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Article History

Received: 17 October 2020

Accepted: 30 October 2020

First Online: 11 November 2020

Ethics approval and consent to participate

: This study will be conducted in accordance with relevant regulations and researchers will be compliant with Good Clinical Practice. This is a multicentre research project, with sites in three Australian states. Ethical and scientific review has been conducted under the National Mutual Acceptance scheme by the Alfred Hospital Human Research Ethics Committee as the administering HREC (43565; local reference: project 506/18) and HREC responsible for auditing the trial. Trial sites have received ethical approval and research governance authorisation by the Alfred Hospital HREC (506/18), Family Planning NSW Ethics Committee (reference R2019–06), or the South Eastern Sydney Local Health District HREC (SSA reference 19/G/053) prior to the study commencing or prior to any protocol amendments being implemented. Therefore, ethical permission has been granted at all sites and patient recruitment has commenced at all sites. All participants will receive oral and written information about the trial and must give their written informed consent to participate. By signing the consent form, participants are consenting to collection and storage of samples for use in this project. They will also be asked if they agree to provide consent for their samples to be stored indefinitely to be used for future research that is closely related to this research project. Participants are free to withdraw at any time and are instructed that their ongoing clinical care will not be affected.

: Not applicable.

: Not applicable.