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Participants will be allocated to groups after completion of baseline assessment.
Important issues related to randomisation are considered below: The subjects will be allocated to groups using a chance procedure, blocking and stratification [ 22].
Participants will be allocated to groups (real or sham tDCS) using computer generated randomisation lists, stratified for high (51-100) and low (20-50) average pain intensities over the past 24 hours.
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Each cluster will be allocated to group or individual therapy by concealed random allocation.
Each cluster (each dialysis clinic) will be randomly prescribed a number and the five clinics with the 5 lowest numbers will be designated into Group 1 (receiving 36 weeks of the exercise intervention), numbers 6 10 will be allocated to Group 2 (receiving 24 weeks of the exercise intervention) and the final 5 clinics will be allocated to Group 3 (receiving 12 weeks of the exercise intervention).
Nine consecutive patients will be allocated to Group 1 before nine more patients will be allocated to Group 2. As the metaparameters α and β are assumed to be correlated between groups, results from group 1 affect the escalation scheme in group 2. The application of replication competent oncolytic viruses is a promising approach to target dismal malignancies such as glioblastoma multiforme.
The first block of each stratum will be allocated to group 1, second block to group 2, third to group 3, and the fourth to group 4. Recruitment of physicians and children is described in detail in Verbakel et al. [ 17].
Patients will be allocated to two groups, early group (experimental) - stoma closure between day 8 and 10 after LAR before starting the adjuvant chemotherapy and late group (standard) - stoma closure after adjuvant chemotherapy around week 26 after LAR.
Participants will be allocated to three groups according to the group number printed inside the envelopes.
Participants will be allocated to study groups using a previously successful "on-off" group assignment method [ 39, 41, 42].
Patients will be allocated to different groups using a random number table to avoid selection bias.
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