Round 18 contained no C18 comments. Changes addressing other reviewers introduce no identified major or minor error in version 0.19.0.
G18-1 and F18-1: Resolved. Absolute effects, protocol.qmd:1041 now explicitly applies known-status criteria to each reference arm. It specifies the arm-specific 95 percent sensitivity threshold, retains unknown participants in the randomized denominator as event free, and requires qualifying follow-up to reach the analyzed horizon. This removes the conflicting trial-wide cross-reference. The offset (\log(f_a/t)) remains consistent with the stated constant-hazard model. The sensitivity analysis makes an explicit missing-outcome assumption; it does not establish absence of bias, consistent with Cochrane guidance.
G18-2 and F18-2: Resolved. Amendments, protocol.qmd:83 now selects comments whose
actionfield containsdeferred to amendment. Read-only evaluation captures all seven applicable entries: F12-note, F14-note, F15-note, F16-note, F17-4, F17-5, and F18-3. Compound action labels are included.F18-0: Resolved as a correction to the response record. Round 18 response:9 acknowledges that the previous reason for deferring F17-4 was invalid. Grouping fixed-time scenario inputs with related reference-risk specifications in one pre-analysis amendment is reasonable. F17-4 itself remains deferred.
F18-3: Not resolved substantively; deferral acceptable. The response acknowledges the missing single-arm and pooling specification for directly reported Aalen-Johansen risks. This is an existing specification gap, now explicitly tracked by the amended pointer. Addressing it with related reference-risk matters is reasonable. Acceptance does not certify this specification as complete or permit undocumented choices after examining affected results.
New findings: No major or minor errors, inconsistencies, or non-executable rules identified as introduced by this revision. No replacement text or values required.
All requested files inspected. Among those files, comparison with version 0.18.0 shows changes only to protocol.qmd and amendments.csv. Read-only checks found no identifier, coverage, or mapping errors across 637 applicable outcome/population window pairs, 43 agent/search-term mappings, reference-SD and Turner mappings, and nonrandomized harms specifications. All 861 registry-candidate rows passed parsing, agent-ID, registration-ID-format, and registration-count checks. These checks do not independently validate inferred doses.
Search concepts remain version 1.2.0. Search renderer reviewed statically; quoted-phrase truncation in its PubMed strategy agrees with NLM documentation. R execution and live database recall were not tested. No files edited, created, or deleted.
Methods acceptable for registration once listed administrative pre-registration conditions are completed. Previously tracked methodological amendments remain required before the affected analyses.
VERDICT: ACCEPT