{ "future_gate_contract": { "aggregate_improvement_may_mask_subgroup_regression": false, "global_and_critical_subgroups_required": true, "missing_or_insufficient_support": "not_evaluable", "numeric_margin": "to_be_frozen_before_protected_access", "unit": "paired independent AOI" }, "reason": "Phase 4 has no valid real incumbent product baseline and no pre-registered candidate; synthetic fixture values cannot define non-inferiority.", "schema_version": 2, "status": "not_evaluable" }