Majoni, Sandawana William http://orcid.org/0000-0003-0039-1913
Nelson, Jane
Germaine, Darren
Hoppo, Libby
Long, Stephanie
Divakaran, Shilpa
Turner, Brandon
Graham, Jessica
Cherian, Sajiv
Pawar, Basant
Rathnayake, Geetha
Heron, Bianca
Maple-Brown, Louise
Batey, Robert
Morris, Peter
Davies, Jane
Fernandes, David
Sundaram, Madhivanan
Abeyaratne, Asanga
Wong, Yun Hui Sheryl
Lawton, Paul D.
Taylor, Sean
Barzi, Federica
Cass, Alan
,
Funding for this research was provided by:
National Health and Medical Research Council (GRANT1163841)
Article History
Received: 2 October 2021
Accepted: 20 November 2021
First Online: 2 December 2021
Declarations
:
: The study is conducted according to the declaration of Helsinki, the Australian National Health and Medical Research Council (NHMRC) criteria for the ethical conduct of research in humans and the principles of Good Clinical Practice [CitationRef removed].All drugs in this study are registered for use in Australia. Both treatments are unlikely to cause harm and have been proven safe as they are used daily in routine clinical practice. Written informed consent will be sought from all participants.Approval has been awarded by the relevant human research ethics committees (HRECs) for all sites (The Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC) Reference Number: 2019-3536 and Central Australia Human Research Committee (CAHREC); Reference Number: CA-19-3567).The study protocol, patient information sheet, participant consent forms, and any other documents or media required for ethics approval were submitted to the relevant Human Research Ethics Committees for approval before the study commenced. Each HREC reviewing the protocol was properly constituted as per regulatory requirements (according to NHMRC requirements) and had the capacity to review the study. Approvals specified the study title and version numbers, identified all documents reviewed and stated the date of review. No amendments to, or deviations from, the protocol will be initiated without prior written approval from the relevant HREC. The exceptions to this are: UnorderedList removed<i>Regulatory approvals</i>: Even though all products are licenced for use in Australia, IV iron will be used outside the current guideline recommendations. Hence, a Clinical Trials Notification (CTN) has been lodged with the Therapeutic Goods Administration (TGA).
: No applicable
: All the authors declare that they have no competing interests