Document is current

Article History

Received: 5 April 2024

Accepted: 13 December 2024

First Online: 21 February 2025

Declarations

:

: We confirm that we have read the journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines. The study was conducted in compliance with good clinical practice guidelines, including the International Conference on Harmonization guidelines. All study documentation was approved by Western Independent Review Board (tracking number 20217011) before recruitment. Experts, patient advocates, and caregivers provided consent to participate. Data analyzed from the ELEKTRA clinical trial database were collected under the approvals and informed consents in place for that study, with no additional patient or caregiver contact. All applicable laws and regulatory requirements were adhered to throughout the study.

: Not applicable.

: JSA, DS, MA, and AB are employees of Takeda Development Center Americas, Inc., and own stock or stock options in Takeda Pharmaceutical Company Limited. SH and LS are employees of Clinical Outcomes Solutions, which received funding from Takeda Development Center Americas, Inc. to carry out this study. AN and TS were employees of Clinical Outcomes Solutions at the time of the study.