Randomisation will be conducted independently (and after the baseline interview) by a statistician, using the minimisation method [ 23].
Through a minimisation software, the eligible patients will be allocated using the minimisation method with a preset variable the presence of syringomyelia.
The study was stratified for individual trial, tumour type, age and sex using the minimisation method, which was implemented in the CTU's Oracle database.
Having allocated the patient to a hygienist, the patient was then allocated to either intervention or control group using the minimisation method (with weighted randomisation) [ 14, 15].
A similar distribution of sex, graft, and meniscus repair in the two groups was ensured by using the minimisation method with the aid of a computer program [ 37] for the randomization.
Randomisation was performed centrally, with assignment for pathological T and N stage balanced using the minimisation method with probability and the method of Zelen (Yonekura et al, 1999; Tanaka et al, 2002).
The randomisation used the minimisation method [ 18] to give an equal balance between groups of the following: gender, age, date of diagnosis, and whether patients could or could not communicate.
Stratified randomisation was carried out using the minimisation method based on the following factors: primary site (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs node positive).
Randomisation will be computerised and patients will be randomised at a ratio of 1 1 1 1 to one of the groups, A D, using the minimisation method, a method of randomisation accounting for factors known to affect the outcome used in small trials to prevent selection bias.
The randomisation was conducted independently by statistical colleagues after the baseline interview, independent of the research and clinical team, using the minimisation method[ 25] to give an equal balance between groups of the following: gender, age, and date of diagnosis and according to whether patients could or could not communicate.
