{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2955-s0", "verdict_number": "2955", "title": "Quercetin 500 mg daily × Reduced MRI liver fat over 12 weeks — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Single crossover trial in nonalcoholic fatty liver disease: 41 randomized and 36 completed. Detailed eligibility/baseline, sequence/period populations, MRI observations/denominators and exclusions/missingness are unverified. Do not sum two periods/measures from the same participants as independent trials/participants.", "intervention": "Quercetin 500 mg daily as the original study condition. Product/batch, raw material/formulation, actual adherence/stopping and concomitant exposure are unverified. Do not convert this to effects of other polyphenols/foods, products or doses, or create new intake/treatment instructions.", "dose": "Preserve the original design of 12 weeks of quercetin or placebo followed by crossover after a 4-week washout. Actual sequence/period-specific exposure/completion, carryover/return to baseline and visit windows are unverified. Do not sum/convert new total duration/exposure.", "comparator": "Randomized double-blind placebo-controlled crossover comparison. Placebo/sensory matching, sequence allocation/concealment, MRI-assessor/analyst masking, concomitant diet/activity and original crossover models/missingness/adherence are unverified. Do not inherit original design/ITT accounts as current procedural verification.", "endpoint": "Selected statistically positive 12-week MRI-PDFF intrahepatic-lipid surrogate. Preserve quercetin-period 11.5%±6.4 to 9.6%±5.8, the original approximate −1.9 percentage points, placebo-period change −0.1%±2.6, P=.013 and multiplicity-adjusted P=.028. Original %/%p wording is retained separately in the preserved original; do not create new changes/between-treatment differences, ratios/CIs or unit corrections. The type of ± quantity, within-person/period models, observed/ITT denominators and exact estimates are unverified. Distinguish the historical checking scope for between-treatment CIs and prespecified minimum MRI thresholds.", "duration": "The MRI primary outcome is at 12 weeks; distinguish the 4-week washout/crossover from actual measurement in each period. Post-treatment durability, overall long-term/clinical/harm outcomes are unverified. Do not calculate a new total follow-up duration from original periods.", "excluded_extensions": [ "New effect/change/response-rate/CI calculations or arbitrary %/%p corrections from MRI baseline/final values, placebo change, original approximate −1.9 percentage points/P values/± quantities and sample sizes", "Summing two crossover periods/the same participants as new independent trials/participants, or deriving hypothetical total duration/exposure from 12 weeks/4 weeks", "Filling an ITT account with unverified observed denominators, imputation models or an all-completer population", "Turning weight correlation and MRI benefit into confirmation of direct hepatic causation/separated mediation, or calculating new direct effects", "Reusing MRI/liver-enzyme/other secondary outcomes as improved cirrhosis/hospitalization/death, or exactly zero clinical effects/equivalence", "Inheriting historical CI/funding checking in abstracts/public tables/full text as current whole external-document reading/review", "Turning undisclosed manufacturer support, institutional affiliations/no-COI declarations and original I2 into absence of each support item/current independence verification", "Turning original safety non-reporting/nonsignificance and rare-harm limitations into zero harms or treatment-safety certification", "Creating currently absent clinical original reports/registration/follow-up materials or invented citations/values", "Inheriting parent scores/axes and historical cross-checking as subclaim scores/current review/external reading", "New calculations, hypothetical values, effects/CIs, grades, independence certification or product-intake/diet/activity/testing/treatment implementation guidance" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected 12-week MRI outcome and original values", "needed": "Selected existing question, grade/note, parent context and presence of score/status/axes", "role": "Required", "role_reason": "Distinguish Selected existing question, grade/note, parent context and presence of score/status/axes to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Selected existing question, grade/note, parent context and presence of score/status/axes requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Connect the original question to additional materials in proposed update research; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the subclaim C and statistically positive surrogate note for reduced MRI liver fat over 12 weeks. Parent C with 54 points and original axes are parent-verdict context.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. The subclaim lacks score, status and axes; do not fill them with parent values. Do not create a new grade/effect or certification of clinical outcomes. Content review remains incomplete.", "missingness": "The subclaim lacks score, status and axes; do not fill them with parent values. Do not create a new grade/effect or certification of clinical outcomes.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Data distinguishing the selected row from the original parent verdict" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Participants with nonalcoholic fatty liver disease", "needed": "Disease, recruitment/eligibility, baseline risk and arm/period characteristics", "role": "Required", "role_reason": "Distinguish Disease, recruitment/eligibility, baseline risk and arm/period characteristics to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Disease, recruitment/eligibility, baseline risk and arm/period characteristics requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on population conditions and applicability; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original population of 41 participants with nonalcoholic fatty liver disease. Do not generalize to all fatty liver/liver diseases or other populations.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Detailed eligibility, age/baseline liver fat, weight/metabolic/comorbid conditions and sequence-specific characteristics are unverified. Content review remains incomplete.", "missingness": "Detailed eligibility, age/baseline liver fat, weight/metabolic/comorbid conditions and sequence-specific characteristics are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/eligibility, baseline and sequence/period-specific participant data" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Quercetin 500 mg and formulation", "needed": "Specific study product, formulation/ingredients/batch and exposure", "role": "Required", "role_reason": "Distinguish Specific study product, formulation/ingredients/batch and exposure to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Specific study product, formulation/ingredients/batch and exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research distinguishing formulation from result attribution; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve quercetin 500 mg daily as the original study condition. Do not turn this into effects of every polyphenol/food or other products.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Raw material/manufacturing, product/batch, detailed composition, actual use/adherence and supply are unverified. Do not create intake instructions, conversions or product recommendations. Content review remains incomplete.", "missingness": "Raw material/manufacturing, product/batch, detailed composition, actual use/adherence and supply are unverified. Do not create intake instructions, conversions or product recommendations.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/batch, composition, supply and actual exposure data" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Placebo and crossover comparison", "needed": "Actual placebo, sensory matching and conditions in each period", "role": "Required", "role_reason": "Distinguish Actual placebo, sensory matching and conditions in each period to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual placebo, sensory matching and conditions in each period requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on comparator conditions and period-specific comparison definitions; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original randomized double-blind placebo-controlled crossover design. Do not use two periods from the same participants as independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Placebo identity/matching, sequence/period-specific exposure/adherence, concomitant conditions and actual deviations are unverified. Content review remains incomplete.", "missingness": "Placebo identity/matching, sequence/period-specific exposure/adherence, concomitant conditions and actual deviations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo/matching, period-specific exposure and adherence/deviation data" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "12 weeks and four-week washout", "needed": "Intervention/measurement periods, washout and actual sequence", "role": "Required", "role_reason": "Distinguish Intervention/measurement periods, washout and actual sequence to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Intervention/measurement periods, washout and actual sequence requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on time/carryover and observed results; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original account of 12 weeks of quercetin or placebo followed by crossover after a 4-week washout. Do not sum or convert a new total duration/exposure.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Individual period starts/completion, washout adherence, subsequent return to baseline, actual assessment windows and stopping are unverified. Content review remains incomplete.", "missingness": "Individual period starts/completion, washout adherence, subsequent return to baseline, actual assessment windows and stopping are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence/period, washout and individual exposure/measurement data" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomized sequence and concealment", "needed": "Crossover allocation sequence, generation/concealment and actual procedures", "role": "Required", "role_reason": "Distinguish Crossover allocation sequence, generation/concealment and actual procedures to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Crossover allocation sequence, generation/concealment and actual procedures requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 §8.1–8.2.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M08 §8.2.2, M15 §15.3.1; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on allocation and period-specific population relationships; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the randomized crossover trial and 41 randomized participants as recorded.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Sequence-specific denominators, generation/concealment, blocking/stratification, access/changes and actual implementation documents are unread. A design label alone does not certify absence of bias. Content review remains incomplete.", "missingness": "Sequence-specific denominators, generation/concealment, blocking/stratification, access/changes and actual implementation documents are unread. A design label alone does not certify absence of bias.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sequence-allocation, access/change and actual participant-flow data" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Masking and MRI assessment", "needed": "Role-specific masking, measurement/image assessment and analysis procedures", "role": "Required", "role_reason": "Distinguish Role-specific masking, measurement/image assessment and analysis procedures to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Role-specific masking, measurement/image assessment and analysis procedures requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M03 §3.2.4; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on measurement/assessment bias and MRI results; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the double-blind design.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Actual masking of participants/researchers, MRI measurement/readers and analysts, maintenance/unmasking and imaging/region-of-interest standards are unverified. Content review remains incomplete.", "missingness": "Actual masking of participants/researchers, MRI measurement/readers and analysts, maintenance/unmasking and imaging/region-of-interest standards are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Role-specific masking and MRI measurement/reading/analysis records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "MRI-PDFF and the 12-week measure", "needed": "Definition, units/measurement and timing of the intrahepatic-lipid measure", "role": "Required", "role_reason": "Distinguish Definition, units/measurement and timing of the intrahepatic-lipid measure to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Definition, units/measurement and timing of the intrahepatic-lipid measure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research distinguishing imaging measures from other outcomes; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes MRI-PDFF intrahepatic lipid as an imaging surrogate and the 12-week primary outcome. It is distinct from cirrhosis, hospitalization and death.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Measurement/regions of interest, actual visits/repeats, baseline/final/period-specific comparison definitions and arm-specific observations are unverified. Content review remains incomplete.", "missingness": "Measurement/regions of interest, actual visits/repeats, baseline/final/period-specific comparison definitions and arm-specific observations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original MRI measure, measurements/repeats and period/observation data" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Quercetin-period baseline and final values", "needed": "Periods/populations, dispersion and distinction from change in original MRI values", "role": "Required", "role_reason": "Distinguish Periods/populations, dispersion and distinction from change in original MRI values to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Periods/populations, dispersion and distinction from change in original MRI values requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on final values/change and period-specific analysis definitions; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve quercetin-period 11.5%±6.4 to 9.6%±5.8 exactly. The manuscript’s approximate −1.9 percentage points is an existing historical reported/explanatory value, not a calculation performed now.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Arm/sequence, period-baseline/final observations, the type of ± quantity, models/adjustment and individual values are unverified. Do not calculate new changes, response rates or CIs. Content review remains incomplete.", "missingness": "Arm/sequence, period-baseline/final observations, the type of ± quantity, models/adjustment and individual values are unverified. Do not calculate new changes, response rates or CIs.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific baseline/final, dispersion/observation and original-estimate data" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Placebo change and units", "needed": "Placebo-period change/final values, original units and estimands", "role": "Required", "role_reason": "Distinguish Placebo-period change/final values, original units and estimands to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Placebo-period change/final values, original units and estimands requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research distinguishing original estimands/units and comparison relationships; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original placebo-period change of −0.1%±2.6. Keep the Korean concise summary’s %p wording in the whole original summary; do not arbitrarily correct units or create new final values/between-treatment differences.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Placebo-period baseline/final values, exact change definitions/units, the type of ± quantity, observed denominators/models and period matching are unverified. Content review remains incomplete.", "missingness": "Placebo-period baseline/final values, exact change definitions/units, the type of ± quantity, observed denominators/models and period matching are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original placebo-period values/units, change/observations and analysis data" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "P=.013 and adjusted P=.028", "needed": "Original test for the selected comparison, multiplicity/models and precision", "role": "Required", "role_reason": "Distinguish Original test for the selected comparison, multiplicity/models and precision to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Original test for the selected comparison, multiplicity/models and precision requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on tests/multiplicity and uncertainty; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve between-treatment P=.013 and multiplicity-adjusted P=.028 exactly. Do not calculate/certify new risk ratios/response rates, exact effects/CIs or clinical success.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Period/sequence, within-person correlation, adjustment/multiplicity methods, test lists and original estimates/outputs are unread. Content review remains incomplete.", "missingness": "Period/sequence, within-person correlation, adjustment/multiplicity methods, test lists and original estimates/outputs are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analyses/SAP, models, multiplicity and exact-output data" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Between-treatment CI and historical checking scope", "needed": "Precision and abstract/public-table checking versus current reading scope", "role": "Required", "role_reason": "Distinguish Precision and abstract/public-table checking versus current reading scope to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Precision and abstract/public-table checking versus current reading scope requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose update research distinguishing precision data from materials actually read; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original statement that a between-treatment 95% CI was absent within the historically checked abstract/public-result-table scope. Only the preserved summary is read now; do not extend this to absence from the whole paper.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original estimates/outputs, whole text/supplements and current CI/analysis data are unread. Do not create a new CI from original ± values, P values or sample sizes. Content review remains incomplete.", "missingness": "Original estimates/outputs, whole text/supplements and current CI/analysis data are unread. Do not create a new CI from original ± values, P values or sample sizes.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper/supplements, exact outputs and between-treatment CI data" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Prespecified important MRI threshold", "needed": "Prespecified minimum clinically important difference and interpretation/success definitions", "role": "Required", "role_reason": "Distinguish Prespecified minimum clinically important difference and interpretation/success definitions to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Prespecified minimum clinically important difference and interpretation/success definitions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research distinguishing statistical results from important differences/clinical meaning; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original statement that no minimum clinically important MRI-PDFF reduction threshold was declared. Do not promote statistical positivity to long-term clinical outcomes or confirmatory success.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Prespecified criteria, power/plans, correspondence to clinical measures and exact estimates/CIs are unverified. Content review remains incomplete.", "missingness": "Prespecified criteria, power/plans, correspondence to clinical measures and exact estimates/CIs are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified plans, important differences/power and clinical-correspondence data" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "41 to 36: completion and analysis", "needed": "Randomized/completed participants, period-specific observations/analysis and missingness", "role": "Required", "role_reason": "Distinguish Randomized/completed participants, period-specific observations/analysis and missingness to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Randomized/completed participants, period-specific observations/analysis and missingness requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on selected populations and missing-data assumptions; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve 41 randomized and 36 completed exactly. Do not calculate/declare new missing counts/rates, summed periods or a completer-only ITT population.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Sequence/period-specific completion, endpoint observations, withdrawal/missingness reasons, actual analysis populations and sensitivity analyses are unverified. Content review remains incomplete.", "missingness": "Sequence/period-specific completion, endpoint observations, withdrawal/missingness reasons, actual analysis populations and sensitivity analyses are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence/period-specific flow, observation/missingness and analysis data" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "ITT and crossover model", "needed": "Actual ITT/allocation and period/sequence/within-person comparison definitions", "role": "Required", "role_reason": "Distinguish Actual ITT/allocation and period/sequence/within-person comparison definitions to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual ITT/allocation and period/sequence/within-person comparison definitions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research on allocation/period, missing-data assumptions and estimation; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original account that ITT results were reported. Do not fill this in as verified MRI observations/denominators in every period for all 41 participants or a particular imputation model.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. MRI ITT denominators, within-person correlation, period/sequence, missing-data models, sensitivity analyses and actual original analyses are unread. Content review remains incomplete.", "missingness": "MRI ITT denominators, within-person correlation, period/sequence, missing-data models, sensitivity analyses and actual original analyses are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT/crossover models and period-specific denominator/missingness/sensitivity data" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Washout, carryover and period effects", "needed": "Carryover/sequence, period-specific baselines and analytical handling", "role": "Required", "role_reason": "Distinguish Carryover/sequence, period-specific baselines and analytical handling to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Carryover/sequence, period-specific baselines and analytical handling requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research distinguishing carryover/period effects from same-participant outcomes; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original design of crossover after a 4-week washout. Do not treat the two periods as different participants or independent replication.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Return to baseline, carryover/sequence/period effects, tests/interactions, actual analyses and exposure adherence are unverified. Content review remains incomplete.", "missingness": "Return to baseline, carryover/sequence/period effects, tests/interactions, actual analyses and exposure adherence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period baselines, carryover/sequence handling and model/exposure data" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Weight change and correlation", "needed": "Separate weight/liver-fat measures and causal/mediation relationships", "role": "Required", "role_reason": "Distinguish Separate weight/liver-fat measures and causal/mediation relationships to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Separate weight/liver-fat measures and causal/mediation relationships requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.4; custom extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose follow-up research distinguishing weight/exposure from result attribution; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original weight change of −1.5±2.6 kg during quercetin versus −0.2±1.8 kg during placebo and its correlation with liver-fat reduction. Direct hepatic and weight-mediated effects were not separated.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Correlation estimates, timing/populations, models/mediation analyses, concomitant activity/diet and original individual data are unverified. Do not calculate a new direct hepatic effect. Content review remains incomplete.", "missingness": "Correlation estimates, timing/populations, models/mediation analyses, concomitant activity/diet and original individual data are unverified. Do not calculate a new direct hepatic effect.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual weight/fat trajectories, correlation/mediation models and concomitant exposure data" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Null liver-enzyme and other secondary outcomes", "needed": "Definitions/hierarchy of other endpoints, original results and the selected measure", "role": "Required", "role_reason": "Distinguish Definitions/hierarchy of other endpoints, original results and the selected measure to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Definitions/hierarchy of other endpoints, original results and the selected measure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research on other measures, discordance and uncertainty; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original account that liver enzymes and other secondary endpoints were not significant. Do not reuse MRI positivity as benefits for liver enzymes or every clinical outcome.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Each measure/time point, denominator, value/estimate/CI, multiplicity and hierarchy are unverified. Do not turn nonsignificance into an exactly zero effect or equivalence. Content review remains incomplete.", "missingness": "Each measure/time point, denominator, value/estimate/CI, multiplicity and hierarchy are unverified. Do not turn nonsignificance into an exactly zero effect or equivalence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans/measurements, values/estimates and CIs for each secondary measure" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Concomitant exposure, adherence and subsequent care", "needed": "Arm/period-specific activity/diet, drugs/products and actual exposure", "role": "Required", "role_reason": "Distinguish Arm/period-specific activity/diet, drugs/products and actual exposure to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Arm/period-specific activity/diet, drugs/products and actual exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research on concomitant exposure and result attribution; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original scope of the specific quercetin/placebo crossover.", "condition_status": "Unverified", "status_reason": "Information currently needed is unverified in the preserved summary. Diet/activity, weight management, drugs/supplements, actual intake/stopping/crossover and exposure in each period are unverified. Do not create new weight/diet/exercise, treatment or intake instructions. Content review remains incomplete.", "missingness": "Diet/activity, weight management, drugs/supplements, actual intake/stopping/crossover and exposure in each period are unverified. Do not create new weight/diet/exercise, treatment or intake instructions.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific concomitant exposure, adherence/changes and weight/management records" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "ChiCTR and prespecified plans", "needed": "Registration identity, plans/changes and correspondence to reports", "role": "Required", "role_reason": "Distinguish Registration identity, plans/changes and correspondence to reports to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Registration identity, plans/changes and correspondence to reports requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research connecting prespecified plans to result reporting; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original registration-field value ChiCTR2100047904. A registration number alone does not verify prespecification, original plans or CIs/criteria now.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Registration history, protocol/SAP, recruitment/measurement/analysis timing, multiplicity and amendments are unread. Content review remains incomplete.", "missingness": "Registration history, protocol/SAP, recruitment/measurement/analysis timing, multiplicity and amendments are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol/SAP and report/amendment data" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Funding-agency names and unverified scope", "needed": "Funders, roles and the scope of the public text", "role": "Required", "role_reason": "Distinguish Funders, roles and the scope of the public text to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Funders, roles and the scope of the public text requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose update research on historical checking scope and current materials; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original funding/Korean-English account that a separate joint funding-agency name was not identified in the public text. Do not turn this into no funding or independence certification.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Actual providers/contracts, research/analysis/writing/publication roles and complete disclosures are unread now. Content review remains incomplete.", "missingness": "Actual providers/contracts, research/analysis/writing/publication roles and complete disclosures are unread now.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding contracts, providers/roles and original disclosures for each support item" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Manufacturer, product and analysis disclosures", "needed": "Individual records of commercial funding/products and analysis/writing/publication support", "role": "Required", "role_reason": "Distinguish Individual records of commercial funding/products and analysis/writing/publication support to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Individual records of commercial funding/products and analysis/writing/publication support requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research distinguishing gaps in individual disclosures/support; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account states that commercial-manufacturer funding, free products and outsourced analysis were not disclosed in the public text. Do not convert non-disclosure into no support or verification of all independence.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Manufacturing/supply, individual support, writing/publication fees and actual complete original disclosures are unread. Content review remains incomplete.", "missingness": "Manufacturing/supply, individual support, writing/publication fees and actual complete original disclosures are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/support, manufacturing/contribution and original writing/publication disclosures" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Institutional affiliations and COI declarations", "needed": "Distinguish author affiliations/employment from contributions/interests", "role": "Required", "role_reason": "Distinguish Distinguish author affiliations/employment from contributions/interests to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinguish author affiliations/employment from contributions/interests requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research on declarations and author/institutional roles; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original account of Army Medical University/Xinqiao Hospital affiliations and a no-competing-interests declaration. Institutional affiliation does not certify funding or current independence.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Staff/contributions, timing of relationships/employment, equity/other COIs and detailed disclosures are unread. Content review remains incomplete.", "missingness": "Staff/contributions, timing of relationships/employment, equity/other COIs and detailed disclosures are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author-specific affiliation/employment, contribution and original COI disclosures" }, { "item_id": "N24", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Safety measures and rare harms", "needed": "Harm collection/definitions, populations/periods and original reporting scope", "role": "Supplementary", "role_reason": "Distinguish Harm collection/definitions, populations/periods and original reporting scope to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Supplement gaps in safety materials for the selected subclaim. Do not judge safety from MRI/clinical results or parent safety wording, or create harm-incidence estimates/new use instructions.", "criterion": "Harm collection/definitions, populations/periods and original reporting scope requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research on harm-reporting scope and rare/long-term outcomes; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Preserve the original account that significant between-treatment differences in routine blood and other safety measures and intervention-related adverse events were not reported, together with the limitation that 41 participants are too few to evaluate rare harms.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Arm/period-specific harm denominators/events, collection/stopping/relatedness/missingness and long-term/vulnerable populations are unverified. Do not turn non-reporting/nonsignificance into zero harms or safety certification. Content review remains incomplete.", "missingness": "Arm/period-specific harm denominators/events, collection/stopping/relatedness/missingness and long-term/vulnerable populations are unverified. Do not turn non-reporting/nonsignificance into zero harms or safety certification.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm collection, arm-specific denominators/events and stopping/follow-up data" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Relationships within the same trial across periods/reports", "needed": "Distinguish reports/trials/participants, crossover/measures and independent replication", "role": "Required", "role_reason": "Distinguish Distinguish reports/trials/participants, crossover/measures and independent replication to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinguish reports/trials/participants, crossover/measures and independent replication requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research on same-data/period relationships and separate replication; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Do not sum the single Li 2024/ChiCTR trial, 41 participants/36 completers, two periods/measurement times or MRI/weight/liver enzymes/sibling sheets as new independent trials/participants. Original R1/I2 are historical axes.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. External correspondence of same-participant periods/endpoints, unique populations/follow-up reports and independent replication under matching conditions has not been checked. Do not invent follow-up reports. Content review remains incomplete.", "missingness": "External correspondence of same-participant periods/endpoints, unique populations/follow-up reports and independent replication under matching conditions has not been checked. Do not invent follow-up reports.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/registration/participant, period/endpoint/report relationships and separate evidence" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Clinical outcomes and other formulations/durations", "needed": "Distinguish selected MRI results from actual clinical outcomes/outside populations", "role": "Required", "role_reason": "Distinguish Distinguish selected MRI results from actual clinical outcomes/outside populations to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinguish selected MRI results from actual clinical outcomes/outside populations requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M03 §3.2.4; custom extension boundary; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose research distinguishing imaging from clinical outcomes and selected conditions; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "MRI positivity is not evidence of improved cirrhosis, hospitalization or death. Do not extend the specific 500 mg/12-week result to every polyphenol or other formulations/populations/long-term effects.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Direct clinical outcomes, post-treatment durability, other doses/populations/periods and harms are unverified. Do not create treatment/intake methods. Content review remains incomplete.", "missingness": "Direct clinical outcomes, post-treatment durability, other doses/populations/periods and harms are unverified. Do not create treatment/intake methods.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional clinical-endpoint, formulation/population and long-term follow-up materials" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Original axes, Korean/English text, dates and corrections", "needed": "Distinguish subclaim/parent values, original evidence date/corrections and history", "role": "Required", "role_reason": "Distinguish Distinguish subclaim/parent values, original evidence date/corrections and history to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Distinguish subclaim/parent values, original evidence date/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose update research on source-material changes and production versions; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The whole preserved summary retains subclaim C/note, parent C with 54 points/Good, B/S/R1/I2/E+/B1, unrecorded precision, three false flags, empty override reasons, Korean/English text, 2026-08-26 and empty corrections/deliberation.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Historical cross-check/abstract/public-table/full-text checking accounts are not current external reading/review or newly fulfilled conditions. Do not fill absent subclaim score/status/axes or absent parent classification keys. Content review remains incomplete.", "missingness": "Historical cross-check/abstract/public-table/full-text checking accounts are not current external reading/review or newly fulfilled conditions. Do not fill absent subclaim score/status/axes or absent parent classification keys.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict/corrections, amended manuscripts and human comments" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Summary reading and externally unread materials", "needed": "Actual reading for each material, citations/URLs and gaps in additional materials", "role": "Required", "role_reason": "Distinguish Actual reading for each material, citations/URLs and gaps in additional materials to connect materials needed for the selected question with the current materials in this production item.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Actual reading for each material, citations/URLs and gaps in additional materials requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The preserved summary was read for production, and the Li 2024/PMID 39032786 citation/URL is linked. Paper/registration/protocol/SAP/disclosures remain unread, with no access attempted.", "condition_status": "Partly verified", "status_reason": "Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original URLs/registration and historical accounts do not raise current acquisition/reading/review status; external links/clicks have not been checked. Content review remains incomplete.", "missingness": "Original URLs/registration and historical accounts do not raise current acquisition/reading/review status; external links/clicks have not been checked.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports/registration/plans/disclosures and human comments" } ], "reports": [ { "report_id": "S01", "title": "Li N et al. 2024", "url": "https://pubmed.ncbi.nlm.nih.gov/39032786/", "report_type": "Randomized double-blind placebo-controlled crossover trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2955-LI-2024", "independent_replication": null, "observed_result": "11.5%±6.4 to 9.6%±5.8 versus placebo change −0.1%±2.6; P=0.013, adjusted P=0.028. Original grade C with 54 points: in the 41-participant double-blind crossover trial, quercetin-period liver fat changed from 11.5%±6.4 to 9.6%±5.8, an approximate 1.9-percentage-point reduction, versus placebo change −0.1%±2.6; between-treatment P=0.013 and multiplicity-adjusted P=0.028. The original approximate −1.9 percentage points already appears in the preserved manuscript as a historical reported/explanatory value, not a new calculation. Distinguish original absence of a CI/minimum important threshold, period/unit/weight-mediation gaps and currently unread external materials.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39032786/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "Existing content review remains incomplete.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Li 2024/ChiCTR2100047904 is a single double-blind placebo-controlled crossover trial in nonalcoholic fatty liver disease, with 41 randomized and 36 completed. Distinguish original quercetin 500 mg/day, 12-week intervention and crossover after a 4-week washout from unverified actual sequence/period/exposure and ITT/observation/missing-data models. Quercetin-period MRI 11.5%±6.4 to 9.6%±5.8, original approximate −1.9 percentage points, placebo change −0.1%±2.6, P=.013 and adjusted P=.028 are original surrogate results, not new calculations. Do not arbitrarily correct %/%p wording; retain gaps in the type of ± quantity, between-treatment CI/important difference and original period/within-person estimates. Weight changes −1.5±2.6 kg versus −0.2±1.8 kg, correlation with MRI reduction/unseparated direct hepatic effects, nonsignificant liver enzymes/other secondary outcomes and untested clinical cirrhosis/hospitalization/death are distinct outcomes. Do not sum the same participants/arms, crossover periods, MRI/weight/liver enzymes, citations or sibling sheets as new independent trials/participants. Do not create follow-up reports/clinical effects or inherit original R1/I2 and historical abstract/public-table/full-text checking accounts as current review/external reading. Report/material-slot counts are not unique clinical trial/participant/independent-replication totals; no new sums or independence certification are performed." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-12" }