Low-free-sugar diet × Long-term liver-disease events: the gap beyond eight-week MRI

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing long-term liver-disease claim is being presented?Required	The selected wording is reduced long-term liver-disease events, and the original subclaim grade is ?. The note states that the eight-week surrogate trial did not measure this outcome. Subclaim score, status and axes are absent and are preserved separately from parent C with 54 points. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separation of selected subclaim wording and grade from the parent surrogate outcome	Materials needed: Materials directly providing long-term event definitions, comparisons, duration and denominators, and review of the claim boundary. Parent scores are not inserted as subclaim scores. Only material requests and research needs are recorded; no search or research is conducted in this work.
2	Unverified	Full text not readStored summary read	N02 · Evidence conditionWere long-term liver-disease events measured directly?Required	The original subclaim note and Korean and English text state that the eight-week surrogate trial did not measure long-term liver-disease events and that long-term clinical effects are unconfirmed. Events not measured are not recast as zero events, reduced risk or zero effect. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Directness of surrogate and clinical liver-disease outcomes	Materials needed: Direct material with prespecified definitions and ascertainment methods for each clinical liver-disease event, actual event counts, group denominators, follow-up duration, comparative effects and CIs. No search or calculation is conducted here. Only material requests and research needs are recorded; no search or research is conducted in this work.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhich adolescents contributed the short-term findings?Required	The trial allocated 40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10% in a 1:1 ratio. Findings are not extended to all adolescents, girls, adults or other liver diseases. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinction between the original population and populations for long-term application	Materials needed: Complete eligibility and exclusion criteria, disease severity, comorbidities and direct long-term results by population. MRI-PDFF criteria and histological diagnosis are not converted into long-term events. Only material requests and research needs are recorded; no search or research is conducted in this work.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWas the trial intervention simple advice to restrict sugar?Required	The eight-week intervention provided food for the whole household and lowered free sugars below 3% of total energy. The stored summary includes professional menu design, household food provision and twice-weekly checks. These identify the research intervention and do not instruct readers to implement a diet. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	The actual intervention including household food provision	Materials needed: Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified. Only material requests and research needs are recorded; no search or research is conducted in this work.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat were the actual comparator and concurrent changes?Required	The original classification fields identify usual diet as the comparator. The intensive intervention changed the household food environment and contact, and the intervention group also lost more weight. An effect from free sugars alone is not certified. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinction between usual diet, the food environment and weight	Materials needed: Data on actual food and intake, contact, weight, concurrent behavior or treatment and adherence in both groups, and the effect of interest. Long-term events in the comparator group were not measured directly. Only material requests and research needs are recorded; no search or research is conducted in this work.
6	Unverified	Full text not readStored summary read	N06 · Evidence conditionAre eight-week results distinguished from long-term follow-up?Required	The efficacy material covers eight weeks. The original material distinguishes this from proof of long-term liver-disease improvement or the long-term safety of restrictive diets during growth. No post-treatment follow-up period is invented. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	The intervention endpoint and event observation period	Materials needed: Actual post-treatment follow-up plans and completion, event ascertainment, observation time, attrition and clinical results. Eight weeks is not repurposed as a long-term follow-up denominator. Only material requests and research needs are recorded; no search or research is conducted in this work.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionIs the short-term participant denominator also the long-term event denominator?Required	The original evidence list records 40 boys, allocated 20/20, all completing eight weeks. Short-term completion does not establish complete long-term event observation or long-term analysis denominators. People, households, repeated MRI measurements and time points are not added as new participants. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Allocation, completion, endpoint-specific analysis and long-term follow-up denominators	Materials needed: Group-specific long-term populations at risk, event-specific analysis denominators, follow-up losses and reasons, and analysis populations. No new attrition counts, rates or person-years are calculated. Only material requests and research needs are recorded; no search or research is conducted in this work.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich question do the MRI-PDFF effect numbers address?Required	The parent eight-week MRI-PDFF adjusted between-group difference is -6.23 percentage points, 95% CI -9.45 to -3.02, P<.001. This is an effect on a short-term liver-fat surrogate, not a risk difference, RR or HR for long-term clinical events. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original adjusted between-group MRI-PDFF difference, CI and P value	Materials needed: Separate effect estimates, CIs, follow-up and denominators for long-term clinical events. MRI percentage points are not converted into event risk or long-term treatment benefits. Only material requests and research needs are recorded; no search or research is conducted in this work.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre within-group changes separated from the adjusted between-group difference?Required	The original Korean research explanation separately records liver fat changing from 25% to 17%, control from 21% to 20%, and the adjusted between-group difference of -6.23 percentage points. Within-group changes are not used to calculate a new unadjusted difference, ratio or long-term event effect. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original group MRI values and the comparative estimate	Materials needed: Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre MRI, histological diagnosis and other liver markers the same outcome?Required	Histological NAFLD identifies the population at enrollment; the primary result is change in MRI-PDFF liver fat from baseline to eight weeks. The preserved material does not provide quantitative results for other imaging or histological follow-up, other liver tests or long-term clinical events. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinction between diagnosis, imaging surrogates and clinical outcomes	Materials needed: Original material is needed to establish the actual measurements, time points and material-specific findings for histological follow-up and tests or imaging other than MRI. Unread material is not declared unreported. Only material requests and research needs are recorded; no search or research is conducted in this work.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWas the prespecified primary endpoint a long-term event?Required	The original evidence list records change in MRI-PDFF liver fat from baseline to eight weeks as a positive prespecified primary MRI endpoint. The selected long-term events were not measured directly. Long-term events are not newly labeled as coprimary, secondary or registered outcomes. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinction between the prespecified MRI endpoint and long-term event plans	Materials needed: Endpoint definitions, time points and hierarchy in the original registration, protocol and SAP, and separate plans and findings for long-term event research. External material remains unread. Only material requests and research needs are recorded; no search or research is conducted in this work.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionDoes the weight-adjusted sensitivity result establish long-term event benefits?Required	The original text states that the intervention group lost more weight and that liver-fat findings remained favorable in a sensitivity analysis additionally adjusting for weight change. No separate sensitivity effect or CI, isolated free-sugar causal effect or long-term event effect is created. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Scope of weight change and sensitivity analysis	Materials needed: Weight-adjusted models, estimates, uncertainty, covariate timing and direct comparative long-term event data. Adjustment wording does not certify that all confounding or concurrent changes were resolved. Only material requests and research needs are recorded; no search or research is conducted in this work.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAt which stage was masking applied?Required	The original design is an open-label two-center randomized food-provision trial with masked MRI assessment. Masking of participants, intervention providers or long-term event adjudicators is not additionally claimed. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Open-label intervention and masked MRI assessment	Materials needed: Original material on allocation concealment, MRI assessment, departures during the open-label intervention, assessment procedures and long-term event adjudication. No formal RoB assessment is produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHave intervention intensity and population boundaries been lost?Required	The original material explains that reducing the intervention to simple sugar-restriction advice or a fatty-liver cure erases its intensity and population. Short-term MRI findings are not extended into implementation evidence for long-term liver-disease management or everyday diets. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Application limited to the household food environment and adolescent boys	Materials needed: Direct comparisons by population, implementation intensity and sustainability, and long-term clinical outcomes. No diet, child or adolescent care or treatment-replacement instructions are provided. Only material requests and research needs are recorded; no search or research is conducted in this work.
15	Partly verified	Full text not readStored summary read	N15 · Harm-information gaps supplementing the efficacy tableWhat does the short-term adverse-event wording delimit?Supplementary	The original material records completion by all 40 participants and no reported study-related adverse events. It states that the trial did not assess long-term safety of restrictive diets during adolescence. This is not recast as zero harm of every kind or proof of long-term safety. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Study-related adverse events and long-term safety during growth	Materials needed: Adverse-event collection, group harm denominators and observation, event definitions, relatedness and discontinuation, and long-term follow-up during growth. No new harm counts, rates or management instructions are produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat materials were actually read in this work?Required	The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Stored summary and access status of external material	Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat does the registration number establish?Required	The original evidence and citation lists contain NCT02513121. The identifier is retained; registration content, versions, timing, posted results and consistency with plans have not been newly read or verified. An official registration URL is not guessed. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Registration identifier in references and evidence versus actual registration reading	Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionWere the protocol and SAP acquired?Required	Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate entries for prespecified plans, amendments and analysis material	Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre funding, support, authors and research involvement separated?Required	Original funding is Nutrition Science Initiative plus foundation, academic and NIH support, which the parent text describes as independent funding. Company funding, food or product support, employee authorship and involvement in analysis or design have not been individually checked against original source material here. Absence of all four is not newly certified. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Four categories of company involvement versus public and academic support	Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre unmeasured outcomes, unverified details and null results distinguished?Required	Long-term events not measured directly and unverified external details are distinct. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Reasons for question-specific result and access statuses	Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre reports, trials, people, measurements and related sheets separated?Required	Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. One linked report is not a certified count of unique trials or participants. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Reference linkage and meaning without double counting	Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionIs there evidence of separate independent replication?Supplementary	Original parent replication and independence axes R1/I2 are preserved. Reusing citations and sibling sheets does not certify new independent replication of efficacy or harms. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Report identity versus independent confirmation	Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre subclaim grades separated from parent scores and axes?Required	The selected subclaim grade and note are preserved; absent score, status and axes remain unrecorded. Parent C with 54 points, safety and axes provide parent context. No new scores, grades or formal RoB2 or GRADE certification are produced. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Selected-record absences versus the parent verdict	Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre Korean, English and classification scopes preserved as the same original record?Required	The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original Korean and English texts and structured fields	Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre reference dates, corrections and historical verification separated?Required	The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original reference date versus creation and application times	Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat material would directly fill this gap?Supplementary	The short-term positive MRI findings are preserved, although long-term events were not observed directly. This direct evidence gap requires research on long-term clinical events and cannot be replaced by another surrogate. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Question-specific direct comparisons, follow-up and denominator material	Materials needed: Prespecified long-term liver-disease event definitions, actual observations and group denominators, follow-up and attrition, comparative effects and CIs, and long-term adolescent safety data. Only material requests and research needs are recorded; no search or research is conducted in this work.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionIs production separated from content review and implementation advice?Supplementary	This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged. R01	An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Production request and responsibility for review of existing content	Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed.

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27 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10%; the population and follow-up denominators for long-term events remain directly unverified.
Ingredient, formulation and route: A low-free-sugar diet including whole-household food provision, professional menu design and twice-weekly checks.
Dose: Identification of the original study: a free-sugar target below 3% of total energy for eight weeks. This is not guidance for implementing diets or managing adolescents or liver disease.
Comparator: Usual diet, distinguished from other changes in the food environment, weight and contact.
Measured outcome: Selected outcome: reduced long-term liver-disease events, not directly measured. Parent outcome: eight-week change in MRI-PDFF liver fat.
Duration: An eight-week trial; follow-up, denominators and direct effects for long-term clinical events remain unverified.
Questions outside this scope: Transferring MRI-PDFF effects into reduced risk of long-term liver-disease events or clinical treatment benefits; Treating histological diagnosis at enrollment as post-treatment histological or clinical improvement; Certifying household food provision as simple sugar-restriction advice or an isolated free-sugar effect; Adding the same citation, trial, people, households, measurements or sibling sheets as new independent trials or participants; New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions for diets, child or adolescent care, liver-disease management or treatment replacement

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Schwimmer JB, Ugalde-Nicalo P, Welsh JA, et al. Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial. JAMA. 2019;321(3):256-265. PMID: 30667502. PMCID: PMC6440226. DOI: 10.1001/jama.2018.20579. NCT02513121.

PubMed

Material type: Open-label two-center randomized food-provision trial with masked MRI assessment
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored summary: Adjusted between-group difference -6.23 percentage points (95% CI -9.45 to -3.02), P<.001
Record level: Parent-endpoint summary in the original evidence list; the scope of the selected direct endpoint and other findings is distinguished through conditions and roles.
Study overlap and independent replication: Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. Citation-based linkage is provisional; review of actual cohort and independent-study relationships remains incomplete.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
External abstract	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
External full text	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
Original registration	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.
Protocol/SAP	An original identifier, reference or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed URLs, PMCIDs and registration numbers are retained; no new external reading, access, confirmation of prespecification or certification of fulfillment. Full-text and registration URLs are not guessed.

Report counts versus independent study counts

Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. Citation-based linkage is provisional; review of actual cohort and independent-study relationships remains incomplete.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing long-term liver-disease claim is being presented?

Required materials and conditions: Separation of selected subclaim wording and grade from the parent surrogate outcome
Conditions for verification: Present original material concerning Separation of selected subclaim wording and grade from the parent surrogate outcome together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Separation of selected subclaim wording and grade from the parent surrogate outcome with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N02 · Were long-term liver-disease events measured directly?

Required materials and conditions: Directness of surrogate and clinical liver-disease outcomes
Conditions for verification: Present original material concerning Directness of surrogate and clinical liver-disease outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Directness of surrogate and clinical liver-disease outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N03 · Which adolescents contributed the short-term findings?

Required materials and conditions: Distinction between the original population and populations for long-term application
Conditions for verification: Present original material concerning Distinction between the original population and populations for long-term application together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Distinction between the original population and populations for long-term application with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N04 · Was the trial intervention simple advice to restrict sugar?

Required materials and conditions: The actual intervention including household food provision
Conditions for verification: Present original material concerning The actual intervention including household food provision together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects The actual intervention including household food provision with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N05 · What were the actual comparator and concurrent changes?

Required materials and conditions: Distinction between usual diet, the food environment and weight
Conditions for verification: Present original material concerning Distinction between usual diet, the food environment and weight together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Distinction between usual diet, the food environment and weight with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N06 · Are eight-week results distinguished from long-term follow-up?

Required materials and conditions: The intervention endpoint and event observation period
Conditions for verification: Present original material concerning The intervention endpoint and event observation period together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects The intervention endpoint and event observation period with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N07 · Is the short-term participant denominator also the long-term event denominator?

Required materials and conditions: Allocation, completion, endpoint-specific analysis and long-term follow-up denominators
Conditions for verification: Present original material concerning Allocation, completion, endpoint-specific analysis and long-term follow-up denominators together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Allocation, completion, endpoint-specific analysis and long-term follow-up denominators with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N08 · Which question do the MRI-PDFF effect numbers address?

Required materials and conditions: Original adjusted between-group MRI-PDFF difference, CI and P value
Conditions for verification: Present original material concerning Original adjusted between-group MRI-PDFF difference, CI and P value together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Original adjusted between-group MRI-PDFF difference, CI and P value with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N09 · Are within-group changes separated from the adjusted between-group difference?

Required materials and conditions: Original group MRI values and the comparative estimate
Conditions for verification: Present original material concerning Original group MRI values and the comparative estimate together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Original group MRI values and the comparative estimate with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N10 · Are MRI, histological diagnosis and other liver markers the same outcome?

Required materials and conditions: Distinction between diagnosis, imaging surrogates and clinical outcomes
Conditions for verification: Present original material concerning Distinction between diagnosis, imaging surrogates and clinical outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Distinction between diagnosis, imaging surrogates and clinical outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N11 · Was the prespecified primary endpoint a long-term event?

Required materials and conditions: Distinction between the prespecified MRI endpoint and long-term event plans
Conditions for verification: Present original material concerning Distinction between the prespecified MRI endpoint and long-term event plans together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Distinction between the prespecified MRI endpoint and long-term event plans with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N12 · Does the weight-adjusted sensitivity result establish long-term event benefits?

Required materials and conditions: Scope of weight change and sensitivity analysis
Conditions for verification: Present original material concerning Scope of weight change and sensitivity analysis together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Scope of weight change and sensitivity analysis with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N13 · At which stage was masking applied?

Required materials and conditions: Open-label intervention and masked MRI assessment
Conditions for verification: Present original material concerning Open-label intervention and masked MRI assessment together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Open-label intervention and masked MRI assessment with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N14 · Have intervention intensity and population boundaries been lost?

Required materials and conditions: Application limited to the household food environment and adolescent boys
Conditions for verification: Present original material concerning Application limited to the household food environment and adolescent boys together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Application limited to the household food environment and adolescent boys with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N15 · What does the short-term adverse-event wording delimit?

Required materials and conditions: Study-related adverse events and long-term safety during growth
Conditions for verification: Present original material concerning Study-related adverse events and long-term safety during growth together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Requirement and applicability: Supplementary
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Study-related adverse events and long-term safety during growth with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N16 · What materials were actually read in this work?

Required materials and conditions: Stored summary and access status of external material
Conditions for verification: Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N17 · What does the registration number establish?

Required materials and conditions: Registration identifier in references and evidence versus actual registration reading
Conditions for verification: Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N18 · Were the protocol and SAP acquired?

Required materials and conditions: Separate entries for prespecified plans, amendments and analysis material
Conditions for verification: Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N19 · Are funding, support, authors and research involvement separated?

Required materials and conditions: Four categories of company involvement versus public and academic support
Conditions for verification: Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Four categories of company involvement versus public and academic support with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N20 · Are unmeasured outcomes, unverified details and null results distinguished?

Required materials and conditions: Reasons for question-specific result and access statuses
Conditions for verification: Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N21 · Are reports, trials, people, measurements and related sheets separated?

Required materials and conditions: Reference linkage and meaning without double counting
Conditions for verification: Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N22 · Is there evidence of separate independent replication?

Required materials and conditions: Report identity versus independent confirmation
Conditions for verification: Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N23 · Are subclaim grades separated from parent scores and axes?

Required materials and conditions: Selected-record absences versus the parent verdict
Conditions for verification: Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N24 · Are Korean, English and classification scopes preserved as the same original record?

Required materials and conditions: Original Korean and English texts and structured fields
Conditions for verification: Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This connects Original Korean and English texts and structured fields with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N25 · Are reference dates, corrections and historical verification separated?

Required materials and conditions: Original reference date versus creation and application times
Conditions for verification: Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N26 · What material would directly fill this gap?

Required materials and conditions: Question-specific direct comparisons, follow-up and denominator material
Conditions for verification: Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N27 · Is production separated from content review and implementation advice?

Required materials and conditions: Production request and responsibility for review of existing content
Conditions for verification: Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Why this condition is needed: This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-15 · Public page/material version 1.0

Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing long-term liver-disease claim is being presented?

Current findings: The selected wording is reduced long-term liver-disease events, and the original subclaim grade is ?. The note states that the eight-week surrogate trial did not measure this outcome. Subclaim score, status and axes are absent and are preserved separately from parent C with 54 points.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Materials directly providing long-term event definitions, comparisons, duration and denominators, and review of the claim boundary. Parent scores are not inserted as subclaim scores.
Required materials and conditions: Separation of selected subclaim wording and grade from the parent surrogate outcome
Materials to obtain first: Materials directly providing long-term event definitions, comparisons, duration and denominators, and review of the claim boundary. Parent scores are not inserted as subclaim scores.
Further research: Materials needed: Materials directly providing long-term event definitions, comparisons, duration and denominators, and review of the claim boundary. Parent scores are not inserted as subclaim scores. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Separation of selected subclaim wording and grade from the parent surrogate outcome together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Separation of selected subclaim wording and grade from the parent surrogate outcome with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N02 · Were long-term liver-disease events measured directly?

Current findings: The original subclaim note and Korean and English text state that the eight-week surrogate trial did not measure long-term liver-disease events and that long-term clinical effects are unconfirmed. Events not measured are not recast as zero events, reduced risk or zero effect.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Direct material with prespecified definitions and ascertainment methods for each clinical liver-disease event, actual event counts, group denominators, follow-up duration, comparative effects and CIs. No search or calculation is conducted here.
Required materials and conditions: Directness of surrogate and clinical liver-disease outcomes
Materials to obtain first: Direct material with prespecified definitions and ascertainment methods for each clinical liver-disease event, actual event counts, group denominators, follow-up duration, comparative effects and CIs. No search or calculation is conducted here.
Further research: Materials needed: Direct material with prespecified definitions and ascertainment methods for each clinical liver-disease event, actual event counts, group denominators, follow-up duration, comparative effects and CIs. No search or calculation is conducted here. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Directness of surrogate and clinical liver-disease outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Directness of surrogate and clinical liver-disease outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N03 · Which adolescents contributed the short-term findings?

Current findings: The trial allocated 40 boys aged 11 to 16 with histological NAFLD and MRI-PDFF above 10% in a 1:1 ratio. Findings are not extended to all adolescents, girls, adults or other liver diseases.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Complete eligibility and exclusion criteria, disease severity, comorbidities and direct long-term results by population. MRI-PDFF criteria and histological diagnosis are not converted into long-term events.
Required materials and conditions: Distinction between the original population and populations for long-term application
Materials to obtain first: Complete eligibility and exclusion criteria, disease severity, comorbidities and direct long-term results by population. MRI-PDFF criteria and histological diagnosis are not converted into long-term events.
Further research: Materials needed: Complete eligibility and exclusion criteria, disease severity, comorbidities and direct long-term results by population. MRI-PDFF criteria and histological diagnosis are not converted into long-term events. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Distinction between the original population and populations for long-term application together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Distinction between the original population and populations for long-term application with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N04 · Was the trial intervention simple advice to restrict sugar?

Current findings: The eight-week intervention provided food for the whole household and lowered free sugars below 3% of total energy. The stored summary includes professional menu design, household food provision and twice-weekly checks. These identify the research intervention and do not instruct readers to implement a diet.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified.
Required materials and conditions: The actual intervention including household food provision
Materials to obtain first: Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified.
Further research: Materials needed: Original material on food provision, menu design, contact, adherence and other components. Equivalent effects from simple advice and long-term implementation are not certified. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning The actual intervention including household food provision together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects The actual intervention including household food provision with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N05 · What were the actual comparator and concurrent changes?

Current findings: The original classification fields identify usual diet as the comparator. The intensive intervention changed the household food environment and contact, and the intervention group also lost more weight. An effect from free sugars alone is not certified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Data on actual food and intake, contact, weight, concurrent behavior or treatment and adherence in both groups, and the effect of interest. Long-term events in the comparator group were not measured directly.
Required materials and conditions: Distinction between usual diet, the food environment and weight
Materials to obtain first: Data on actual food and intake, contact, weight, concurrent behavior or treatment and adherence in both groups, and the effect of interest. Long-term events in the comparator group were not measured directly.
Further research: Materials needed: Data on actual food and intake, contact, weight, concurrent behavior or treatment and adherence in both groups, and the effect of interest. Long-term events in the comparator group were not measured directly. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Distinction between usual diet, the food environment and weight together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Distinction between usual diet, the food environment and weight with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N06 · Are eight-week results distinguished from long-term follow-up?

Current findings: The efficacy material covers eight weeks. The original material distinguishes this from proof of long-term liver-disease improvement or the long-term safety of restrictive diets during growth. No post-treatment follow-up period is invented.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual post-treatment follow-up plans and completion, event ascertainment, observation time, attrition and clinical results. Eight weeks is not repurposed as a long-term follow-up denominator.
Required materials and conditions: The intervention endpoint and event observation period
Materials to obtain first: Actual post-treatment follow-up plans and completion, event ascertainment, observation time, attrition and clinical results. Eight weeks is not repurposed as a long-term follow-up denominator.
Further research: Materials needed: Actual post-treatment follow-up plans and completion, event ascertainment, observation time, attrition and clinical results. Eight weeks is not repurposed as a long-term follow-up denominator. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning The intervention endpoint and event observation period together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects The intervention endpoint and event observation period with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N07 · Is the short-term participant denominator also the long-term event denominator?

Current findings: The original evidence list records 40 boys, allocated 20/20, all completing eight weeks. Short-term completion does not establish complete long-term event observation or long-term analysis denominators. People, households, repeated MRI measurements and time points are not added as new participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific long-term populations at risk, event-specific analysis denominators, follow-up losses and reasons, and analysis populations. No new attrition counts, rates or person-years are calculated.
Required materials and conditions: Allocation, completion, endpoint-specific analysis and long-term follow-up denominators
Materials to obtain first: Group-specific long-term populations at risk, event-specific analysis denominators, follow-up losses and reasons, and analysis populations. No new attrition counts, rates or person-years are calculated.
Further research: Materials needed: Group-specific long-term populations at risk, event-specific analysis denominators, follow-up losses and reasons, and analysis populations. No new attrition counts, rates or person-years are calculated. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Allocation, completion, endpoint-specific analysis and long-term follow-up denominators together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Allocation, completion, endpoint-specific analysis and long-term follow-up denominators with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N08 · Which question do the MRI-PDFF effect numbers address?

Current findings: The parent eight-week MRI-PDFF adjusted between-group difference is -6.23 percentage points, 95% CI -9.45 to -3.02, P<.001. This is an effect on a short-term liver-fat surrogate, not a risk difference, RR or HR for long-term clinical events.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Separate effect estimates, CIs, follow-up and denominators for long-term clinical events. MRI percentage points are not converted into event risk or long-term treatment benefits.
Required materials and conditions: Original adjusted between-group MRI-PDFF difference, CI and P value
Materials to obtain first: Separate effect estimates, CIs, follow-up and denominators for long-term clinical events. MRI percentage points are not converted into event risk or long-term treatment benefits.
Further research: Materials needed: Separate effect estimates, CIs, follow-up and denominators for long-term clinical events. MRI percentage points are not converted into event risk or long-term treatment benefits. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Original adjusted between-group MRI-PDFF difference, CI and P value together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Original adjusted between-group MRI-PDFF difference, CI and P value with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N09 · Are within-group changes separated from the adjusted between-group difference?

Current findings: The original Korean research explanation separately records liver fat changing from 25% to 17%, control from 21% to 20%, and the adjusted between-group difference of -6.23 percentage points. Within-group changes are not used to calculate a new unadjusted difference, ratio or long-term event effect.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced.
Required materials and conditions: Original group MRI values and the comparative estimate
Materials to obtain first: Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced.
Further research: Materials needed: Analysis models, covariates, group estimates and variances, missing-data handling and actual long-term comparative data. No calculations beyond preserving original numbers are produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Original group MRI values and the comparative estimate together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Original group MRI values and the comparative estimate with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N10 · Are MRI, histological diagnosis and other liver markers the same outcome?

Current findings: Histological NAFLD identifies the population at enrollment; the primary result is change in MRI-PDFF liver fat from baseline to eight weeks. The preserved material does not provide quantitative results for other imaging or histological follow-up, other liver tests or long-term clinical events.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original material is needed to establish the actual measurements, time points and material-specific findings for histological follow-up and tests or imaging other than MRI. Unread material is not declared unreported.
Required materials and conditions: Distinction between diagnosis, imaging surrogates and clinical outcomes
Materials to obtain first: Original material is needed to establish the actual measurements, time points and material-specific findings for histological follow-up and tests or imaging other than MRI. Unread material is not declared unreported.
Further research: Materials needed: Original material is needed to establish the actual measurements, time points and material-specific findings for histological follow-up and tests or imaging other than MRI. Unread material is not declared unreported. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Distinction between diagnosis, imaging surrogates and clinical outcomes together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Distinction between diagnosis, imaging surrogates and clinical outcomes with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N11 · Was the prespecified primary endpoint a long-term event?

Current findings: The original evidence list records change in MRI-PDFF liver fat from baseline to eight weeks as a positive prespecified primary MRI endpoint. The selected long-term events were not measured directly. Long-term events are not newly labeled as coprimary, secondary or registered outcomes.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Endpoint definitions, time points and hierarchy in the original registration, protocol and SAP, and separate plans and findings for long-term event research. External material remains unread.
Required materials and conditions: Distinction between the prespecified MRI endpoint and long-term event plans
Materials to obtain first: Endpoint definitions, time points and hierarchy in the original registration, protocol and SAP, and separate plans and findings for long-term event research. External material remains unread.
Further research: Materials needed: Endpoint definitions, time points and hierarchy in the original registration, protocol and SAP, and separate plans and findings for long-term event research. External material remains unread. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Distinction between the prespecified MRI endpoint and long-term event plans together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Distinction between the prespecified MRI endpoint and long-term event plans with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N12 · Does the weight-adjusted sensitivity result establish long-term event benefits?

Current findings: The original text states that the intervention group lost more weight and that liver-fat findings remained favorable in a sensitivity analysis additionally adjusting for weight change. No separate sensitivity effect or CI, isolated free-sugar causal effect or long-term event effect is created.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Weight-adjusted models, estimates, uncertainty, covariate timing and direct comparative long-term event data. Adjustment wording does not certify that all confounding or concurrent changes were resolved.
Required materials and conditions: Scope of weight change and sensitivity analysis
Materials to obtain first: Weight-adjusted models, estimates, uncertainty, covariate timing and direct comparative long-term event data. Adjustment wording does not certify that all confounding or concurrent changes were resolved.
Further research: Materials needed: Weight-adjusted models, estimates, uncertainty, covariate timing and direct comparative long-term event data. Adjustment wording does not certify that all confounding or concurrent changes were resolved. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Scope of weight change and sensitivity analysis together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Scope of weight change and sensitivity analysis with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N13 · At which stage was masking applied?

Current findings: The original design is an open-label two-center randomized food-provision trial with masked MRI assessment. Masking of participants, intervention providers or long-term event adjudicators is not additionally claimed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original material on allocation concealment, MRI assessment, departures during the open-label intervention, assessment procedures and long-term event adjudication. No formal RoB assessment is produced.
Required materials and conditions: Open-label intervention and masked MRI assessment
Materials to obtain first: Original material on allocation concealment, MRI assessment, departures during the open-label intervention, assessment procedures and long-term event adjudication. No formal RoB assessment is produced.
Further research: Materials needed: Original material on allocation concealment, MRI assessment, departures during the open-label intervention, assessment procedures and long-term event adjudication. No formal RoB assessment is produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Open-label intervention and masked MRI assessment together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Open-label intervention and masked MRI assessment with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N14 · Have intervention intensity and population boundaries been lost?

Current findings: The original material explains that reducing the intervention to simple sugar-restriction advice or a fatty-liver cure erases its intensity and population. Short-term MRI findings are not extended into implementation evidence for long-term liver-disease management or everyday diets.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Direct comparisons by population, implementation intensity and sustainability, and long-term clinical outcomes. No diet, child or adolescent care or treatment-replacement instructions are provided.
Required materials and conditions: Application limited to the household food environment and adolescent boys
Materials to obtain first: Direct comparisons by population, implementation intensity and sustainability, and long-term clinical outcomes. No diet, child or adolescent care or treatment-replacement instructions are provided.
Further research: Materials needed: Direct comparisons by population, implementation intensity and sustainability, and long-term clinical outcomes. No diet, child or adolescent care or treatment-replacement instructions are provided. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Application limited to the household food environment and adolescent boys together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Application limited to the household food environment and adolescent boys with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N15 · What does the short-term adverse-event wording delimit?

Current findings: The original material records completion by all 40 participants and no reported study-related adverse events. It states that the trial did not assess long-term safety of restrictive diets during adolescence. This is not recast as zero harm of every kind or proof of long-term safety.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Adverse-event collection, group harm denominators and observation, event definitions, relatedness and discontinuation, and long-term follow-up during growth. No new harm counts, rates or management instructions are produced.
Required materials and conditions: Study-related adverse events and long-term safety during growth
Materials to obtain first: Adverse-event collection, group harm denominators and observation, event definitions, relatedness and discontinuation, and long-term follow-up during growth. No new harm counts, rates or management instructions are produced.
Further research: Materials needed: Adverse-event collection, group harm denominators and observation, event definitions, relatedness and discontinuation, and long-term follow-up during growth. No new harm counts, rates or management instructions are produced. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original material concerning Study-related adverse events and long-term safety during growth together with subclaim and parent boundaries, reporting and measurements, denominators and the scope of external material actually read.
Why this condition is needed: This connects Study-related adverse events and long-term safety during growth with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N16 · What materials were actually read in this work?

Current findings: The complete parent summary was read for production and preserved in its original form. Summary reading in material entries refers to the stored summary; external abstract, full text, registration, protocol and SAP were not read. The presence of a URL or PMCID is not promoted into external reading.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.
Required materials and conditions: Stored summary and access status of external material
Materials to obtain first: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing.
Further research: Material needed: Material for recording actual acquisition and reading scope, versions and dates of external material. No new link, click or access testing. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on stored summary and access status of external material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect stored summary and access status of external material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N17 · What does the registration number establish?

Current findings: The original evidence and citation lists contain NCT02513121. The identifier is retained; registration content, versions, timing, posted results and consistency with plans have not been newly read or verified. An official registration URL is not guessed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.
Required materials and conditions: Registration identifier in references and evidence versus actual registration reading
Materials to obtain first: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration.
Further research: Material needed: Actual registration versions, timelines, original plans and results, and report links. Unread external material is not converted into absence of registration. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on registration identifier in references and evidence versus actual registration reading, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This connects Registration identifier in references and evidence versus actual registration reading with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N18 · Were the protocol and SAP acquired?

Current findings: Specific protocol and SAP URLs, original text, versions and dates were not newly acquired or read. Parent statements about prespecified endpoints and historical cross-checking are retained as history and are not described as new content review.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.
Required materials and conditions: Separate entries for prespecified plans, amendments and analysis material
Materials to obtain first: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes.
Further research: Material needed: Original protocol, SAP, amendment history, disclosure timing, complete endpoints, models, denominators and missing-data plans. Material additions are distinguished from condition or verdict changes. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on separate entries for prespecified plans, amendments and analysis material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This connects Separate entries for prespecified plans, amendments and analysis material with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N19 · Are funding, support, authors and research involvement separated?

Current findings: Original funding is Nutrition Science Initiative plus foundation, academic and NIH support, which the parent text describes as independent funding. Company funding, food or product support, employee authorship and involvement in analysis or design have not been individually checked against original source material here. Absence of all four is not newly certified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification.
Required materials and conditions: Four categories of company involvement versus public and academic support
Materials to obtain first: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification.
Further research: Material needed: Separate original funding sources, food or device support, employee and executive authors, design, analysis and data control, and conflicts of interest. Original independence axes are not used as new independence certification. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on four categories of company involvement versus public and academic support, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This connects Four categories of company involvement versus public and academic support with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N20 · Are unmeasured outcomes, unverified details and null results distinguished?

Current findings: Long-term events not measured directly and unverified external details are distinct.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects.
Required materials and conditions: Reasons for question-specific result and access statuses
Materials to obtain first: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects.
Further research: Material needed: Material to establish direct measurement, original tables, analysis plans and material access. Unread material is not substituted for unreported findings, zero studies or zero effects. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on reasons for question-specific result and access statuses, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect reasons for question-specific result and access statuses with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N21 · Are reports, trials, people, measurements and related sheets separated?

Current findings: Parent verdict 2983 and the MRI and long-term-event sheets share the same Schwimmer2019 report and 40-person trial context. Reports, people, households, repeated measurements and time points are not added as new independent trials or participants. One linked report is not a certified count of unique trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.
Required materials and conditions: Reference linkage and meaning without double counting
Materials to obtain first: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded.
Further research: Material needed: Original study and report identity, shared cohorts and analyses, registration and follow-up, and duplication relationships. Unique trial counts and participant totals remain unrecorded. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on reference linkage and meaning without double counting, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect reference linkage and meaning without double counting with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N22 · Is there evidence of separate independent replication?

Current findings: Original parent replication and independence axes R1/I2 are preserved. Reusing citations and sibling sheets does not certify new independent replication of efficacy or harms.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication.
Required materials and conditions: Report identity versus independent confirmation
Materials to obtain first: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication.
Further research: Material needed: Reports with separate prespecified plans, populations, interventions and controls, direct endpoints, follow-up, effects and CIs, and funding and author relationships appropriate to the question. No new search or independence adjudication. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on report identity versus independent confirmation, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect report identity versus independent confirmation with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N23 · Are subclaim grades separated from parent scores and axes?

Current findings: The selected subclaim grade and note are preserved; absent score, status and axes remain unrecorded. Parent C with 54 points, safety and axes provide parent context. No new scores, grades or formal RoB2 or GRADE certification are produced.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.
Required materials and conditions: Selected-record absences versus the parent verdict
Materials to obtain first: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values.
Further research: Material needed: Review of the selected and parent meaning boundary, and actual correction material. Parent values do not fill missing subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on selected-record absences versus the parent verdict, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect selected-record absences versus the parent verdict with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N24 · Are Korean, English and classification scopes preserved as the same original record?

Current findings: The complete parent Korean and English texts, classification information, evidence and citations, and selected subclaim wording, grade and note are preserved in the complete stored summary. This is not a new comparison with the English original paper or another verdict.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof.
Required materials and conditions: Original Korean and English texts and structured fields
Materials to obtain first: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof.
Further research: Material needed: Material for review of differences in original languages, selected and parent claims, terminology, visits and measurement definitions. General wording is not extended into new clinical proof. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original Korean and English texts and structured fields, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This connects Original Korean and English texts and structured fields with the selected question, actual population, intervention and comparator, outcome and time point, effect of interest, denominators, follow-up, reporting and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N25 · Are reference dates, corrections and historical verification separated?

Current findings: The original reference date 2026-09-07, empty correction array and empty deliberation string are retained. Cross-checking in the historical verdict-decision record is original history, distinct from current production dates, condition-application times or completed content review.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified.
Required materials and conditions: Original reference date versus creation and application times
Materials to obtain first: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified.
Further research: Material needed: If new material or corrections arise, preserve original text and separate events, conditions and observations, and verdict decisions for review. Existing records are not retrospectively certified. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original reference date versus creation and application times, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect original reference date versus creation and application times with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N26 · What material would directly fill this gap?

Current findings: The short-term positive MRI findings are preserved, although long-term events were not observed directly. This direct evidence gap requires research on long-term clinical events and cannot be replaced by another surrogate.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Prespecified long-term liver-disease event definitions, actual observations and group denominators, follow-up and attrition, comparative effects and CIs, and long-term adolescent safety data.
Required materials and conditions: Question-specific direct comparisons, follow-up and denominator material
Materials to obtain first: Prespecified long-term liver-disease event definitions, actual observations and group denominators, follow-up and attrition, comparative effects and CIs, and long-term adolescent safety data.
Further research: Materials needed: Prespecified long-term liver-disease event definitions, actual observations and group denominators, follow-up and attrition, comparative effects and CIs, and long-term adolescent safety data. Only material requests and research needs are recorded; no search or research is conducted in this work.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on question-specific direct comparisons, follow-up and denominator material, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect question-specific direct comparisons, follow-up and denominator material with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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N27 · Is production separated from content review and implementation advice?

Current findings: This is a record of applied conditions based on a stored summary. Existing content and claim-boundary review is incomplete; candidate review-pending and production-eligibility indicators are retained as history. The original review status is recorded unchanged.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the stored summary that distinguishes selected and parent material and reports. Detailed original material is unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed.
Required materials and conditions: Production request and responsibility for review of existing content
Materials to obtain first: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed.
Further research: Material needed: Review of existing content and subsequent actual material and correction records. During the original production, clinical original-material comparisons, external reading, new calculations, grade changes, and device, diet or treatment implementation advice were not performed. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material is unread and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on production request and responsibility for review of existing content, together with the selected-subclaim and parent boundary, reports and measurements, denominators and external reading scope.
Why this condition is needed: This is needed to connect production request and responsibility for review of existing content with the selected question, actual population, intervention and control, endpoint and visit, effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish short-term MRI-PDFF, histological diagnosis at enrollment and other liver markers from long-term clinical events, alongside intervention intensity, population, comparator, weight and sensitivity analysis, denominators, follow-up, effects and harms. Only original numbers are preserved; no new calculations, hypothetical quantitative examples, effects, CIs, grades, regrading, independence certification or diet, device or treatment instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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