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Authors
Howard, Kellee https://orcid.org/0009-0009-8608-3161
Adelman, Daniel https://orcid.org/0000-0002-0470-3235
Ghura, Sonal https://orcid.org/0009-0004-8615-9297
Acaster, Sarah https://orcid.org/0000-0003-1025-2546
Clifford, Sarah https://orcid.org/0000-0002-6811-4691
Kelly, Ciaran P. https://orcid.org/0000-0002-8216-1240
Martin, Susan A. https://orcid.org/0000-0002-9594-5036
Meckley, Lisa M. https://orcid.org/0000-0002-4791-4294
Leffler, Daniel A. https://orcid.org/0000-0002-0750-3386
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Funding
Funding for this research was provided by:
Takeda Pharmaceuticals U.S.A.
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Article History
Accepted: 27 September 2024
First Online: 26 October 2024
Declarations
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: KH is an employee of IQVIA, Montreal, Quebec, Canada and was an employee of ICON plc during the development of CDSD 1.0<sup>©</sup>. DA currently serves on the faculty of the University of California, San Francisco, CA, USA and was an employee of Alvine Pharmaceuticals at the time of the development of CDSD version 1.0<sup>©</sup>. SG is an employee of Takeda Development Center Americas Inc., Cambridge, MA, USA and receives stock or stock options. SA is an owner and shareholder of Acaster Lloyd Consulting Ltd, London, UK and was an employee of Oxford Outcomes Ltd (later acquired by ICON plc) during the development of CDSD 1.0<sup>©</sup>. SC is an employee of Sprout Health Solutions, Los Angeles, CA, USA and was an employee of ICON plc during the development of CDSD 1.0<sup>©</sup>. CPK is an employee of Beth Israel Deaconess Medical Center, Boston, MA, USA and has acted as a consultant to COUR Pharmaceuticals, Janssen, Kanyos/Anokion, Merck, Milky Way Life Sciences, Takeda Pharmaceuticals and Theravance and has received stock options from COUR Pharmaceuticals. SAM is an employee of RTI Health Solutions, Ann Arbor, MI, USA. RTI Health Solutions were paid consultants to conduct the qualitative research evaluating the CDSD v2.1<sup>©</sup>. LMM was an employee of Takeda Development Center Americas Inc., Cambridge, MA, USA during development of CDSD 2.1<sup>©</sup> and holds Takeda stock. DAL is an employee of Beth Israel Deaconess Medical Center, Boston, MA, USA and Takeda Development Center Americas Inc., Cambridge, MA, USA and receives stock or stock options.
: The studies described in this manuscript were approved by the relevant Institutional Review Board (IRB) for each institution (see Online Resource).
: Written IRB-approved informed consent documents (or assent documents for participants 17 years of age or younger) were obtained from all participants prior to taking part in each study. Each study was fully explained to all potential participants, including the purpose of the study, the type of questions asked and the time required. Participants were able to ask questions before agreeing to participate.
