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A Priori Re-Randomization Criteria
| Time after initial randomization |
Diet acceptability | Weight change | Glycemia change |
|---|---|---|---|
| ~3 and 6 months | Unacceptable based on Diet Acceptability Form | Not achieving at least 2% loss in body weight from previous measurement visit. | HbA1c increased ≥ 0.5% or self-report of increased and problematic hypoglycemia on Diet Acceptability Form. |
Re-assignment of diet occurred if one or more criteria were met.
