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. 2022 Apr 21;23:335. doi: 10.1186/s13063-022-06237-5
Title {1} Tolvaptan versus fluid restriction in acutely hospitalised patients with moderate-severe hyponatraemia (TVFR-HypoNa): Design and implementation of an open-label randomised trial
Trial registration {2a and 2b}. Australia and New Zealand Clinical Trials Registry ACTRN12619001683123. Registered 2 December 2019.
Protocol version {3} 16 April 2021, Version 16
Funding {4}

Investigator-initiated trial.

Otsuka Australia Pharmaceutical (maker of tolvaptan) have agreed to provide financial support to reimburse study drug purchase and expenses.

National Health and Medical Research Council of Australia has awarded a postgraduate research scholarship to AMW for financial support during PhD candidature.

Author details {5a}

Dr Annabelle M Warren MBBS

Corresponding author – annabelle.warren@austin.org.au

Prof Mathis Grossmann PhD

Prof Rudolf Hoermann PhD

Prof Jeffrey D Zajac PhD

Dr Nicholas Russell MBBS

Affiliations above

Name and contact information for the trial sponsor {5b}

The University of Melbourne

Department of Medicine, Austin Health

Level 7, Lance Townsend Building

145 Studley Rd, Heidelberg

Victoria, 3084, Australia

Role of sponsor {5c} The sponsor (The University of Melbourne) and the funding sources (Otsuka Australia Pharmaceutical and National Health and Medical Research Council of Australia) do not have any role in study design, data collection, analysis or interpretation, nor in decision to submit the report for publication.