Clinical trials referenced in this document:
Documents that mention this clinical trial
Pharmacokinetics, Safety, and Tolerability of SHP465 Mixed Amphetamine Salts After Administration of Multiple Daily Doses in Children Aged 4–5 Years with Attention-Deficit/Hyperactivity Disorder
https://doi.org/10.1007/s40263-021-00870-5
Funding for this research was provided by:
Shire Development, LLC, a Takeda company, Lexington, MA, USA
Article History
Accepted: 17 October 2021
First Online: 26 November 2021
Declarations
:
: This study and open-access publication fee were funded by Shire Development, LLC, a member of the Takeda group of companies, Lexington, MA, USA. Takeda Pharmaceuticals USA, Cambridge, MA, USA provided funding to ICON (North Wales, PA, USA) for support in writing and editing this manuscript.
: KI and BY are employees of Takeda Pharmaceuticals USA, and own stock in Takeda. AK is a consultant for Shire, a member of the Takeda group of companies, and owns stocks in Takeda. NM has served as a consultant for Shire, a member of the Takeda group of companies.
: The study protocol, final approved informed consent document, and all supporting information were submitted to and approved by Schulman Associates Institutional Review Board, Cincinnati, OH, USA (part of Advarra Institutional Review Board since November 2017) and University Hospitals Cleveland Medical Center Institutional Review Board, Cleveland, OH, USA, and by the US Food and Drug Administration, as appropriate, before study initiation. The study was conducted in accordance with guidelines of the International Council for Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, and applicable FDA regulations.
: Written informed consent was obtained from the participant’s parent or legally authorized representative and, if applicable, assent was obtained from the participant.
: Not applicable.
: The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participant’s data supporting the results reported in this article, will be made available within 3 months from an initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
: Not applicable.
: KI designed the study; NM and KI performed the research; and KI, BY, and AK analyzed and interpreted the data. KI critically revised the draft manuscript. All authors critically reviewed the manuscript, agree to be fully accountable for ensuring the integrity and accuracy of the work, and read and approved the final manuscript.