Stanley, I. Kitty
Palma, Anton M.
Viecelli, Andrea K.
Johnson, David W.
Hawley, Carmel M.
Staatz, Christine E.
Mallett, Andrew J. http://orcid.org/0000-0002-8752-2551
Article History
Received: 14 December 2023
Accepted: 15 January 2024
First Online: 21 March 2024
Declarations
:
: AMP is an employee of Otsuka Pharmaceutical Development & Commercialization. AJM is supported by a Queensland Health Advancing Clinical Research Fellowship.
: The institutional review board or ethics committee at each site for the TEMPO 3:4 [NCT00428948] and REPRISE [NCT02160145] clinical trials provided ethical approval for each trial.
: The TEMPO 3:4 [NCT00428948] and REPRISE [NCT02160145] clinical trials were carried out in accordance with and adhered to all relevant human rights and research guidelines and regulations.
: All participants in both the TEMPO 3:4 [NCT00428948] and REPRISE [NCT02160145] clinical trials provided written informed consent for participation, data collection and analysis.