Randomisation and allocation
COME
RECRUITMENT
Using computer-generated random numbers, a biostatistician not affiliated with this study randomised the centres into either: the COMB (i.e., the experimental), the active control (i.e., the EXER), and the passive control (i.e., the control) groups at a 1:1:1 ratio. Convenience sampling was used to recruit study participants from each centre. They were allocated to either the COME, the EXER, or the control group based on the randomised group allocated to their centre. To avoid selection biases, the allocation to the study groups was concealed from the researchers until the recruitment of the sample and measurement of the baseline had been completed.