Ramanan, Athimalaipet V.
Guly, Catherine M.
Keller, Stuart Y.
Schlichting, Douglas E.
de Bono, Stephanie
Liao, Ran
Quartier, Pierre
Funding for this research was provided by:
Eli Lilly and Company
Article History
Received: 18 June 2020
Accepted: 23 September 2021
First Online: 9 October 2021
Declarations
:
: This trial will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The design was approved by the European Medicines Agency’s (EMA) Paediatric Committee (PDCO) (EudraCT 2019-000119-10) and by various country-level regulatory agencies and ethical review boards, including the CEIm del Hospital Universitario y Politécnico la Fe (Valencia, Spain), Comitato Etico San Martino (Genoa, Italy), Comitato Etico Milan Area 2 (Milan, Italy), CPP Nord Ouest IV – Lille (Lille, France), Landesamt für Gesundheit und Soziales (LaGeSo) (Berlin, Germany), and North West – Liverpool Central Research Ethics Committee (Liverpool, UK). All parents or legal guardians and patients (as appropriate) will provide written informed consent and assent, respectively. Patient confidentiality will be maintained in accordance with the Data Privacy Statement in the Informed Consent Form.
: Not applicable.
: AVR has received consultancies and/or speaking fees from AbbVie, Roche, UCB, Eli Lilly and Company, and Sobi. CMG has received consultancies and/or speaking fees from Eli Lilly and Company and Novartis. SYK, DES, SdB, and RL are employees and may be shareholders of Eli Lilly and Company. PQ has received consultancies and/or speaking fees from AbbVie, BMS, Chugai-Roche, Eli Lilly and Company, Novartis, Novimmune, and Sobi and served on two data safety monitoring boards for Sanofi.