{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2980-s1", "verdict_number": "2980", "title": "Casein-derived MKP × Orientation: Positive secondary finding and gaps in total-score and multiplicity evidence", "view_version": "1.0", "view_created_date": "2026-10-15", "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": "268 community-dwelling Japanese adults aged 40 or older without dementia; intention-to-treat analysis, 134/134. Completion, withdrawal and observed denominators for the selected endpoint are not verified in detail.", "intervention": "Casein hydrolysate tablets containing the casein-derived peptide Met-Lys-Pro (MKP)", "dose": "Original study exposure only: MKP 200 μg/day for 24 weeks. No cumulative dose calculation or advice on consuming MKP, milk or products.", "comparator": "Dextrin placebo tablets, 134 participants; sensory matching, blinding and concurrent exposures are not verified in detail.", "endpoint": "Secondary Orientation subscale finding, P=.022; distinguished from the primary total score, other subscales, global cognition and clinical function", "duration": "24 weeks; actual adherence, discontinuation, visit-specific follow-up and follow-up after the study are not verified in detail.", "excluded_extensions": [ "Promoting positive Orientation findings into primary total-score success, improved global cognition, dementia prevention or clinical function", "Copying group-specific total-score values, d, P or CI limitations into subscale results", "Rejudging within-group improvement as an additional effect versus placebo, equivalence, noninferiority or a zero effect", "Adding the same paper, registration, people, groups, visits, subscales or related sheets as new independent trials or participants", "New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions on MKP, milk or product consumption, cognition or dementia care, or replacement of treatment" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing Orientation claim is being presented?", "needed": "Separate the selected subscale wording and subclaim grade from parent values", "role": "Required", "role_reason": "This is needed to connect separate the selected subscale wording and subclaim grade from parent values with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on separate the selected subscale wording and subclaim grade from parent values, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The selected claim is improved Orientation subscale, with original subclaim grade C and a note that P=0.022 does not overturn failure of the primary total score. Subclaim score, status and axes are absent and are retained separately from parent D30 values.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which population's subscale results are these?", "needed": "Community-dwelling Japanese adults aged 40 or older without dementia", "role": "Required", "role_reason": "This is needed to connect community-dwelling Japanese adults aged 40 or older without dementia with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on community-dwelling Japanese adults aged 40 or older without dementia, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original trial involved 268 community-dwelling Japanese adults aged 40 or older without dementia. The subscale signal is not extended to people with dementia, all cognitive problems, or other ages or regions.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are baseline total scores also baseline Orientation scores?", "needed": "Baseline distributions of total scores and subscale scores", "role": "Required", "role_reason": "This is needed to connect baseline distributions of total scores and subscale scores with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on baseline distributions of total scores and subscale scores, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Baseline total scores were MKP 4.08±2.17 and placebo 4.10±2.10. Group-specific baseline and final Orientation values and distributions are not established in the summary. Total-score values are not used to create subscale values or floor or ceiling effects.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is study MKP distinguished from ordinary milk?", "needed": "Study tablets containing casein-derived MKP", "role": "Required", "role_reason": "This is needed to connect study tablets containing casein-derived MKP with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on study tablets containing casein-derived MKP, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original intervention was casein-derived Met-Lys-Pro (MKP), 200 μg/day, and the manufacturer supplied casein-hydrolysate tablets containing MKP. This is not converted into amounts of ordinary milk or other products, or their subscale effects.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the actual control and concurrent exposures?", "needed": "Dextrin placebo and conditions in both groups", "role": "Required", "role_reason": "This is needed to connect dextrin placebo and conditions in both groups with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on dextrin placebo and conditions in both groups, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original record states allocation to MKP or dextrin placebo tablets, 134/134. Actual placebo conditions, contact, diet and medication in both groups, expectations and adherence are not verified in detail.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Is 24-week exposure distinguished from sustained improvement?", "needed": "Original duration, actual exposure and post-study follow-up", "role": "Required", "role_reason": "This is needed to connect original duration, actual exposure and follow-up after the study with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on original duration, actual exposure and follow-up after the study, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The study used 200 μg/day for 24 weeks, with Orientation as a secondary finding from that trial. Actual exposure, adherence and discontinuation, visit-specific analyses and persistence after the study are not verified in detail. Sustained subscale efficacy is not newly established.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are ITT denominators separated from observed subscale denominators?", "needed": "ITT for 268 participants and Orientation-specific missingness and completion", "role": "Required", "role_reason": "This is needed to connect ITT for 268 participants and Orientation-specific missingness and completion with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on ITT for 268 participants and Orientation-specific missingness and completion, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The existing evidence list records 268 randomized participants and ITT analysis (134/134). Actual observed and analyzed Orientation denominators, completion, withdrawal and missingness are not verified in detail. ITT is not recast as observation or completion by everyone for the subscale.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What exactly did Orientation measure?", "needed": "Subscale definition, scores and interpretation", "role": "Required", "role_reason": "This is needed to connect subscale definition, scores and interpretation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on subscale definition, scores and interpretation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material provides the subscale name Orientation and P=0.022. Items, score range and direction, test version, assessors, visits and details of its relationship to the total score are not established in the summary.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Were subscale effect sizes and CIs provided?", "needed": "Orientation P value and unverified quantitative effects", "role": "Required", "role_reason": "This is needed to connect Orientation P value and unverified quantitative effects with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on Orientation P value and unverified quantitative effects, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original subscale P=0.022 is retained. Group-specific values, exact between-group differences, effect sizes, CIs and variance are not provided in the current stored summary. Total-score d=0.12, P=.302 or before-and-after values are not copied into the subscale.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which comparison or model produced the subscale P value?", "needed": "Orientation effect of interest, within-group and between-group comparisons, and adjustment", "role": "Required", "role_reason": "This is needed to connect Orientation effect of interest, within-group and between-group comparisons, and adjustment with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on Orientation effect of interest, within-group and between-group comparisons, and adjustment, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Detailed comparisons, models, adjustment and visits underlying Orientation P=0.022 are not specified in the summary. It is not automatically declared to use the same model as the baseline-adjusted total score, and within-group improvement is not transferred into additional between-group benefit.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Is the null primary total score retained separately?", "needed": "Different findings for the global cognition total score and Orientation", "role": "Required", "role_reason": "This is needed to connect different findings for the global cognition total score and Orientation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on different findings for the global cognition total score and Orientation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original record that the baseline-adjusted total-score result was null, P=.302 and d=.12, with no 95% CI reported, is retained. The original statement that Orientation P=.022 neither means total-score success nor overturns its failure is preserved.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are secondary and exploratory findings distinguished from prespecified plans?", "needed": "Relationship between the secondary subscale and registered primary endpoint", "role": "Required", "role_reason": "This is needed to connect relationship between the secondary subscale and registered primary endpoint with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on relationship between the secondary subscale and registered primary endpoint, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original Korean and English texts disclose Orientation as a secondary finding. The registration citation lists ADAS-Jcog as the prespecified primary endpoint. Orientation's prespecification, exact secondary or exploratory hierarchy, and amendment history have not been established through new reading of the registration or protocol.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are multiplicity plans and adjustments verified?", "needed": "Testing specifications for multiple subscales and tests", "role": "Required", "role_reason": "This is needed to connect testing specifications for multiple subscales and tests with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on testing specifications for multiple subscales and tests, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material explains that one positive subscale is not promoted into a total-score effect. The total number of tests, multiplicity adjustment, allocation of significance levels and selective reporting are not verified in detail. Significance or nonsignificance after adjustment is not newly adjudicated.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are total-score and Orientation numbers distinguished?", "needed": "Before-and-after total scores and d versus the subscale P value", "role": "Required", "role_reason": "This is needed to connect before-and-after total scores and d versus the subscale P value with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on before-and-after total scores and d versus the subscale P value, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Total scores of 4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10, with d=.12, and Orientation P=.022 are different findings. Within-group total-score decreases, d and the absence of reported CIs are not copied into Orientation values, variance or effects.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Have other subscale and test findings been newly filled in?", "needed": "Scope of all tests and subscales", "role": "Required", "role_reason": "This is needed to connect scope of all tests and subscales with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on scope of all tests and subscales, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The current stored material distinguishes the total score and Orientation. Other subscale or test names, the number of tests, group-specific results and comparisons are not verified in detail. Unread material is not treated as proof that all other findings were null or absent.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the repeat-testing interpretation automatically applied to the subscale?", "needed": "Original total-score interpretation and the Orientation comparison", "role": "Required", "role_reason": "This is needed to connect original total-score interpretation and the Orientation comparison with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on original total-score interpretation and the Orientation comparison, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material interprets total-score improvement in both groups as a repeat-testing effect. Orientation values in both groups, practice effects, expectations and comparison-model details are unverified. The total-score interpretation is not newly established as a causal mechanism for the subscale.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is the subscale extended to global cognition, dementia prevention or clinical function?", "needed": "Directness of the selected subscale for clinical outcomes", "role": "Required", "role_reason": "This is needed to connect directness of the selected subscale for clinical outcomes with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on directness of the selected subscale for clinical outcomes, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material explains that a positive Orientation finding is not evidence of improved global cognition. Separate direct data on dementia prevention, daily function and clinical outcomes are not provided within the preserved scope. These are not established from the subscale signal.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the same design and people counted as separate independent replication?", "needed": "Total-score and subscale findings from the same randomized trial", "role": "Required", "role_reason": "This is needed to connect total-score and subscale findings from the same randomized trial with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on total-score and subscale findings from the same randomized trial, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original design statements on computer block allocation, multiple blinding roles and ITT apply to Orientation within the same trial context. Total scores, subscales, visits, groups, references, registration and related sheets are not added as new independent trials or participants.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence." }, { "item_id": "N19", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Is safety separate from subscale efficacy?", "needed": "Related serious adverse events over 24 weeks, allergy and long-term harms", "role": "Supplementary", "role_reason": "This is needed to connect related serious adverse events over 24 weeks, allergy and long-term harms with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Present original data on related serious adverse events over 24 weeks, allergy and long-term harms, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original material retains the scope that no serious adverse events attributed to MKP consumption were reported over 24 weeks, together with the milk-protein allergy caution. This is not evidence of Orientation efficacy and is not extended to zero harms of every kind or long-term safety.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Preserved-summary reading and external paper or registration status", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Preserved-summary reading and external paper or registration status.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Preserved-summary reading and external paper or registration status.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading refers to the stored summary; the external abstract, full paper, UMIN registration, protocol and SAP remain unread in this work. The existence of a URL is not promoted into reading.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are historical registration dates and primary-endpoint names distinguished from current reading?", "needed": "UMIN000032833 history and prespecified plans", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: UMIN000032833 history and prespecified plans.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: UMIN000032833 history and prespecified plans.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original Korean and English texts describe prospective registration, with disclosure on 2018-06-04 and a planned start on 2018-06-07. The registration citation describes prespecified ADAS-Jcog and manufacturer funding. Only original dates and statements are retained; actual start, versions and plan agreement are not newly verified.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were protocol, SAP, subscale and multiplicity plans acquired?", "needed": "Separate evidence for prespecified plans, analyses and changes", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate evidence for prespecified plans, analyses and changes.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate evidence for prespecified plans, analyses and changes.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Original registration and historical cross-checking statements are retained. The original protocol and SAP, versions and dates, subscale and multiplicity plans, and clinical thresholds have not been read in this work. A registration statement about the primary endpoint does not establish all secondary plans.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are company funding, product support, employee authors and research roles separated?", "needed": "Four categories of Morinaga involvement and other support", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Four categories of Morinaga involvement and other support.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Four categories of Morinaga involvement and other support.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The source records Morinaga Milk study support, manufacture and supply of MKP-containing hydrolysate and placebo tablets, four employee authors N.Y., M.T., K.Y. and F.A., and a supervision fee for N.S. The original limitation that separate public cofunding, medical-writing and publication support were not reported is retained. Design, analysis and data-control details are not newly established.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are null, positive secondary and unverified findings distinguished?", "needed": "Total-score and subscale findings and material-access states", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total-score and subscale findings and material-access states.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total-score and subscale findings and material-access states.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The null original total-score result, P=.302 and d=.12, is retained alongside the positive secondary Orientation P=.022, which does not overturn failure of the total score. Unverified details of CIs, plans and denominators differ from unread external material.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Were the paper and registration counted as separate clinical trials?", "needed": "Report and registration linkage versus actual trials and participants", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Report and registration linkage versus actual trials and participants.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Report and registration linkage versus actual trials and participants.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01", "R02" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial. The same people, groups, visits, total scores, subscales, references, registration and related sheets are not added as new independent trials or participants. Two linked documents comprise one clinical paper and one registration record, not certified counts of unique trials or participants.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is there separate independent confirmation?", "needed": "Distinguish a single manufacturer trial from independent replication", "role": "Supplementary", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Distinguish a single manufacturer trial from independent replication.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Distinguish a single manufacturer trial from independent replication.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The original parent replication axis R1 and independence axis I0 are retained. The paper, registration, subscales in the same participants and related sheets are not certified as new independent replications. No separate replication of harm findings is created in this work.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are subclaim grades distinguished from original parent scores and axes?", "needed": "Subclaim grade, note and absences versus parent D30", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Subclaim grade, note and absences versus parent D30.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Subclaim grade, note and absences versus parent D30.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The selected record's grade, note and Korean and English question wording are retained; absent subclaim score, status and axes remain unrecorded. Parent D30, Good safety and B/P/R1/I0/E0/B0/C0 are parent context and are not transferred to the subclaim.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are both languages and absent structured fields preserved?", "needed": "Korean and English originals and absent separate classification fields", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Korean and English originals and absent separate classification fields.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Korean and English originals and absent separate classification fields.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The parent Korean and English texts, evidence and citations, axes and original selected subclaim are retained in the full stored summary. Separate Korean and English classification fields are absent; no new fields are inserted into the original summary. No external comparison with the English paper was performed.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are the reference date, corrections and historical cross-checking separated from production?", "needed": "Original 2026-08-26 reference date and empty corrections", "role": "Required", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original 2026-08-26 reference date and empty corrections.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original 2026-08-26 reference date and empty corrections.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "The 2026-08-26 reference date, empty correction array and deliberation string, and historical cross-checking in the verdict-decision record are retained. The original date and history are not condition-freezing, application, production or completed-content-review dates.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Which direct material would fill the selected gaps?", "needed": "Prespecified questions, direct effects, CIs, plans and follow-up", "role": "Supplementary", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Prespecified questions, direct effects, CIs, plans and follow-up.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Prespecified questions, direct effects, CIs, plans and follow-up.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "Gaps in the secondary Orientation signal, quantitative effects, CIs, hierarchy and multiplicity are retained. Confirmation of the subscale requires prespecified direct comparison data for that endpoint; it is not converted into total-score success or dementia prevention.", "condition_status": "Unverified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are production, existing content review and practical instructions separated?", "needed": "Production request, historical candidate record and responsibility for existing content review", "role": "Supplementary", "role_reason": "This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Production request, historical candidate record and responsibility for existing content review.", "application_exception": "Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.", "criterion": "Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Production request, historical candidate record and responsibility for existing content review.", "basis": "Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.", "condition_origin": "Conditions for presenting a preserved existing subclaim; these are not preregistration, use of an official tool or completed content review.", "proposed_research": "Material needed: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement. Only material requests and research needs are recorded; no retrieval or research is performed in this work.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is retained; public availability, acquisition and actual reading of detailed external material remain separately unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration, protocol and SAP unread", "observation": "This is an application-condition record based on the preserved summary. Existing content and question-boundary review are incomplete; historical candidate pending and eligibility labels are retained as history. Existing review status is recorded as it stands.", "condition_status": "Partly verified", "status_reason": "An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.", "missingness": "Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement.", "uncertainty": "External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement." } ], "reports": [ { "report_id": "R01", "title": "Yuda N, et al. Effect of the Casein-Derived Peptide Met-Lys-Pro on Cognitive Function in Community-Dwelling Adults Without Dementia. Clin Interv Aging. 2020;15:743-754. PMID: 32546992.", "url": "https://pubmed.ncbi.nlm.nih.gov/32546992/", "report_type": "Double-blind randomized placebo-controlled parallel trial", "existence": "The existing citation contains the paper reference; external public availability and access are unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration and plans unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same paper and registration; no certification of a separate independent trial or replicated efficacy", "observed_result": "4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10; baseline-adjusted P=0.302, d=0.12; 95% CI not reported", "result_level": "Total-score summary in the preserved evidence list; Orientation is linked separately to its subclaim and the original counterview.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "A preserved local copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "External abstract", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "External full text", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Original registration", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Protocol/SAP", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32546992/" } ] }, { "report_id": "R02", "title": "UMIN Clinical Trials Registry. UMIN000032833.", "url": "https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037442", "report_type": "Official registration record for the same trial; not a separate report of effects", "existence": "The existing citation contains the registration reference; external public availability and access are unverified.", "acquired_read": "Stored summary read; external abstract, full text, registration and plans unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same paper and registration; no certification of a separate independent trial or replicated efficacy", "observed_result": "ADAS-Jcog was the prespecified primary endpoint, and public disclosure preceded the planned start.", "result_level": "Existing citation statement about registration plans; not a new clinical effect or result", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "A preserved local copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Original registration", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Registration amendment history", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Original protocol", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." }, { "material_type": "Original analysis plan", "public_status": "An original identifier, citation or needed-material entry; public availability and access details are unverified.", "access_status": "Unread; no access test performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed." } ], "links": [ { "label": "Official source", "url": "https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037442" } ] } ], "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence." }, "history": [ { "date": "2026-10-15", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-15" }