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Only those participants eligible for further participation will be randomized.
Ethical considerations in participants' abilities to consent to research participation will be addressed as described below.
All participants will receive information about the study, and their participation will be voluntary.
Participation will be based on opt-in, with no way to vet any participants beforehand.
Participation will be voluntary.
Participation will be considered exceptional.
Participation will be contingent on specific circumstances.
* Public participation will be increased at all stages.
The process of participation will be as follows.
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At all stages of the trial, any reason for non-participation will be recorded, if given.
Reasons for non-participation will be recorded for all screened patients.
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