We stratified randomisation
by site and maintained balance between groups within each stratum using a minimisation method using computer -
generated random numbers to give an equal
chance of allocation to each group when groups within the stratum were balanced and an increased
chance (0.667) of allocation to the smaller group when there was an imbalance within the stratum.69 The randomisation service at Warwick Clinical Trials Unit
generated the
random allocation sequence and informed the FLNP co-ordinators of group allocation following recruitment of a family
by the researchers.