Randomisation
Randomisation was performed by a trial pharmacist using an online
randomisation sequence generator and opaque envelopes. Participants were
stratified into two arms based on their haemoglobin at time of
screening, < 105 g.l-1 or ≥ 105
g.l-1. Study participants, clinicians, researchers,
and statistician were masked to treatment allocation until after all
analyses were complete.
After data review at trial completion, 14 ineligible participants were
discovered to have been mistakenly enrolled and randomised. These
participants were excluded from the analysis (Figure 1); this is not
expected to cause bias. (26)