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Evidentiary Basis of the First Regulatory Qualification of a Digital Primary Efficacy Endpoint

Laurent Servais,Paul Strijbos,Margaux Poleur,Andrada Mirea,Nina Butoianu,Valeria A. Sansone,Carole Vuillerot,Ulrike Schara-Schmidt,Mariacristina Scoto,Andreea M. Seferian,Stefano C. Previtali,Mar Tulinius,Andres Nascimento,Pat Furlong,Teji Singh, Roxana Donisa Dreghici,Nathalie Goemans,Eugenio Mercuri,Volker Straub, Maitea Guridi Ormazabal,Jessica Braid,Francesco Muntoni, Alexis Tricot,Melanie Annoussamy,Damien Eggenspieler

SCIENTIFIC REPORTS（2024）

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Key words
Stride Velocity 95th Centile,Digital endpoints,Wearables,Duchenne muscular dystrophy,Regulatory qualification,V3 framework
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