Harlin, Matthew http://orcid.org/0000-0001-7087-2734
Yildirim, Murat http://orcid.org/0000-0001-6192-1047
Such, Pedro http://orcid.org/0000-0003-1905-1142
Madera-McDonough, Jessica http://orcid.org/0000-0003-2887-7480
Jan, Michael http://orcid.org/0000-0001-7638-4766
Jin, Na
Watkin, Suzanne
Larsen, Frank http://orcid.org/0000-0002-8318-1681
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder
https://doi.org/10.1007/s40263-023-00996-8
Funding for this research was provided by:
Otsuka Pharmaceutical Development and Commercialization
H. Lundbeck A/S
Article History
Accepted: 27 February 2023
First Online: 24 March 2023
Declarations
:
: This work was sponsored 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 study, the collection, analysis and interpretation of data, the writing and reviewing of this article, and the decision to submit the article for publication. Open access publication was funded by Otsuka Pharmaceutical Development & Commercialization Inc.
: Matthew Harlin, Jessica Madera-McDonough, Michael Jan, Na Jin, and Suzanne Watkin are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. Murat Yildirim, Pedro Such, and Frank Larsen are full-time employees of H. Lundbeck A/S.
: Matthew Harlin and Frank Larsen participated in trial conception and design. All authors were involved in data collection and/or analysis; participated in the drafting or critical review of the article; gave final approval of the version to be published; and agree to be accountable for all aspects of this work.
: 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 ExternalRef removed. For all approved IPD access requests, Otsuka will share anonymized IPD on a remotely accessible data-sharing platform.
: The study was conducted in accordance with the International Council for Harmonization Good Clinical Practice guidelines and local regulatory requirements. The study protocol was approved by the governing Institutional Review Board or independent Ethics Committee for each investigational site.
: All study participants provided written informed consent prior to the start of the study.
: Not applicable.
: Not applicable.