Through a minimisation software, the eligible patients will be allocated using the minimisation method with a preset variable the presence of syringomyelia.
Study group allocation will be conducted at individual level, using the minimisation technique.
Randomisation will be conducted independently (and after the baseline interview) by a statistician, using the minimisation method [ 23].
Patients returning these documents were randomised 1 : 1 by an independent secretary using the minimisation technique 21 and the SiMin software.
Randomisation to the three groups, or entry to the minimisation procedure, was determined according to a pre-specified allocation schedule generated using the method of randomised permuted blocks of nine participants.
The list of vaccinated subject numbers which was tracked using the central randomisation system on Internet (SBIR) and was randomised (1 1) by the sponsor using SAS version 9.2 to receive a second dose at either Day 21 (Group A) or Day 182 (Group B) taking into account the minimisation procedure for centre and age.
We will use the minimisation method for randomisation to assure an equal distribution of baseline characteristics.
Using a minimisation procedure based on practice size, area deprivation (the area index of multiple deprivation), and contractual status (contracted either to the National Health Service or to the local primary care trust) we allocated practices 1 1 to intervention or control groups.
Participants are randomly allocated to one of the three groups using a partial minimisation procedure to adjust the randomisation probabilities between groups to balance important covariates including duration of diabetes, HbA1c, and prior medication using a computer programme (Minim, ).
Second, we strengthen the randomisation using a computerised minimisation procedure with factors that are likely to influence the outcome measures (exercise capacity, pulmonary state and presence and absence of affective disorders).
