{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2966-s0", "verdict_number": "2966", "title": "Camu-camu fruit extract · 12-week MRI liver fat — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-13", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Overweight adults with elevated fasting triglycerides. Diagnosis, numeric eligibility thresholds, baseline HFF and detailed characteristics are unverified.", "intervention": "Camu-camu fruit extract, 1.5 g/day", "dose": "Original extract exposure of 1.5 g/day for each 12-week intervention period. Ingredient quantification, raw-material equivalents and actual adherence are unverified; this is not usage guidance.", "comparator": "Placebo sequence crossover. Placebo composition, actual masking and accompanying management details are unverified.", "endpoint": "Change from baseline in MRI hepatic fat fraction. Relative changes were -7.43% versus +8.42%; the original relative difference was -15.85%, P=0.003. Approximately 1.6 percentage points as the median absolute HFF decrease is a separate measure. The original record of unreported treatment-effect CI is retained.", "duration": "Each 12-week intervention followed by crossover after washout. Washout length, total actual duration and visit windows are unverified.", "excluded_extensions": [ "Transferring the 30 completers wholesale into actual MRI analysis denominators of 20/25", "Turning the -15.85% relative difference into a 15.85-percentage-point absolute decrease", "Defining the approximately 1.6-percentage-point median as a new adjusted between-treatment mean difference or relative-difference conversion", "Summing participants or independent trials across periods, regions of interest and parent/subclaim sheets", "Extending MRI imaging results to cirrhosis, hospitalization, death or long-term treatment/prevention efficacy", "Generalizing efficacy/safety to other polyphenols, products, ingredients, doses or durations", "Implementation guidance for product intake/usage, diet, liver-disease management or treatment replacement" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy, boundaries and materials", "question": "What is the selected subclaim and its original record?", "needed": "Original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat.", "application_exception": "Do not turn parent/subclaim overlap into new independent trials or additional structural units.", "criterion": "Link original Korean/English wording and the question/record relationship for reduced 12-week MRI liver fat to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "If the question boundary changes, retain the original wording separately from the change event.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected existing subclaim is reduced MRI liver fat at 12 weeks; its original verdict record is distinguished from the question. The parent question concerns reduced 12-week liver fat in overweight adults with elevated triglycerides.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.", "missingness": "Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.", "uncertainty": "Within the preserved-summary preparation scope. Independent-claim status was not certified. The single existing subclaim is not newly split and no hypothetical main claim is created.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preserved copies of the selected subclaim and complete parent summary" }, { "item_id": "N02", "question_type": "Efficacy, boundaries and materials", "question": "How are the subclaim C and parent C54, axes and history distinguished?", "needed": "Subclaim grade/note, absence of score/status/axes and preservation of parent values", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of subclaim grade/note, absence of score/status/axes and preservation of parent values.", "application_exception": "C54, B2 and historical cross-checks are preserved history, not new score calculation, RoB execution or completed content review.", "criterion": "Link subclaim grade/note, absence of score/status/axes and preservation of parent values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When a separate evidence-update event occurs, distinguish preservation of original values from the new decision.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Subclaim C and the note that the relative difference was -15.85%, P=0.003, but the endpoint was an imaging surrogate are retained. Subclaim score/status/axes keys are absent. Parent C54/Caution and B/S/R1/I2/E+/B2, with precision not recorded, are parent context.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.", "missingness": "Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.", "uncertainty": "Within the preserved-summary preparation scope. Subclaim score, status and axes remain unrecorded. Parent scores or historical cross-checks are not assigned as current subclaim review or verdict values.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subclaim record, parent grade/score/axes and Korean/English verdict history" }, { "item_id": "N03", "question_type": "Efficacy, boundaries and materials", "question": "Which selected adult population was actually studied?", "needed": "Eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides.", "application_exception": "Fatty-liver/MASLD tag names alone do not establish every participant’s diagnosis or severity.", "criterion": "Link eligibility and baseline liver fat in overweight adults with elevated fasting triglycerides to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish applicability to other populations using direct eligibility and baseline-characteristic materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original study was a camu-camu/placebo sequence crossover trial in 35 overweight adults with elevated fasting triglycerides.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.", "missingness": "Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.", "uncertainty": "Within the preserved-summary preparation scope. Numeric BMI/triglyceride thresholds, age/sex, liver-disease diagnosis, baseline HFF, metabolic conditions and detailed inclusion/exclusion criteria are absent from the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility, baseline characteristics/liver fat and diagnostic definitions" }, { "item_id": "N04", "question_type": "Efficacy, boundaries and materials", "question": "What was the tested extract?", "needed": "Actual formulation, quantification and manufacture of Myrciaria dubia fruit extract", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of actual formulation, quantification and manufacture of Myrciaria dubia fruit extract.", "application_exception": "Do not convert 1.5 g of extract into 1.5 g of vitamin C, fruit raw-material quantity or equivalents of other products.", "criterion": "Link actual formulation, quantification and manufacture of Myrciaria dubia fruit extract to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish other camu-camu products when actual composition/formulation and direct materials are available.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Camu-camu is Myrciaria dubia fruit extract. The original safety account records gastrointestinal discomfort possibly related to capsules.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.", "missingness": "Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Extract standardization, raw-material equivalents, vitamin C/polyphenol quantification, manufacturer/batches, capsule count and composition are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Test-product composition, standardization, batches and manufacturing/supply records" }, { "item_id": "N05", "question_type": "Efficacy, boundaries and materials", "question": "What were the research exposure and actual implementation?", "needed": "Research exposure of 1.5 g/day for each 12-week period and actual adherence", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of research exposure of 1.5 g/day for each 12-week period and actual adherence.", "application_exception": "No intake, capsule-count, dose-conversion, product-selection or treatment-implementation guidance is written.", "criterion": "Link research exposure of 1.5 g/day for each 12-week period and actual adherence to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link follow-up materials while distinguishing nominal exposure from actual exposure.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original trial used camu-camu fruit extract at 1.5 g/day for 12 weeks. This preserves the research exposure.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.", "missingness": "Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Individual intake/adherence, discontinuation/dose reduction, capsule composition and direct comparisons with other doses are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/adherence/discontinuation records and test-product details" }, { "item_id": "N06", "question_type": "Efficacy, boundaries and materials", "question": "What was in the placebo and which comparison was made?", "needed": "Placebo composition/appearance, masking and treatment comparison", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of placebo composition/appearance, masking and treatment comparison.", "application_exception": "Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.", "criterion": "Link placebo composition/appearance, masking and treatment comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Do not automatically combine materials using a different control into the same contrast.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original double-blind crossover trial compared camu-camu with placebo. The relative-change contrast is camu-camu versus placebo.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.", "missingness": "Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.", "uncertainty": "Within the preserved-summary preparation scope. Placebo ingredients, calories, formulation, matching appearance/taste and actual delivery differences are absent from the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, product comparison and actual exposure records" }, { "item_id": "N07", "question_type": "Efficacy, boundaries and materials", "question": "How are intervention periods and washout distinguished?", "needed": "Each 12-week period, crossover after washout and actual schedule", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of each 12-week period, crossover after washout and actual schedule.", "application_exception": "Do not add the two 12-week periods into a new total duration or claim that everyone completed identical total exposure.", "criterion": "Link each 12-week period, crossover after washout and actual schedule to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP; Design-specific harm questions in M19 §19.2; Detailed temporal relationships are internally designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When timing materials become available, link baseline/end measurements separately for each period.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original account describes each 12-week exposure followed by crossover after washout. The selected result concerns 12-week MRI liver fat.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.", "missingness": "Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Washout length, total actual participation duration, visit windows and measurement timing between interventions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original visit schedule, washout, crossover timing and actual implementation" }, { "item_id": "N08", "question_type": "Efficacy, boundaries and materials", "question": "What were crossover allocation and comparison units?", "needed": "Randomized intervention sequence and repeated comparison in the same participants", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of randomized intervention sequence and repeated comparison in the same participants.", "application_exception": "Do not count camu-camu and placebo periods as independent parallel groups or two trials.", "criterion": "Link randomized intervention sequence and repeated comparison in the same participants to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 §8.1–8.2.3; CHAMGAP adaptation; Distinction between studies and reports in M04 §4.6.1–4.6.2; Cohort/outcome connections are CHAMGAP adaptations", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Retain distinctions between sequence, period and the same participants in new reports.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The double-blind crossover trial randomized 35 participants to camu-camu/placebo sequence. Thirty completed both periods.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.", "missingness": "Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Sequence-specific allocation counts, allocation generation/concealment and actual intervention switching are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence allocation, concealment methods and crossover flow diagram" }, { "item_id": "N09", "question_type": "Efficacy, boundaries and materials", "question": "Are the actual roles and maintenance of double blinding known?", "needed": "Masking/unmasking of participants, assessors and analysts", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of masking/unmasking of participants, assessors and analysts.", "application_exception": "Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.", "criterion": "Link masking/unmasking of participants, assessors and analysts to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish the double-blind label from actual roles and procedures in additional materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original design was recorded as double-blind.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.", "missingness": "Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.", "uncertainty": "Within the preserved-summary preparation scope. Who was blinded, product distinguishability, MRI reader/analyst masking and unmasking timing are unverified because external materials remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods, masking/unmasking records and reading procedures" }, { "item_id": "N10", "question_type": "Efficacy, boundaries and materials", "question": "What accompanying diet, weight and medication changes occurred?", "needed": "Period-specific co-exposure, weight changes and medication/behavior conditions", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of period-specific co-exposure, weight changes and medication/behavior conditions.", "application_exception": "Do not newly establish a weight-independent effect or causal effect of an individual ingredient.", "criterion": "Link period-specific co-exposure, weight changes and medication/behavior conditions to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Retain actual measurement/adjustment of accompanying changes together with extract exposure in follow-up research.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved summary describes only camu-camu/placebo sequence comparison and liver-fat change.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.", "missingness": "Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Diet, alcohol, exercise, medication, weight change, common management and period-specific differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific co-exposure, weight, diet and medication records" }, { "item_id": "N11", "question_type": "Efficacy, boundaries and materials", "question": "How was MRI liver fat actually measured?", "needed": "MRI hepatic fat fraction, change from baseline and equipment/methods", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of mRI hepatic fat fraction, change from baseline and equipment/methods.", "application_exception": "Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.", "criterion": "Link mRI hepatic fat fraction, change from baseline and equipment/methods to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When methods are supplied, link actual technique, units and reading scope to the result.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original evidence-list endpoint was change from baseline in MRI hepatic fat fraction. Results were recorded as imaging HFF.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.", "missingness": "MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.", "uncertainty": "Within the preserved-summary preparation scope. MRI technique/equipment, reading, reproducibility, detailed fat-fraction definition and unit handling are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRI measurement/reading methods and endpoint definitions" }, { "item_id": "N12", "question_type": "Efficacy, boundaries and materials", "question": "Are five regions of interest distinguished from participant counts?", "needed": "Mean MRI regions of interest per participant and analysis unit", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of mean MRI regions of interest per participant and analysis unit.", "application_exception": "Do not count five regions as five times the participants, independent observations or new trials.", "criterion": "Link mean MRI regions of interest per participant and analysis unit to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 Table 8.2.a, M03 §3.2.4; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish regions, averages and participant-level analysis units in new measurement reports.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original research account states that mean HFF from five MRI regions per participant was used for the prespecified hepatic-steatosis analysis.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.", "missingness": "Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Region locations/selection, missing regions, averaging and valid measurement criteria per participant are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Region selection, participant-level HFF aggregation and valid measurement criteria" }, { "item_id": "N13", "question_type": "Efficacy, boundaries and materials", "question": "Are relative change from baseline and final HFF distinguished?", "needed": "Period-specific baseline, change, relative/absolute measures and final values", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of period-specific baseline, change, relative/absolute measures and final values.", "application_exception": "Do not turn relative-change proportions into final hepatic fat fraction or percentage-point absolute decreases.", "criterion": "Link period-specific baseline, change, relative/absolute measures and final values to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link baseline, final values, absolute change and relative change separately when result tables are added.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The endpoint was change from baseline in MRI HFF; the original reader answer describes relative change.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.", "missingness": "Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.", "uncertainty": "Within the preserved-summary preparation scope. Period-specific baseline HFF, final absolute HFF, change dispersion and the original definition of relative-change calculation are absent from the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific baseline/end/change values and original analysis definitions" }, { "item_id": "N14", "question_type": "Efficacy, boundaries and materials", "question": "What were the original relative changes by period?", "needed": "Attribution of -7.43% to camu-camu and +8.42% to placebo", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of attribution of -7.43% to camu-camu and +8.42% to placebo.", "application_exception": "Do not turn placebo increases or extract decreases into guaranteed individual effects or changes in everyone.", "criterion": "Link attribution of -7.43% to camu-camu and +8.42% to placebo to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When original results are supplemented, link each period/measure and preserve current original values.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserved relative MRI liver-fat changes were -7.43% with camu-camu versus +8.42% with placebo.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.", "missingness": "Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Dispersion/intervals for each relative change, period baselines and links to actual analysis participants are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific relative changes, denominators, dispersion and baselines" }, { "item_id": "N15", "question_type": "Efficacy, boundaries and materials", "question": "Which contrast does the original -15.85% relative difference represent?", "needed": "Between-treatment contrast in relative change from baseline and P value", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of between-treatment contrast in relative change from baseline and P value.", "application_exception": "Do not recalculate from -7.43 and +8.42 or newly define -15.85 as an absolute percentage-point or adjusted effect.", "criterion": "Link between-treatment contrast in relative change from baseline and P value to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 §8.2.2, M15 §15.3.1; CHAMGAP adaptation; M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are designed by CHAMGAP", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When analysis materials arrive, link the relative-change contrast and original adjustment to that analysis.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original between-treatment relative difference was -15.85%, P=0.003. The summary explicitly describes a relative-change contrast, not a 15.85-percentage-point absolute reduction.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.", "missingness": "Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Exact paired estimand, model, adjustment, sequence/period handling and effect interval are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment-contrast model, original result tables and estimand definition" }, { "item_id": "N16", "question_type": "Efficacy, boundaries and materials", "question": "How is the approximately 1.6-percentage-point median absolute HFF decrease retained?", "needed": "Absolute-change median, population/contrast and separate relative-measure labeling", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of absolute-change median, population/contrast and separate relative-measure labeling.", "application_exception": "Do not assert that approximately 1.6 percentage points is a new adjusted between-treatment mean difference or conversion of -15.85%.", "criterion": "Link absolute-change median, population/contrast and separate relative-measure labeling to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design; M15 §15.3.1–15.3.3; our own application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When materials are added, link the original median to its actual population, measure and interval.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved median absolute HFF decrease was approximately 1.6 percentage points. The original summary states that it should be presented alongside the relative difference.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.", "missingness": "The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.", "uncertainty": "Within the preserved-summary preparation scope. The exact population, period, contrast definition, interval, dispersion and baseline for this median are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absolute HFF change tables, median population/contrast definitions and dispersion" }, { "item_id": "N17", "question_type": "Efficacy, boundaries and materials", "question": "What is the scope of the account that the effect CI was unreported?", "needed": "Original unreported-CI record and actual external reading scope", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of original unreported-CI record and actual external reading scope.", "application_exception": "Do not newly calculate CI, variance or effect size from P values or sample size.", "criterion": "Link original unreported-CI record and actual external reading scope to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link supplied intervals with their actual original location, measure and analysis while preserving the original record.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original result, reader answer and synthesis recorded that the treatment-effect CI was unreported. This historical account is retained.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.", "missingness": "External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.", "uncertainty": "Within the preserved-summary preparation scope. External result tables, supplements and interval reporting were not read here. Nonreporting across all current materials was not newly verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original full text, supplementary tables, estimation intervals and denominators" }, { "item_id": "N18", "question_type": "Efficacy, boundaries and materials", "question": "What was the clinically important HFF threshold?", "needed": "Prespecified importance criterion, measure and uncertainty", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of prespecified importance criterion, measure and uncertainty.", "application_exception": "Do not newly establish clinically sufficient reduction from a positive P value or 1.6 percentage points.", "criterion": "Link prespecified importance criterion, measure and uncertainty to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M15 §§15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When direct criteria are supplied, distinguish prespecified/post hoc status, measure and applicable population.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original rationale states that a prespecified clinically important between-treatment HFF threshold was unreported.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Validated thresholds for that population/measure and original planning materials were not read here.", "missingness": "Validated thresholds for that population/measure and original planning materials were not read here.", "uncertainty": "Within the preserved-summary preparation scope. Validated thresholds for that population/measure and original planning materials were not read here.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical-importance validation and criteria in prespecified plans" }, { "item_id": "N19", "question_type": "Efficacy, boundaries and materials", "question": "Which denominators are 35 allocated and 30 completing both periods?", "needed": "Allocation, sequence, period completion and completer analysis", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of allocation, sequence, period completion and completer analysis.", "application_exception": "Do not copy the 30 completers as the actual MRI analysis denominator for every result.", "criterion": "Link allocation, sequence, period completion and completer analysis to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When flow is supplemented, record allocation, each-period completion and both-period completion separately.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original evidence record states 35 randomized and 30 completing both periods analyzed. These numbers describe allocation and completion of both periods.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.", "missingness": "Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Sequence-specific completer counts, period-specific discontinuation/withdrawal and completion definitions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover flow, sequence-specific completion and discontinuation reasons" }, { "item_id": "N20", "question_type": "Efficacy, boundaries and materials", "question": "How do the MRI analysis counts of 20 and 25 differ?", "needed": "Actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period.", "application_exception": "Do not calculate 20+25 as total participants or interpret them as two independent groups.", "criterion": "Link actual endpoint denominators of 20 in the camu-camu period and 25 in the placebo period to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link completer counts separately from actual endpoint-analysis denominators in new analysis materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original research account and grade rationale specify 20 in the camu-camu period and 25 in the placebo period for primary MRI liver-fat analysis, distinct from 30 completing both periods.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.", "missingness": "Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Number of the same participants with MRI in both periods, sequence-specific n, valid paired data and missingness reasons are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MRI endpoint flow, valid paired/unilateral observations and period/sequence-specific n" }, { "item_id": "N21", "question_type": "Efficacy, boundaries and materials", "question": "How were completion, MRI selection and missingness handled?", "needed": "Completer analysis, missing MRI, missingness reasons/handling and sensitivity", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of completer analysis, missing MRI, missingness reasons/handling and sensitivity.", "application_exception": "Do not calculate or invent unmeasured counts, withdrawal/analysis-exclusion rates or new ITT results.", "criterion": "Link completer analysis, missing MRI, missingness reasons/handling and sensitivity to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Retain reasons/assumptions for differences between all allocated participants and actual outcome analysis in follow-up research.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent summary identifies analysis of 30 completers from 35 randomized and period-specific MRI counts of 20/25 as key limitations of the positive result.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.", "missingness": "Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Reasons for MRI nonmeasurement/exclusion, whole-randomized-population analysis, imputation, missingness assumptions and sensitivity analyses are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Missingness reasons, analysis populations, MRI selection and sensitivity results" }, { "item_id": "N22", "question_type": "Efficacy, boundaries and materials", "question": "How were sequence, period and carryover effects handled?", "needed": "Crossover model, washout, sequence/period/carryover effects and correlation", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of crossover model, washout, sequence/period/carryover effects and correlation.", "application_exception": "Washout alone does not establish no carryover, independent periods or a complete paired analysis.", "criterion": "Link crossover model, washout, sequence/period/carryover effects and correlation to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M08 §8.1–8.2.3; internal application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link both periods in the same participants and report carryover/period assumptions separately in crossover analysis materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original study crossed over after washout. Actual analysis is summarized as a treatment contrast in relative HFF change.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.", "missingness": "Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Carryover assessment, sequence/period effects, paired correlation, model, adjustment and assumptions are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover statistical model, period baselines and carryover/sequence analyses" }, { "item_id": "N23", "question_type": "Efficacy, boundaries and materials", "question": "What was the hierarchy of the prespecified MRI endpoint and other outcomes?", "needed": "Hepatic-steatosis planning, primary MRI and other markers", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of hepatic-steatosis planning, primary MRI and other markers.", "application_exception": "Do not use liver injury markers in the paper title to create the same numerical effect as MRI or additional clinical efficacy.", "criterion": "Link hepatic-steatosis planning, primary MRI and other markers to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 Table 8.2.a, M04 §4.6.3; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When plans are supplied, distinguish actual prespecified/post hoc and primary/supporting results.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved research account records prespecified hepatic-steatosis analysis using mean HFF from five regions and the primary MRI endpoint.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.", "missingness": "Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.", "uncertainty": "Within the preserved-summary preparation scope. Original plan dates/definitions, multiplicity and hierarchy of other liver-injury/microbiome results are unverified because external materials remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint/timing and multiple-testing plans in protocol, SAP and registration history" }, { "item_id": "N24", "question_type": "Efficacy, boundaries and materials", "question": "What is the status of NCT04130321 and the current original registration?", "needed": "Original registration identity, planning/change history and actual reading", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of original registration identity, planning/change history and actual reading.", "application_exception": "A number’s presence does not establish registration reading, prespecification certification or a completed link check.", "criterion": "Link original registration identity, planning/change history and actual reading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish the original number, historical records and current reading scope when registration materials are supplied.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "NCT04130321 appears in the original evidence registration field and research account. It is preserved as registration identity.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.", "missingness": "Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.", "uncertainty": "Within the preserved-summary preparation scope. Registration full text/date, change history, current recruitment/result disclosure and endpoint correspondence were not newly checked. The citation has no separate registration-number key.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/history and links between actual plans and results" }, { "item_id": "N25", "question_type": "Efficacy, boundaries and materials", "question": "What are the report identity and actual preserved-summary locations?", "needed": "Marette 2024, Cell Reports Medicine, PMID and original evidence/citation records", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of marette 2024, Cell Reports Medicine, PMID and original evidence/citation records.", "application_exception": "Do not infer or generate DOI/PMCID from the PMID or article number.", "criterion": "Link marette 2024, Cell Reports Medicine, PMID and original evidence/citation records to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When bibliography is supplemented, retain original literal wording together with the change event.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "R01 is the Marette A et al. camu-camu randomized crossover report, Cell Rep Med 2024;5:101682, PMID 39168095, linked to original evidence and citation records.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.", "missingness": "DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.", "uncertainty": "Within the preserved-summary preparation scope. DOI, PMCID and current external bibliography/full-text locations are unspecified in this summary and were not looked up here.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography, abstract/full text and trial linkage" }, { "item_id": "N26", "question_type": "Efficacy, boundaries and materials", "question": "Are the same trial, periods and regions kept separate from new independent replication?", "needed": "Same crossover population, two periods, regions of interest and report family", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of same crossover population, two periods, regions of interest and report family.", "application_exception": "Do not sum 35, 30, 20, 25, five regions or parent/subclaim sheets into new participant or independent-trial totals.", "criterion": "Link same crossover population, two periods, regions of interest and report family to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish recruitment, registration and participant relationships when new independent materials are supplied.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary contains one evidence record, one citation and one existing subclaim. Period crossover in the same participants and averaging regions belong to the same trial result structure.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.", "missingness": "Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.", "uncertainty": "Within the preserved-summary preparation scope. Unique trial/participant totals were not newly certified or summed during preparation. No new direct independent-replication materials were sought.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report–trial–sequence–participant–period–MRI region linkage" }, { "item_id": "N27", "question_type": "Efficacy, boundaries and materials", "question": "Are MRI reduction and actual liver-disease outcomes distinguished?", "needed": "Imaging surrogate versus cirrhosis, hospitalization, death and other clinical events", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of imaging surrogate versus cirrhosis, hospitalization, death and other clinical events.", "application_exception": "Do not extend positive 12-week MRI results to liver-disease treatment, complication/death prevention or long-term efficacy.", "criterion": "Link imaging surrogate versus cirrhosis, hospitalization, death and other clinical events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link new clinical outcomes with definitions, timing and denominators separate from MRI.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original crux/product facts explicitly distinguish MRI liver fat as an imaging surrogate from clinical events such as cirrhosis, hospitalization or death.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.", "missingness": "Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.", "uncertainty": "Within the preserved-summary preparation scope. Direct long-term fibrosis, cirrhosis, hospitalization, death, symptom and quality-of-life outcomes are unverified within the preserved scope.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons of clinical events and long-term outcomes" }, { "item_id": "N28", "question_type": "Efficacy, boundaries and materials", "question": "What are the product, duration and ingredient boundaries?", "needed": "Tested extract, 1.5 g/day, 12 weeks and other polyphenols", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of tested extract, 1.5 g/day, 12 weeks and other polyphenols.", "application_exception": "Preserve the historical mention of verdict 2962 for a different plant extract without opening its materials/page or treating it as the same trial.", "criterion": "Link tested extract, 1.5 g/day, 12 weeks and other polyphenols to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish replication of the same question from applicability to different ingredients/products in independent follow-up research.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original counterview describes differing green-tea, curcumin, resveratrol and hesperidin results and rejects generalization to polyphenol efficacy. The verdict is limited to this extract, dose, duration and MRI endpoint.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.", "missingness": "Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Direct comparisons of other camu-camu products, isolated ingredients, doses/durations, populations/diseases and long-term maintenance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual product, duration, population and direct-result materials" }, { "item_id": "N29", "question_type": "Efficacy, boundaries and materials", "question": "What is the scope of opposing, conflicting and individual-difference materials?", "needed": "Positive result, uncertainty and differences between ingredients/subgroups", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of positive result, uncertainty and differences between ingredients/subgroups.", "application_exception": "No search does not mean no other studies; results for other ingredients do not become direct refutation of this trial.", "criterion": "Link positive result, uncertainty and differences between ingredients/subgroups to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish actual conflict for the same question from differences between ingredients/measures in new materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The summary retains a single small positive imaging result alongside completer/MRI denominator limitations. Differences between other polyphenols provide context for separate questions.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.", "missingness": "Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.", "uncertainty": "Within the preserved-summary preparation scope. Other direct trials for the same camu-camu question, individual responses and sequence/sex/baseline-liver-fat subgroup results were not sought or checked here.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent direct results for the same question and prespecified subgroup tables" }, { "item_id": "N30", "question_type": "Efficacy, boundaries and materials", "question": "Which original records describe support and industry relationships?", "needed": "Nonprofit/public support, manufacturer-reporting status and research-chair disclosures", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of nonprofit/public support, manufacturer-reporting status and research-chair disclosures.", "application_exception": "Do not convert public/nonprofit funding or unreported-support records into new certification of no conflicts or no manufacturer support.", "criterion": "Link nonprofit/public support, manufacturer-reporting status and research-chair disclosures to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish direct support, external relationships and analysis/publication roles in newly disclosed materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original record describes Weston Family Microbiome Initiative/CIHR support and unreported manufacturer funding, free product, commercial analysis, writing and publication costs. It records A. Marette’s Pfizer/CIHR joint research chair and Y. Desjardins’s NSERC–Diana Food industrial research chair disclosures.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.", "missingness": "Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.", "uncertainty": "Within the preserved-summary preparation scope. Original contracts, supply details, current relationships and company analysis/publication roles remain unread. No separate sponsor name appears in the summary.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific funding, support/product supply and author-conflict declarations" }, { "item_id": "N31", "question_type": "Efficacy, boundaries and materials", "question": "How are original dates, corrections, empty values, Korean/English wording and history preserved?", "needed": "2026-08-26, empty correction/deliberation records and original verdict/axes", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of 2026-08-26, empty correction/deliberation records and original verdict/axes.", "application_exception": "Do not fill unrecorded original precision/empty values with new numbers or axes, or transfer historical cross-checks into current review.", "criterion": "Link 2026-08-26, empty correction/deliberation records and original verdict/axes to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When materials change, record the complete earlier text, event, version and separate application distinctly.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original verified date is 2026-08-26; corrections are an empty array and deliberation an empty string. Korean/English wording, synthesis, grade-decision records, axes and false flags are preserved in the complete summary.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.", "missingness": "Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.", "uncertainty": "Within the preserved-summary preparation scope. Separate facets and primary-failed/secondary-positive keys are absent. Empty corrections do not establish a current external correction/retraction check.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete previous summary and actual change/correction events" }, { "item_id": "N32", "question_type": "Efficacy, boundaries and materials", "question": "What was actually read and what are the material-slot states?", "needed": "Distinction between preserved summary and external abstract, full text, registration and plans", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of distinction between preserved summary and external abstract, full text, registration and plans.", "application_exception": "URLs, citations or preserved copies do not establish external reading, successful access or a completed link check.", "criterion": "Link distinction between preserved summary and external abstract, full text, registration and plans to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When materials are supplied, separately record acquisition, publication, access, actual reading scope and dates.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preparation read the complete 2966 summary and its selected existing subclaim. One report’s summary-read slot is distinguished from unread external/required-material slots.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.", "missingness": "External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.", "uncertainty": "Within the preserved-summary preparation scope. External abstract, full text, registration, protocol, SAP, supplementary results/harms and support declarations were not accessed or obtained.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials or user-supplied files and actual reading records" }, { "item_id": "N33", "question_type": "Efficacy, boundaries and materials", "question": "What should be linked when new evidence or corrections arrive?", "needed": "Separation of conditions, original materials, observations, reading and change events", "role": "Required", "role_reason": "Preparation condition retaining the actual scope of separation of conditions, original materials, observations, reading and change events.", "application_exception": "Original candidate review-pending/production-eligibility markers are history; they do not revive an active review wait or approval process.", "criterion": "Link separation of conditions, original materials, observations, reading and change events to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Only for new materials and actual changes, distinguish complete earlier files, events, condition version/freeze, separate application and current handoff.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preparation transfers the existing question and original verdict into the same seven-column format. Conditions were saved/frozen before writing at a separate application time.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.", "missingness": "No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.", "uncertainty": "Within the preserved-summary preparation scope. No new clinical search, calculation, regrading, effect/CI, independence certification or model/self content review was performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-supplied MRI analysis/crossover flow, plans, corrections and harms materials" }, { "item_id": "H01", "question_type": "Harms", "question": "How were gastrointestinal discomfort and adverse events defined and collected?", "needed": "Mild gastrointestinal discomfort, relatedness and adverse-event collection/grading", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of mild gastrointestinal discomfort, relatedness and adverse-event collection/grading.", "application_exception": "Prepare only the preserved-summary scope without adding definitions, values or denominators absent from original materials.", "criterion": "Link mild gastrointestinal discomfort, relatedness and adverse-event collection/grading to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §§19.1.2–19.2.4; detailed distinctions are Chamgap-designed; M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Retain consistent collection/grading for gastrointestinal events and other harms in follow-up research.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original safety account records one participant discontinuing for mild gastrointestinal discomfort considered possibly capsule-related.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.", "missingness": "Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Adverse-event definitions, severity criteria, collection methods, relatedness adjudication and complete event lists are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harms definitions, collection/relatedness review and complete result tables" }, { "item_id": "H02", "question_type": "Harms", "question": "What were actual event timing and exposure?", "needed": "Intervention period, washout/switching and onset/discontinuation timing", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of intervention period, washout/switching and onset/discontinuation timing.", "application_exception": "Without original timing, do not convert the record into a confirmed camu-camu-period event rate or long-term harm.", "criterion": "Link intervention period, washout/switching and onset/discontinuation timing to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §19.2 design-specific harm questions; timing details are Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish event periods, actual exposure at risk and postdiscontinuation course in harms reports.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original harms record concerns possibly capsule-related gastrointestinal discomfort leading to discontinuation in the crossover trial.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.", "missingness": "Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Which intervention/sequence/period, onset/discontinuation timing, actual exposure and postdiscontinuation follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event–sequence–period–exposure–discontinuation linkage and observation duration" }, { "item_id": "H03", "question_type": "Harms", "question": "Are harms compared by camu-camu/placebo period?", "needed": "Period-specific events, relatedness, severity and control comparison", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of period-specific events, relatedness, severity and control comparison.", "application_exception": "Historical absence of arm-specific counts does not establish zero events or safety equivalence.", "criterion": "Link period-specific events, relatedness, severity and control comparison to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §§19.2.2–19.2.4 and M03 §3.2.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When actual harms materials are added, link period-specific exposure in the same participants to original definitions.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent summary describes a safety-data gap because systematic adverse-event tables and arm-specific serious-event counts were absent.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.", "missingness": "Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Current external tables remain unread. Complete period-specific adverse events, serious events and intervals are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover period-specific adverse/serious events, controls and intervals" }, { "item_id": "H04", "question_type": "Harms", "question": "How do withdrawal and harms denominators differ?", "needed": "Original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population.", "application_exception": "Do not use new calculations such as 35-30 or 1/5 to create withdrawal reasons or adverse-effect rates.", "criterion": "Link original five withdrawals, one gastrointestinal-discomfort withdrawal and actual safety population to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish allocation, exposure, period-specific collection and analysis denominators in harms materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary states that one of five withdrawals followed mild gastrointestinal discomfort possibly capsule-related. This harms record is separate from allocation of 35, completion of 30 and MRI counts of 20/25.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.", "missingness": "Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Other withdrawal reasons, period-specific harms-exposure n, collection/analysis denominators and repeated event counts are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Withdrawal reasons, period-specific exposure and safety-analysis flow" }, { "item_id": "H05", "question_type": "Harms", "question": "What level of signal does possible capsule relatedness represent?", "needed": "Discomfort timing, alternative factors and possible-relatedness judgment", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of discomfort timing, alternative factors and possible-relatedness judgment.", "application_exception": "One case does not establish confirmed camu-camu toxicity, a general incidence rate or absence of harm.", "criterion": "Link discomfort timing, alternative factors and possible-relatedness judgment to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was executed", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish a possible-relatedness signal from direct causal judgment in additional harms materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original record is a case of discontinuation for mild gastrointestinal discomfort considered possibly capsule-related.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.", "missingness": "Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Diagnosis, accompanying food/medication, background symptoms, rechallenge, independent relatedness review and confirmed cause are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original case course, alternative explanations and relatedness judgment" }, { "item_id": "H06", "question_type": "Harms", "question": "Are unread, unreported, uncollected and actual zero outcomes distinguished?", "needed": "Unread external scope and gaps in harms results", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of unread external scope and gaps in harms results.", "application_exception": "Unread external materials do not mean zero adverse effects, no paper or failed access.", "criterion": "Link unread external scope and gaps in harms results to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §§19.1.2–19.2.4 and M04 §4.6.3; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Link actual zero, missing, unreported and uncollected states separately only for supplied materials.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary records absent systematic adverse-event tables and arm-specific serious-event counts. External papers/supplements were not read here.", "condition_status": "Unverified", "status_reason": "Required direct definitions, values and materials are unverified within the current preserved-summary/unread-external scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.", "missingness": "Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Actual distinctions in current external originals between uncollected, unreported, missing and zero events are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harms collection plans, complete results, missingness reasons and supplementary tables" }, { "item_id": "H07", "question_type": "Harms", "question": "Are crossover harms and reports protected from duplicate summing?", "needed": "Harms linkage in the same participants across two periods and one report", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of harms linkage in the same participants across two periods and one report.", "application_exception": "Do not sum the two periods or allocation/completion/measurement counts as harms participants or independent trials.", "criterion": "Link harms linkage in the same participants across two periods and one report to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Distinguish rereporting of the same event from new events when harms materials are supplemented.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The crossover trial in this summary is one report in which the same participants undergo camu-camu and placebo periods.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.", "missingness": "Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.", "uncertainty": "Within the preserved-summary preparation scope. Duplicate/repeated relationships of participants/events by sequence and period and new independent harms materials are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant–sequence–period–event–report linkage" }, { "item_id": "H08", "question_type": "Harms", "question": "What gaps remain in long-term safety and other risk populations?", "needed": "12-week research exposure and safety for longer periods, other formulations/populations/diseases", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of 12-week research exposure and safety for longer periods, other formulations/populations/diseases.", "application_exception": "Do not extend positive 12-week imaging results into long-term safety guarantees or safety of other polyphenols.", "criterion": "Link 12-week research exposure and safety for longer periods, other formulations/populations/diseases to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "M19 §§19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "Retain actual exposure, population, duration and collection methods in long-term safety research.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "Parent safety is Caution. The original question concerns MRI liver-fat change with a specific extract and research exposure.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.", "missingness": "Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.", "uncertainty": "Within the preserved-summary preparation scope. Direct harms from longer exposure, other doses/formulations, liver-disease severity, vulnerable populations and drug interactions were not checked here.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct population/product/period-specific harms and long-term collection materials" }, { "item_id": "H09", "question_type": "Harms", "question": "Are limitations of imaging benefits and harms signals retained together?", "needed": "Separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps", "role": "Supporting harm information", "role_reason": "Preparation condition retaining the actual scope of separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps.", "application_exception": "Do not turn positive imaging results into liver-treatment recommendations, usage/product-selection or treatment-replacement guidance, or a definitive harms verdict.", "criterion": "Link separation of positive MRI, uncertainty, gastrointestinal discomfort and systematic-harms gaps to the corresponding research exposure, period, measure and denominator, distinguishing unverified matters.", "basis": "Chamgap interpretive boundary informed by M19 principles; no formal causality tool was run", "condition_origin": "Chamgap-designed production based on originals; existing content review remains assigned separately", "proposed_research": "When new materials are supplied, link imaging, clinical and harms results and their change events separately.", "current_reports": [ "R01" ], "existence": "Preserved-summary linkage; existence/current publication of required external details is separately unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected original MRI result is grade C/positive, alongside small-crossover/completer/MRI denominator limitations, a gastrointestinal-discomfort case and harms-data gaps.", "condition_status": "Partly verified", "status_reason": "Corresponding preserved-summary content is linked for preparation; this does not establish clinical verification, fulfilled conditions or completed content review. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.", "missingness": "No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.", "uncertainty": "Within the preserved-summary preparation scope. No new benefit–harm synthesis, clinical treatment selection or usage guidance was created.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original direct-result, harms and follow-up materials" } ], "reports": [ { "report_id": "R01", "title": "Marette A, et al. Camu-camu decreases hepatic steatosis and liver injury markers in overweight, hypertriglyceridemic individuals: a randomized crossover trial. Cell Rep Med. 2024;5:101682. PMID: 39168095.", "url": "https://pubmed.ncbi.nlm.nih.gov/39168095/", "report_type": "Double-blind randomized placebo-controlled crossover report", "existence": "Bibliography and URL preserved in the original summary citation record", "acquired_read": "Summary read; external materials not read", "study_family": "Marette 2024 camu-camu · NCT04130321 crossover population", "independent_replication": false, "observed_result": "-7.43% versus +8.42%; relative difference -15.85%, P=0.003; median absolute HFF decrease approximately 1.6 percentage points; CI unreported. The original 30 completers are distinguished from actual MRI analysis of 20 in the camu-camu period and 25 in the placebo period. Relative difference is not converted into percentage-point absolute decrease.", "result_level": "Preserved first evidence record and complete parent summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved summary", "access_status": "Local copy acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T16:07:02.141283+09:00", "qualification": "The corresponding bibliography, results, MRI denominators and harms context in the complete 2966 preserved summary were read. This is not external-paper reading." }, { "material_type": "External abstract", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the preserved-summary citation link is connected. Abstract content or successful current access was not confirmed." }, { "material_type": "External full text", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the preserved bibliographic-identity link is connected. Full-text location, publication and access are unverified." }, { "material_type": "Registration", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original registration number is preserved; current content, dates and endpoint correspondence remain unread." }, { "material_type": "Protocol", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot. Actual file existence/publication, washout and MRI plans are unverified." }, { "material_type": "Statistical analysis plan", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required-material slot. Actual sequence, period, carryover, paired/missingness and estimand plans are unverified." }, { "material_type": "Results, denominator and harm details", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Slot requiring original tables linking actual MRI counts of 20/25 with 30 completers, intervals, absolute median and period-specific harms." }, { "material_type": "Support and interests", "public_status": "Current publication/access unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Historical support, nonreporting and research-chair disclosure accounts in the preserved summary are distinguished from current external original declarations." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39168095/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Single preserved-summary crossover population of Marette 2024/NCT04130321. The same participants’ periods, regions, allocation of 35, completion of 30, MRI counts of 20/25 and parent/subclaim sheets are not summed into new independent trials or participants." }, "history": [ { "date": "2026-10-13", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed." } ], "language": "en", "translation_date": "2026-10-13" }