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Randomisation, Allocation Concealment and Blinding

AC Anne B. Chang
MT Maree Toombs
MC Mark D. Chatfield
RM Remai Mitchell
SF Siew M. Fong
MB Michael J. Binks
HS Heidi Smith-Vaughan
SP Susan J. Pizzutto
KL Karin Lust
PM Peter S. Morris
JM Julie M. Marchant
SY Stephanie T. Yerkovich
HO Hannah O'Farrell
PT Paul J. Torzillo
CM Carolyn Maclennan
DS David Simon
HU Holger W. Unger
HE Hasthika Ellepola
JO Jens Odendahl
HM Helen S. Marshall
GS Geeta K. Swamy
KG Keith Grimwood
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At enrolment, participants are randomised to one of the two study arms (intervention or control). The random treatment allocation is computer-generated, stratified by site, using permuted blocks sizes of various sizes, concealed and supervised by a statistician.

Participants and study teams are unaware of the treatment to be allocated before the patients are entered into the study. The study is not placebo-controlled, but assessors collecting study outcome data are blinded to treatment allocation.

Copyright and License information:  ©2022 Chang, Toombs, Chatfield, Mitchell, Fong, Binks, Smith-Vaughan, Pizzutto, Lust, Morris, Marchant, Yerkovich, O'Farrell, Torzillo, Maclennan, Simon, Unger, Ellepola, Odendahl, Marshall, Swamy and Grimwood.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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