Document is current

Article History

Accepted: 23 January 2022

First Online: 31 March 2022

Declarations

:

: This study was primarily funded by contracts from Allaysis, LLC awarded to the University of Minnesota and to Optum. Should the investigational intravenous baclofen formulation being developed by Allaysis LLC be commercialized, the University of Minnesota and James Cloyd may receive royalty payments.

: This work was supported by Allaysis LLC.

: Data used in this study were de-identified and in full compliance with the Health Insurance Portability and Accountability Act (HIPPA); Declaration of Helsinki, and ICH GCP. This study did not require review or approval by ethics committees or informed consent.

: Not applicable.

: All authors of this manuscript and agree with its publication in Drugs–Real World Outcomes.

: The data that support the findings of this study are available from Optum, Inc. and Allaysis LLC. but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with permission from Optum, Inc. and Allaysis LLC.

: Not applicable.

: NS study conception, data interpretation, and writing (drafted original manuscript and substantial edits); MA data acquisition, analysis, and interpretation, and writing (contributed substantial edits); KW data acquisition and analysis; SG data acquisition and analysis; JC study conception, data interpretation, and writing (contributed substantial edits); JS study conception, data interpretation, and writing (contributed substantial edits); RK study conception, data interpretation, and writing (contributed substantial edits).