Randomization and group allocation
We used a blocked randomization method. Instead of randomizing each patient individually, this scheme randomizes several patients at a time in such a way as to ensure that equal numbers are allocated to each group across each segment of time during the length of the study. For example, if the block size is four, we randomize four patients at a time ensuring that two patients are allocated to the C.S.I group and two patients to the traditional group. As it happens, there are six different possible ways we could randomize four patients equally to two treatments. The randomization was done following the baseline assessment and only the study statistician had access to the randomization sequence.