Standard or Extended Lymphadenectomy for Muscle-Invasive Bladder Cancer.
Lerner SP, Tangen C, Svatek RS, Daneshmand S, Pohar KS, Skinner E, Schuckman A, Sagalowsky AI, Smith ND, Kamat AM, Kassouf W, Plets M, Bangs R, Koppie TM, Alva A, La Rosa FG, Pal SK, Kibel AS, Canter DJ, Thompson IM Jr, SWOG S1011 Trial Investigators
- DOI
- 10.1056/NEJMoa2401497
- Record issued
- 2026-08-16
- Engine
- 7.39.0
- Exported
- 2026-09-20
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/47fc880f-7dde-4451-82a3-af2736359b28 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×2−1★
- StatisticsStatistic did not reproduce−0.5★
- StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
- ReportingData & code availability partially met−0.25★
- 01Printed percentage does not match its own count
43.6% does not match the reported count 129/300
“129 (43.6%)”
Table 3 - 02Printed percentage does not match its own count
0.8% does not match the reported count 1/300
“1 (0.8%) participant in the SLND arm”
ResultsFind in source - 03Printed percentage does not match its own count
2.7% does not match the reported count 7/300
“7 (2.7%)”
Table 3
This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-conducted and well-reported multicenter randomized phase III trial with a clear scientific premise, rigorous design, and transparent reporting. The main weakness is the lack of a data availability statement and unspecified statistical software, which are minor reporting gaps.
Both reviewers classified the study as interventional, and this was adopted. The evaluation covered the full text, including methods, results, and discussion. Non-applicable criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of tests; the 3 inconsistent tests were not listed and no decision errors were found, so statistics are not fully verified but no demonstrable errors were identified.
Numerical inconsistencies
3 findings · worst highValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
- Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
- Printed percentage does not match its own countRecomputed
- Internal contradictions in the reported numbersAssessed
Recomputed 4 tests: 4 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 3 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT). 2 printed percentages that do not match their own count.
- PERCENT0.8% does not match the reported count 1/300
“1 (0.8%) participant in the SLND arm”
ResultsFind in source - PERCENT2.7% does not match the reported count 7/300
“7 (2.7%)”
Table 3 - PERCENT43.6% does not match the reported count 129/300
“129 (43.6%)”
Table 3
- CONSISTENTreported p = .450 · recomputed p = .443Recomputed HR 1.10 (95% CI 0.86–1.40), reported p=0.45
“HR 1.10; 95% CI 0.86, 1.40; p=0.45”
Taken as given: 0.86–1.40 is a two-sided 95% confidence interval for the HR of 1.10, not a range, an IQR, or a different interval level; the HR is a RATIO measure, so the interval is symmetric on the log scale; p=0.45 is the p for THIS estimate, not for another comparison in the same sentenceMethod: back the two-tailed p out of the log-scale CI width and compare it against the printed pHow we recomputed it: pCI(1.1, 0.86, 1.4, 1) - CONSISTENTreported p = .450 · recomputed p = .443Reviewers 1, 2Primary DFS hazard ratio p-value
“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45).”
Taken as given: The HR is a ratio (log=1).; The CI is a 95% confidence interval.Method: Two-tailed p-value derived from the hazard ratio and its 95% CI using the normal approximation.How we recomputed it: pCI(1.10, 0.86, 1.40, 1) - CONSISTENTreported p = .450 · recomputed p = .337Reviewer 1Overall survival hazard ratio p-value
“Overall 5-year survival was 59% and 63%, respectively (HR 1.13; 95% CI 0.88, 1.45).”
Taken as given: The HR is a ratio (log=1).; The CI is a 95% confidence interval.Method: Two-tailed p-value derived from the hazard ratio and its 95% CI using the normal approximation.How we recomputed it: pCI(1.13, 0.88, 1.45, 1) - UNCOMPUTABLEreported p = .007 · recomputed p = .017Reviewer 1Comparison of Grade 3-5 AE rates between arms
“The proportion of patients in the SLND with a G3–5 AE or death within 90 days of surgery was 44% (132/300) and 55% (161/292) for ELND (includes 4 additional patients who died without reporting a G3–5 AE) (p=0.007).”
Taken as given: The counts are 132 events out of 300 for SLND and 161 events out of 292 for ELND.; The test is a two-sided chi-square test.Method: Two-sided Pearson chi-square test on the 2x2 table.How we recomputed it: pChi2x2(132, 168, 157, 135) - CONSISTENTreported p = .340 · recomputed p = .337Reviewer 2OS analysis: HR 1.13, 95% CI 0.88-1.45
“Overall 5-year survival was 59% and 63%, respectively (HR 1.13; 95% CI 0.88, 1.45)”
Taken as given: The HR is from a Cox model.; The CI is two-sided at 95%.; The p-value is not reported, but can be derived from the CI.Method: p-value derived from the reported HR and 95% CI using the formula for a ratio (log scale).How we recomputed it: pCI(1.13, 0.88, 1.45, 1)
- lowinternal contradictionTable 3 reports 'Maximum grade any AE' as 129 (43.6%) for SLND and 157 (53.8%) for ELND, but the text reports 44% (132/300) and 54% (157/292) for Grade 3-5 AEs. The discrepancy is due to the inclusion of deaths without a reported AE in the text. This is explained in the footnote.
“The proportion of patients in the SLND with a G3–5 AE or death within 90 days of surgery was 44% (132/300) and 55% (161/292) for ELND (includes 4 additional patients who died without reporting a G3–5 AE) (p=0.007).”
Table 3Find in source - lowinternal contradictionThe abstract reports 130 (44.5%) recurrence or death in ELND and 127 (42.3%) in SLND, but the results section reports 5-year DFS as 56% and 60%, which are consistent. No contradiction.
“the number of patients who had recurrence or death was 130 (44.5%) with extended lymphadenectomy versus 127(42.3%) with standard lymphadenectomy.”
AbstractFind in source
Overstated conclusions
1 finding · worst lowConclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.
- Conclusions only partially backed by the presented evidenceAssessed
6 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewer 1The surgeon credentialing process contributed to the completeness of the lymphadenectomy.The paper describes the credentialing process and high compliance, but does not provide a direct comparison to a non-credentialed group to prove causality.Evidence: Description of credentialing and high compliance rates.
“A unique study feature was a surgeon credentialing process to optimize adherence to protocol-specified lymphadenectomy and radical cystectomy.”
Discussion ¶1Find in source - partialReviewer 2The surgeon credentialing process contributed to high protocol compliance.The paper describes the credentialing process and reports high compliance, but does not provide a quantitative comparison to non-credentialed settings to directly support the claim of contribution.Evidence: Description of credentialing process and compliance data (Table S3).
“Each surgeon underwent rigorous credentialing prior to registering their first patient and submitted operative and pathology reports and representative intra-operative photos from five recent RCs to verify compliance with the study protocol.”
Methods ¶2Find in source - supportedReviewer 1Extended lymphadenectomy did not result in improved disease-free or overall survival compared to standard lymphadenectomy.The primary and secondary outcomes show no significant difference, with HRs close to 1 and p-values >0.05.Evidence: DFS HR 1.10 (95% CI 0.86-1.40, p=0.45); OS HR 1.13 (95% CI 0.88-1.45).
“Compared to standard lymphadenectomy, extended lymphadenectomy did not result in improved disease-free or overall survival for patients with curable muscle invasive bladder cancer undergoing radical cystectomy and was associated with increased peri-operative morbidity and mortality.”
ConclusionFind in source - supportedReviewers 1, 2Extended lymphadenectomy was associated with increased peri-operative morbidity and mortality.The trial reported higher rates of Grade 3-5 adverse events and 90-day mortality in the ELND arm.Evidence: Grade 3-5 AEs: 54% vs 44%; 90-day mortality: 6.5% vs 2.3%.
“Grade 3–5 adverse events occurred in 157 (54%) of extended lymphadenectomy patients vs. 132 (44%) with standard lymphadenectomy; deaths within 90 days of surgery occurred in 19 (6.5%) vs. 7 (2.3%), respectively.”
AbstractFind in source - supportedReviewer 2Extended lymphadenectomy did not improve disease-free survival compared to standard lymphadenectomy.The primary analysis shows no statistically significant difference (HR 1.10, 95% CI 0.86-1.40, p=0.45), supporting the claim.Evidence: HR 1.10, 95% CI 0.86-1.40, p=0.45
“Estimated 5-year disease-free survival probability was 56% and 60%, respectively (HR 1.10; 95% CI 0.86, 1.40; p=0.45)”
AbstractFind in source - supportedReviewer 2Extended lymphadenectomy did not improve overall survival compared to standard lymphadenectomy.The analysis shows no statistically significant difference (HR 1.13, 95% CI 0.88-1.45), supporting the claim.Evidence: HR 1.13, 95% CI 0.88-1.45
Overall 5-year survival was 59% and 63%, respectively (HR 1.13; 95% CI 0.88; 1.45)
Abstractreviewer’s wording
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
1 finding · worst mediumRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
- Data/code availability incompleteAssessed
The introduction cites multiple retrospective series and a prospective observational study suggesting a survival benefit for extended lymphadenectomy, but also acknowledges the limitations of these studies (biases inherent in observational studies). It references randomized trials in endometrial, gastric, and pancreatic cancers that did not show improved survival with extended lymphadenectomy, and notes the potential for increased morbidity. The rationale linking the premise to the study objective is clear: to determine whether extended lymphadenectomy improves disease-free survival compared to standard lymphadenectomy. The paper does not explicitly describe how limitations of prior research are addressed beyond the randomized design, but the design itself addresses the key limitation of selection bias.
“Data from several retrospective series and one prospective observational study suggested that compared to a limited pelvic lymphadenectomy, an extended pelvic lymphadenectomy was associated with a survival benefit ().”
“We conducted a randomized-controlled phase III trial of extended (ELND) versus standard (SLND) pelvic lymphadenectomy (LND) during RC for patients with MIBC with the primary objective to compare disease-free survival (DFS).”
“However, conclusions from these studies are limited by biases inherent in observational studies.”
“Data from several retrospective series and one prospective observational study suggested that compared to a limited pelvic lymphadenectomy, an extended pelvic lymphadenectomy was associated with a survival benefit ().”
“However, conclusions from these studies are limited by biases inherent in observational studies.”
“We conducted a randomized-controlled phase III trial of extended (ELND) versus standard (SLND) pelvic lymphadenectomy (LND) during RC for patients with MIBC with the primary objective to compare disease-free survival (DFS).”
Randomization was intra-operative, 1:1, dynamically balanced by three stratification factors. The randomization method is described as dynamic balancing, which is adequate. The unit of randomization is the patient. Blinding is not applicable for a surgical trial, but the paper does not explicitly state that blinding was not feasible; however, this is a standard limitation of surgical trials and the paper does not claim blinding. Power analysis is detailed with a target hazard ratio, sample size, and power. Inclusion/exclusion criteria are pre-specified. Outlier handling is not explicitly discussed, but the analysis population (ITT) is defined. Controls are inherent in the comparison of two surgical arms. Independent replication is not applicable for a single pivotal trial.
“Patients were then randomized 1:1, and dynamically balanced by three stratification factors (clinical stage, performance status and receipt of neoadjuvant chemotherapy; see ), to either bilateral SLND or bilateral extended lymphadenectomy.”
“Assuming exponential DFS, 5 years of patient accrual, 3 additional years of follow-up and a sample size of 564 eligible, randomized patients, the study had 85% power to detect a 28% reduction in the hazard rate of recurrence or death with ELND vs. SLND.”
“Eligible patients had predominant urothelial cancer clinical stage T2–4a, N0–2 (AJCC 7 th edition, 2010) and elected radical cystectomy with curative intent. Exclusion criteria included prior partial cystectomy, prior pelvic surgery obviating a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or surgeon-determined inability to perform a thorough pelvic node dissection.”
“Patients were then randomized 1:1, and dynamically balanced by three stratification factors (clinical stage, performance status and receipt of neoadjuvant chemotherapy; see ), to either bilateral SLND or bilateral extended lymphadenectomy.”
“Assuming exponential DFS, 5 years of patient accrual, 3 additional years of follow-up and a sample size of 564 eligible, randomized patients, the study had 85% power to detect a 28% reduction in the hazard rate of recurrence or death with ELND vs. SLND.”
“Eligible patients had predominant urothelial cancer clinical stage T2–4a, N0–2 (AJCC 7 th edition, 2010) and elected radical cystectomy with curative intent. Exclusion criteria included prior partial cystectomy, prior pelvic surgery obviating a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or surgeon-determined inability to perform a thorough pelvic node dissection.”
Sex is reported (78% male in SLND, 81% male in ELND). Age is reported as median and range. Race and ethnicity are reported. BMI and performance status are reported. Clinical stage is reported. Since both sexes are enrolled, sex_justified is not applicable. Species/strain/source and housing conditions are not applicable for a human trial. Demographics are adequately reported.
“Male n (%) | 234 (78%) | 236 (81%)”
“Age median (range) | 68 (38, 90) | 69 (37, 92)”
“White n (%) | 271 (90%) | 265 (91%)”
“Male n (%) | 234 (78%) | 236 (81%) | | Age median (range) | 68 (38, 90) | 69 (37, 92) | | Race | | White n (%) | 271 (90%) | 265 (91%)”
The study was approved by the NCI Central Institutional Review Board (CIRB), and patients provided written informed consent. The trial was conducted according to the Declaration of Helsinki. This satisfies all applicable criteria.
“SWOG S1011 was reviewed and approved by the NCI Central Institutional Review Board (CIRB); patients provided written informed consent; it was conducted according to the Declaration of Helsinki guidelines.”
“SWOG S1011 was reviewed and approved by the NCI Central Institutional Review Board (CIRB); patients provided written informed consent; it was conducted according to the Declaration of Helsinki guidelines.”
The paper describes the surgical procedures (standard and extended lymphadenectomy) in detail, including anatomical boundaries and specimen handling. This serves as the investigational product. The statistical software is not explicitly named in the text, but the paper states that CT takes responsibility for the accuracy and completeness of analyses, and the protocol is available. However, the paper does not name the statistical software used (e.g., SAS, R). This is a minor omission. No antibodies, cell lines, or other reagents are used, so those criteria are not applicable.
“SLND included external and internal iliac and obturator nodes. All potential lymph node bearing tissue was to be removed within the boundaries including the genitofemoral nerve laterally; distally Cooper’s ligament including the lymph node of Cloquet; proximally the CI bifurcation; medially the bladder to include the tissue medial to the hypogastric artery; and posteriorly the floor of the obturator fossa with circumferential mobilization of the external iliac artery and vein unless contraindicated due to extensive atherosclerotic vascular disease.”
“SLND included external and internal iliac and obturator nodes. All potential lymph node bearing tissue was to be removed within the boundaries including the genitofemoral nerve laterally; distally Cooper’s ligament including the lymph node of Cloquet; proximally the CI bifurcation; medially the bladder to include the tissue medial to the hypogastric artery; and posteriorly the floor of the obturator fossa with circumferential mobilization of the external iliac artery and vein unless contraindicated due to extensive atherosclerotic vascular disease.”
The primary test is named (stratified log-rank test). The paper reports exact p-values (p=0.45 for DFS) and hazard ratios with 95% confidence intervals. The statistical software is not identified, but the analysis is standard. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks: the reported percentages and counts are consistent (e.g., 130/292 = 44.5% for ELND events, 127/300 = 42.3% for SLND events). The paper does not explicitly verify assumptions (e.g., proportional hazards), but the use of a log-rank test and Cox regression is standard for survival analysis and the paper does not claim to have tested assumptions. This is acceptable for a large clinical trial.
“Using an ITT analysis, a stratified logrank test with a one-sided alpha= 0.025 was specified.”
“Estimated 5-year disease free survival was 56% for ELND and 60% for SLND (HR 1.10; 95% CI 0.86,1.40; p=0.45)”
“Figure 2. A -Disease-free survival; B -Overall survival”
The paper states that the protocol is available at nejm.org, and the trial is registered at ClinicalTrials.gov. However, there is no data availability statement indicating where the individual patient data can be accessed (e.g., via a managed access platform). No code sharing is mentioned. For a clinical trial, a data availability statement is expected, even if it states that data are available on request. The absence of any statement is a reporting gap.
“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”
“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”
Methods are detailed enough for replication. The trial is registered (NCT01224665). No specific reporting guideline (e.g., CONSORT) is mentioned, but the paper includes a CONSORT flow diagram (Figure 1). All pre-specified outcomes are reported. Limitations are discussed (e.g., lack of blinding, generalizability to non-white populations, ERAS protocols). Conclusions are proportional: the paper states that ELND did not improve survival and was associated with increased morbidity. Funding sources and conflicts of interest are disclosed.
“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”
“Our study was conducted during the time that enhanced recovery after surgery (ERAS) protocols were being adopted. We did not collect data on use of ERAS other than pre-and post-op anticoagulation, which were widely considered standard of care prior to trial inception.”
“NCT01224665 (https://clinicaltrials.gov/ct2/show/NCT01224665)”
“Our patient population was predominantly Non-Hispanic White (90%), and median age was slightly younger than the most recent SEER data for localized invasive and in situ cancer ().”
“Funding Statement: NIH/NCI grant awards U10CA180888 U10CA180819, U10CA180820, U10CA180821, and U10CA180863 and Canadian Cancer Society grant# 707213.”
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
None foundReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
Checked — nothing surfaced.
Checked 26 references by DOI: 24 verified — 2 no DOI (shown, not verified).
- NO DOIRadical cystectomy: extending the limits of pelvic lymph node dissection improves survival for patients with bladder cancer confined to the bladder wallNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICystectomy for bladder cancer: a contemporary seriesNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 of 3 data/code links checked; 1 live; 2 not probed.
- datahttps://clinicaltrials.gov/ct2/show/NCT01224665LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttps://www.nejm.org/doi/full/10.1056/NEJMoa2401497UNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
- datahttp://nejm.orgUNVERIFIEDHTTP 403Liveness indeterminate — content not checked.
Copyediting
5 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 5 minor suggestions below.
5 copyedit issues flagged: mostly consistency, typo, clarity.
- MINORtypoAbstract, Results“127(42.3%)”→ Add a space: '127 (42.3%)'Missing space before parenthesis.
- MINORconsistencyResults, paragraph 3“HR 1.13; 95% CI 0.88; 1.45”→ Use comma instead of semicolon: 'HR 1.13; 95% CI 0.88, 1.45'Inconsistent use of semicolon in CI.
- MINORclarityTable 3, footnote“1 death occurred at 102 days due to multiple surgical complications and is included.”→ Clarify that this death is included in the 90-day mortality analysis.Potential confusion about inclusion criteria.
- MINORpunctuationAbstract, Results“HR 1.13; 95% CI 0.88; 1.45”→ HR 1.13; 95% CI 0.88, 1.45Semicolon used instead of comma in the CI range.
- MINORconsistencyTable 3, footnote“1 death occurred at 102 days due to multiple surgical complications and is included.”→ Consider moving this note to the main text or clarifying that it is included in the 90-day mortality analysis.The footnote mentions a death at 102 days, which is outside the 90-day window, but it is included. This could be clarified.
The published work is robust and well-reported; an informed reader should weigh the absence of a data availability statement and the unspecified statistical software as minor transparency gaps. No erratum or re-analysis is warranted based on the identified issues.
- 1.HIGHdata codeAdd a data availability statement in the Methods or after the Discussion specifying how de-identified individual patient data can be accessed (e.g., via a managed access platform like Vivli or on request with a data-sharing agreement).The absence of any data availability statement is a reporting gap that undermines reproducibility and is expected for a clinical trial.
- 2.HIGHstatisticsIdentify the statistical software used (e.g., SAS version 9.4, R version 4.0) in the Statistical Analyses section.Naming the software is a standard reporting requirement that aids reproducibility and was flagged by both reviewers.
- 3.MEDIUMstatisticsAdd a statement about verification of the proportional hazards assumption for the Cox model, or note that it was assessed and satisfied.Explicitly addressing model assumptions strengthens the statistical reporting and was noted as missing by one reviewer.
- 4.MEDIUMreportingMention adherence to the CONSORT reporting guideline explicitly in the Methods section, even though a CONSORT flow diagram is present.Explicitly naming the reporting guideline clarifies compliance and was flagged as inadequate by one reviewer.
- 5.MEDIUMstatisticsProvide a brief statement on how outliers were handled in the analysis, or note that no outliers were excluded.Clarifying outlier handling addresses a discrepancy between reviewers and improves transparency.
- 6.LOWcopyeditFix the missing space before the parenthesis in the abstract: change '127(42.3%)' to '127 (42.3%)'.Minor typographical error that affects readability.
- 7.LOWcopyeditReplace semicolons with commas in confidence intervals in the Results section (e.g., 'HR 1.13; 95% CI 0.88; 1.45' should be 'HR 1.13; 95% CI 0.88, 1.45').Inconsistent punctuation in CI ranges is a copyedit issue that could cause confusion.
- 8.LOWcopyeditClarify the Table 3 footnote about the death at 102 days to explicitly state that it is included in the 90-day mortality analysis.The footnote is ambiguous about inclusion criteria and could be misinterpreted.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
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Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
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