Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
88
Countries
9
Sites
31
Crohn's Disease
To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in achieving clinical remission and endoscopic response in pediatric participants with moderately to severely active CD at Week 52 who do not require modification of IP regimen, IP rescue therapy, or non-IP rescue therapy
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Mar 2024 → ongoing
- Decision date (initial)
- 2024-08-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511472-32-00
- EudraCT number
- 2022-000811-29
- WHO UTN
- U1111-1303-8651
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Safety, Efficacy, Pharmacokinetic, Therapy, Pharmacoeconomic
To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in achieving clinical remission and endoscopic response in pediatric participants with moderately to severely active CD at Week 52 who do not require modification of IP regimen, IP rescue therapy, or non-IP rescue therapy
Conditions and MedDRA coding
Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002208-PIP01-17
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- Participants must have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
- Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
- Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or IV corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor.
Exclusion criteria 3
- Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
- Participants must not have an abscess.
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and endoscopic response based on SES-CD
- Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and clinical remission based on PCDAI
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082863 · Product
- Active substance
- Mirikizumab
- 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
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10725963 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- 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 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Data management, Code 9 |
| Eli Lilly & Co. ORG-100000156
|
Indianapolis, United States | Interactive response technologies (IRT) |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
Locations
9 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1 | 1 |
| Belgium | Ongoing, recruiting | 4 | 4 |
| France | Ended | 4 | 4 |
| Italy | Ongoing, recruiting | 5 | 7 |
| Netherlands | Ongoing, recruiting | 1 | 1 |
| Norway | Ongoing, recruiting | 4 | 4 |
| Poland | Ongoing, recruiting | 4 | 4 |
| Portugal | Ongoing, recruiting | 3 | 3 |
| Spain | Ongoing, recruiting | 4 | 3 |
| Rest of world
Israel, United States, Australia, Korea, Republic of, Canada, Brazil, United Kingdom, Japan
|
— | 58 | — |
Investigational sites
Medical University Of Vienna
Department of Pediatric Nephrology and Gastroenterology, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Brussel
Pediatric gastroenterology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Gent
Pediatric gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
Pediatric gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Pediatric gastroenterology, Herestraat 49, 3000, Leuven
Assistance Publique Hopitaux De Paris
Pediatric, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire Amiens Picardie
Pediatric, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Assistance Publique Hopitaux De Paris
Pediatric, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire De Lille
Pediatric, Avenue Eugene Avinee, 59037, Lille Cedex
ASST Fatebenefratelli Sacco
Gastroenterologia e Nutrizione, Via Lodovico Castelvetro 32, 20154, Milan
Ospedale Pediatrico Bambino Gesu
OU di Epatologia, Gastroenterologia e Nutrizione, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Gastroenterologia ed Epotologia Pediatrica, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Pediatrics Unit, Spalto Marengo 46, 15121, Alexandria
Azienda Unita Sanitaria Locale Di Bologna
Pediatria, Largo Bartolo Nigrisoli 2, 40133, Bologna
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Epatologia e Gastroenterologia Pediatrica e dei Trapianti, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Meyer IRCCS
Gastroenterologia e Nutrizione, Viale Gaetano Pieraccini 24, 50139, Florence
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gastroenterology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
St. Olavs Hospital HF
Doctor of Medicine, P. O. Box 3250, Torgarden, Trondheim
Universitetssykehuset Nord-Norge HF
Doctor of Medicine, P. O. Box 100, 9038, Tromsoe
Oslo University Hospital HF
Doctor of Pediatric Medicine, Taarnbygget, Kirkeveien 166, Oslo
Akershus University Hospital
Doctor of Medicine, Sykehusveien 27, 1478, Lorenskog
Instytut Pomnik Centrum Zdrowia Dziecka
Klinika Gastroenterologii, Hepatologii, Zaburzeń odżywiania i Pediatrii, Aleja Dzieci Polskich 20, 04-730, Warsaw
Gabinet Lekarski Bartosz Korczowski
N/A, ul. Litewska 4A/7, 35-302, Rzeszów
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Unidade Local De Saude De Santa Maria E.P.E.
Serviço de Pediatria, Avenida Professor Egas Moniz, 1649-035, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Serviço de Pediatria, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local de Saude de Sao Joao E.P.E.
Serviço de Pediatria, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Universitario Y Politecnico La Fe
Gastroenterology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Pediatric Gastroenterology, Avenida Menendez Pidal S/n, 14004, Cordoba
Parc Tauli Hospital Universitari
Pediatric Gastroenterology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
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 | 2024-09-30 | 2025-11-11 | |||
| Belgium | 2024-07-26 | 2024-10-02 | |||
| France | 2024-07-10 | 2025-09-10 | 2024-12-13 | 2025-09-10 | |
| Italy | 2024-05-10 | 2024-06-10 | |||
| Netherlands | 2024-09-20 | 2025-11-21 | |||
| Norway | 2024-03-12 | 2024-03-13 | |||
| Poland | 2024-03-27 | 2024-04-04 | |||
| Portugal | 2024-09-09 | 2025-02-12 | |||
| Spain | 2024-06-26 | 2024-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 708 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Clarification Letter_PLATFORM_2024-511472-32-00_red | NA |
| Protocol (for publication) | D1_Protocol Memo_2024-511472-32-00_ISA | na |
| Protocol (for publication) | D1_Protocol_ISA_2024-511472-32-00_red | C |
| Protocol (for publication) | D1_Protocol_PLATFORM_2024-511472-32-00_red | AM3 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Abdominal Pain NRS_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Child_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_BMC_Observer_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Bowel Movement Count_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General Well-Being_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Child_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_Observer_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_General_Well_Being_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Patient reported outcomes_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Child_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_Observer_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Stool_Frequency_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal Pain_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal Pain_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal Pain_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Child_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Child_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Child_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Observer_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Observer_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst Abdominal_Pain_Observer_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal Pain_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal Pain_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Child_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_Observer_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_CDAI_Worst_Abdominal_Pain_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_EN_2024-511472-32-00_red | 2 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_Part I_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_Part II_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Slate Subject Facing_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_EN_2024-511472-32-00_red | 2 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch Subject Facing_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_eCOA_Touch_Subject Facing_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_AT-DE_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_BE_FR_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_BE_NL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_Paper_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Child version_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_EN_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_ES_ES_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_FR_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_IT_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_NL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_NO_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_Paper_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_Observer version_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_PL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_Fatigue_PT_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_AT-DE_2024-511472-32-00 | Dec2013 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_BE_FR_2024-511472-32-00 | Oct2016 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_BE_NL_2024-511472-32-00 | Oct2016 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_EN_2024-511472-32-00 | June2013 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_ES_ES_2024-511472-32-00 | Dec2013 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_FR_2024-511472-32-00 | Nov2016 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_NO_2024-511472-32-00 | April2014 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_Paper_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_PL_2024-511472-32-00 | Oct.07 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_PT_2024-511472-32-00 | Mar2011 |
| Protocol (for publication) | D4_Patient-facing_IMPACT-III_updated_ES_ES_2024-511472-32-00 | Jan2021 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_ObsRO_Items_Crohns_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Adult_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_Child_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Instructions_for_PRO_Items_Crohns_ES-ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00 AT-de | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_BE-fr | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_BE-nl | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_EN | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_ES-es | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_FR-fr | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_IT-it | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_NL-nl | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_NO-no | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_PL-pl | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PCDAI_Patient Diary_2024-511472-32-00_PT-pt_v 1.0 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_AT-DE_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_EN_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_ES_ES_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_IT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_NO_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_PL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-A_PT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_AT-DE_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_EN_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_ES_ES_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_IT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_NO_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_PL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-C_PT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_AT-DE_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_EN_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_ES_ES_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_IT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_NO_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_PL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PT_PT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_AT-DE_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_EN_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_ES_ES_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_IT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_NO_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_PL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL_Core-Acute-PYC_PT_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-A_BE_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-A_BE_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-C_BE_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-C_BE_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-PT_BE_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-PT_BE_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-PYC_BE_FR_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_PedsQL-Core-Acute-PYC_BE_NL_2024-511472-32-00 | 4.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_AT-DE_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_BE_FR_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_BE_NL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_EN_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_ES_ES_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_FR_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_IT_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_NL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_NO_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_PL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Female_Self-Reported_PT_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_AT-DE_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_BE_FR_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_BE_NL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_EN_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_ES_ES_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_FR_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_IT_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_NL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_NO_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_PL_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Tanner Stage Form_Male_Self-Reported_PT_2024-511472-32-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency NRS_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Crohns_Child version_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_AT-DE_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_BE_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_BE_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_EN_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_ES_ES_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_FR_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_IT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_NL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_NO_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_PL_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_Urgency_Observer version_PT_2024-511472-32-00 | 1 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_AT_DE_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_BE_FR_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_BE_NL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_EN_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_ES_ES_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_FR_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_IT_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_NL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_NO_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_PL_2024-511472-32-00 | 2 |
| Protocol (for publication) | D4_Patient-facing_WPAI-CIQ-CD_PT_2024-511472-32-00 | 2 |
| Recruitment arrangements (for publication) | K1_2024-511472-32_Recruitment and Consent_FRA | 1 |
| Recruitment arrangements (for publication) | K1_Bank Transfer FAQ | 10.0 |
| Recruitment arrangements (for publication) | K1_Bank Transfer FAQ_german | 10.0 |
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| Recruitment arrangements (for publication) | K1_Bank Transfer Standard Message Template_AUT | 10.0 |
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| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_San | Italy |
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| Recruitment arrangements (for publication) | K2_ Dispute Form | V10.0 |
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| Recruitment arrangements (for publication) | k2_C-SSRS-Since Last Assessed_2subscales_AU5 2 | 1 |
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| Recruitment arrangements (for publication) | K2_Clin Carrier | V10.1 |
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| Recruitment arrangements (for publication) | K2_Lilly_Parent-Guardian Study Guide_red-san | V03 ITA |
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| Recruitment arrangements (for publication) | K2_Recruitment material_PGI-C_Crohns_Child_san | 1.0 |
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| Recruitment arrangements (for publication) | K2_Recruitment material_PGI-C_Crohns_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PGR-S_Crohns_Child_san | 1.0 |
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| Recruitment arrangements (for publication) | K2_Recruitment material_PGR-S_Crohns_san | 1.0 |
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| Recruitment arrangements (for publication) | K2_Recruitment materials_UCT Younger Kids_nl_san | V1.0 |
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| Recruitment arrangements (for publication) | K2_School Employer Letter | V01AUT01 |
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| Recruitment arrangements (for publication) | K2_Travel Contact Card | V10.0 |
| Recruitment arrangements (for publication) | K2_Travel Reference Guide | V10.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_FSR_12-17y_FRA | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_FSR_Parental_FRA | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_FSR_Turning 18_FRA | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Greenphire_Parental_FRA | 2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Greenphire_Turning 18_FRA | 2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_I6T-MC-AMAY_12-17y_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_I6T-MC-AMAY_6-11y_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_I6T-MC-AMAY_Parental_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_I6T-MC-AMAY_PP_FRA | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_I6T-MC-AMAY_Turning 18_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Platform 12-17y_FRA | 5.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Platform Parental_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Platform Turning 18_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Platform_2-5y_FRA | 3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-511472-32_ICF_Platform_6-11y_FRA | 4.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Greenphire | V1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Lilly Addendum 12-17 years_red | 5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Lilly Parental-Turning 18_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Master Parental Main_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Turning 18 Main | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Lilly PP_red | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Lilly_Addendum 6-11 years_red | 5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Master Main Assent 6-11 years_san | V4.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_ Assent 5-11 years old ICF | V4.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Assent 12-15 years old_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_ Addendum Turning 18 years_Red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_16 - 17 years_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 12-15 years old_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 16 -17 years_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum 5-11 years old_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Addendum Parental_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Parental_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Pregnancy Addendum_red | V3.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_Main ICF_Turning 18 years_red | V5.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_Master ICF Assent 12 -17 years_red | V5.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional FSR Assent_12-17 years_Red_San_CCI | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V1.0NOR1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ _Parental Main_Red_San_CCI | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum Assent 13-14_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum Assent 8-12_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum to Pregnant Partner ICF_LILLY_Red_San_CCI | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF__Turning 18 Main ICF_Red_San_CCI | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Parental_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Assent 12-17 years_LILLY_Red_San_CCI | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Assent 6-11 years_LILLY_Red_San_CCI | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Parental Main ICF_LILLY_Red_San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Turning 18 Main ICF_LILLY_Red_San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_ PP_redacted | V3.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Turning 18_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent _Assent 6-11 years old_Red_San_CCI | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17 yo_Red-San | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-17_Red_San_CCI | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 15-17 Greenphire | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 2-5 years_Red_San_CCI | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 6-11 yo_San | V4.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_12 to 17 years_Addendum_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_6 to 11 years_Addendum_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_ 12-16y Assent ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_ Eli Lilly_Pregnant Partner_red_san | V3.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_ Parental ICF_nl_red_san | V5.0NLD3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_ up to 12y Assent ICF_nl_red_san | V5.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_12-17 Assent ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_12-17 Assent ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_12-17 Assent ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_6-11 Assent ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_6-11 Assent ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_6-11 Assent ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Adult_ ICF_nl_red_san | V5.0NLD3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Parental Turning 18 ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Parental Turning 18 ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Parental Turning 18 ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Pregnant Partner ICF_en_redacted | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Pregnant Partner ICF_fr_redacted | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Eli Lilly_Pregnant Partner ICF_nl_redacted | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly CONFIDENTIAL Addendum 13-18 years old_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly CONFIDENTIAL Addendum 6-13 years old_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly CONFIDENTIAL ICF Parental Addendum_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly CONFIDENTIAL PP ICF Addendum_PL_redacted | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly CONFIDENTIAL Turning 18 ICF Addendum_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Assent 12-17 yo_Red-San | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Assent 6-11 yo_Red-San | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Parental Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Parental Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Turning 18 yo Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Addendum to Turning 18 yo Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Lilly_Pregnancy_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Addendum_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 13-14_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 13-18 years_PL_redacted | V5.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 15-17_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 6-13 years old_PL_san | V4.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent 8-12 | V4.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_12 to 17 years_san | V4.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_12-17 years_san_red | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_2 to 5 years_red_san | V4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Assent_6 to 11 years_san | V4.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parental_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PP ICF_clean | V1.0AUT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Turning 18_redacted | V5.0AUT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-16 Assent ICF_nl_red_san | 5.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_12-17 Assent ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_en_redacted | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_fr_redacted | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_6-11 Assent ICF_nl_redacted | V4.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Assent 2-5 yo_red-san | V4.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Main ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_nl_red_san | V5.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Parental Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_en_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_fr_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 Years Main ICF_nl_redacted | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_Turning 18 yo Main_Red-San | V6.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Protocol_up to 12_ Assent ICF_nl_red_san | V4.0NLD3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR _Participants turning 18_red_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR Assent_12-17 yo_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Assent 13-18 Years_PL_redacted | V3.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Parental_PL_redacted | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Parental_red_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Parental_Red_San_CCI | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR ICF_Turning 18_Red_San_CCI | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR Turning to 18 ICF_PL_redacted | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Assent_12-17 years_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Parental_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional FSR_Turning 18 yo_Red-San | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental ICF_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parental Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Participants turning 18_red_san | V5.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Addendum_san | V2.0NOR1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_PL_san | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_Red_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Greenphire | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 ICF_PL_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Years and Parental Greenphire ICF_Clean_san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 Years and Parental Greenphire ICF_PL_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Turning 18 yo Main Privacy_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_CDI-2-Self Report SHORT Response Form_San | 1 |
| Subject information and informed consent form (for publication) | L2_GP Letter_San | 2 |
| Subject information and informed consent form (for publication) | L2_Greenphire packet with Data Privacy_for EC | v10.0 |
| Subject information and informed consent form (for publication) | L2_LilyClinicalTrials-7-12yr_San | 1 |
| Subject information and informed consent form (for publication) | L2_Non-Screening Fecal Sample Collection Instructions_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ A-1130-0120-5151QRG | v1_ptPT |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ MACARONI-23_Patient ID Card | V02 PRTpt |
| Subject information and informed consent form (for publication) | L2_Other subject information material_3D Secure Terms of Use_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Baseline Screening | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Baseline Screening_nl_san | AU5.3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Baseline Screening_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Since Last Assessed | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_C-SSRS-Since Last Assessed_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDAI_Average Abdominal Pain_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDI 2 Self Report | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CDI-2-Self Report SHORT Response Form_PL_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder FAQ_PL_san | 11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Msg Templates_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Cardholder Website Screenshots_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Card_Carrier_PL_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Fee_Schedule_PL_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Generic_Image_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Privacy Policy_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EC_packet_Data_Privacy_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Card Carrier | V10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Cardholder FAQ | V11.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard EC Submission Overview | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Privacy Policy_TPML | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Website Screenshots | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ConneX | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Dispute Form | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Fee Schedule | V10.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Secure Terms of Use | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Guide to the eDiary ORG_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_i2c EU Dispute Form_PL_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter to School Employer_PL_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly_Study Guide for Parents_ Guardians_PL_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MACARONI-23_Patient-facing Non-Screening | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MACARONI-23_Patient-facing Screening | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Milestone Certificate_PL_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParentGuardian Study Guide_red | V3.0PRT1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient ID card_PL_san | V02POL(pl) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Stool Collection Materials | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Observer_nl_san | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_Crohns_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns | v1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Child | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Child_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Observer | v1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_Observer_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_Crohns_PL_san | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Sample_ICF_Notice_EU_PL_san | 8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Stool Sampling Instructions for Non-Screening Visit_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Stool Sampling Instructions for Screening Visit_PL_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Assistance Items | V01Global |
| Subject information and informed consent form (for publication) | L2_Other subject information_GP Letter_Red-San | ITA V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Greenphire Plantilla mensaje ClinCard | V10 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Greenphire Tarjeta de contacto para viajes | V10 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_San | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Study Guide_San | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_C-SSRS baseline Screening_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_C-SSRS since last assessed_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_CDAI Average Abdominal Pain_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_CDI-2-Self Report SHORT Response Form_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_EC Submission Overview_FRA | 9.0 |
| Subject information and informed consent form (for publication) | L2_Patient_eDiary study guide_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_Fecal collection instructions Non screening_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Fecal collection instructions Screening_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Automatic transfers FAQ_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_CardHolder FAQ_FRA | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Carrier_FRA | 3 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Clincard_FRA | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Contact Card_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Fee schedule_FRA | NA |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Msg Template_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Greenphire_Travel Ref Guide_FRA | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Milestone certificate_FRA | 01 |
| Subject information and informed consent form (for publication) | L2_Patient_Parental study guide_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_Patient Card_FRA | 02FRA(fr) |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C Observer_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGI-C_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S Child_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S Observer_FRA | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_PGR-S_FRA | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient_School employer letter_FRA | 01FRA(fr) |
| Subject information and informed consent form (for publication) | L2_PGI-C_Crohns_Child_San | 1 |
| Subject information and informed consent form (for publication) | L2_PGI-C_Crohns_Observer_San | 1 |
| Subject information and informed consent form (for publication) | L2_PGI-C_Crohns_San | 1 |
| Subject information and informed consent form (for publication) | L2_PGR-S_Crohns_Child_San | 1 |
| Subject information and informed consent form (for publication) | L2_PGR-S_Crohns_Observer_San | 1 |
| Subject information and informed consent form (for publication) | L2_PGR-S_Crohns_San | 1 |
| Subject information and informed consent form (for publication) | L2_Screening Fecal Sample Collection Instructions_San | 1 |
| Subject information and informed consent form (for publication) | Li_SIS and ICF_ Addendum Assent 15-17_redacted | V5.0AUT1.0 |
| Subject information and informed consent form (for publication) | Li_SIS and ICF_Parental Greenphire | V2.0AUT1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_de_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_de_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_de_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_de_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_fr_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_fr_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_nl_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_nl_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-511472-32-00_ISA_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-511472-32-00_Platform_red | AM2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA_2024-511472-32-00_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_nl_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_nl_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NO_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NO_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2024-511472-32-00_Platform_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Platform_2024-511472-32-00_red | AM3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2024-511472-32-00_ISA_red | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2024-511472-32-00_Platform_red | AM3 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Netherlands | Acceptable with conditions 2024-07-31
|
2024-07-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-24 | Netherlands | Acceptable with conditions 2024-07-31
|
2024-09-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | Netherlands | Acceptable 2025-02-07
|
2025-02-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-31 | Netherlands | Acceptable 2025-06-02
|
2025-06-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-09 | Netherlands | Acceptable | 2025-07-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-15 | Acceptable 2025-06-02
|
2025-07-15 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-24 | Acceptable 2025-06-02
|
2025-07-24 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-30 | Acceptable | 2025-09-25 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-17 | Netherlands | Acceptable 2025-12-10
|
2025-12-15 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-27 | Acceptable | 2026-04-29 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-27 | Acceptable 2025-12-10
|
2026-05-27 |