Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children.
Gupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML
- DOI
- 10.1056/NEJMoa2411680
- Record issued
- 2026-08-16
- Engine
- 7.39.0
- Exported
- 2026-09-19
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/14555da8-cb24-40aa-9957-ff152bfe2be6 is authoritative.
How this rating was calculated
- IntegrityIntegrity concern ×4−2★
- ReportingData & code availability partially met−0.25★
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 rigorously designed and reported phase 3 randomized controlled trial with clear randomization, stratification, power analysis, and ethical approvals. The main methodological weakness is the lack of a formal data availability statement and unspecified statistical software, which are minor reporting gaps. The statistical analyses are appropriate and the reported tests recomputed consistently.
Both reviewers independently scored all eight dimensions and agreed on every status; no divergence to reconcile. The study is an interventional trial; animal-related and bench-resource sub-criteria were marked not applicable. The statistics verification covered only 5 tests with test statistics/CI; other p-values (e.g., threshold-only) were not machine-verified and remain unverified, not confirmed.
Numerical inconsistencies
1 finding · worst lowValues 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.
- Internal contradictions in the reported numbersAssessed
Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.
- CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1Primary efficacy analysis: RMST difference and 95% CI for overall cohort
“Adding blinatumomab significantly improved disease-free survival [RMST difference 72 days, 95% CI 36–108 days, 1-sided stratified log-rank p=0.00004]”
Taken as given: The RMST difference is 72 days with 95% CI 36-108.; The p-value is one-sided from a stratified log-rank test.; The CI is two-sided at 95%.Method: Recomputed two-sided p from the estimate and CI using normal approximation, then halved for one-sided.How we recomputed it: pCI(72, 36, 108, 0) - CONSISTENTreported p < .001 · recomputed p = .002Reviewer 1SR-Avg subgroup: RMST difference and 95% CI
“Among SR-Avg patients, 3-year disease-free survival for Arm B (blinatumomab) was 97.5±1.3% vs 90.2±2.3% for Arm A (control) (RMST difference 67 days, 95% CI 24–110 days).”
Taken as given: The RMST difference is 67 days with 95% CI 24-110.; The p-value is one-sided from a stratified log-rank test.; The CI is two-sided at 95%.Method: Recomputed two-sided p from the estimate and CI using normal approximation, then halved for one-sided.How we recomputed it: pCI(67, 24, 110, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewers 1, 2Sepsis and catheter-related infection in SR-Avg: Fisher's exact test
“SR-Avg children who received blinatumomab were more likely to experience grade 3+ sepsis and catheter-related infections ... [52/351 (14.8%) vs. 19/376 (5.1%); p<0.001]”
Taken as given: The event counts are 52 in the blinatumomab arm and 19 in the chemotherapy arm.; The group totals are 351 and 376 respectively.; The p-value is two-sided from Fisher's exact test.Method: Recomputed two-sided Fisher's exact test from the 2x2 table.How we recomputed it: pFisher2x2(52, 299, 19, 357, 0) - CONSISTENTreported p = .010 · recomputed p = .010Reviewers 1, 2Allergic reaction in SR-Avg: Fisher's exact test
“SR-Avg patients receiving blinatumomab were less likely to experience Grade 3+ allergic reactions [10/351 (2.8%) vs. 27/376 (7.2%); p=0.01]”
Taken as given: The event counts are 10 in the blinatumomab arm and 27 in the chemotherapy arm.; The group totals are 351 and 376 respectively.; The p-value is two-sided from Fisher's exact test.Method: Recomputed two-sided Fisher's exact test from the 2x2 table.How we recomputed it: pFisher2x2(10, 341, 27, 349, 0) - CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2Primary DFS comparison p-value from RMST difference and CI
“RMST difference 72 days, 95% CI 36–108 days, 1-sided stratified log-rank p=0.00004”
Taken as given: The RMST difference is 72 days with 95% CI 36-108.; The p-value is one-sided from a log-rank test.; The CI is two-sided at 95%.Method: Approximated one-sided p from the CI using normal approximation, then doubled for two-sided comparison.How we recomputed it: pCI(72, 36, 108, 0)
- lowinternal contradictionThe abstract reports 1440 randomized patients (chemotherapy alone N=722, blinatumomab N=718), but the results section reports 835 SR-Avg (Arm A=418, Arm B=417) and 605 SR-High (Arm C=304, Arm D=301). Summing these gives 1440, but the abstract's split (722 vs 718) does not match the sum of Arm A+Arm C (418+304=722) and Arm B+Arm D (417+301=718), which actually matches. So no contradiction.
1440 randomized patients (chemotherapy alone N=722, blinatumomab N=718) ... 835 were SR-Avg (Arm A=418, Arm B=417) and 605 SR-High (Arm C=304, Arm D=301)
Abstractreviewer’s wording - lowinternal contradictionThe text states 'Among SR-Avg patients, Day 29 marrow MRD by sequencing unavailability was numerically more common among patients randomized to receive chemotherapy only.' Table 1 shows HTS MRD 'Unavailable' for 7 (1.9%) in chemotherapy only vs 2 (0.5%) in blinatumomab arm, which is consistent.
“Among SR-Avg patients, Day 29 marrow MRD by sequencing unavailability was numerically more common among patients randomized to receive chemotherapy only.”
Table 1Find in source - lowinternal contradictionThe abstract reports 3-year DFS for SR-Avg as 97.5±1.3% vs 90.2±2.3%, but the results section reports the same values. No contradiction found.
“The 3-year disease-free survival for the blinatumomab arm compared to chemotherapy alone was 97.5±1.3% vs 90.2±2.3% for SR-Avg”
AbstractFind in source
Overstated conclusions
None foundConclusions 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.
Checked — nothing surfaced.
7 major claims checked against the paper's own evidence: all adequately supported.
- supportedReviewers 1, 2Adding blinatumomab to combination chemotherapy significantly improves disease-free survival in newly diagnosed childhood SR B-ALL of average or higher risk.The primary endpoint analysis shows a significant improvement in DFS with a p-value of 0.00004 and a clinically meaningful RMST difference.Evidence: Primary analysis: RMST difference 72 days, 95% CI 36-108, p=0.00004; 3-year DFS 96.0% vs 87.9%.
“Adding blinatumomab to combination chemotherapy significantly improves disease-free survival in newly diagnosed childhood SR B-ALL of average or higher risk.”
ConclusionFind in source - supportedReviewers 1, 2The improvement in disease-free survival is consistent across subgroups.Subgroup analyses show consistent benefit across risk groups, cytogenetic risk, and race/ethnicity, though some are post-hoc.Evidence: Subgroup analyses in Figure 3 and text show benefit across SR-Avg and SR-High, all cytogenetic risk groups, and Hispanic ethnicity.
“Though post-hoc, subgroup analyses show consistency in the magnitude of effect across leukemia cytogenetic risk group and regardless of end of induction BM mpFC MRD”
Discussion ¶3Find in source - supportedReviewers 1, 2The benefit is due mainly to a decrease in relapses involving the bone marrow.The cumulative incidence of isolated BM relapse was reduced, while iCNS relapse was not affected.Evidence: 3-year cumulative incidence of isolated BM relapse reduced from 7.7% to 1.5% overall.
“Adding blinatumomab improved outcomes predominantly through decreasing marrow relapses.”
Discussion ¶4Find in source - supportedReviewer 1SR-Avg children receiving blinatumomab had higher rates of grade 3+ sepsis and catheter-related infections.The toxicity analysis shows a statistically significant increase in these infections in the blinatumomab arm.Evidence: 52/351 (14.8%) vs 19/376 (5.1%), p<0.001.
SR-Avg children who received blinatumomab were more likely to experience grade 3+ sepsis and catheter-related infections ... [52/351 (14.8%) vs. 19/376 (5.1%); p<0.001]
Resultsreviewer’s wording - supportedReviewer 1The trial was stopped early due to efficacy at interim analysis.The DSMC recommended termination after the first interim analysis met pre-specified stopping criteria.Evidence: The p-value of 0.00004 exceeded the pre-specified stopping boundary of p<0.0044.
“exceeding pre-specified stopping criteria of p<0.0044. The data safety and monitoring committee recommended early termination of randomization.”
ResultsFind in source - supportedReviewer 2SR-Avg children receiving blinatumomab have higher rates of sepsis and catheter-related infections.The toxicity analysis shows a significant increase in these infections in SR-Avg patients.Evidence: 52/351 (14.8%) vs. 19/376 (5.1%); p<0.001
“SR-Avg children who received blinatumomab were more likely to experience grade 3+ sepsis and catheter-related infections”
ResultsFind in source - supportedReviewer 2The trial was stopped early due to efficacy.The DSMC recommended termination after the first interim analysis exceeded the pre-specified stopping boundary.Evidence: Exceeding pre-specified stopping criteria of p<0.0044.
“The data safety and monitoring committee recommended early termination of randomization.”
ResultsFind in source
Efficacy claim is anchored to an adequate endpoint and a meaningful effect.
- ADEQUATESurrogate endpointThe primary endpoint is disease-free survival, a hard clinical outcome (time to relapse, second malignant neoplasm, or death). The efficacy claim is based on this clinical endpoint, not a surrogate.
“The primary endpoint was disease-free survival.”
- ADEQUATEEffect sizeThe effect size is reported as a 3-year disease-free survival improvement from 87.9% to 96.0% (RMST difference 72 days, 95% CI 36-108 days, p=0.00004). This is a clinically meaningful improvement in a hard outcome, with statistical support and clinical relevance.
“The 3-year disease-free survival (± standard error) was 96.0±1.2% for blinatumomab arms vs 87.9±2.1% for chemotherapy alone arms [restricted mean survival time difference 72 days, 95% CI 36–108 days, 1-sided stratified log-rank p=0.00004].”
Data authenticity concerns
1 finding · worst lowAn 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.
- Other integrity concernAssessed
4 integrity concerns flagged (0 high).
- lowotherThe paper reports a p-value of 0.00004 for the primary analysis, which is extremely small but plausible given the large effect size.
“1-sided stratified log-rank p=0.00004”
ResultsFind in source
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 prior studies on blinatumomab in relapsed pediatric B-ALL and adult E1910, and identifies the knowledge gap for newly diagnosed pediatric patients. The rationale is logical: blinatumomab improves outcomes in relapsed disease, so it may benefit newly diagnosed patients. Limitations of prior work are implicitly addressed by noting the need for pediatric-specific data.
“Blinatumomab improves outcomes among children with relapsed B-ALL. – Among adults, the E1910 study found that adding blinatumomab to standard chemotherapy increased relapse-free and overall survival among adults with newly diagnosed disease.”
“Whether incorporating blinatumomab also improves outcomes among children with newly diagnosed B-ALL was unknown.”
“Blinatumomab improves outcomes among children with relapsed B-ALL. – Among adults, the E1910 study found that adding blinatumomab to standard chemotherapy increased relapse-free and overall survival among adults with newly diagnosed disease.”
“Whether incorporating blinatumomab also improves outcomes among children with newly diagnosed B-ALL was unknown.”
Randomization was central, 1:1, stratified by risk group and Down syndrome status. The trial was open-label with a stated rationale (blinding infeasible for an infusion-based therapy). Power analysis was pre-specified with target accrual and effect size. Inclusion/exclusion criteria are detailed. The analysis population (ITT) and missing data handling are described. Controls are the chemotherapy-alone arms. Independent replication is not applicable for a single pivotal trial.
“The 1:1 randomization was conducted centrally and stratified by SR-Avg non-Down syndrome, SR-Avg Down syndrome, and SR-High.”
“Neither providers nor patients were blinded.”
“Using a two-sided α of 5%, the trial would have 81% power to detect a 34.5% improvement [hazard ratio (HR)=0.655] in disease-free survival, with 194 events at final analysis.”
“The 1:1 randomization was conducted centrally and stratified by SR-Avg non-Down syndrome, SR-Avg Down syndrome, and SR-High.”
“Neither providers nor patients were blinded.”
“Using a two-sided α of 5%, the trial would have 81% power to detect a 34.5% improvement [hazard ratio (HR)=0.655] in disease-free survival, with 194 events at final analysis.”
Sex, age, race/ethnicity, and key disease features are reported in Table 1. Both sexes are enrolled, so sex justification is not applicable. Age and health status are reported. Species/strain and housing are not applicable for a human trial. Demographics are comprehensive.
“The median age of randomized patients was 4.3 years [interquartile range (IQR) 2.8–6.4]; 52.6% were male, 26% were Hispanic and 5% were non-Hispanic Black.”
“Table 1. Characteristics of the Patients who Underwent Randomization”
“Median age (range) – yr | 4.3 (1.0–10.0) | 4.0 (1.0–9.9) | 4.2 (1.0–10.0) | 4.2 (1.1–9.9) | 4.6 (1.0–10.0) | 4.4 (1.0–10.0)”
“Hispanic | 104 (24.9%) | 100 (24.0%) | 204 (24.4%) | 84 (27.6%) | 84 (27.9%) | 168 (27.8%)”
The protocol was approved by the NCI Central IRB and local IRBs. Written informed consent from guardians and assent as necessary are described. Regulatory compliance is implied through the approval process. The trial is registered (NCT03914625).
“The protocol was approved by the pediatric Central Institutional Review Board (CIRB) of the NCI and local IRBs.”
“Each patient’s legal guardian provided written informed consent; assent was obtained as necessary.”
“ClinicalTrials.gov (http://www.clinicaltrials.gov/) number NCT03914625”
“The protocol was approved by the pediatric Central Institutional Review Board (CIRB) of the NCI and local IRBs.”
“Each patient’s legal guardian provided written informed consent; assent was obtained as necessary.”
Blinatumomab is named with manufacturer (Amgen) and dosing regimen. The trial is a drug trial, so bench reagents are not applicable. Statistical software is not explicitly named, but the analysis methods are described.
“Patients assigned to experimental arms received two cycles of continuous intravenous infusion blinatumomab 15µg/m 2 /day (max 28µg/day) for 28 days”
“sequencing MRD was measured using ClonoSEQ B-cell clonality/tracking assays.”
“Patients assigned to experimental arms received two cycles of continuous intravenous infusion blinatumomab 15µg/m 2 /day (max 28µg/day) for 28 days”
The primary analysis used RMST due to nonproportionality, with a 1-sided stratified log-rank p=0.00004. Effect sizes are reported as RMST differences with 95% CIs. Tests are named (log-rank, Cox, Fisher's exact). Assumptions are handled by design (RMST for nonproportionality). Software is not identified, but this is minor. Data presentation includes Kaplan-Meier curves and tables with per-group Ns. Mathematical plausibility checks are not applicable for large-N continuous outcomes.
“Adding blinatumomab significantly improved disease-free survival [RMST difference 72 days, 95% CI 36–108 days, 1-sided stratified log-rank p=0.00004]”
“disease-free survival was compared between the chemotherapy and the chemotherapy plus blinatumomab groups using a log-rank test stratified by non-Down syndrome SR-Avg vs. Down syndrome SR-Avg vs. SR-High.”
“1-sided stratified log-rank p=0.00004”
“RMST difference 72 days, 95% CI 36–108 days”
The paper states that the protocol is available at NEJM.org, but does not provide a clear data availability statement for the clinical data. No repository deposit or accession numbers are provided for the trial data. No custom code is mentioned, so code sharing is not applicable.
“Full statistical analysis plans are detailed in the protocol, available at NEJM.org (http://www.nejm.org/) .”
“Detailed eligibility criteria are included in the trial protocol (available NEJM.org (http://www.nejm.org/) ).”
The trial is registered (NCT03914625). Methods are detailed. All outcomes are reported, including negative toxicity findings. Limitations are discussed (e.g., post-hoc subgroup analyses, lack of CNS activity). Conclusions are proportional. Funding and COI are disclosed.
“ClinicalTrials.gov (http://www.clinicaltrials.gov/) number NCT03914625”
“Though post-hoc, subgroup analyses show consistency in the magnitude of effect across leukemia cytogenetic risk group”
“This study was supported by grants from the National Institutes of Health/National Cancer Institute (U10CA180899; U20CA180886) and from the St. Baldrick’s Foundation.”
“ClinicalTrials.gov (http://www.clinicaltrials.gov/) number NCT03914625”
“This study was supported by grants from the National Institutes of Health/National Cancer Institute (U10CA180899; U20CA180886) and from the St. Baldrick’s Foundation.”
Registered (3 IDs: 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 41 references by DOI: 36 verified — 5 no DOI (shown, not verified).
- NO DOIOutstanding Outcome for Children with Standard Risk-Low (SR-Low) Acute Lymphoblastic Leukemia (ALL) and No Benefit to Intensified Peg-Asparaginase (PEG-ASNase) Therapy: Results of Children’s Oncology Group (COG) Study AALL0331No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIIntensification of oral methotrexate is not superior to standard methotrexate dosing during maintenance in children with National Cancer Institute (NCI) standard-risk B actue lymphoblastic leukemia (SR B-ALL): A report from the Children's Oncology Group (COG) study AALL0932No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIHigh dose methotrexate does not reduce the risk of CNS relapse in children and young adults with acute lymphoblastic leukaemia and lymphoblastic lymphoma. Results of the randomised phase III study UKALL 2011No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOICommon Terminology Criteria for Adverse Events (CTCAE) v. 5.0No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOINonparametric estimation from incomplete observationsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
3 data/code links checked; 3 live.
- datahttps://clinicaltrials.gov/ct2/show/NCT03914625LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttps://clinicaltrials.gov/ct2/show/NCT03643276LIVEHTTP 200Resolves, but the content could not be matched to the paper.
- datahttps://clinicaltrials.gov/ct2/show/NCT03117751LIVEHTTP 200Resolves, but the content could not be matched to the paper.
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 typo, consistency, clarity.
- MINORtypoDiscussion, paragraph 2“Treatement-related mortality”→ Treatment-related mortalityMisspelling of 'Treatment'.
- MINORconsistencyResults, Efficacy outcomes“1-sided stratified log-rank p=0.00004”→ Consider reporting as p<0.0001 or with more consistent significant figures.p-value reported with 5 decimal places; elsewhere p-values are reported with 2-3 decimals.
- MINORclarityMethods, Statistical Analysis“alpha-t square spending functions”→ alpha-spending functionsUnclear phrasing; likely meant 'alpha-spending functions'.
- MINORtypoDiscussion, paragraph 1“Treatement-related mortality”→ Treatment-related mortalitySpelling error.
- MINORconsistencyAbstract, Results“96.0±1.2% for blinatumomab arms vs 87.9±2.1% for chemotherapy alone arms”→ Ensure consistent use of 'blinatumomab' vs 'blinatumomab and chemotherapy'Minor inconsistency in arm naming.
The published work is methodologically robust and the reported statistics are consistent with the subset that could be recomputed. An informed reader should weigh the absence of a formal data availability statement and the unspecified statistical software as minor transparency gaps; no erratum appears warranted based on the integrity checks, which found no internal contradictions or unsupported claims.
- 1.HIGHdata codeAdd a formal data availability statement in the Methods or a dedicated section, specifying how de-identified individual patient data can be accessed (e.g., via a managed access process through the COG data sharing committee) with conditions and timeframe.The paper currently only mentions protocol availability, which is inadequate for a data-driven clinical trial and would be flagged by reviewers.
- 2.HIGHstatisticsIdentify the statistical software (e.g., SAS version, R version) used for analyses in the Statistical Analysis section.Reproducibility requires naming the software and version; both reviewers noted this omission.
- 3.MEDIUMreportingReference the CONSORT reporting guideline in the Methods or provide a completed CONSORT checklist as supplementary material.Explicitly citing CONSORT enhances transparency and is expected for a randomized trial.
- 4.MEDIUMdata codeProvide accession numbers for any genomic or sequencing data generated (e.g., HTS MRD data) if deposited in a public repository.Accession numbers enable verification and reuse of sequencing data.
- 5.MEDIUMdata codeClarify the data sharing policy for the trial protocol and statistical analysis plan, possibly with a link or DOI to a public repository.A clear policy improves transparency and reader trust.
- 6.LOWdata codeIf custom code was used for analyses, share it in a public repository (e.g., GitHub) with a DOI.Sharing code facilitates full reproducibility.
- 7.LOWcopyeditFix the misspelling 'Treatement-related mortality' to 'Treatment-related mortality' in Discussion paragraphs 1 and 2.Typos in a high-profile journal undermine professionalism.
- 8.LOWcopyeditConsider reporting the primary p-value as p<0.0001 or with consistent significant figures across the paper.The p-value 0.00004 is reported with 5 decimals while others use 2-3; consistency improves clarity.
- 9.LOWcopyeditClarify 'alpha-t square spending functions' to 'alpha-spending functions' in Methods, Statistical Analysis.The current phrasing is unclear and likely a typo.
- 10.LOWcopyeditEnsure consistent naming of the experimental arm (e.g., 'blinatumomab' vs 'blinatumomab and chemotherapy') throughout the abstract and results.Consistent terminology avoids confusion.
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.
The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.
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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