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Article History

Accepted: 5 June 2025

First Online: 19 July 2025

Declarations

:

: This work was supported by Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Denmark). The sponsors were involved in the design of the research, the analysis and interpretation of data, and the writing and reviewing of this article. The sponsors paid the open access fee.

: Alpesh Shah, Dalei Chen, Denise Chang, Mary Slomkowski, Mary Hobart, and Malaak Brubaker are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. Alvin Estilo, Daniel Lee, and Saloni Behl were full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. at the time of this work. Pamela L. Sheridan was a full-time employee of Lundbeck LLC at the time of this work. Uwa Kalu is a full-time employee of Lundbeck LLC. Nanco Hefting and Pedro Such are full-time employees of H. Lundbeck A/S. George T Grossberg has received consulting fees from Acadia, Abbott, Axsome, Biogen, BMS, BioXcel, Eisai, Karuna, Lundbeck, MapLight Therapeutics, Otsuka, and Takeda. George T. Grossberg is on the Editorial Board for CNS Drugs, Journal of the American Medical Directors Association, and International Journal of Alzheimer’s Disease; he was not involved in the selection of peer reviewers for this manuscript nor any of the subsequent editorial decisions. He is on Safety Monitoring Committees for Anavex, Quince, Merck, Newron, and Oligomerix.

: To submit inquiries related to Otsuka clinical research, or to request access to individual participant data (IPD) associated with any Otsuka clinical trial, please visit . For all approved IPD access requests, Otsuka will share anonymized IPD on a remotely accessible data sharing platform.

: This analysis used pooled data from published clinical trials. The trials were approved by relevant institutional review boards and independent ethics committees and were performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.

: Not applicable.

: Not applicable.

: This analysis used pooled data from published clinical trials. All participants and/or their legal representatives provided written or electronic informed consent prior to the start of the trials.

: All authors contributed to the study conception and design. Data analysis was performed by Dalei Chen and Denise Chang. All authors critically reviewed the manuscript for intellectual content. All authors read and approved the final manuscript.