Muntoni, Francesco
Byrne, Barry J.
McMillan, Hugh J.
Ryan, Monique M.
Wong, Brenda L.
Dukart, Juergen
Bansal, Amita
Cosson, Valerie
Dreghici, Roxana
Guridi, Maitea
Rabbia, Michael
Staunton, Hannah
Tirucherai, Giridhar S.
Yen, Karl
Yuan, Xiling
Wagner, Kathryn R.
,
Carvajal, Irvith
Chimalakonda, Anjaneya
Gokemeijer, Jochem
Gulianello, Michael
Hellbach, Nicole
Kozhich, Alexander
Kukral, Daniel
Malone, Harold
Meredith, Jere E. Jr
Pletcher, Mathew
Rakestraw, Ginger
Schneeweis, Lumelle
Swain, Joanna
Zambito, Frank
Chang, Ming
Hamuro, Lora
Luo, Feng
Peterson, Jon E.
Hocknell, Peter
Lou, Zhen
Madireddi, Malavi
Pletcher, Mathew
Bechtold, Clifford M.
Ahlijanian, Michael K.
Chang, Ming
Hamuro, Lora
Jacobsen, Leslie K.
Kozhich, Alexander
Luo, Feng
Peterson, Jon E.
Zambito, Frank
Kletzl, Heidemarie
Dubrovsky, Alberto L.
Mesa, Lilia
Chloca, Fernando
Jauregu, Agustin
Jones, Kristi
Ryan, Monique
Campbell, Craig
Mah, Jean
Ho, Alice
Chiu, Angela
D’Souza, Vanessa
Sadowski, Raymy
Dao, Julie
Grice, Michaela
Price, Tiffany
McMillan, Hugh
Sell, Erick
McCormick, Anna
Gidaro, Teresa
Seferian, Andrea
Péréon, Yann
Magot, Armelle
Vuillerot, Carole
Schara-Schmidt, Ulrike
Sansone, Valerie
Albamonte, Emilio
Di Bari, Alessandra
Refran, Jasmine
Salmin, Francesca
Vita, Giuseppe
Vita, Gian Luca
Consulo, Chiara
Komaki, Hirofumi
Ishiyama, Akihiko
Matsumura, Tsuyoshi
Saito, Toshio
Ichihara, Kana
Hayashi, Naoki
Terada, Kouji
Takehara, Kenji
Hayashi, Nobuko
Takeshima, Yasuhiro
Nascimiento, Andres
Natera, Daniel
Carrera, Laura
Exposito, Jesica
Ortez, Carlos
Medina, Julita
Moya, Obdulia
Roca, Sandra
Rodriguez, Alicia
Valle, Maria
de Groot, Imelda J. M.
Niks, Erik H.
van Heur-Neuman, Marjolein J.
van der Holst, Menno
Scoto, Mariacristina
Brusa, Chiara
Afazal, Abidha
Miller, Eveline
Byrne, Barry J.
Cripe, Linda
Finkel, Richard S.
Heydemann, Peter
Matthews, Katherine
Miller, Chandra
Laubsher, Katie
Mockeler, Shelley
Phan, Han
Sivakumar, Kumaraswamy
Osgood, Kristy
Statland, Jeffrey
Tian, Cuixia
Wagner, Kathryn R.
Leung, Doris
Bibat, Genila
Stinson, Nikia
Servais, Laurent
Mercuri, Eugenio
Duong, Tina
Scoto, Mariacristina
Campbell, Craig
Strijbos, Paul
Veenstra, Klaas
Funding for this research was provided by:
Bristol-Myers Squibb
F. Hoffmann-La Roche
Article History
Received: 11 September 2023
Accepted: 22 November 2023
First Online: 8 January 2024
Conflict of Interest
: Francesco Muntoni was a site principal investigator in the trial and received support for the trial conduct. He has also received consultancy payments from F. Hoffmann-La Roche Ltd for participation in scientific advisory boards. Barry J. Byrne was a site principal investigator in the trial and received support for the trial conduct. Hugh J. McMillan was a site principal investigator in the trial and has received support for the trial conduct. He has also received consultancy payments from F. Hoffmann-La Roche Ltd for participation in scientific advisory boards. Monique M. Ryan was a site principal investigator in the trial and has received support for the trial conduct. Brenda L. Wong was a site principal investigator in the trial and received support for the trial conduct. Jurgen Dukart is a former employee of and received consultancy fees from F. Hoffmann–La Roche Ltd. Amita Bansal is a former employee of F. Hoffmann-La Roche Ltd. New affiliation: Novartis International AG, Basel, Switzerland. Roxana Dreghici is a former employee and shareholder of F. Hoffmann-La Roche Ltd. New affiliation: Solid Biosciences Inc., Charlestown, MA, USA. Valerie Cosson is an employee and shareholder of Roche Products Ltd. Maitea Guridi is an employee and shareholder of F. Hoffmann-La Roche Ltd. Michael Rabbia is an employee and shareholder of Genentech, Inc, a member of the Roche Group. Hannah Staunton is an employee and shareholder of Roche Products Ltd. Giridhar S Tirucherai is a former employee and shareholder of Bristol Myers Squibb. New affiliation: Scholar Rock Inc., Cambridge, MA, USA. Karl Yen is a former employee and shareholder of F. Hoffmann-La Roche Ltd. New affiliation: Sanofi SA, Basel, Switzerland. Xiling Yuan is an employee and shareholder of Bristol Myers Squibb. Kathryn R. Wagner was a site principal investigator in the trial and received support for the trial conduct. She is a former employee of F. Hoffmann-La Roche Ltd. New affiliation: Novartis International AG, Basel, Switzerland.
: The taldefgrobep alfa clinical trials were conducted in accordance with the principles of the 1964 Declaration of Helsinki and its later amendments, and in accordance with Good Clinical Practice guidelines. Approval from the institutional review board/independent ethics committee at each participating study site was obtained before each of the studies started and the studies were registered with ClinicalTrials.gov. Signed written informed consent was collected prior to study participation from participants, and, in the case of minors, from parents, guardians, or legally acceptable representatives.