Funding for this research was provided by:
EMD Serono
Article History
Accepted: 26 April 2022
First Online: 30 June 2022
Declarations
:
: This psychometric analysis was funded by EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100004755). The clinical trial from which this analysis was derived was sponsored by Merck (CrossRef Funder ID: 10.13039/100009945), as part of an alliance between Merck and Pfizer.
: Cheryl D. Coon is an employee of Outcometrix and received funding for this psychometric analysis from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100004755). Michael Schlichting is an employee of Merck Healthcare KGaA, Darmstadt, Germany. Xinke Zhang is an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.
: The study protocol was approved by Institutional Review Boards and Ethics Committees at each institution. The study was conducted in accordance with the protocol, Good Clinical Practice guidelines, and the Declaration of Helsinki. All study participants provided written informed consent.
: Informed consent was obtained from all individual participants included in the original study, whose PRO data were evaluated in the analysis reported herein.
: Not applicable (no identifying information is included in this article).
: For all new products or new indications approved in both the European Union and the US after 1 January 2014, Merck (CrossRef Funder ID: 10.13039/100004755) shares patient-level and study-level data after de-identification, and redacted study protocols and clinical study reports from clinical trials in patients. These data will be shared with qualified scientific and medical researchers, upon the researcher’s request, as necessary for legitimate research. Such requests should be submitted in writing to Merck’s data sharing portal. When Merck has a co-research, co-development, co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck will endeavor to gain agreement to share data in response to requests.
: Not applicable.
: This psychometric analysis used data from a clinical trial that is registered with ClinicalTrials.gov, identifier NCT02395172.
: All authors contributed to the design of the psychometric study and were involved in analysis of data, interpretation of results, and drafting and revising the manuscript. All authors read and approved the final manuscript.