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Authors
Stewart, Adam G. https://orcid.org/0000-0002-7262-7529
Harris, Patrick N. A.
Chatfield, Mark D.
Littleford, Roberta
Paterson, David L.
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Funding
Funding for this research was provided by:
Merck Sharp and Dohme
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Article History
Received: 9 December 2020
Accepted: 18 March 2021
First Online: 22 April 2021
Declarations
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: Ethical approval was given by The Royal Brisbane and Women’s Hospital HREC (HREC/2019/QRBW/59232 as part of the National Mutual Acceptance Scheme in Australia. International sites will seek local HREC/IRB approval as per local procedures. The protocol has been given ethical approval by the Royal Brisbane and Women’s Hospital on 28th February 2020 (HREC/2019/QRBW/59232). This study will be conducted in accordance with the ICH-GCP Guidelines and the principles in the Declaration of Helsinki. Potential participants or substitute decision-makers will be approached and provided with information sheets outlining the risks, benefits and procedures of the trial, and then will be invited to provide written informed consent prior to enrolment. This was conducted to ICH-GCP standards and all other regulatory requirements.
: See Supplementary material.
: DLP has received funding from AstraZeneca, Leo Pharmaceuticals, Bayer, GlaxoSmithKline (GSK), Cubist, Venatorx and Accelerate; reports board membership from Entasis, Qpex, Merck, Shionogi, Achaogen, AstraZeneca, Leo Pharmaceuticals, Bayer, GSK, Cubist, Venatorx, and Accelerate; reports grants/grants pending from Shionogi and Merck; and has received payment for lectures including service on speaker’s bureaus from Pfizer, outside the submitted work. PNAH has received research grants from MSD. All other authors have no competing interests to declare.
