Both round 17 comments resolved. No new major or minor error identified in version 0.18.0.
C17-1: Resolved. Absolute effects, protocol.qmd:1030 now requires finite positive transformed standard error, known confidence level, and limits satisfying (0<L<U<1). Formula uses (z_{1-\alpha/2}); Greenwood variance remains an alternative, followed by Poisson and binomial inputs when Kaplan-Meier uncertainty does not qualify. This addresses both boundary failure and assumed 95 percent coverage. Configurable coverage and log-log transformation are consistent with R survival documentation. Numerical checks reproduced standard errors of 0.120132 for 95 percent coverage and 0.143146 for 90 percent coverage using limits 0.08 and 0.125. Response fully adopts correction.
C17-2: Resolved. Absolute effects, protocol.qmd:1068 limits normal sampling of reference log hazards to piecewise integration and exponential approximation. Explicit exclusion of directly reported Aalen-Johansen cumulative incidence removes requirement for potentially unidentified hazard coordinates and covariance. Response fully adopts correction.
Changes addressing other reviewers introduce no identified error:
- Summing finer interval counts and corresponding person time preserves Poisson likelihood’s dependence on the parameter under retained constant hazard assumption. Numerical comparison confirmed equivalence up to a parameter-independent constant.
- Single usable arm now has explicit reference risk, consistent with PR02 and scenario construction. PR02, priors.csv:3 records corresponding prior uses.
- Arm-specific known-status wording clarifies eligibility without changing relative effect network requirements.
- Naming relative-only fallback and linking deferred matters introduce no conflicting rule.
F17-0’s correction accurately acknowledges partial adoption. Deferring F17-4 and F17-5 remains reasonable as explicitly tracked, pre-existing scenario specification and reporting refinements for the promised pre-analysis amendment. This judgment does not treat them as completed or authorize an undocumented choice after examining results.
New findings: None requiring replacement text or values.
All requested files inspected. 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, nonrandomized harms specifications, and 861 registry-candidate rows. Only protocol.qmd, priors.csv, and amendments.csv changed among requested files since version 0.17.0.
Search renderer reviewed statically. R execution could not proceed because read-only environment prevented temporary-file creation; live database recall was not tested. No files changed.
Methods acceptable for registration once listed administrative pre-registration conditions are completed. Their present absence does not reduce this judgment.
VERDICT: ACCEPT