Document is current
Any future updates will be listed below
-
Authors
Shields, Alan L. https://orcid.org/0000-0003-3362-3135
Galipeau, Nina
Litcher-Kelly, Leighann
Moreno-Koehler, Alejandro
Chacko, Jimmy
- License Information
-
More Information
Article History
Received: 24 February 2025
Accepted: 22 October 2025
First Online: 12 December 2025
Declarations
:
: For study SBL-INI-02–13, full Institutional Review Board (IRB) approval was obtained from Salus IRB (USA) prior to recruitment and written informed consent was obtained prior to enrollment. For the patient concept elicitation interview study, approval to execute the study was received from Copernicus Group IRB (USA) and from the Aston University Ethics Committee (UK) prior to recruitment, and written informed consent was obtained prior to data collection. The patient content evaluation interview study was granted approval from Copernicus Group IRB (USA) prior to recruitment, and written informed consent was obtained prior to data collection.
: Not applicable.
: JC is an employee of Lenstec, Inc., the study sponsor. AS, NG, LLK, and AMK are employees of Adelphi Values, which was contracted by Lenstec, Inc. for work on the original research study and the manuscript.
