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AUD-TR-01

Evidence source and scope

TR-01 · report qualification needed

Classification and audit outcome: report qualification needed; supported report qualification.

Finding

The report says the sample contained eight per arm. Eight per arm is the randomized allocation, while CONSORT records a post-randomization reassignment and analysis counts 7/8/9.

Current amendment or qualification

Replace “the sample contained eight participants per arm” with “eight participants were randomized per arm; after one BPT participant was reassigned to control following a lesion, the analyzed groups contained seven, eight and nine participants.” Add this analytical limitation to the appraisal.

Integration note: Distinguish randomization from analyzed allocation; do not silently resolve separate sex-count inconsistencies.

Remaining limitation: Distinguish randomization from analyzed allocation; do not silently resolve separate sex-count inconsistencies.

Evidence and provenance

PARKEX original CONSORT Figure 1, Methods and Table 2. Demographic sex counts 6/8/7 still do not reconcile and should remain a separate unresolved source-denominator issue.

Affected reports

Original audit locator(s): P0246; contextual addition P0062

Audit corrections describe the report only where that classification is explicit. A disagreement within a study, missing protocol, statistical query, access upgrade or optional addition is not silently converted into a report error or a new clinical threshold.

Audit register · Unresolved evidence queue

Linked knowledge pages

Located in this vault

Mapping status: exact. An exact location match is not an additional empirical verification.