13 lines
517 B
JSON
13 lines
517 B
JSON
{
|
|
"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"
|
|
}
|