Roberts, Lynne
Henry, Amanda
Harvey, Samuel B.
Homer, Caroline S. E.
Davis, Gregory K.
Article History
Received: 29 October 2021
Accepted: 28 January 2022
First Online: 7 February 2022
Declarations
:
: The P4 Study was approved by the South East Sydney Local Health District (SESLHD) Human Research Ethics Committee (HREC ref no: 12/195) and Governance approval was obtained from SESLHD (SSA ref: 12/G/224). All participating women were provided with the approved invitation, Participant Information Sheet and Consent Form (PISCF) and given time to ask questions before providing written consent. Consent was obtained from each participating woman at the six month study visit prior to any study procedure taking place. All study methods and procedures were performed in accordance with the relevant guidelines and regulations, in accordance with the approved study protocol. The P4 Study was retrospectively registered in the Australian and New Zealand Clinical Trials Registry Number: ACTRN12613001260718.
: Not applicable
: Professor Amanda Henry is an Associate Member of the editorial board of this journal. Professor Amanda Henry is also a co-author of the submitted paper. However, to avoid any perception or reality of conflict of interest, Prof Amanda Henry will not participate in any part of the allocation and actual peer review process. The other authors declare that they have no competing interests.