{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3069-main", "verdict_number": "3069", "title": "Berberine hydrochloride plus lifestyle intervention × Reduction of ¹H-MRS liver fat in adults with NAFLD", "view_version": "1.0", "view_created_date": "2026-10-27", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, "claim_context": { "population": "Adults with NAFLD. Detailed diagnosis, eligibility, diabetes composition, disease stage, concomitant medicines and baseline liver fat in S1 remain unverified. They are not assumed identical to the diabetes-free obese MASLD population in S2.", "intervention": "Oral berberine hydrochloride tablets with standardized lifestyle intervention. Botanical source, product purity, batch, manufacturing specifications and actual lifestyle implementation remain unverified. Extracts, combination products, other derivatives and topical products are not interchangeable.", "dose": "The nominal S1 dose is 500 mg 3 times daily (1.5 g/day). Actual intake, adherence, changes and discontinuation remain unverified. It is not a direct dose comparison with 1 g/day in S2 or an instruction for personal use.", "comparator": "The selected S1 comparator is lifestyle intervention alone. The overall study is a 3-arm open-label randomized parallel trial; specifications of the other arm, common management and rescue treatment remain unverified. Distinguish the double-blind placebo comparator in S2.", "endpoint": "Relative change in 16-week ¹H-MRS liver fat. Retain reductions of 52.7% versus 36.4% and P=.008 without converting them into a percentage-point difference. Distinguish the original statement that the registry endpoint was secondary from the currently unread registration and analysis plan.", "duration": "S1 has a nominal duration of 16 weeks. Individual actual exposure, assessment windows, post-discontinuation measurements and persistence remain unverified. The 6 months in S2 belong to a trial under different conditions, not extension follow-up of the same participants.", "excluded_extensions": [ "Original C, 50 points, Warning and B/S/R0/I2/EX/B2/CX are retained. Checklist statuses are not new efficacy scores or clinical certification.", "S1 records 184 randomized participants and completion counts of 53/47/55. Arm assignment of those completion counts, actual 16-week analysis counts, dispersion, and the exact between-arm effect and CI remain unverified. No new sums, attrition rates, effects or intervals are calculated.", "The original verdict describes S1 liver fat as secondary in the registry. It is not converted into prespecified primary-endpoint E+ success, and current direct comparison of the original registration, protocol and SAP is not claimed.", "S2 is a different comparison: 337 participants, diabetes-free obese MASLD, 1 g/day, placebo, 6 months and MRI liver fat. Retain the original between-group 0.9 percentage points, 97.5% CI −0.4~2.1 and the reported lack of benefit. This is not converted into proof of 0 effect, equivalence or failure of the exact S1 comparison.", "S1 and S2 differ in dose, population, comparator, duration and measurement. They are not merged into direct dose-response evidence, an interaction by diabetes status, long-term persistence or independent replication of the exact question, and participant counts are not added.", "Weight, HOMA-IR, lipids, liver enzymes, MRI-PDFF, histologic recovery and cirrhosis prevention are distinguished from the selected liver-fat question. The result is not extended to benefit in every person with MASLD or to personal safety.", "Retain the original warning about gastrointestinal adverse effects, hypoglycemia/interactions in liver disease or diabetes-medicine use, and pregnancy, lactation and infants. Event counts, safety denominators, exposure time, causation and long-term/rare harms remain unverified.", "Retain the distinction between the 2026-09-14 record of wording correction in 2 English fields and the generic English descriptions still present. New reader English corresponds to retained Korean content and is not presented as new clinical verification or a new verdict." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which liver-fat question is being checked?", "needed": "The current original claim, formulation, population, comparator, measurement and timing", "role": "Required", "role_reason": "The claim boundary must be fixed to avoid mixing results from other MASLD trials.", "application_exception": "Cirrhosis prevention or histologic recovery is not imposed as a requirement for the 16-week liver-fat question.", "criterion": "Link the original claim unchanged and identify 1.5 g/day plus lifestyle, 16 weeks, relative ¹H-MRS change and the lifestyle comparator.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "If the question changes, review different interventions, comparators and endpoints as separate comparisons.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original claim is reduction of ¹H-MRS liver fat in adults with NAFLD. The selected scope is the 16-week comparison of berberine hydrochloride plus lifestyle intervention.", "condition_status": "Met", "status_reason": "This checks the question boundary in the retained text. Clinical sufficiency and full-text verification are separate.", "missingness": "This checks the question boundary in the retained text. Clinical sufficiency and full-text verification are separate.", "uncertainty": "This checks the question boundary in the retained text. Clinical sufficiency and full-text verification are separate.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The complete current text and claim identity" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Do the actual product and salt form match?", "needed": "Hydrochloride tablets, product specifications, purity, batch, manufacturing and botanical source", "role": "Required", "role_reason": "An ingredient name alone does not make different extracts, derivatives or combination products the same intervention.", "application_exception": "The berberine description in S2 does not automatically fill in the exact product or salt form in S1.", "criterion": "Link tablet specifications, manufacturing and composition/batch records for each trial to establish whether they match the selected intervention.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Distinguish product variants and do not treat an unverified product as interchangeable.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records purified berberine hydrochloride tablets plus standardized lifestyle intervention. The botanical source is unverified. S2 product details are not established in the retained summary.", "condition_status": "Partly verified", "status_reason": "Exact specifications, purity, batch and manufacturing records are absent, and whether the product matches S2 is unknown.", "missingness": "Exact specifications, purity, batch and manufacturing records are absent, and whether the product matches S2 is unknown.", "uncertainty": "Exact specifications, purity, batch and manufacturing records are absent, and whether the product matches S2 is unknown.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods, product supplements and supply records for each trial" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What are the nominal dose and actual intake?", "needed": "Nominal 500 mg TID, actual intake, adherence, discontinuation and exposure", "role": "Required", "role_reason": "Differences between prescribed dose and actual exposure affect interpretation of the effect of interest and harms.", "application_exception": "The 1 g/day in S2 is not used as actual intake or a dose-reduction record for S1.", "criterion": "Link the nominal schedule to actual arm-specific intake/adherence, changes and discontinuation to assess actual exposure.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain actual dosing/change information relevant to the effect of interest and do not combine it with other doses.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The nominal S1 dose is 500 mg 3 times daily (1.5 g/day), while S2 describes 1 g/day under different conditions.", "condition_status": "Partly verified", "status_reason": "Actual S1 intake, adherence criteria, arm-specific changes, rescue treatment and their analysis handling remain unverified.", "missingness": "Actual S1 intake, adherence criteria, arm-specific changes, rescue treatment and their analysis handling remain unverified.", "uncertainty": "Actual S1 intake, adherence criteria, arm-specific changes, rescue treatment and their analysis handling remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing/return records, arm-specific adherence and discontinuation tables, and the analysis plan" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adults with NAFLD were selected?", "needed": "Diagnosis, eligibility/exclusions, age, baseline liver fat, diabetes composition and concomitant medicines", "role": "Required", "role_reason": "The labels NAFLD and diabetes-free obese MASLD alone do not establish identical populations.", "application_exception": "The diabetes-free obese eligibility in S2 is not retrospectively assigned to S1.", "criterion": "Check S1 diagnosis, eligibility and baseline state/diabetes composition to explain matches and differences from the selected population.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Limit interpretation to populations with direct material; application to other populations is a separate question.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 concerns adults with NAFLD and retains an unverified note that detailed diabetes composition depends on the paper. S2 concerns a different population: diabetes-free obese adults with MASLD.", "condition_status": "Partly verified", "status_reason": "Detailed S1 diagnosis, diabetes proportion, disease stage, concomitant medicines and baseline state cannot be established from the retained summary.", "missingness": "Detailed S1 diagnosis, diabetes proportion, disease stage, concomitant medicines and baseline state cannot be established from the retained summary.", "uncertainty": "Detailed S1 diagnosis, diabetes proportion, disease stage, concomitant medicines and baseline state cannot be established from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility criteria, baseline characteristics and comorbidity/medicine tables" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What was the actual comparator strategy?", "needed": "Lifestyle alone, medicines/management in each of the 3 arms, and the S2 placebo", "role": "Required", "role_reason": "Different comparator contents change the question answered by a between-arm difference.", "application_exception": "The open-label lifestyle comparator is not converted into a blinded placebo comparator.", "criterion": "Check whether actual S1 arm contents, the selected lifestyle comparator and rescue/common management correspond to original material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Specify the complete comparator and interpret trials with different common management separately.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected S1 comparator is lifestyle intervention alone. The overall design is a 3-arm open-label randomized parallel trial. S2 is a double-blind placebo trial.", "condition_status": "Partly verified", "status_reason": "The summary lacks details of the remaining S1 arm specifications, management, common medicines and arm-specific changes.", "missingness": "The summary lacks details of the remaining S1 arm specifications, management, common medicines and arm-specific changes.", "uncertainty": "The summary lacks details of the remaining S1 arm specifications, management, common medicines and arm-specific changes.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific treatments/management and rescue-treatment criteria in the methods" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How was background lifestyle intervention applied in each arm?", "needed": "Diet, activity, visits, education, support, actual implementation and differences", "role": "Required", "role_reason": "In an add-on comparison, differences in lifestyle implementation cannot be merged into the selected drug contribution.", "application_exception": "Identical behavioral change is not imposed, but actual arm differences and their handling must be checked.", "criterion": "Check lifestyle contents, implementation/changes and analysis implications in both arms to interpret the added-drug difference.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Observe common management and actual implementation and analyze them in relation to the add-on effect of interest.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records comparison of added berberine with lifestyle intervention alone against a background of standardized lifestyle intervention.", "condition_status": "Unverified", "status_reason": "The current summary lacks details of diet/activity prescriptions, actual implementation, counseling, rescue treatment and arm differences.", "missingness": "The current summary lacks details of diet/activity prescriptions, actual implementation, counseling, rescue treatment and arm differences.", "uncertainty": "The current summary lacks details of diet/activity prescriptions, actual implementation, counseling, rescue treatment and arm differences.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Lifestyle protocol, arm-specific implementation/change records and analysis plan" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Do the 16-week treatment and observation periods match?", "needed": "Start, actual treatment, 16-week assessment, discontinuation and follow-up schedule", "role": "Required", "role_reason": "Nominal treatment duration cannot be converted into actual exposure or every participant’s observation time.", "application_exception": "The 6 months in S2 are not counted as extension follow-up for S1.", "criterion": "Check S1 treatment, assessment, discontinuation and missingness timing and link it to the 16-week result.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain differences between the specified outcome time and actual observation; persistence requires separate follow-up.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records 16 weeks. The 6-month MRI result in S2 is a report under different conditions.", "condition_status": "Partly verified", "status_reason": "Individual S1 exposure, assessment windows, early discontinuation and measurements after discontinuation remain unverified.", "missingness": "Individual S1 exposure, assessment windows, early discontinuation and measurements after discontinuation remain unverified.", "uncertainty": "Individual S1 exposure, assessment windows, early discontinuation and measurements after discontinuation remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial schedule, visit/discontinuation tables and assessment-time records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which test measured liver fat?", "needed": "¹H-MRS equipment, acquisition, region, quality control and test timing", "role": "Required", "role_reason": "A matching test name alone does not establish measurement conditions or bias.", "application_exception": "S1 ¹H-MRS is not replaced by MRI-PDFF, and the detailed MRI technique in S2 is not inferred.", "criterion": "Check test protocol, assessment region, quality control and identical arm-specific measurement to interpret the selected result.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Match measurement methods and conditions; do not substitute different technologies as an identical measure.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records relative change in 16-week ¹H-MRS hepatic fat content. The retained description distinguishes it from MRI-PDFF. S2 concerns 6-month MRI liver fat.", "condition_status": "Partly verified", "status_reason": "Equipment, acquisition/region, reading/quality control and detailed S2 MRI technique are absent from the summary.", "missingness": "Equipment, acquisition/region, reading/quality control and detailed S2 MRI technique are absent from the summary.", "uncertainty": "Equipment, acquisition/region, reading/quality control and detailed S2 MRI technique are absent from the summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocols for each test and reading/quality-control supplements" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Can relative reduction be distinguished from percentage points?", "needed": "Baseline/final liver fat, relative-change definition, dispersion and between-arm estimate units", "role": "Required", "role_reason": "Numbers under different units and times must not be read as the same effect.", "application_exception": "52.7%/36.4% are not converted into percentage points, and no new difference against S2 is calculated.", "criterion": "Check each result’s measure, reference value, direction, unit and actual between-arm estimate/interval to explain whether they match.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain original units and do not convert, add or generate new effects without original data.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records liver-fat reductions of 52.7% versus 36.4% and P=.008. S2 records a between-group 0.9 percentage points and 97.5% CI −0.4~2.1 under different measures and conditions.", "condition_status": "Partly verified", "status_reason": "S1 baseline values, original definitions, dispersion and the exact between-arm estimate/CI are absent; the values cannot be compared as the same unit.", "missingness": "S1 baseline values, original definitions, dispersion and the exact between-arm estimate/CI are absent; the values cannot be compared as the same unit.", "uncertainty": "S1 baseline values, original definitions, dispersion and the exact between-arm estimate/CI are absent; the values cannot be compared as the same unit.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Result tables, measure definitions, baseline/final values, dispersion and between-arm estimates" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What was the planned hierarchy of the selected liver-fat endpoint?", "needed": "Primary/secondary status and change times in the initial registration, protocol and SAP", "role": "Required", "role_reason": "A principal-outcome label and prespecified primary designation are different information.", "application_exception": "Failure to read the registry currently does not establish nonregistration or selective reporting.", "criterion": "Check liver-fat hierarchy, change timing and reasons in relevant registration/plan versions and compare them with actual reporting.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain the original endpoint-hierarchy description; distinguish changes from added evidence after actual version comparison.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The claim conditions label 16-week liver fat as the principal endpoint, but the original reader answer/grade rationale record that it was secondary in the registry.", "condition_status": "Partly verified", "status_reason": "The initial registration, protocol and SAP were not read currently, so the original locations for hierarchy and changes were not compared.", "missingness": "The initial registration, protocol and SAP were not read currently, so the original locations for hierarchy and changes were not compared.", "uncertainty": "The initial registration, protocol and SAP were not read currently, so the original locations for hierarchy and changes were not compared.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial/amended registrations, protocol, SAP and reported-endpoint table" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were planned analyses/times compared with actual reporting?", "needed": "Planned analysis populations, missing-data handling, adjustment, timing and reasons for changes", "role": "Required", "role_reason": "Having seen a result does not establish agreement with the planned analysis.", "application_exception": "A historical registration-comparison statement in the public text is not promoted to current SAP reading.", "criterion": "Compare planned and actual analysis, timing and population for the selected result using original versions, retaining differences and reasons for changes.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Link material that permits planned-versus-reported comparison; lack of comparison does not establish selective reporting.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original research-review field states that the NCT00633282 paper/registration were compared with the NCT05647915 trial.", "condition_status": "Unverified", "status_reason": "Only the retained summary was read currently; direct plan/registration items and analysis-change tables are absent.", "missingness": "Only the retained summary was read currently; direct plan/registration items and analysis-change tables are absent.", "uncertainty": "Only the retained summary was read currently; direct plan/registration items and analysis-change tables are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Plan/SAP, registration history and actual-analysis sections in the paper" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What was the randomized design?", "needed": "3-arm parallel randomization, allocation ratio, sequence generation and recruitment/allocation timing", "role": "Required", "role_reason": "A randomized label alone does not verify the actual allocation process.", "application_exception": "Unverified design is not replaced by nonapplicability of crossover/cluster designs.", "criterion": "Check the actual design, random sequence/allocation ratio and implementation for the selected comparison to explain confounding limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Check actual allocation and implementation; a label alone does not establish absence of bias.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 is recorded as a 3-arm open-label randomized parallel trial.", "condition_status": "Partly verified", "status_reason": "Allocation ratio, sequence generation, implementation responsibilities and allocation after recruitment are absent from the retained summary.", "missingness": "Allocation ratio, sequence generation, implementation responsibilities and allocation after recruitment are absent from the retained summary.", "uncertainty": "Allocation ratio, sequence generation, implementation responsibilities and allocation after recruitment are absent from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial methods, randomization/allocation supplements and protocol" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Was allocation concealed?", "needed": "Allocation-concealment method, predictability and enrollment/allocation responsibilities", "role": "Required", "role_reason": "Open-label treatment and allocation concealment are different procedures that require separate checks.", "application_exception": "An open-label design alone does not establish allocation-concealment failure.", "criterion": "Check who could see the sequence before allocation and the evidence of actual concealment implementation.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Check actual allocation procedures relevant to selection bias; do not describe an unverified item as established failure.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 retains only the design label of open-label randomization.", "condition_status": "Unverified", "status_reason": "Direct methods concerning concealment, role separation and predictability are absent.", "missingness": "Direct methods concerning concealment, role separation and predictability are absent.", "uncertainty": "Direct methods concerning concealment, role separation and predictability are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation-concealment methods, implementation records and protocol" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How were assessor blinding and arm-specific measurements handled?", "needed": "Blinded reading, identical tests, measurement/exclusion decisions and missingness", "role": "Required", "role_reason": "Objective tests can still be affected by acquisition, reading and exclusion decisions.", "application_exception": "Participant open-label information does not automatically determine assessor-blinding status.", "criterion": "Check assessor access to information and arm-specific differences in testing, reading and quality control to explain measurement limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Assess limitations according to observed measurement conditions; inability to blind does not automatically establish efficacy failure.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records open-label treatment and liver-fat measurement by ¹H-MRS.", "condition_status": "Unverified", "status_reason": "Assessor blinding, identical arm-specific measurement and test-quality exclusion criteria cannot be established from the summary.", "missingness": "Assessor blinding, identical arm-specific measurement and test-quality exclusion criteria cannot be established from the summary.", "uncertainty": "Assessor blinding, identical arm-specific measurement and test-quality exclusion criteria cannot be established from the summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reading/acquisition protocols, blinding explanations and test-exclusion tables" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Were baseline states balanced in the selected comparison?", "needed": "Arm-specific liver fat, diabetes/weight, medicines, sex and baseline risk", "role": "Required", "role_reason": "The results of selection and allocation are needed to interpret actual between-arm differences.", "application_exception": "S2 population composition is not evidence of baseline balance in S1.", "criterion": "Check arm-specific baseline tables, selection processes and relevant adjustments to explain important differences.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Check analysis information relevant to the direct population and arm-specific baseline differences.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 concerns adults with NAFLD, but detailed diabetes composition remains unverified.", "condition_status": "Unverified", "status_reason": "Arm-specific baseline liver fat, diabetes/weight, concomitant medicines, balance and adjustment information are absent.", "missingness": "Arm-specific baseline liver fat, diabetes/weight, concomitant medicines, balance and adjustment information are absent.", "uncertainty": "Arm-specific baseline liver fat, diabetes/weight, concomitant medicines, balance and adjustment information are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline characteristics, selection flow and adjustment model" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What were the randomized, completed and analyzed counts in each arm?", "needed": "Arm-specific randomized n, 16-week measured n, completed n and n for each analysis", "role": "Required", "role_reason": "Using 184 or completion counts as the selected effect’s analysis denominator would introduce error.", "application_exception": "Completion counts of 53/47/55 are not assigned to arms, summed or used to calculate new attrition rates.", "criterion": "Link randomized, measured, completed and analyzed counts for the selected arms and the overall 3 arms to actual flow/result tables.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Directly check denominator type and arm attribution; do not infer unreported denominators.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 retains records of 184 randomized participants and completion counts of 53/47/55.", "condition_status": "Partly verified", "status_reason": "The summary lacks completion-count arm assignment and actual 16-week analysis n, so denominators cannot be established.", "missingness": "The summary lacks completion-count arm assignment and actual 16-week analysis n, so denominators cannot be established.", "uncertainty": "The summary lacks completion-count arm assignment and actual 16-week analysis n, so denominators cannot be established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "CONSORT flow and arm-specific randomized/measured/completed/analyzed tables" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How were missingness, attrition and outcome measurement handled?", "needed": "Reasons/timing for missingness and attrition, arm differences, missing-data handling and sensitivity analyses", "role": "Required", "role_reason": "Analysis attrition can affect interpretation of both actual effects and harms.", "application_exception": "Completion tables alone do not establish attrition causes, adverse-event discontinuations or random missingness.", "criterion": "Check arm-specific missingness/attrition, liver-fat measurement, handling models and sensitivity analyses to explain limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Check missing-data handling and interpretation for the effect of interest; do not calculate new effects from attrition counts.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original reader answer identifies analysis-attrition limitations, and the S1 evidence-weight description identifies open-label treatment and attrition.", "condition_status": "Partly verified", "status_reason": "Arms, timing, reasons, missing-data handling and outcome implications of missingness/attrition are unverified.", "missingness": "Arms, timing, reasons, missing-data handling and outcome implications of missingness/attrition are unverified.", "uncertainty": "Arms, timing, reasons, missing-data handling and outcome implications of missingness/attrition are unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reasons for attrition/missingness, measurement status and missing-data/sensitivity analyses" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which analysis population and model produced the reported effect?", "needed": "ITT/PP/completers, between-arm change, adjustment, model and effect of interest", "role": "Required", "role_reason": "It is necessary to know whether arm-specific relative reductions estimate assignment effects or completer effects.", "application_exception": "Without analysis information, do not label the result as ITT, PP or adjusted effect.", "criterion": "Check the actual analysis population, model, adjustment and effect of interest for the selected between-arm result and explain alignment with the question.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Distinguish assignment/adherence effects of interest from actual estimates; do not invent an analysis label.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 is retained as reporting a 52.7% reduction with lifestyle plus berberine versus 36.4% with lifestyle alone, P=.008.", "condition_status": "Unverified", "status_reason": "The summary lacks definitions of the result’s analysis population, adjustment model, baseline handling and between-arm change estimate.", "missingness": "The summary lacks definitions of the result’s analysis population, adjustment model, baseline handling and between-arm change estimate.", "uncertainty": "The summary lacks definitions of the result’s analysis population, adjustment model, baseline handling and between-arm change estimate.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Statistical-analysis section, SAP, complete result tables and analysis-population definitions" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Were the 16-week between-arm estimate and interval adequately reported?", "needed": "Exact between-arm effect, CI level, dispersion, denominator and estimation model", "role": "Required", "role_reason": "Statistical significance alone cannot establish effect magnitude or precision.", "application_exception": "The 97.5% CI in S2 is not inherited as the S1 interval or changed into a 95% CI.", "criterion": "Link the effect estimate, interval and dispersion/denominator for the selected 16-week comparison to interpret the range of effects it permits.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain reported numbers only; do not calculate new differences, CIs or meta-analyses.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 retains reductions of 52.7% versus 36.4%/P=.008 but no exact between-arm effect/CI. S2 retains 0.9 percentage points/97.5% CI −0.4~2.1.", "condition_status": "Partly verified", "status_reason": "The exact between-arm estimate, interval, dispersion and model for the selected 16-week comparison are absent, preventing a completed precision assessment.", "missingness": "The exact between-arm estimate, interval, dispersion and model for the selected 16-week comparison are absent, preventing a completed precision assessment.", "uncertainty": "The exact between-arm estimate, interval, dispersion and model for the selected 16-week comparison are absent, preventing a completed precision assessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "S1 between-arm estimate/interval, dispersion and denominator result tables" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What defines clinical importance for liver-fat change?", "needed": "A justified important liver-fat difference, measure, population, duration and interval", "role": "Required", "role_reason": "Statistical P values and clinically meaningful changes must be distinguished.", "application_exception": "Do not invent universal minimum sample-size, duration or effect-magnitude thresholds.", "criterion": "Check a justified importance threshold for relative ¹H-MRS change in the relevant population and its relationship to the selected effect/interval.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Explain an evidence-based importance threshold first; do not create new efficacy scores or grades.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected result is 16-week relative change in liver fat, a surrogate outcome. The retained summary has no importance threshold.", "condition_status": "Unverified", "status_reason": "A justified importance threshold for the measure/population and the selected between-arm CI are lacking.", "missingness": "A justified importance threshold for the measure/population and the selected between-arm CI are lacking.", "uncertainty": "A justified importance threshold for the measure/population and the selected between-arm CI are lacking.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical-importance/measurement-change criteria and the S1 between-arm interval" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Which study family is each report linked to?", "needed": "Reports, PMID/DOI/PMCID, registration identity, population/arms and overlapping participants", "role": "Required", "role_reason": "Multiple paper, bibliography and registration gateways do not imply multiple trials.", "application_exception": "Identifier strings alone do not establish trial families or total independent-trial counts.", "criterion": "Link each report’s identity and same/different/uncertain family relationship using original material, retaining the undetermined total unique-trial count.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Link reports separately from study families; do not count identifiers as independent trials.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "There are identity clues for S1: Yan2015/PMID26252777/PMC4529214/DOI10.1371/journal.pone.0134172/NCT00633282; and for S2: PMID41543854/NCT05647915.", "condition_status": "Partly verified", "status_reason": "Original-trial/family links, related-report lists and participant overlap for the reports were not currently verified against external originals.", "missingness": "Original-trial/family links, related-report lists and participant overlap for the reports were not currently verified against external originals.", "uncertainty": "Original-trial/family links, related-report lists and participant overlap for the reports were not currently verified against external originals.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original papers, registration identity/family tables and related-report lists" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were the conditions of the opposing 2026 result retained?", "needed": "S2 population, 1 g/day, placebo, 6 months, MRI and original effect/interval", "role": "Required", "role_reason": "Keeping only the favorable 16-week result would lose related opposing results and applicability differences.", "application_exception": "S2 under different conditions is not converted into direct failure of the exact 16-week comparison or replication at the same dose.", "criterion": "Retain the recorded S2 direction, original numbers and condition differences together; do not combine them as the same estimate as S1.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Do not hide opposing results under different conditions; review individually whether they answer the same question.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S2 concerns 337 participants, 1 g/day, 6 months, diabetes-free obese MASLD, placebo and MRI. Retain the between-group 0.9 percentage points/97.5% CI −0.4~2.1 and the original null-result description.", "condition_status": "Met", "status_reason": "This checks that the related opposing result and condition differences in the retained text are both displayed. It does not mean 0 effect, equivalence or review of all current literature.", "missingness": "This checks that the related opposing result and condition differences in the retained text are both displayed. It does not mean 0 effect, equivalence or review of all current literature.", "uncertainty": "This checks that the related opposing result and condition differences in the retained text are both displayed. It does not mean 0 effect, equivalence or review of all current literature.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete S2 paper, population/measure details and registration versions" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were unique trials and participants protected from double counting?", "needed": "Relationships among reports, trials, participants and endpoints/times/analyses", "role": "Required", "role_reason": "Simply adding Korean/English text, PubMed/PMC/registration gateways or reports under different conditions inflates evidence counts.", "application_exception": "Do not add 184 and 337 or sum completion counts of 53/47/55.", "criterion": "Retain established report relationships and uncertainties; do not generate overall unique-trial/participant totals without evidence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Group related reports into families before counting; do not create totals without independence information.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The evidence/citation lists have 2 entries each; the multiple identifiers for S1 are clues to one report. No total unique-trial/participant count was generated currently.", "condition_status": "Met", "status_reason": "This checks the counting boundary that report-entry counts are not used as clinical independence or study sufficiency.", "missingness": "This checks the counting boundary that report-entry counts are not used as clinical independence or study sufficiency.", "uncertainty": "This checks the counting boundary that report-entry counts are not used as clinical independence or study sufficiency.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-family and overlapping-participant linkage material" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How were funding, product provision and interests checked?", "needed": "Funding, product supply/manufacturer roles, author employment/patents, COI and design control", "role": "Supplementary; required for independence claims", "role_reason": "Checking public funding differs from checking product/design control and author interests.", "application_exception": "Academic/public support or the original I2 is not inherited as complete verification of independence.", "criterion": "Link funding, product provision, author/patent/COI information and design-control scope for each report to actual disclosures.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Review funding, product provision and author interests separately; unverified information is not independent funding.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 records Chinese public research support with manufacturer roles requiring separate checking; S2 records academic/public support.", "condition_status": "Partly verified", "status_reason": "Detailed funder names, product provision, manufacturer roles, author employment/patents, declared COI and design control are absent.", "missingness": "Detailed funder names, product provision, manufacturer roles, author employment/patents, declared COI and design control are absent.", "uncertainty": "Detailed funder names, product provision, manufacturer roles, author employment/patents, declared COI and design control are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Funding/COI statements, product supply, author affiliations and control descriptions" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Which materials were acquired and read in this review?", "needed": "Current material type, original bytes, actual reading scope and external access/reading attempts", "role": "Required", "role_reason": "Reading a local summary must be distinguished from reading an external paper/registration in full.", "application_exception": "The existence of PMC/DOI/registration links is not converted into full-text acquisition or successful access.", "criterion": "Ensure acquisition, actual reading, times/locations/SHA for each material match actual actions, retaining unattempted external access.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "When new material is actually read, link its type, time, scope and original location/SHA separately.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The complete retained 3069 summary was actually read. External PubMed, PMC, DOI and registration originals were not accessed or read in this conversion.", "condition_status": "Met", "status_reason": "This checks disclosure of actual reading scope and unread external material; it is not clinical full-text certification.", "missingness": "This checks disclosure of actual reading scope and unread external material; it is not clinical full-text certification.", "uncertainty": "This checks disclosure of actual reading scope and unread external material; it is not clinical full-text certification.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current input copies, actual reading events and material-specific access records" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Were the evidence date and this review date distinguished?", "needed": "Original verdict-review date, historical search records, current reading date and item-specific access dates", "role": "Required", "role_reason": "A historical text’s review date cannot be retrospectively assigned as current external access.", "application_exception": "The original 2026-09-08 is not used as a new search date or an individual PubMed/PMC access date.", "criterion": "Link the meaning of the original date, current reading date, unperformed search/access and the scope of absence statements.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Record dates and actual verification scope of additional material separately, updating only the linked rows.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original verdict-review date is 2026-09-08. The current date concerns conversion of the retained summary; clinical searches and external accesses in this conversion total 0.", "condition_status": "Met", "status_reason": "Separate evidence-search cutoff and individual access-date fields are absent. The current scope is the retained summary, not a judgment that no current evidence exists.", "missingness": "Separate evidence-search cutoff and individual access-date fields are absent. The current scope is the retained summary, not a judgment that no current evidence exists.", "uncertainty": "Separate evidence-search cutoff and individual access-date fields are absent. The current scope is the retained summary, not a judgment that no current evidence exists.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search records, individual access/reading dates and evidence-date definition" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How were citation registration identifiers and the structured registration field handled?", "needed": "Bibliographic identifiers, original registration-check values, original-registry links and corrections", "role": "Required", "role_reason": "Unverified structured fields and bibliographic clues cannot overwrite each other.", "application_exception": "S1/S2 identifiers are not interchanged or presented as actual current registration comparison.", "criterion": "Retain both unverified original registration-check fields and citation identifiers; verify exact trial links against original material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain conflicting/unverified identifiers; do not upgrade linkage without original-material comparison.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The S1/S2 evidence-table registration fields both say unverified. The citations record NCT00633282/NCT05647915 respectively.", "condition_status": "Partly verified", "status_reason": "The identifiers are retained identity clues rather than results of reading the original registrations currently. Structured-field and actual-registration linkage remain unverified.", "missingness": "The identifiers are retained identity clues rather than results of reading the original registrations currently. Structured-field and actual-registration linkage remain unverified.", "uncertainty": "The identifiers are retained identity clues rather than results of reading the original registrations currently. Structured-field and actual-registration linkage remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Each original registration, identifier identity and report correspondence" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Were generic English descriptions and the existing correction retained?", "needed": "Original Korean/English values, 2026-09-14 correction scope and original verdict/score", "role": "Required", "role_reason": "Generic English descriptions cannot substitute for actual denominator/CI verification.", "application_exception": "The existence of a correction note is not promoted to additional clinical verification in this conversion.", "criterion": "Link original Korean/English text, correction and score/axes unchanged; do not use generic descriptions to fill specific unknowns.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Keep new evidence additions separate from wording/condition changes and preserve complete before/after texts.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The existing correction records wording changes in 2 English fields on 2026-09-14, without new research or reassessment. Some English evidence fields retain generic descriptions.", "condition_status": "Met", "status_reason": "This checks preservation of original values and historical corrections. C50/S/R0/I2/EX/B2/CX is not inherited as new condition statuses or a new verdict.", "missingness": "This checks preservation of original values and historical corrections. C50/S/R0/I2/EX/B2/CX is not inherited as new condition statuses or a new verdict.", "uncertainty": "This checks preservation of original values and historical corrections. C50/S/R0/I2/EX/B2/CX is not inherited as new condition statuses or a new verdict.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete before/after texts, correction event and original assessment axes" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were persistence and discontinuation effects beyond 16 weeks checked?", "needed": "Extension/post-discontinuation follow-up under the same conditions, with effects/denominators at additional times", "role": "Supplementary; required when extending to persistence", "role_reason": "Short-term liver-fat results alone cannot establish post-discontinuation persistence or long-term benefit.", "application_exception": "The 6 months in S2 are not used as extension follow-up of the same S1 participants.", "criterion": "Link direct extension/discontinuation follow-up under the same 16-week conditions, with time-specific estimates and denominators, to the persistence question.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "When claiming persistence, review a separate question using direct follow-up; do not impose an arbitrary minimum duration.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 concerns 16-week results; S2 is a 6-month report with different population, dose, comparator and measurement.", "condition_status": "Unverified", "status_reason": "Extension/discontinuation follow-up, persistent effects and time-specific denominators under the same conditions are absent from the retained summary.", "missingness": "Extension/discontinuation follow-up, persistent effects and time-specific denominators under the same conditions are absent from the retained summary.", "uncertainty": "Extension/discontinuation follow-up, persistent effects and time-specific denominators under the same conditions are absent from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "S1 extension/post-discontinuation follow-up and time-specific results/denominators" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were the doses directly compared?", "needed": "Randomized dose comparisons in the same population/comparator/test, with adherence and estimates", "role": "Supplementary; required for optimal-dose claims", "role_reason": "Differences between 1.5 g and 1 g in separate trials do not show a direct dose response.", "application_exception": "A dose-comparison trial is not imposed unconditionally for the narrow 16-week question.", "criterion": "Link direct dose-comparison design, actual exposure and between-arm estimates to optimal-dose/dose-response questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "When extending the dose question, use a direct design that separates differences in other conditions.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 at 1.5 g/day and S2 at 1 g/day also differ in duration, population, comparator and measurement.", "condition_status": "Unverified", "status_reason": "The retained summary has no direct dose comparison under identical conditions, so optimal dose/dose response is not judged.", "missingness": "The retained summary has no direct dose comparison under identical conditions, so optimal dose/dose response is not judged.", "uncertainty": "The retained summary has no direct dose comparison under identical conditions, so optimal dose/dose response is not judged.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, actual dosing and dose-specific estimates/intervals" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can effects by diabetes status and disease stage be distinguished?", "needed": "Prespecified subgroups, composition, interactions, estimates/intervals and denominators", "role": "Supplementary; required for subgroup application", "role_reason": "Overall effects in different populations cannot be converted into effect modification by diabetes status.", "application_exception": "Diabetes-free eligibility in S2 alone does not establish an interaction relative to a diabetic group.", "criterion": "Check prespecified relevant subgroups, composition, interactions and subgroup estimates/denominators to assess effect modification.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Subgroup application requires direct plans/estimates; different significance across separate trials is not an interaction.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Detailed diabetes composition in S1 is unverified, while S2 concerns a different population of diabetes-free obese adults with MASLD.", "condition_status": "Unverified", "status_reason": "Prespecified subgroups, disease stage, diabetes composition and direct interactions/denominators are absent.", "missingness": "Prespecified subgroups, disease stage, diabetes composition and direct interactions/denominators are absent.", "uncertainty": "Prespecified subgroups, disease stage, diabetes composition and direct interactions/denominators are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroup plans, baseline composition, interactions and estimates/intervals" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Does the liver-fat result answer cirrhosis or histologic-recovery questions?", "needed": "Direct data for the selected liver-fat measure versus histology, clinical events and quality of life", "role": "Supplementary; required when extending to clinical events", "role_reason": "A reduction in a surrogate cannot automatically be extended to cirrhosis prevention or benefit in all MASLD.", "application_exception": "Not every clinical-event trial is imposed as required for a liver-fat numerical question.", "criterion": "Review extensions to clinical events, histology or quality of life using their direct results, denominators and estimates.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "When extending to clinical-event questions, review a separate table of direct endpoints.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original advertising-limit description excludes cirrhosis prevention, histologic recovery and application to all MASLD. Weight, HOMA-IR, lipids and liver enzymes are separate endpoints.", "condition_status": "Unverified", "status_reason": "The selected liver-fat material alone cannot establish direct evidence for separate clinical events or histologic recovery.", "missingness": "The selected liver-fat material alone cannot establish direct evidence for separate clinical events or histologic recovery.", "uncertainty": "The selected liver-fat material alone cannot establish direct evidence for separate clinical events or histologic recovery.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct plans/results for histology, clinical events and quality of life" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How were recorded gastrointestinal adverse effects defined and collected?", "needed": "Symptom/diagnosis definitions, collection methods, severity, harm-related discontinuation and each arm", "role": "Supplementary; required for the harm in question", "role_reason": "Warnings or general symptom descriptions differ from complete harm counts.", "application_exception": "Keep liver-fat efficacy status separate from harm-record status.", "criterion": "Check event definitions, ascertainment/collection, severity and arm-specific reporting for the selected exposure to explain the harm-information level.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Check actual harm counts and event definitions separately from efficacy.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original product-facts/safety-detail descriptions warn that gastrointestinal adverse effects occurred.", "condition_status": "Partly verified", "status_reason": "Specific events, collection methods, severity, arms, discontinuations and event counts are absent from the retained summary.", "missingness": "Specific events, collection methods, severity, arms, discontinuations and event counts are absent from the retained summary.", "uncertainty": "Specific events, collection methods, severity, arms, discontinuations and event counts are absent from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific adverse-event definitions, collection, severity and discontinuation tables" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How do harm onset/recovery and dosing timing relate?", "needed": "Exposure start, discontinuation, onset, recovery, re-exposure and follow-up duration", "role": "Supplementary; required for harm timing", "role_reason": "A nominal 16-week treatment period alone cannot establish event latency or recovery.", "application_exception": "Without recovery-after-discontinuation or re-exposure information, do not create a causal timeline.", "criterion": "Link actual exposure, harm onset/recovery timelines and observation limits to direct material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Obtain timing material appropriate to the harm question; temporal order alone does not establish cause.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "S1 treatment lasts 16 weeks, and the retained description warns of gastrointestinal adverse effects, but individual event timelines are absent.", "condition_status": "Unverified", "status_reason": "Onset, recovery, discontinuation, re-exposure and event follow-up duration cannot be established from the retained summary.", "missingness": "Onset, recovery, discontinuation, re-exposure and event follow-up duration cannot be established from the retained summary.", "uncertainty": "Onset, recovery, discontinuation, re-exposure and event follow-up duration cannot be established from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event timelines, dosing/discontinuation and recovery/re-exposure records" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Against which exposures and concurrent treatments were harms compared?", "needed": "Arm-specific exposure, lifestyle, diabetes/concomitant medicines, baseline disease and event comparisons", "role": "Supplementary; required for comparative harm/causation", "role_reason": "Without concurrent-treatment, baseline-risk and actual event comparisons, a particular drug contribution cannot be established.", "application_exception": "The existence of an efficacy comparator is not converted into completed harm-event comparison.", "criterion": "Link arm-specific events, exposure/concomitant medicines, baseline risks, alternative explanations and adjustments to explain comparative-harm limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Review harm comparisons and alternative causes individually; theoretical warnings are not observed incidence.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original warning calls for checking hypoglycemia and interactions in people with liver disease or diabetes-medicine use. The S1 efficacy comparator is lifestyle alone.", "condition_status": "Partly verified", "status_reason": "Direct material on actual arm-specific harms, diabetes/concomitant medicines, baseline events and alternative explanations is absent.", "missingness": "Direct material on actual arm-specific harms, diabetes/concomitant medicines, baseline events and alternative explanations is absent.", "uncertainty": "Direct material on actual arm-specific harms, diabetes/concomitant medicines, baseline events and alternative explanations is absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific adverse events/concurrent exposures, baseline risks and adjustment information" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are event counts and exposure denominators available for harm frequency?", "needed": "People/events affected, arm-specific safety denominators, exposure time, discontinuation and CI", "role": "Supplementary; required for incidence", "role_reason": "Randomized totals or warnings alone cannot be used to calculate harm frequency.", "application_exception": "Do not use 184, 337 or completion counts of 53/47/55 as safety denominators or create 0 events.", "criterion": "Directly link each event’s counts, arm-specific exposed/safety denominators, observation time and reported estimates.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Link reported harm frequencies only to their denominators/times; do not calculate new incidence.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Retained material records S1 with 184 randomized participants/completion counts of 53/47/55, S2 with 337 participants, and general warnings.", "condition_status": "Unverified", "status_reason": "Arm-specific event counts, safety denominators, exposure time and harm intervals are absent, so frequency cannot be displayed.", "missingness": "Arm-specific event counts, safety denominators, exposure time and harm intervals are absent, so frequency cannot be displayed.", "uncertainty": "Arm-specific event counts, safety denominators, exposure time and harm intervals are absent, so frequency cannot be displayed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific safety denominators, event counts, exposure/follow-up and reported estimates" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Were missing harm reports and overlapping related reports checked?", "needed": "Collection/detection, spontaneous/systematic reporting, attrition, related reports and opposing records", "role": "Supplementary; required for repeated signals", "role_reason": "Unreported harms differ from absent events, and repeat citations differ from independent events.", "application_exception": "Regulatory warnings or repeated citations of the same case are not counted as independent events.", "criterion": "Link actual event collection/selection, missingness, the full disclosure scope and related-report families/overlap to original material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Retain opposing/unreported records and actual event families; do not infer new replication counts.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "General warnings and S1 analysis-attrition limitations remain. There is no separate list of event-report families.", "condition_status": "Unverified", "status_reason": "Harm collection/detection differences, events among dropouts, the complete disclosure scope and related-event overlap are unverified.", "missingness": "Harm collection/detection differences, events among dropouts, the complete disclosure scope and related-event overlap are unverified.", "uncertainty": "Harm collection/detection differences, events among dropouts, the complete disclosure scope and related-event overlap are unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-collection plans/complete tables, attrition follow-up and original related-report/regulatory-citation material" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What is known about long-term/rare harms and vulnerable groups?", "needed": "Long-term/rare events, liver disease/diabetes medicines, pregnancy/lactation/infants and interactions", "role": "Supplementary; required for that safety extension", "role_reason": "Short-term results in a restricted population cannot be extended to every person’s safety.", "application_exception": "Not all rare-harm studies are imposed as efficacy requirements for the selected 16-week liver-fat question.", "criterion": "Explain direct harm material and applicability limits for the duration, vulnerable population or concurrent exposure to which claims are extended.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Review safety extensions using separate questions, designs and material; unverified information is not personal safety.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original warning mentions liver disease, diabetes-medicine use, pregnancy, lactation and infants.", "condition_status": "Unverified", "status_reason": "Direct actual exposure/denominator and timing material for vulnerable groups, long-term/rare events and interactions is absent.", "missingness": "Direct actual exposure/denominator and timing material for vulnerable groups, long-term/rare events and interactions is absent.", "uncertainty": "Direct actual exposure/denominator and timing material for vulnerable groups, long-term/rare events and interactions is absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up, interaction and harm material appropriate to the relevant exposures/vulnerable groups" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How far does the current warning support harm statements?", "needed": "Event reports, comparisons, denominators, timing, alternatives and the evidence level behind the warning", "role": "Supplementary; required for harm causation", "role_reason": "General warnings differ from actual causation, incidence and personal-safety assessments.", "application_exception": "Do not remove the original warning or convert it into a new safety grade or personal dosing instruction.", "criterion": "Link the warning’s actual evidence level and distinguish verified scope and limits for signals, comparative harms, causation and frequency.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Describe only the observable harm-information level; do not generate safety certification or a new verdict.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Current retained material preserves the original warning about gastrointestinal adverse effects, hypoglycemia/interactions and vulnerable groups.", "condition_status": "Partly verified", "status_reason": "Current material does not provide detailed events/exposure, comparisons, timing and alternatives, so causation or incidence is not established.", "missingness": "Current material does not provide detailed events/exposure, comparisons, timing and alternatives, so causation or incidence is not established.", "uncertainty": "Current material does not provide detailed events/exposure, comparisons, timing and alternatives, so causation or incidence is not established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct warning sources and event/exposure/alternative-explanation material" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Which rows should be updated when new material arrives?", "needed": "Identity, material type, date, actual reading, original location/SHA and condition/observation versions", "role": "Required", "role_reason": "New file collection must be tracked separately from condition revisions and actual review/display changes.", "application_exception": "New API responses or historical verification dates alone do not automatically satisfy a condition.", "criterion": "Identify facts, locations, versions and linked rows for each added material; preserve the complete previous material and condition-revision event.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are in-house conditions for adding berberine hydrochloride versus lifestyle intervention alone on 16-week ¹H-MRS liver fat, developed with knowledge of retained content. They do not establish blinding, clinical preregistration, official-method certification or independent clinical validation.", "proposed_research": "Preserve the complete previous version, separate material additions from condition revisions, then recheck linked-row evidence, statuses and reading links.", "current_reports": [ "S1", "S2" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Current observations link to actual locations and SHA in the immutable 3069 input summary. Additional external-material acquisition/reading events in this conversion total 0.", "condition_status": "Met", "status_reason": "This checks update-tracing rules, not new material acquisition, complete clinical review or completed publication.", "missingness": "This checks update-tracing rules, not new material acquisition, complete clinical review or completed publication.", "uncertainty": "This checks update-tracing rules, not new material acquisition, complete clinical review or completed publication.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material identity/version, original location/SHA and actual review event" } ], "reports": [ { "report_id": "S1", "title": "Yan HM et al. PLoS One. 2015;10:e0134172. PMID: 26252777. PMCID: PMC4529214. DOI: 10.1371/journal.pone.0134172. NCT00633282.", "url": "https://pubmed.ncbi.nlm.nih.gov/26252777/", "report_type": "Retained result/bibliographic summary of the Yan 2015 liver-fat trial", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "A report of 16-week ¹H-MRS with berberine hydrochloride plus lifestyle versus lifestyle alone. Multiple identifiers are links to one report, not a count of independent trials.", "independent_replication": "The retained summary has two report entries, S1/S2. PubMed, PMC, DOI, registration identifiers and Korean/English text for S1 are not independent trials. Family links and participant overlap between reports under different conditions were not newly checked against external originals; total unique trials and participants remain undetermined.", "observed_result": "Lifestyle plus berberine: 52.7% reduction versus 36.4% with lifestyle alone, P=.008. Separately retain 184 randomized participants and completion counts of 53/47/55. Completion-count arm assignment, analysis n and the exact between-arm effect/CI remain unverified.", "result_level": "A retained summary of positive results and open-label/attrition limitations. Preserve the original statement that the registry endpoint was secondary. Current external full-text, registration or SAP verification and new effect calculation were not performed.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained judgment evidence/bibliographic summary", "public_status": "Retained summary acquired/read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External PubMed bibliography/abstract gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained bibliographic gateway. Current existence, public availability, acquisition, content and reading of the external document were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External PMC full-text gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained bibliographic gateway. Current existence, public availability, acquisition, content and reading of the external document were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External DOI article gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained bibliographic gateway. Current existence, public availability, acquisition, content and reading of the external document were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External trial-registration gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The registration number is a retained bibliographic clue. Preserve the unconfirmed registration-check field; actual original-registration/plan comparison was not performed. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26252777/" } ] }, { "report_id": "S2", "title": "2026 randomized trial. PMID: 41543854. NCT05647915.", "url": "https://pubmed.ncbi.nlm.nih.gov/41543854/", "report_type": "Retained opposing-result/bibliographic summary of the 2026 MASLD trial under different conditions", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "A report in diabetes-free obese MASLD with 1 g/day, placebo, 6 months and MRI liver fat. It is not merged with S1 as the same population, dose, duration, comparator or measurement.", "independent_replication": "The retained summary has two report entries, S1/S2. PubMed, PMC, DOI, registration identifiers and Korean/English text for S1 are not independent trials. Family links and participant overlap between reports under different conditions were not newly checked against external originals; total unique trials and participants remain undetermined.", "observed_result": "337 participants. Retain the original between-group 0.9 percentage points, 97.5% CI −0.4~2.1 and the statement of no liver-fat benefit. Analysis denominators, exact product and detailed MRI technique remain unverified.", "result_level": "A related opposing result under different conditions. It is not converted into direct failure of the exact 16-week comparison, 0 effect, equivalence or new independent replication. External full text and registration remain unread.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained judgment evidence/bibliographic summary", "public_status": "Retained summary acquired/read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Retained evidence, bibliography and text summaries were read. Distinguish these from clinical full texts and original binaries. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External PubMed bibliography/abstract gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained bibliographic gateway. Current existence, public availability, acquisition, content and reading of the external document were not newly verified. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." }, { "material_type": "External trial-registration gateway", "public_status": "Public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The registration number is a retained bibliographic clue. Preserve the unconfirmed registration-check field; actual original-registration/plan comparison was not performed. Historical individual access levels/dates are unrecorded. Original review narratives do not establish current external full-text reading. The displayed material date is the case-record review date. Original verdict review, correction and case review dates are not historical access dates for individual external materials or search cut-offs. Historical external access dates and reading scope are unrecorded; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41543854/" } ] } ], "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; distinguish intervention variants.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Link studies and reports separately; do not omit studies solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "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.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some retained information is available while required unverified material remains.", "Unverified": "The criterion cannot be established within the retained scope; this does not mean 0 studies, 0 effect or no harm.", "Review incomplete": "Original-material comparison/search was not performed within the permitted scope.", "Not reported": "A scope-limited status meaning the item was not stated in the particular material/section that was read.", "Inaccessible": "Used only for material for which access was actually attempted and failed. It was not assigned to clinical material in this conversion.", "Insufficient evidence matching the conditions": "Used only after relevant studies within a defined scope have been reviewed and evidence is insufficient to answer the criterion. It was not applied indiscriminately in this conversion.", "Not applicable": "A specific exception based on applicability conditions, not a substitute for unread material.", "Conflicting data": "Used when incompatible information for the same question, time and analysis has been compared. Different review estimates alone do not establish this status.", "Met": "The specified retained information and reading/attribution/counting boundary were checked; this is not certification of efficacy, full-text reading or reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The retained summary has two report entries, S1/S2. PubMed, PMC, DOI, registration identifiers and Korean/English text for S1 are not independent trials. Family links and participant overlap between reports under different conditions were not newly checked against external originals; total unique trials and participants remain undetermined." }, "history": [ { "date": "2026-10-27", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 40 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }