Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
816
Countries
15
Sites
102
Sjögren's Disease
To evaluate the efficacy of nipocalimab compared to placebo in participants with moderate to severe SjD.
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 16 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Therapy, Others, Safety, Pharmacogenomic, Pharmacodynamic
To evaluate the efficacy of nipocalimab compared to placebo in participants with moderate to severe SjD.
Conditions and MedDRA coding
Sjögren's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10040767 | Sjogren´s syndrome | 100000004859 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513965-38-00 | A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjögren's Disease (SjD) | Janssen Cilag International |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory tests performed at screening.
- 2. Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria.
- 3. Seropositive for antibodies to Ro/SSA at screening.
- 4. Total ClinESSDAI score greater than or equal to (>=) 5 at screening.
- 5. Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization.
Exclusion criteria 5
- 1. Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory.
- 2. Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation.
- 3. Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency.
- 4. Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example [e.g.], monoclonal antibodies, intravenous immunoglobulin).
- 5. Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12057025 · Product
- Active substance
- Nipocalimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 144 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo subcutaneous without Nipocalimab
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
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Clario Medical Imaging Inc. ORG-100052770
|
Seattle, United States | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
Locations
15 EU/EEA countries · 102 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 26 | 5 |
| Bulgaria | Ongoing, recruitment ended | 26 | 9 |
| Czechia | Ongoing, recruitment ended | 7 | 5 |
| Denmark | Ongoing, recruitment ended | 18 | 3 |
| France | Ongoing, recruitment ended | 17 | 9 |
| Germany | Ongoing, recruitment ended | 45 | 11 |
| Hungary | Ongoing, recruitment ended | 32 | 7 |
| Italy | Ongoing, recruitment ended | 18 | 11 |
| Netherlands | Ongoing, recruitment ended | 3 | 1 |
| Norway | Ongoing, recruitment ended | 3 | 2 |
| Poland | Ongoing, recruitment ended | 60 | 14 |
| Portugal | Ongoing, recruitment ended | 10 | 4 |
| Romania | Ongoing, recruitment ended | 16 | 7 |
| Slovakia | Ended | 7 | 6 |
| Spain | Ongoing, recruitment ended | 21 | 8 |
| Rest of world
United Kingdom, Mexico, Argentina, United States, Brazil, Japan, Korea, Democratic People's Republic of, China, Taiwan
|
— | 507 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
III Med, Muellner Hauptstrasse 48, 5020, Salzburg
Klinik Hietzing
2. Medical Department, Wolkersbergenstrasse 1, Hietzing, Vienna
Medical University Of Graz
Division of Rheumatology and Immunology, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
Department of Internal Medicine III, Division of Rheumatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Landesklinikum Stockerau
2. Med. Department, with main focus on Rheumatology, Landstrasse 18, 2000, Stockerau
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Rheumatology, Ulitsa Urvich 13, 1612, Sofia
Military Medical Academy
Rheumatology Department, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Rheumatology Clinic, Zapaden District, Sofia Str 64, Plovdiv
Medical Center Teodora EOOD
Not Applicable, Ulitsa Mutkurova 101, 7000, Ruse
Medical Center Artmed Ltd.
Not Applicable, Ulitsa Mladost 8, 4002, Plovdiv
Diagnostic Consultative Center Equita OOD
Not Applicable, Bulevard Tsar Osvoboditel 5, 9000, Varna
Diagnostic-Consultative Center Alexandrovska EOOD
Not Applicable, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
MBAL Sveta Marina EAD
Rheumatology Clinic, Hristo Smirnenski Str 1, 9010, Varna
Mbal Lyulin EAD
Rheumatology Department, Lyulin 6, Ulitsa D-R Petir Dertliev 81, Sofiya
MUDr. Zuzana Stejfova
NA, Taborska 325/57, 140 00, Praha 4
Revmatologie s.r.o.
NA, Halasovo Namesti 597/1, Lesna, Brno-Sever
Artroscan s.r.o.
NA, Trebovicka 5114/106, Trebovice, Ostrava
Revimex pro s.r.o.
NA, Frystatska 168/32, 733 01, Karvina
MEDICAL PLUS Research s.r.o.
NA, Obchodni 1507, 686 01, Uherske Hradiste
Region Sjaelland
Reumatology Department, Lykkebaekvej 1, 4600, Koege
Rigshospitalet
Reumatology Department, Blegdamsvej 9, 2100, Copenhagen Oe
Aarhus University Hospital
Reumatology Department, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Assistance Publique Hopitaux De Paris
Rheumatology Department, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire De Montpellier
Rheumatology Department, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier Universitaire De Dijon
Internal Medicine and Clinical Immunology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Saint Etienne
Rheumatology Department, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Les Hopitaux Universitaires De Strasbourg
Rheumatology Department, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Bordeaux
Internal Medicine and Clinical Immunology, 1 Rue Jean Burguet, 33000, Bordeaux
Assistance Publique Hopitaux De Paris
Rheumatology Department, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Centre Hospitalier Universitaire De Lille
Rheumatology Department, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Regional Et Universitaire De Brest
Rheumatology Department, Boulevard Tanguy Prigent, 29200, Brest
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Medical Center - University Of Freiburg
Department of Rheumatology and clinical Immunology, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Krankenhaus Porz Am Rhein gGmbH
Klinik für Rheumatologie, Urbacher Weg 19, Porz, Cologne
Universitaetsklinikum Wuerzburg AöR
Medical Department III, Rheumatology and Immunology, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medical Department III, Rheumatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Erlangen AöR
Rheumatologie and Immunology, Ulmenweg 18, Innenstadt, Erlangen
LMU Klinikum Muenchen AöR
Klinik f. Rheumatologie, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Medicover GmbH
Medicover Muenchen Ost MVZ, Orleansplatz 3, Au-Haidhausen, Munich
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, Wanne, Herne
Medizinische Hochschule Hannover
Klinik für Rheumatologie & Immunologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Studienambulanz Rheumazentrum Ratingen GbR
NA, Calor-Emag-Strasse 3, Zentrum, Ratingen
Clinexpert Kft.
NA, Kaszasdulo Utca 5, 1033, Budapest III
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
NA, Frankel Leo Ut 17-19, 1027, Budapest II
University Of Debrecen
Clinic of Internal Medicine, Department of Clinical Immunology, Moricz Zsigmond Korut 22, 4032, Debrecen
Vita Verum Medical Bt.
NA, Fiskalis Ut 43, 8000, Szekesfehervar
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Internal medicine- immunology ambulance, Albert Florian Ut 5-7, 1097, Budapest IX
University Of Szeged
NA, Kalvaria Sugarut 57, 6725, Szeged
Semmelweis University
Reumatológiai és Immunológiai Klinika, Frankel Leo Ut 38-40, Kerulet, Budapest
Azienda Sanitaria Universitaria Friuli Centrale
S.O.C. Clinica di Reumatologia - ASUFC, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Clinica Reumatologica, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Scienze Cliniche Internistiche Anestesiologiche Cardiovascolari -UOC Reumatologia, Viale Del Policlinico 155, 00161, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Rheumatology, Largo Francesco Vito 1, 00168, Rome
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
U.O.C. Reumatologia Clinica, Piazza Cardinale Andrea Ferrari 1, 20122, Milan
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
U.O.C di Immunoreumatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliero Universitaria Pisana
Medicina Clinica e Sperimentale - U.O. di Reumatologia, Via Roma 67, 56126, Pisa
Humanitas Mirasole S.p.A.
U.O.C. Rheumatology, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Santa Maria Della Misericordia
Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia
Ospedale San Raffaele S.r.l.
Clinical Unit of Immunology, Rheumatology, Allergy and Rare diseases, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Di Modena
S.C. Reumatologia, Largo Del Pozzo 71, 41124, Modena
Medisch Spectrum Twente
Rheumatology, Koningsplein 1, 7512 KZ, Enschede
Helse Stavanger HF
Dept of Rheumatology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Oslo Universitetssykehus HF
Dept of Rheumatology, Sognsvannsveien 20, 0372, Oslo
Lukmed 2 Sp. z o.o.
ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
Futuremeds Sp. z o.o.
Futuremeds - Wroclaw, Ul. Legnicka 16, 53-673, Wroclaw
Futuremeds Sp. z o.o.
Futuremeds - Krakow, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Centrum Medyczne Oporow
NA, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
ETG Lublin Sp. z o.o.
ETG Debica, Ul. Czarnieckiego 5, 39-200, Debica
Ai Centrum Medyczne Sp. z o.o.
NA, Ul. Swietojanska 1, 61-113, Poznan
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatolgii i Ukladowych Chorob Tkanki Łacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
NA, Ul. 1 Maja 13 C, 10-117, Olsztyn
Malopolskie Badania Kliniczne Sp. z o.o.
NA, Ul. Pradnicka 12/502, 30-002, Cracow
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badan Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
ETG Lublin Sp. z o.o.
ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Futuremeds Sp. z o.o.
Futuremeds - Targowek, Ul. Sw. Wincentego 93 Lok. 5/6/7, 03-291, Warsaw
Instituto Portugues De Reumatologia
Rheumatology, Rua Da Beneficencia Nr 7, 1050-034, Lisbon
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Rheumatology, Rua Da Junqueira 126, 1349-019, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Rheumatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Rheumatology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Spitalul Clinic Judetean De Urgenta Cluj
Rheumatology, Strada Clinicilor 4-6, 400006, Cluj-Napoca
Saint Maria Hospital
Rheumatology, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Policlinica CCBR S.R.L.
N/A, Aleea Buchetului 2 Block C2 Sector 3, 030463, Bucharest
Selfmed Clinique S.R.L.
N/A, Bulevardul Barnutiu Simion 21, 300133, Timisoara
Spitalul Clinic Colentina Bucuresti
IIIrd Internal Medicine, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Medisof Diagnostic S.R.L.
Rheumatology, Strada Caracal 33, 200347, Craiova
Hiperdia S.A.
N/A, Soseaua Oltenitei Sector 4 Nr 87-99, 041312, Bucharest
Artromac N.O.
NA, Toryska 275/1, Zapad, Kosice
Reumex s.r.o.
NA, Zeleznicna 686/23, 979 01, Rimavska Sobota
Reumamed Poprad s.r.o.
NA, Rovna 5614/19, Spisska Sobota, Poprad
Medman s.r.o.
NA, Thurzova 437/15, 036 01, Martin
Thermium s.r.o.
NA, E. Bellusa 6, 921 01, Piestany
Narodny Ustav Reumatickych Chorob
NA, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Hospital Universitario 12 De Octubre
Rheumatology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Navarra
Rheumatology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital De La Santa Creu I Sant Pau
Rheumatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Sanitas S.A. De Hospitales
Internal Medicine, Passeig De Manuel Girona 33, 08034, Barcelona
Hospital Universitari Vall D Hebron
Internal Medicine, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Marques De Valdecilla
Rheumatology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Juan Ramon Jimenez
Rheumatology, Ronda Exterior Norte S/n, 21005, Huelva
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 | 2025-07-29 | 2025-07-29 | 2026-01-20 | ||
| Bulgaria | 2025-07-16 | 2025-07-16 | 2026-01-20 | ||
| Czechia | 2026-01-15 | 2026-01-19 | 2026-01-20 | ||
| Denmark | 2025-09-24 | 2025-09-24 | 2026-01-20 | ||
| France | 2025-07-31 | 2025-07-31 | 2026-01-22 | ||
| Germany | 2025-06-24 | 2025-06-24 | 2026-01-20 | ||
| Hungary | 2025-07-14 | 2025-07-14 | 2026-01-20 | ||
| Italy | 2025-09-11 | 2025-09-11 | 2026-01-20 | ||
| Netherlands | 2026-01-20 | 2026-01-20 | 2026-01-21 | ||
| Norway | 2026-01-20 | 2026-01-20 | 2026-01-20 | ||
| Poland | 2025-06-25 | 2025-06-25 | 2026-01-20 | ||
| Portugal | 2025-07-31 | 2025-07-31 | 2026-01-20 | ||
| Romania | 2025-08-13 | 2025-08-13 | 2026-01-20 | ||
| Spain | 2025-06-16 | 2025-06-16 | 2026-01-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 373 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2024-513965-38 | Am4 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instruction_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instruction_SK_slo_2024-513965-38 | 3 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions PT_POR_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_ENG_2024-513965-38 | 3 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instructions_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary PT_PT_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF dosing diary_ENG_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Dosing diary_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Inter_CZ_CZE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Inter_Multicountry_Multilingual_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Inter_SK_SLO_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Self_CZ_CZE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Self_Multicountry_Multilingual_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF EQ-5D-5L Self_SK_SLO_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF ESSPRI_CZ_CZE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF ESSPRI_Multicountry_Multilingual_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF ESSPRI_SK_SLO_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Exit Inter Disc App_Multicountry_ENG_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Facit-Fatigue_CZ_CZE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Facit-Fatigue_Multicountry_Multilingual_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Facit-Fatigue_SK_SLO_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instruction FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instruction_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instruction_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP Instruction_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP Instructions AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP Instructions for Handling_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP Instructions for Handling_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instructions PT_PT_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instructions_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instructions_ENG_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instructions_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF IP instructions_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Females_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_CZ_cze_2024-513865-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Dryness Males_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Fatigue_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIC Sjogrens Joint Pain_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Females_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Dryness Males_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Fatigue_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_BG_BUL_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_ENG_2024-513965-38 | 0.2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_ES_SPA_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_PT_POR_2024-513965-38 | AU1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS Sjogrens Joint Pain_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PtGA FR_FRE_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA PT_PT_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PtGA Sjogrens_CZ_cze_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA Sjogrens_SK_slo_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_AT_GER_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_DE_GER_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_ENG_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_HU_HUN_2024-513965-38 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PtGA_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF SF-36v2_CZ_CZE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF SF-36v2_Multicountry_Multilingual_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF SF-36v2_SK_SLO_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female PT_PT_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_ENG_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Female_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Females_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male FR_FRE_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male PT_PT_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_AT_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_BG_bul_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_DE_GER_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_ES_SPA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_HU_HUN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Male_RO_RUM_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Males_DK_DAN_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogren Symptoms Males_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogrens Symptoms Females_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogrens Symptoms Females_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogrens Symptoms Male_ENG_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogrens Symptoms Males_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Sjogrens Symptoms Males_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Dosing Diary_CZ_cze_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Dosing Diary_SK_slo_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PRO_AE_Text 1A_IT_ITA_2024-513965-38 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PtGA Sjogrens_IT_ITA_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements Addendum_BG_BUL_2024-513965-38 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _IT_ENG_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements Addendum_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_AT_ENG_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BG_bul_2024-513965-38 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_eng_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DE_ENG_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DK_ENG_2024-513965-38 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_ENG_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_FR_FRE_2024-513965-38 | 6 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NL_Eng_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NO_ENG_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PL_POL_2024-513965-38 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PT_ENG_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_RO_ENG_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_SK_eng_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Advert for Subject Recruitment1_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Advert for Subject Recruitment2_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_AT_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_ES_SPA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_IT_ITA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_RO_RUM_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ClinLife digital campaign_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ClinLife Portal_EC Document_DE_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ClinLife_EC-Notes_DE_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Digital Ad visuals_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Digital Ad_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Doctor to Patient Email_ES_SPA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Doctor to Patient Email_PT_POR_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient Email_AT_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient email_IT_ITA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient Email_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient email_RO_RUM_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Keywords_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Landing Page Copy screenshot_PL_POL_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Master Pre-screening Script_PL_POL_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Master WS Script_PL_POL_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Messaging_PL_POL_2024-513965-38 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Poster_ES_SPA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Poster_IT_ITA_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Poster_RO_RUM_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment brochure_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Brochure_PT_POR_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Poster_AT_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment poster_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Recruitment Poster_PT_POR_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Search Ads_PL_POL_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Brochure_HU_HUN_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_ClinLife EC Notes_HU_HUN_2024-513965-38 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_ClinLife_EC Document Recruitment_BG_bul_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Doctor to Patient Email_BG_bul_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Dr to Patient Email _DE_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_EC Document _HU_HUN_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Poster_BG_bul_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Poster_DE_GER_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Poster_HU_HUN_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Recruitment Brochure_BG_bul_2024-513965-38 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Recruitment Brochure_DE_GER_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Country Optional GenRes _BG_bul_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Country Optional GenRes _BG_eng_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Withdrawal _BG_bul_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Withdrawal _BG_eng_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum _ES_SPA_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_NO_NOR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum LTE_PT_POR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF addendum OLE_DK_DAN_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_AT_GER_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_PL_POL_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_RO_RUM_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Adult_NL_Dut_2024-513965-38 | 2.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Biobanking_IT_ITA_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Highlighted_CZ_CZE_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical v3 Addendum LTE_IT_ITA_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_Addendum_DE_GER_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_CZ_cze_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DE_GER_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_DAN_2024-513965-38 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_POL_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PT_POR_2024-513965-38 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_RO_RUM_2024-513965-38 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Compatible use_NO_NOR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Exit Interview_NO_NOR_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Interview_DK_DAN_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum Highlighted _CZ_CZE_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_CZ_cze_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_Addendum 2_HU_HUN_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_AT_GER_2024-513965-38 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_IT_ITA_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_NO_NOR_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OLE_NL_Dut_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Future Research_DK_dan_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Genetic Sample_IT_ITA_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Genetic Samples_NO_NOR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample _DE_GER_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional sample Highlighted_CZ_CZE_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_AT_GER_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_CZ_cze_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_ES_SPA_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PL_POL_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PT_POR_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_RO_RUM_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy Partner_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_FR_FRE_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_NO_NOR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_PT_POR_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_RO_RUM_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_AT_GER_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_cze_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DE_GER_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_DAN_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Addendum LTE_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Main_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Child exposed to IP_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_cze_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Optional Genetic Sample_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Pregnancy Partner_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _ES_SPA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _RO_RUM_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_AT_GER_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_cze_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_DE_GER_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_POL_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_SK_slo_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_BG_bul_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_BG_eng_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum_FR_FRE_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Main _BG_bul_2024-513965-38 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Main _BG_eng_2024-513965-38 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Pregnant Partner_BG_bul_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Pregnant Partner_BG_eng_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Genetic_HU_HUN_2024-513965-38 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Contact Data Sheet_AT_ENG_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Contact Data Sheet_AT_GER_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main Clinical_HU_HUN_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FRE_2024-513965-38 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Samples_FR_FRE_2024-513965-38 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy_NL_Dut_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_HU_HUN_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_HU_HUN_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_AT_GER_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BG_bul_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2024-513965-38 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2024-513965-38 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_NO_NOR_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2024-513965-38 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_RO_RUM_2024-513965-38 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SK_slo_2024-513965-38 | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _NO_NOR_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_GER_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BG_bul_2024-513965-38 | AM4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2024-51 | AM4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_RO_RUM_2024-513965-38 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SK_slo_2024-513965-38 | Am3 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-19 | France | Acceptable 2025-06-02
|
2025-06-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-09 | France | Acceptable 2025-09-29
|
2025-09-29 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-10-17 | Acceptable 2025-09-29
|
2026-01-19 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-17 | Acceptable 2025-09-29
|
2026-01-19 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-10-20 | 2026-01-14 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-10-20 | 2026-01-20 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-18 | France | Acceptable 2026-05-26
|
2026-05-27 |