Rigor Reviewed

Rigor-Reviewed Manuscript

Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial

Name: Adcurare Rigor Record — Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial
Item: Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial
Rating: 96
Author: Adcurare

Steinhardt LC, Kwambai TK, Oneko M, et al. (Kenya Malaria mAb Trials Team)

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Adcurare Rigor Review — 3.75★ (Adequate), 0 critical, 3 high issues for “Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 5, 2026

Adcurare Rigor Review

Rigor Reviewed

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

CitationsCitations & links (capped) ×28−1★
ReportingData & code availability partially met−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: highReviewer agreement: highEngine: 7.5.0Source: full text

Not verified in this report

No data or code availability links were detected to verify.

Problems surfaced2 types

Data/code availability incomplete
References not resolvable to a published paper

This Adcurare Rigor Review uses AI 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 phase 2 RCT of L9LS for malaria prevention is methodologically sound with a clear premise, rigorous design, and appropriate statistical analysis. The main weaknesses are the absence of an explicit statement of adherence to an international ethical framework, a vague data availability statement with no publicly deposited data, and a lack of CONSORT guideline reference. Numerous references were not found in any registry, raising citation accuracy concerns. Minor copyedit issues are present.

The manuscript was evaluated by three independent reviewers using a structured eight-dimension framework applicable to an interventional RCT. The reviewers converged on most dimensions; ethical approvals had a minor divergence resolved by adopting the more conservative assessment. The citation verification identified 28 references not found in any registry, of which 12 are flagged for verification. The statistics component recomputed 4 of 8 tests consistently, with no errors found; unverified tests are not endorsed.

12 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 4 tests: 4 consistent, 0 inconsistent, 4 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

Prior work on L9LS (phase 1 and 2 trials in the USA and Mali) is cited, with strengths and weaknesses noted. The rationale linking the need for efficacy data in young children and perennial transmission to the study objectives is logically presented. The limitations of prior research (e.g., only seasonal transmission, older children) are explicitly addressed as knowledge gaps the trial fills.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific foundation by citing prior research on L9LS and CIS43LS, articulating the rationale for the study in younger children and perennial transmission settings, and addressing limitations of prior work.

Evidence

direct quote[Introduction, paragraph 1-3]

“Phase 1 and 2 field trials in Africa have shown that CIS43LS and L9LS are safe and highly efficacious against P falciparum infection. In a highly seasonal transmission setting in Mali... L9LS showed 70% efficacy against infection and 77% efficacy against clinical malaria following a single 300 mg dose... to Malian children aged 6–10 years.”

direct quote[Introduction, last paragraph]

“This trial was designed to address several questions... first, whether monoclonal antibodies can maintain efficacy in areas of intense perennial transmission... second, whether protective efficacy can be achieved in infants and young children... third, whether repeated monoclonal antibody dosing can extend protection to 12 months.”

direct quote[Introduction, last paragraph]

“To address these crucial knowledge gaps, this phase 2 trial assessed the safety of L9LS in children aged 5 months to 10 years, and the 12-month efficacy of one or two doses of L9LS... in western Kenya, where intense perennial P falciparum transmission provides a stringent test.”

PASSReviewer 2· 95% conf

The scientific premise is well-established with citation of prior work, a clear rationale linking the premise to the trial objectives, and a discussion of how limitations of prior research are addressed.

Evidence

direct quote[Introduction, paragraph 4]

“Phase 1 and 2 field trials in Africa have shown that CIS43LS and L9LS are safe and highly efficacious against P falciparum infection.”

direct quote[Introduction, paragraph 5]

“This trial was designed to address several questions... first, whether monoclonal antibodies can maintain efficacy in areas of intense perennial transmission... second, whether protective efficacy can be achieved in infants and young children... and third, whether repeated monoclonal antibody dosing can extend protection to 12 months.”

direct quote[Introduction, paragraph 5]

“To address these crucial knowledge gaps, this phase 2 trial assessed the safety of L9LS in children aged 5 months to 10 years, and the 12-month efficacy of one or two doses of L9LS given subcutaneously to infants and young children aged 5–59 months in western Kenya.”

PASSReviewer 3· 95% conf

The paper clearly establishes the scientific premise by citing prior work on L9LS and other antimalaria monoclonal antibodies, explaining the need to test in younger children and perennial transmission, and addressing limitations of previous studies.

Evidence

direct quote[Introduction, paragraph 4]

“Phase 1 and 2 field trials in Africa have shown that CIS43LS and L9LS are safe and highly efficacious against P falciparum infection.”

direct quote[Introduction, paragraph 5]

direct quote[Discussion, 'Research in context']

“However, to date, no published studies have assessed the safety and efficacy of antimalaria monoclonal antibodies in children younger than 6 years... or in a perennial transmission setting.”

Centralized computer-generated permuted block randomization was used with stratified allocation. Masking was ensured by covering syringes and using separate administration staff. An a priori power calculation was performed assuming 60% efficacy, 80% power, and 25% attrition. Inclusion and exclusion criteria are listed with a reference to the appendix. The modified intention-to-treat (mITT) and per-protocol populations are defined, handling protocol deviations.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

All applicable design elements are adequately reported: randomization method, unit, blinding, power analysis, inclusion/exclusion criteria, and analysis population handling.

Evidence

direct quote[Methods, Randomisation and masking section]

“An unmasked trial statistician (VC) provided computer-generated randomisation lists that were shared only with unmasked pharmacy staff... All other study staff, participants, and parents or guardians remained masked to study assignment throughout the study.”

direct quote[Methods, Statistical analysis section]

“For part 2, the sample size was calculated to detect a target 60% protective efficacy of two doses of L9LS against infection at 12 months in the younger age group (5–17 months) with 80% power, assuming a 45% infection rate in the placebo group by 12 months, and 25% attrition, yielding 324 participants.”

direct quote[Methods, Participants section]

“Eligibility criteria for all study parts included HIV-negative status, absence of sickle cell disease, no wasting or stunting... A full list of inclusion and exclusion criteria is in the (pp 2–3).”

PASSReviewer 2· 90% conf

The study design is rigorous with adequate reporting of randomization, blinding, power analysis, inclusion/exclusion criteria, and controls.

Evidence

direct quote[Methods, Randomisation and masking, paragraph 1]

“An unmasked trial statistician (VC) provided computer-generated randomisation lists that were shared only with unmasked pharmacy staff, who sequentially assigned eligible participants at their dosing visit.”

direct quote[Methods, Randomisation and masking, paragraph 1]

“To maintain blinding, syringes were covered with transparent yellow tape to mask the yellowish tint of L9LS versus the colourless placebo.”

direct quote[Methods, Statistical analysis, paragraph 1]

“the sample size was calculated to detect a target 60% protective efficacy of two doses of L9LS against infection at 12 months... with 80% power.”

PASSReviewer 3· 95% conf

The study is a well-designed phase 2 RCT with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria. All applicable sub-criteria are met.

Evidence

direct quote[Methods, Randomisation and masking]

direct quote[Methods, Statistical analysis]

“For part 2, the sample size was calculated to detect a target 60% protective efficacy... with 80% power... yielding 324 participants.”

direct quote[Methods, Participants]

“Eligibility criteria for all study parts included HIV-negative status, absence of sickle cell disease, no wasting or stunting...”

The paper provides a detailed baseline characteristics table (Table 1) with sex, age (median and IQR), weight (mean and SD), and health parameters. Age and weight are reported. The study includes both sexes. Species/strain and housing are not applicable as this is a human trial. Demographics are reported in detail.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex, age, weight, and health status are adequately reported; race/ethnicity and comorbidities are not explicitly detailed, but the overall proportion of applicable criteria is adequate.

Evidence

direct quote[Results, Table 1]

“Female | 29 (54%) | 27 (52%) | 27 (48%) | 28 (52%) | 34 (63%) | 27 (50%)”

paraphrase[Results, Table 1]

“Age in months and weight at first dose are reported per group and age stratum.”

absence[Results, Table 1 and baseline characteristics]

Race/ethnicity is not explicitly reported.

PASSReviewer 2· 90% conf

Biological variables and subject characteristics are adequately reported for a human clinical trial, including sex, age, weight, and health status.

Evidence

direct quote[Results, Table 1]

“Female ... 54 (50%) ... Male ... 25 (46%) ... 25 (48%) ...”

direct quote[Results, Table 1]

“Age, months ... 37 (25–45) ... 10 (6–14) ... Weight at first dose, kg ... 13.6 (2.4) ...”

PASSReviewer 3· 90% conf

Key biological variables (sex, age, weight, health status) are reported for the human participants. Demographics are adequate for a study in a specific geographic population.

Evidence

direct quote[Table 1]

“Table 1: Characteristics of participants enrolled in efficacy cohort ...Sex: Female...Male...Age, months...Weight at first dose, kg”

direct quote[Methods, Participants]

“Healthy children were recruited... Eligibility criteria... included HIV-negative status, absence of sickle cell disease, no wasting or stunting...”

The paper states that the protocol was approved by the Kenya Medical Research Institute (Scientific and Ethics Research Unit; number 4413), the US CDC, and the Liverpool School of Tropical Medicine. It also mentions regulatory review by the Kenya Pharmacy and Poisons Board, and registration on ClinicalTrials.gov. Written informed consent from parents/guardians is described. Compliance with relevant regulations is implied through mention of ethics committee approvals.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Institutional review board approval and informed consent are adequately reported, but regulatory compliance to an international framework (e.g., Declaration of Helsinki) is not explicitly stated, leading to one inadequate sub-criterion.

Evidence

direct quote[Methods, Study design section]

“The study protocol was approved by the institutional review boards of the Kenya Medical Research Institute (Scientific and Ethics Research Unit; number 4413), the US Centers for Disease Control and Prevention, and the Liverpool School of Tropical Medicine, with regulatory review by the Kenya Pharmacy and Poisons Board.”

direct quote[Methods, Participants section]

“Parents or guardians provided written informed consent for their child's participation.”

absence[Methods, Study design / Ethics section]

Adherence to an international ethical framework is not explicitly stated.

PASSReviewer 2· 95% conf

Ethical approvals are adequately reported, including named IRB/ethics committee approval, informed consent, and regulatory compliance.

Evidence

direct quote[Methods, Study design, paragraph 3]

direct quote[Methods, Participants, paragraph 2]

“Parents or guardians provided written informed consent for their child’s participation.”

PASSReviewer 3· 95% conf

The study reports named ethics committee approval, written informed consent, and regulatory compliance. All applicable criteria are met.

Evidence

direct quote[Methods, Study design]

direct quote[Methods, Participants]

“Parents or guardians provided written informed consent for their child's participation.”

direct quote[Methods, Study design]

“regulatory review by the Kenya Pharmacy and Poisons Board (ECCT/22/05/03)”

L9LS, the monoclonal antibody, is described with source (Vaccine Research Center, NIAID/NIH), concentration (150 mg/mL), and formulation. The placebo (normal saline) is named. Statistical software R version 4.5.0 is identified. No other key resources (antibodies, cell lines, organisms) are used in a research capacity beyond the investigational product, so those sub-criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational product (L9LS) and software are adequately identified; other resource types are not applicable.

Evidence

direct quote[Methods, Procedures section]

“L9LS is a human IgG1 monoclonal antibody produced in a recombinant Chinese hamster ovary cell line... L9LS was supplied at a concentration of 150 mg/mL, with 2.2 mL per vial.”

direct quote[Methods, Statistical analysis section]

“R statistical software (version 4.5.0) was used for all analyses.”

PASSReviewer 2· 85% conf

The investigational product (L9LS) is adequately identified, and software tools are named. Other biological resources are not applicable or adequately reported.

Evidence

direct quote[Methods, Procedures, paragraph 1]

“L9LS is a human IgG1 monoclonal antibody produced in a recombinant Chinese hamster ovary cell line. ... L9LS was supplied at a concentration of 150 mg/mL, with 2.2 mL per vial.”

direct quote[Methods, Statistical analysis, paragraph 5]

“R statistical software (version 4.5.0) was used for all analyses.”

PASSReviewer 3· 85% conf

The investigational product (L9LS) and software are identified. Other wet-lab resources are not applicable. Both applicable criteria are adequate.

Evidence

direct quote[Methods, Procedures]

“L9LS is a human IgG1 monoclonal antibody produced in a recombinant Chinese hamster ovary cell line... L9LS was supplied at a concentration of 150 mg/mL, with 2·2 mL per vial.”

direct quote[Methods, Statistical analysis]

“R statistical software (version 4.5.0) was used for all analyses.”

Statistical tests are named (Cox proportional hazards, Kaplan-Meier, log-rank, Anderson-Gill, chi-square). Exact p-values (e.g., p=0.0003, p=0.0001) and 95% CIs are reported. Effect sizes (hazard ratios, protective efficacy) are reported with CIs. Software (R 4.5.0) is identified. Data presentation includes Kaplan-Meier curves, tables with per-group n, and confidence intervals. Mathematical plausibility appears consistent with reported numbers.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

All applicable statistical sub-criteria are adequately reported: tests are named, exact p-values and confidence intervals provided, software identified, and data presentation follows clinical trial conventions.

Evidence

direct quote[Results, paragraph 11]

“the protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months, the primary endpoint, was 42.7% (95% CI 22.5–57.7; p=0.0003)”

direct quote[Methods, Statistical analysis section]

“Protective efficacy was defined as (1–hazard ratio) × 100% and estimated through a Cox proportional hazards model accounting for interval censoring (icenReg R package).”

direct quote[Results, paragraph 7 and Table 1]

“108 children were assigned to one-dose L9LS, 106 to two-dose L9LS, and 110 to placebo. ... 152 (47%) of 324 participants were male, 172 (53%) were female.”

PASSReviewer 2· 85% conf

Statistical tests are named, software is identified, exact p-values and CIs are reported, and data presentation follows clinical trial convention. Assumptions and arithmetic checks are adequate.

Evidence

direct quote[Methods, Statistical analysis, paragraph 2]

“The protective efficacy was estimated using time-to-first-infection analysis, and protective efficacy was defined as (1–hazard ratio) × 100% and estimated through a Cox proportional hazards model accounting for interval censoring (icenReg R package).”

direct quote[Results, paragraph 1]

“protective efficacy 42.7%, 95% CI 22.5–57.7; p=0.0003”

PASSReviewer 3· 90% conf

Statistical methods are appropriately named, exact p-values and CIs are reported, software is identified, and data presentation is adequate. Assumptions are implicitly addressed via standard methods for clinical trials.

Evidence

direct quote[Results, paragraph 6]

“the protective efficacy of two doses of L9LS against P falciparum infection by blood smear at 12 months... was 42·7% (95% CI 22·5–57·7; p=0·0003)”

direct quote[Figure 2]

“Figure 2: Kaplan–Meier curve of time to first Plasmodium falciparum infection... Shaded areas represent 95% CIs.”

direct quote[Methods, Statistical analysis]

“R statistical software (version 4.5.0) was used for all analyses.”

The paper has a data sharing statement: anonymised data will be deposited in a secure institutional repository, available to researchers with a formal proposal, ethics approval, and data use agreement. This is reported_but_inadequate because the repository is not named and the timeline is not specified ('following publication of the trial results'). No code repository is mentioned; the paper uses standard R packages, so code_sharing is not_applicable. The statement's vagueness about the repository and timeline is the main shortcoming.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

A data availability statement is present with a concrete access plan, but the data are not yet deposited in a public repository with a persistent identifier, and no code is shared.

Evidence

direct quote[Data sharing section (before References)]

absence[Data sharing section]

No repository identifier or accession number is provided for the data.

WARNReviewer 2· 90% conf

A data availability statement is present but describes a managed-access process with conditions, which is appropriate for patient data. However, the statement is vague about the timeline and repository, and no code is shared.

Evidence

direct quote[Data sharing section]

“Anonymised data and the accompanying data dictionary will be deposited in a secure, access-controlled institutional repository following publication of the trial results. Access may be granted to researchers submitting methodologically sound proposals through the corresponding authors, subject to approval by the ethics committee (Scientific and Ethics Research Unit) and compliance with Kenyan data protection laws and regulations. Data access will require a formal data use agreement.”

WARNReviewer 3· 90% conf

A data availability statement exists but is vague ('will be deposited' in an unnamed repository, 'on request' through authors). Code is not shared. Only the statement is applicable and it is inadequate.

Evidence

direct quote[Data sharing]

“Anonymised data and the accompanying data dictionary will be deposited in a secure, access-controlled institutional repository following publication... Access may be granted to researchers submitting methodologically sound proposals through the corresponding authors...”

absence[Data sharing]

Code availability is not mentioned.

Methods are detailed enough for replication. Trial registration with NCT05400655 is provided. All pre-specified outcomes are reported. Limitations are discussed in a dedicated paragraph. Conclusions are proportional to the evidence and acknowledge the need for higher doses. Funding and conflicts of interest are declared. The only sub-criterion not met is referencing a reporting guideline (e.g., CONSORT), which is absent. With 6 of 7 applicable criteria adequate (85.7%), the dimension passes.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Most reporting criteria are met, including methods completeness, trial registration, outcome reporting, limitations discussion, proportional conclusions, and funding/COI. No reporting guideline is referenced, but this does not drop the proportion below the pass threshold.

Evidence

direct quote[Abstract and Methods, Study design section]

“This trial is registered with ClinicalTrials.gov (http://ClinicalTrials.gov) (NCT05400655).”

absence[Methods and throughout paper]

No reporting guideline (e.g., CONSORT) is referenced.

direct quote[Funding and Declaration of interests sections]

“This trial was funded by a grant from the Gates Foundation (INV-035091). ... RAS has a patent issued for L9LS. All other authors declare no competing interests.”

PASSReviewer 2· 90% conf

The trial is registered, methods are complete enough for replication, limitations are discussed, and conclusions are proportional. The CONSORT flow diagram is included. Funding and COI are reported.

Evidence

direct quote[Methods, Study design, paragraph 3]

“This study is registered with ClinicalTrials.gov (http://ClinicalTrials.gov) ( NCT05400655 ) and is complete.”

direct quote[Discussion, paragraph 6]

“This study has limitations. First, pharmacokinetic sampling was sparse because of community concerns about paediatric phlebotomy. ...”

PASSReviewer 3· 90% conf

The manuscript is well-reported with detailed methods, trial registration, complete outcome reporting, limitations discussion, proportional conclusions, and funding/COI. The only missing element is an explicit reporting guideline reference.

Evidence

direct quote[Abstract]

“This trial is registered with ClinicalTrials.gov (NCT05400655)”

direct quote[Discussion]

“This study has limitations. First, pharmacokinetic sampling was sparse... Second, the narrow range of L9LS doses...”

absence[Methods]

No reporting guideline is mentioned.

9 copyedit issues flagged: mostly typo, consistency, other.

Checked 30 references: 2 verified — 28 unresolved.

Reproducibility

Registered (6 IDs: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

Post-publication robustness assessment: The paper is generally robust but has notable reporting gaps. An informed reader should weigh that the trial has not yet deposited data in a public repository, the ethical statement lacks an explicit reference to the Declaration of Helsinki or ICH-GCP, and many references were not found in any registry. These issues do not invalidate the primary findings but would warrant a correction or erratum to address data availability, ethical compliance statement, and citation verification.

1.
HIGHdata code
Deposit anonymized data in a named public repository (e.g., ClinicalStudyDataRequest or Vivli) and provide a persistent identifier in the data availability statement to replace the current vague plan.
The current statement promises future deposit with no repository name or DOI, which is inadequate for a published paper and undermines reproducibility.
2.
HIGHethics
Add an explicit statement that the trial was conducted in accordance with the Declaration of Helsinki and/or ICH-GCP guidelines to the ethics section.
The absence of an explicit international ethical framework statement is a standard reporting gap that could be raised by readers or journals.
3.
HIGHreporting
Verify the 12 references that were not found in any registry (World malaria report 2025, Genetic surveillance of insecticide resistance in African Anopheles populations to inform malaria vector control, Artemisinin-resistant malaria, Monoclonal antibodies to the circumsporozoite proteins as an emerging tool for malaria prevention, Malaria prevention: from immunological concepts to effective vaccines and protective antibodies, Monoclonal antibodies for malaria, Safety and efficacy of a monoclonal antibody against malaria in Mali, Subcutaneous administration of a monoclonal antibody to prevent malaria, Post-discharge morbidity and mortality in children admitted with severe anaemia and other health conditions in malaria-endemic settings in Africa: a systematic review and meta-analysis, A monoclonal antibody for malaria prevention, A candidate antibody drug for prevention of malaria, Low-dose subcutaneous or intravenous monoclonal antibody to prevent malaria) and correct or replace them; these may be fabricated or incorrectly cited.
References not found in any registry raise integrity concerns; accurate citations are essential for scholarly trust.
4.
MEDIUMreporting
Reference the CONSORT 2010 checklist and provide a completed checklist as supplementary material, or state adherence in the Methods.
Explicit reporting guideline adherence is expected for clinical trials and facilitates completeness assessment.
5.
MEDIUMreporting
Report race/ethnicity of participants or provide a justification for its omission in the baseline characteristics table.
Though not mandatory, race/ethnicity is a standard demographic variable in clinical trials; its absence may be questioned.
6.
MEDIUMcopyedit
Fix typographical errors: 'chidren' -> 'children' in Figure 1 footnote; '20 m/kg' -> '20 mg/kg' in Results (Pharmacokinetics); '5–17-months' -> '5–17 months' in Table 1 note; and use consistent decimal formatting (period vs. middle dot) for pharmacokinetic values.
These minor errors detract from manuscript polish and could be misinterpreted.
7.
LOWstatistics
Provide a brief verification of the proportional hazards assumption for the Cox models (e.g., test based on Schoenfeld residuals) in the statistical analysis section.
Although the Cox model is standard, formally testing the assumption strengthens the analysis and is a common reviewer request.
8.
LOWdata code
Share the analysis code (R scripts) in a public repository with a DOI to enhance reproducibility.
Even if standard packages were used, sharing code allows full reproducibility and is increasingly expected.
9.
LOWreporting
Include the lot number of L9LS in the Procedures section for complete reagent identification.
Providing a lot number facilitates traceability of the investigational product.
10.
LOWcopyedit
Use consistent terminology: 'modified intent-to-treat' (mITT) throughout instead of alternating with 'intention-to-treat'.
Consistent terminology improves clarity and avoids confusion.

Full text (60,055 chars)Analyzed: Jul 5, 2026

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