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Study Design
Single-blind design
This study will be a single-blind design. The subject will not be aware of to which active procedure group (A, B, or C) he or she has been assigned until after the study is complete. The EMF (the therapeutic modality) generated from the Resonator device when activated does not cause any detectable light, heat, sound, vibration or other sensation that may enable an individual to distinguish between output levels.
Randomization Procedure
Upon study qualification, subjects will be randomized to one of the three procedure groups via a randomized block design with varying block sizes of five subjects. In each block, one or two of the subjects will be randomly assigned to Procedure Group A, B, or C.
Randomization will be attained using computer generation sequence methodology, insuring that the randomization methodology and the generated allocation sequence is concealed from the investigator and subjects.
Concealment will be insured as follows:
- Each computer generated randomization sequence is unique and will therefore not be able to be replicated.
- Randomization will occur to either Procedure Group A, B, or C rather than to a particular dose procedure group. Only the study Sponsor will know which letter group assignment corresponds to which procedure administration (active or placebo). The Sponsor will not reveal this information to any source (investigators, subjects, or study Monitor) until the final subject in the study has completed his or her follow-up phase of participation.
Once a subject has qualified for and enrolled in the study, the Principal Investigator will contact the study Monitor who will act as the central source for providing sequential subject group assignment.
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