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This study was a quasi-experimental design involving one intervention group and one control group which were not subjected to randomization.
We used a two-tier randomization process.
In this way, assessors will be blind to the group allocation-randomization process at the time of the baseline assessment.
To assess the randomization process, we compared the baseline characteristics of subjects assigned to the SDM interventions with those assigned to the control group.
At baseline, however, the exercise group was already doing 42% more exercise than control subjects (casting some doubt on the randomization process); after the 6-year follow-up, their exercise level did not improve significantly from their baseline level.
Patients were allocated to treatments groups by simple randomization with a 1 1 ratio via a central telephone randomization process.
The uneven numbers in the groups were a consequence of the randomization process.
In addition, subjects were required to have an Adult Myopathy Assessment Tool (AMAT) 5 score from 14 to 41. Subject group randomization was achieved using stratified block randomization based on AMAT scores with a block size of four.
A single randomization point assigned subjects to a treatment strategy of vasopressin, epinephrine, and corticosteroids (VSE group) or a treatment strategy of only epinephrine (Epi group).
Descriptions of the entry profile for subjects in each treatment group are contained within Table 1, and demonstrate an effective randomization process.
A central randomization process provided and managed by Medtronic Neuromodulation (Medtronic) assigned a unique randomization code to each subject.
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