b) Was the randomisation list concealed? If so, how - if not, what are the implications? CONSIDER: Was the allocation sequence concealed from investigators and participants? Was allocation concealment sufficient to eliminate systematic bias? c) Were the groups similar at the start of the trial? What are the implications of this? CONSIDER: Were the baseline characteristics of each study group (e.g. age, sex, socio-economic group) clearly set out? Were there any differences between the study groups that could affect the outcome/s