein 1, 7512 KZ, Enschede
Het Van Weel-Bethesda Ziekenhuis
Cardiology, Stationsweg 22, 3247 BW, Dirksland
St. Antonius Ziekenhuis
Nephrology, Koekoekslaan 1, 3435 CM, Nieuwegein
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Cardiology, Tegelseweg 210, 5912 BL, Venlo
Rode Kruis Ziekenhuis B.V.
Cardiology, Vondellaan 13, 1942 LE, Beverwijk
Universitair Medisch Centrum Utrecht
Internal Medicine, Heidelberglaan 100, 3584 CX, Utrecht
Treant Ziekenhuiszorg Stichting
Internal Medicine, Dr G H Amshoffweg 1, 7909 AA, Hoogeveen
Noordwest Ziekenhuisgroep Stichting
Internal Medicine, Wilhelminalaan 12, 1815 JD, Alkmaar
Sint Franciscus Vlietland Groep Stichting
Cardiology, Kleiweg 500, 3045 PM, Rotterdam
Zuyderland Medisch Centrum Stichting
Cardiology, Henri Dunantstraat 5, 6419 PC, Heerlen
Ziekenhuis Gelderse Vallei Stichting
Internal Medicine, Willy Brandtlaan 10, 6716 RP, Ede Gld
Ziekenhuis Rivierenland
Cardiology, President Kennedylaan 1, 4002 WP, Tiel
Catharina Ziekenhuis Stichting
Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven
EB FlevoResearch B.V.
Research Physician, Louis Armstrongweg 88, 1311 RL, Almere
Dokters van Nederhoven
General Practice, Buizerdstraat 4a, 3334 SB, Zwijndrecht
Stichting Radboud University Medical Center
Internal Medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
OLVG Stichting
Cardiology, Oosterpark 9, 1091 AC, Amsterdam
Gelre Hospitals
Internal Medicine, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Spaarne Gasthuis
Cardiology, Boerhaavelaan 22, Haarlem, Noord-Holland
Frisius MC
Cardiology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Meander Medisch Centrum
Internal Medicine, Maatweg 3, 3813 TZ, Amersfoort
Amphia Hospital
Cardiology, Molengracht 21, 4818 CK, Breda
Huisartsenpraktijk Broekman
General Practice, Plantageweg 3b, Zwijndrecht, Zuid-Holland
Sint Franciscus Vlietland Groep Stichting
Cardiology, Kleiweg 500, 3045 PM, Rotterdam
Bravis Ziekenhuis
Cardiology, Boerhaavelaan 25, 4708 AE, Roosendaal
Albert Schweitzer Ziekenhuis
Internal Medicine, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Huisartsenpraktijk Rambharose B.V.
General Practice, Kempstraat 230, 2572 GM, S-Gravenhage
Isala Klinieken Stichting
Internal Medicine, Dokter Van Heesweg 2, 8025 AB, Zwolle
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
NA, Ul. Studzienna 35-36/a, 82-300, Elblag
Centermed Sp. z o.o.
NA, Ul. Weteranow 46, 20-044, Lublin
NZOZ Centurm Medyczne SERAFIN-MED
NA, Hutnicza 1, Dolnoslaskie, Zarow
Endopractica W Beker D Mielczarek P Mielczarek J Struzik s.c.
NA, Ul. Romana Horoszkiewicza 6, 45-001, Opole
Balsam Medica
NA, Goleszowska 1/U5, Mazowieckie, Warszawa
Klimed MK Sp. z o.o.
NA, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
American Heart Of Poland S.A.
N/A, Aleja Armii Krajowej 101, 43-316, Bielsko-Biala
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Cardiology, Ul. Monte Cassino 18, 37-700, Peremyshl
Serce Sp. z o.o.
NA, Ul. Fabryczna 15, 64-100, Leszno
Uniwersyteckie Centrum Kliniczne
NA, Ul. Debinki 7, 80-952, Gdansk
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NA, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
American Heart Of Poland S.A.
NA, Ul. Topolowa 16, 32-500, Chrzanow
Centrum Medyczne Intercor Sp. z o.o.
NA, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Diab Serwis Popenda Sp. j.
NA, Jozefa Ryszki 51, 41-500, Chorzow
Ekamed
NA, Al. Krasnicka 2j, Lubelskie, Lublin
Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M. Zabowka E. Zabowka
NA, Lwowska 197, 33-100, Tarnow
Pro Salus Centrum Medyczne
NA, Ulica Julianowska 54 B, Lodzkie, Lodz
American Heart Of Poland S.A.
NA, Ul. Edukacji 102, 43-100, Tychy
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
NA, Ul. Rusznikarska 17, 31-261, Cracow
Centrum Zdrowia Metabolicznego Pawel Bogdanski
NA, 14F Nowina, Wielkopolskie, Poznan
Societatea Civila Medicala Dr. Paveliu
Diabetes, Strada Dr. Iatropol Panait 24, 050538, Bucharest
Cardiomed S.R.L.
Diabetes, Aleea Neculai Tudor C1, 700732, Jassi
Clinica Korall S.R.L.
Diabetes, P-Ta Eroii Revolutiei, Corp A Apartament M-2 Nr 22, Satu Mare
Medicali's S.R.L.
Cardiology, Strada Cernauti 13, 300362, Timisoara
Lotus Med S.R.L.
Nephrology, Strada Tunari No. 44 Sector 2, 020528, Bucharest
CMI Cardiologie - Dr. Mercea Corina Delia
Cardiology, Str. Petre Dulfu nr. 12A, Spatiu comercial nr. 1, Baia Mare
Institutul De Boli Cardiovasculare Timisoara
Cardiology, Strada Adam Gheorghe Nr 13a, 300310, Timisoara
Cabinet Medical Dr Geru S.R.L.
Diabetes, Aleea Lirei Nr 1, Ap. 2, Timisoara
Nutrilife S.R.L.
Diabetes, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diabetes, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Gensan S.R.L.
Diabetes, Nutrition and Metabolic Disease, Strada Alexandrescu Grigore Nr 1, 550371, Sibiu
CMI DNBM Dr. Pop Lavinia
Diabetes, Strada George Cosbuc nr. 25A, Maramureș, Baia Mare
Milena Sante S.R.L.
Diabetes, Strada Balcescu Nicolae Nr 31, 800001, Galati
Consultmed S.R.L.
Diabetes, Block 550, Soseaua Pacurari 70, Jassi
Spitalul Clinic Judetean De Urgenta Craiova
Cardiology, Strada Tabaci Nr 1, 200642, Craiova
Mediab S.R.L.
Diabetes, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Mediab S.R.L.
Diabetes, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Nicodiab S.R.L.
Diabetes, Strada Polona Nr 92, 010507, Bucharest
Diamed Obesity S.R.L.
Diabetes, Gheorghe Doja Nr 73, 800291, Galati
Dentosim-Queen S.R.L.
Diabetes, Strada Mihai Viteazul 27a, 540098, Targu Mures
Hightech Medical Services S.R.L.
Diabetes, Sector 1 Alexandra Ioan Cuza Blvd 76, 011053, Bucharest
MUDr. Judita Gondová
NA, Sklárska 766/86, Poltár, Poltár
MediPrax s.r.o.
NA, Bernolakova 219, 028 01, Trstena
Cliniq s.r.o.
NA, Bezrucova 5, Stare Mesto, Bratislava
B. Braun Avitum s.r.o.
Nephrology, M. R. Stefanika 10, 902 01, Pezinok
Narodny Endokrinologicky A Diabetologicky Ustav
NA, Kollarova 282/3, 034 91, Lubochna
Intern s.r.o.
Internal, Štúrova 846/39, 019 01, Ilava
B-Medical s.r.o.
NA, Pod Grunom 757/7, 029 42, Bobrov
IN DIA s.r.o.
NA, Mierova 1, 984 01, Lucenec
Fakultna Nemocnica Nitra
Internal and diabetology, Spitalska 6, Stare Mesto, Nitra
B. Braun Avitum s.r.o.
Dialysis, Hodska 2378/85, 924 01, Galanta
Areteus s.r.o.
NA, M. R. Stefanika 25a/3782, 075 01, Trebisov
Tatratrial s.r.o.
NA, Namestie 1. Maja 11, 048 01, Roznava
Iridia s.r.o.
NA, Turciansky Peter 139, 038 41, Turciansky Peter
Sin Azucar s.r.o.
NA, Ludovita Fullu 5274, 901 01, Malacky
Enrin s.r.o.
NA, Okruzna 5671/23e, 979 01, Rimavska Sobota
Medikals s.r.o.
NA, E. Bellusa 8, 921 01, Piestany
AMBORA s.r.o.
NA, J. Krala 341/45, 036 01, Martin
Funkystuff s.r.o
NA, J. Krala 8760/3, 940 02, Nove Zamky
B. Braun Avitum s.r.o.
Dialysis, Mieru 1887/30, 028 01, Trstena
Vseobecna Nemocnica S Poliklinikou n.o.
Diabetology, Namestie Republiky 15, 984 01, Lucenec
JM Interna s.r.o.
NA, Odbojarov 1959/15, 026 01, Dolny Kubin
Endiamed s.r.o.
NA, Dolina 206, Dolina, Zazriva
Hospital Universitario Virgen De La Victoria
Endocrinology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Doctor Peset
Endocrinology, Calle de San Lazaro s/n 1º, Valencia, Valencia
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
No deparment, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Nisa Sevilla Aljarafe
Metabolic Health, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitari Vall D Hebron
Endocrinology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Complexo Hospitalario Universitario A Coruna
Endocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Quironsalud Madrid
Endocrinology and Nutrition, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Area Sanitaria De Ferrol
Endocrinology, Avenida Residencia S/n, 15405, Ferrol
Clinica Juaneda S.A.
Endocrinology, Calle Company 30, 07014, Palma
Hospital Universitario Torrecardenas
Endocrinology, Calle Paraje Torrecardenas S/n, 04009, Almeria
Hospital Universitario De La Ribera
Endocrinology, Carretera Corbera Km 1, 46600, Alzira
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes and Nutrition, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Central De Asturias
Endocrinology and Nutrition, Avenida De Roma S/n, 33011, Oviedo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-07-01 | 2024-07-04 | 2025-08-18 | ||
| Belgium | 2024-06-24 | 2024-07-09 | 2025-08-18 | ||
| Czechia | 2024-05-31 | 2024-06-13 | 2025-08-18 | ||
| Denmark | 2024-06-06 | 2024-06-06 | 2025-08-18 | ||
| France | 2024-05-31 | 2024-06-07 | 2025-08-18 | ||
| Germany | 2024-05-28 | 2024-06-12 | 2025-08-18 | ||
| Greece | 2024-06-27 | 2024-07-01 | 2025-08-18 | ||
| Hungary | 2024-05-31 | 2024-06-17 | 2025-08-18 | ||
| Italy | 2024-06-04 | 2024-06-06 | 2025-08-18 | ||
| Netherlands | 2024-06-12 | 2024-06-21 | 2025-08-18 | ||
| Poland | 2024-06-14 | 2024-06-20 | 2025-08-18 | ||
| Romania | 2024-06-06 | 2024-06-10 | 2025-08-18 | ||
| Slovakia | 2024-06-12 | 2024-06-19 | 2025-08-18 | ||
| Spain | 2024-06-06 | 2024-06-12 | 2025-08-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 518 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508630-34-00_Redacted | e |
| Protocol (for publication) | D1_Protocol_2023-508630-34-00_GR_Redacted | e |
| Protocol (for publication) | D4_Patient facing documents_copyright | 1 |
| Protocol (for publication) | D4_Patient facing documents_PHQ-9_BEDU | 1.0 |
| Protocol (for publication) | D4_Study Participant Contact Card_GR | 2 |
| Recruitment arrangements (for publication) | 1_Recruitment and Informed consent procedure_GR | 2 |
| Recruitment arrangements (for publication) | K1_patient recruitment procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Allocation | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements NLD_TC | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_09Jan2024 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CZ template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Flyer | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Flyer DG | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GZBO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Informed Consent_Patient Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Netherlands | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Poster | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Sponsor Declaration | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trial Brochure | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trial Brochure DG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trialbee_Landing Page | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trialbee_OverviewSupplementaryInfo | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Trialbee_SecondaryAssessmentAndComms | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment Material | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment Material_75871_advert 2 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Doctor referral letter_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Constipation-Guide_Master_v1_ATDE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Doctor referral letter EU | 3.0 |
| Recruitment arrangements (for publication) | K2_Flyer | 3.0 |
| Recruitment arrangements (for publication) | K2_Flyer-DG | 3.0 |
| Recruitment arrangements (for publication) | K2_GZBO Program_Trialbee_Digital Marketing Content_V1_0_02May2024_es_ES | 1 |
| Recruitment arrangements (for publication) | K2_GZBO Program_Trialbee_Landing Page_V1_0_02May2024_es-ES | 1 |
| Recruitment arrangements (for publication) | K2_GZBO Program_Trialbee_OverviewSupplementaryInformation_V1_0_02May2024_es-ES | 1 |
| Recruitment arrangements (for publication) | K2_GZBO Program_Trialbee_Patient Community Outreach_V1_0_02May2024_es-ES | 1 |
| Recruitment arrangements (for publication) | K2_GZBO Program_Trialbee_SecondaryAssessmentAndCommunication_V1_0_02May2024_es | 1 |
| Recruitment arrangements (for publication) | K2_GZBO_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_GZBO_Flyer_Master_v2_06Feb2024_ES_Spain_ | 2 |
| Recruitment arrangements (for publication) | K2_GZBO_Letter-Doctor-Referral-EU_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_GZBO_POSTER_AT_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_GZBO_POSTER_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_GZBO_Trial-Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_GZBO_Trial-Brochure_Master_v2_06Feb2024_ES_Spain_ | 2 |
| Recruitment arrangements (for publication) | K2_HBP_CKD-Diet-Sheet_Master_v2_ATDE | 1 |
| Recruitment arrangements (for publication) | K2_HBP_Manual-Supplement_Master_v2_ATDE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_List of Sites_Redacted | 6 |
| Recruitment arrangements (for publication) | K2_List of Sites_TC_redacted | 5 |
| Recruitment arrangements (for publication) | K2_Poster-EU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements_Flyer_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements_Trial Brochure_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Table Digital Marketing Content | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Table Secondary Assessment And Communication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material List of sites_Redacted | 6.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material List of sites_tracked changes_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Digital Marketing Content | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Landing Page | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Overview Supplementary Information | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Secondary Assessment And Communication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Program Trialbee Table Landing Page | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Recruitment Campaign Ads_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Guide_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Trial Brochure | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Trial Brochure_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material TRIUMPH GI AE Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material TRIUMPH Hypo Awareness Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Visit Card_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Flyer_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_59421 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_66704 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_75871_advert 1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Apothekenumschau | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Apothekenumschau_with TrialBee reference | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_FR_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure-DG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor referal letter_BEDU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor referal letter_BEFR_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer DG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_FR_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GR_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_Print | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer-DG | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer-DG_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer-DG_Master_Print | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBO Program_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBO Program_Trialbee_Landing Page | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBO Program_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBO Program_Trialbee_Patient Community Outreach | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBO Program_Trialbee_SecondaryAssessmentAndCommunication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_LETTER DOCTOR REFERRAL_CZ | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter ZGV | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POSTER_CZ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster-EU_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster-EU_Master_Print | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster-EU_Master_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Flyer DG_BEDU | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Flyer DG_BEFR | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Flyer_BEDU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Flyer_BEFR_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment poster_BEDU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment poster_BEFR_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Guide_FR | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Guide_V1_FRE_Print_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Thank you Card_V1_FRE_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure DG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure-DG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Brochure_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Brochure_Master_Print | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trial-Brochure_Master_redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Brochure_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Brochure-DG_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial-Brochure-DG_Master_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Digital Marketing Content | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Digital Marketing Content_Segment | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee DigitalMarketing | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Landing Page_Segment | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee Landing Page_track change | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee LandingPage | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee Overview | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee OverviewSupplementaryInformation | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee PC Outreach | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee SecondaryAssessmentAndCommunication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee SecondaryAssessmentAndCommunication_Segment | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee SecondAssess | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_TrialBee SecondAssessment_track change | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital marketing content for Dutch speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital marketing content for French speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing page for Dutch speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing page for French speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Overview | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary assessment for Dutch speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary assessment for French speakers | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_SecondaryAssessmentAndCommunication | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit Card_V1_FRE_Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Sanos Recruitment Material | 1.0 |
| Recruitment arrangements (for publication) | K2_Sites website text_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Trial Brochure-DG_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Trial-Brochure_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_Landing Page | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_Landing Page | 1.0 |
| Recruitment arrangements (for publication) | K2_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_OverviewSupplementaryInformation | 1.0 |
| Recruitment arrangements (for publication) | K2_Trialbee_Patient Community Outreach | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_Secondary Assessment And Communication | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_SecondaryAssessmentAndCommunication | 1.0 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland | 3.0 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland_tc | 3.0 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangments_Informed consent and patient recruitment procedure | 1 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 1 |
| Recruitment arrangements (for publication) | List of planned Sites and Subjects_IT | 2.0 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1.0 |
| Subject information and informed consent form (for publication) | e-L2_List of ssICF Contact Details Add-On Sites - Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ Additional Activity ICF-OLE_v1_27Mar2025_DEAT | 1 |
| Subject information and informed consent form (for publication) | L1_Additional Activity ICF_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Additional Activity ICF-OLE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum_TC_ | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_OLE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_GR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_Pre-screening Addendum ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_Pre-screening ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_PreScreening_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_PreScreening_GR_Track Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional activity-OLE_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum_tracked changes | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF OLE_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening Addendum_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum ICF_Open label extension_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Future Research_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Additional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_Open label extension_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Activity Addendum ICF_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Activity Addendum ICF_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional activity addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional activity ICF-OLE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Compensation Information Sheet_BEDU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Compensation Information Sheet_BEFR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Compensation Information Sheet_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic addendum_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO Addendum_Genetic_ FRA_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO Main ICF France_FRA_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO Main ICF France_FRA_TC_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO OLE Addendum_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO Prescreening Addendum ICF France_FRA_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GZBO Prescreening Addendum ICF France_FRA_TC_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Pre-screening_clean_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF CZ_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF initial_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_highlighted_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_TC_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE Addendum_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening Addendum ICF | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF Addendum_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Addendum ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF DU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF DU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum ICF_highighted_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum ICF_TC_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening addendum_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Appreciation Items | 3.0 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_CT_Care-Partner-Guide_Master_v1_11Oct2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_CWM_SHOPPING-LIST_MASTER_V1_0_30JAN2023_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_GZBO_Appreciation items_v2_09Feb24_EN | 2.0 |
| Subject information and informed consent form (for publication) | L2_GZBO_Study Medicine-Reminder-Magnet_Master_v1_09Jan2024_RO | 1 |
| Subject information and informed consent form (for publication) | L2_GZBO_Thank-You-End-Of-Study_Master_v2_16May2024_RO | 2 |
| Subject information and informed consent form (for publication) | L2_GZBO_Thank-You-Participation_Master_v2_16May2024_RO | 2 |
| Subject information and informed consent form (for publication) | L2_GZBO_Thank-You-Screening_Master_v2_16May2024_RO | 2 |
| Subject information and informed consent form (for publication) | L2_GZBO_Visit-Card-EU_Master_v1_31Oct2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_CKD-Diet-Sheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Counselor-Manual_Master_V1_14Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Counselor-Manual-DG_Master_V1_14Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Manual-Supplement_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Manual-Supplement-DG_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-1-Worksheet_Master_V1_05Dec2023_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-10-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-11-Worksheet_Master_V1_05Dec2023_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-12-Worksheet_Master_V1_05Dec2023_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-13-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-14-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-2-Worksheet_Master_V1_16Jan2024_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-3-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-4-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-5-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-6-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-7-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-8-Worksheet_Master_V1_04Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_HBP_Module-9-Worksheet_Master_V1_05Dec2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Instructions for use CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other sbject information_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material _VISIT CARD | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Care Partner Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP CKD Diet Sheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 1 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 10 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 11 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 12 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 13 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 14 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 2 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 3 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 4 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 5 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 6 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 7 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 8 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material HBP Module 9 Worksheet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IFU- Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Letter Participant Welcome | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material SHOPPING LIST | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material STUDY GUIDE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Study Medicine Reminder Magnet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Healthy-Connections | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Managing-Stress | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Moving-More | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-to-Better-Sleep | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Care Partner Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Care Partner Guide_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Care Partner Guide_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Constipation Guide_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Constipation guide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Constipation guide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Country Patient Information Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Care_Partner_Guide_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GI AE Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_GI_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_GI_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Global Study Participant Confidentiality Notice_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP CKD Diet Sheet | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP CKD Diet Sheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP CKD Diet Sheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Couselor DG_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Couselor DG_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Couselor_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Couselor_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Supplement DG_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Supplement DG_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Supplement_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Manual Supplement_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 1 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 1 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 10 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 10 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 11 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 11 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 12 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 12 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 13 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 13 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 14 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 14 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 2 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 2 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 3 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 3 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 4 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 4 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 5 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 5 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 6 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 6 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 7 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 7 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 8 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 8 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 9 Worksheet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_HBP Module 9 Worksheet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_CKD_Diet_Sheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_CKD-Diet-Sheet | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_CKD-Diet-Sheet_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Manual-Supplement_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Manual-Supplement_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 1 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 10 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 11 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 12 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 13 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 14 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 2 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 3 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 4 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 5 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 6 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 7 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 8 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP_Module 9 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_1_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_10_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_11_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_12_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_13_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_14_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_2_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_3_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_4_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_5_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_6_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_7_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_8_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module_9_Worksheet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Hypo Awareness Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Hypoglycemia_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Hypoglycemia_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_ICF Procedure | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_ICF Sponsor Statement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Instructions for use BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Instructions for use BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_List of documents_Part II_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_List of documents_Part II_initial_HU_EN | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Welcome Letter | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Participant_Welcome_Letter_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_Poster-EU_Master_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Reminder Magnet_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Reminder Magnet_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RETATRUTIDE IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SHOPPING LIST | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Shopping List_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Shopping List_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Shopping_list_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Study contact card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_STUDY GUIDE | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_study guide_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_study guide_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_STUDY GUIDE_CZ | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Medicine Reminder Magnet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study_Medicine_Reminder_Magnet_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_STUDY-GUIDE_GR_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_STUDY-GUIDE-EU_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Subject IFU of IP or Device_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Instructions for Use IFU of IP and or Device | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you End of study DU | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you End of study FR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_THANK YOU END OF STUDY_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you Participation DU | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you Participation FR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you Screening DU | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank you Screening FR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure DG_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure DG_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure_BEDU | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure_BEFR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Trial Brochure_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information Material_Trial-Brochure_Master_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TRIUMPH_GI_AE_Brochure_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TRIUMPH_Hypo_Awareness_Brochure_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_visit card DU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_visit card FR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT CARD_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_VISIT-CARD_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT-CARD-EU_MASTER_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Welcome Letter_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Welcome Letter_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome-Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Terms of Service | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_TermsofService | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_ZoomHealth_Screenshots | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_ZoomHealth_Screenshots | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject material_ZoomHealth_TermsofService | 1 |
| Subject information and informed consent form (for publication) | L2_Participant Welcome Letter | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Study Guide-EU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Subject Instructions for Use of IP and-or Device | 1.0 |
| Subject information and informed consent form (for publication) | L2_TRIUMPH_Hypo-Awareness-Brochure_Master_v1_12Dec2023_RO | 1.0 |
| Subject information and informed consent form (for publication) | L2_TRUIMPH_GI-AE-Brochure_Master_v1_09Jan2024_RO | 1.0 |
| Subject information and informed consent form (for publication) | L3_Financial compensations for patients | 2.0 |
| Subject information and informed consent form (for publication) | L3_GZBO_Instructions for Use_AT | 1.0 |
| Subject information and informed consent form (for publication) | L3_GZBO_Instructions for Use_Germany | 1 |
| Subject information and informed consent form (for publication) | L3_GZBO_Study Participant Contact Card | 2 |
| Subject information and informed consent form (for publication) | L3_Patient card_Adlbrecht | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Auer | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Clodi | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Fliesser-Goerzer | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Hanusch | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Kaser | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Kautzky-Willer | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Ludvik | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Sourij | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Stulnig | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Vonbank | 1.0 |
| Subject information and informed consent form (for publication) | L3_Subject Instructions for Use_IFU_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508630-34-00_GR_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508630-34-00_PL_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_2023-508630-34-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEDE_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEDU_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEFR_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DK_2023-508630-34-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-508630-34-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-508630-34-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_2023-508630-34-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2023-508630-34-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2023-508630-34_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2023-508630-34-00_Redacted | e |
Application history
32 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | Hungary | Acceptable 2024-05-06
|
2024-05-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-14 | Acceptable | 2024-05-17 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-16 | Acceptable | 2024-07-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-17 | Acceptable | 2024-06-28 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-01 | 2024-07-01 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-20 | Acceptable | 2024-09-05 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-08-22 | Acceptable | 2024-10-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-08-23 | Acceptable | 2024-10-07 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-08-23 | 2024-10-07 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-08-23 | Acceptable | 2024-11-05 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-08-23 | Acceptable | 2024-10-16 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-08-23 | Acceptable | 2024-09-30 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-08-23 | Acceptable | 2024-10-07 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-26 | Acceptable | 2024-10-11 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-15 | 2024-08-26 | Acceptable | 2024-11-15 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-27 | Acceptable | 2024-10-22 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-08-27 | Acceptable | 2024-10-01 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-11-05 | Acceptable | 2024-11-13 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-11-25 | Hungary | Acceptable 2025-03-17
|
2025-03-17 |
| 20 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-04-07 | Hungary | Acceptable 2025-07-14
|
2025-07-14 |
| 21 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-07-25 | Acceptable | 2025-08-31 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-07-25 | Acceptable | 2025-08-14 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-07-29 | Acceptable | 2025-10-06 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-08-07 | Acceptable | 2025-09-15 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-23 | 2025-08-14 | Acceptable | 2025-09-23 | |
| 26 | SUBSTANTIAL MODIFICATION | SM-24 | 2025-09-01 | Acceptable | 2025-09-19 | |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-22 | Acceptable | 2025-10-22 | |
| 28 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-11-14 | Hungary | Acceptable 2026-03-09
|
2026-03-09 |
| 29 | SUBSTANTIAL MODIFICATION | SM-26 | 2026-03-19 | Acceptable | 2026-04-27 | |
| 30 | SUBSTANTIAL MODIFICATION | SM-27 | 2026-03-20 | Acceptable | 2026-04-29 | |
| 31 | SUBSTANTIAL MODIFICATION | SM-28 | 2026-03-23 | Acceptable | 2026-04-07 | |
| 32 | SUBSTANTIAL MODIFICATION | SM-31 | 2026-03-27 | Acceptable | 2026-04-02 |