{ "schema_version": "chamgap-public-criteria-1.0", "title": "Long-term whey alone × HbA1c and complication outcomes", "language": "en", "translation_date": "2026-10-16", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Awaiting user review, or actual review remains incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which original long-term subclaim is being checked?", "needed": "Original long-term claim and its boundary with parent/short-term context", "role": "Required", "role_reason": "This condition connects Original long-term claim and its boundary with parent/short-term context with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original long-term claim and its boundary with parent/short-term context must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct long-term whey-only endpoint and analysis material is unverified. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are subclaim ? and parent C50 separate?", "needed": "Original ? and note, absent score/status, and parent C50/safety", "role": "Required", "role_reason": "This condition connects Original ? and note, absent score/status, and parent C50/safety with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original ? and note, absent score/status, and parent C50/safety must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Subclaim score/status fields are absent. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Who is the long-term whey-only question about?", "needed": "Adults with type 2 diabetes, original non-insulin-treated context and long-term eligibility", "role": "Required", "role_reason": "This condition connects Adults with type 2 diabetes, original non-insulin-treated context and long-term eligibility with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Adults with type 2 diabetes, original non-insulin-treated context and long-term eligibility must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only populations, baseline/complication status, treatment and exclusions are unverified. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are long-term whey alone and combinations different interventions?", "needed": "Whey formulation/ingredient, WPI, guar/MCT and long-term whey-only specifications", "role": "Required", "role_reason": "This condition connects Whey formulation/ingredient, WPI, guar/MCT and long-term whey-only specifications with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Whey formulation/ingredient, WPI, guar/MCT and long-term whey-only specifications must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only formulation, components, dose, isolated comparison and actual adherence are unverified. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What are the actual long-term duration and observation windows?", "needed": "Long-term exposure/follow-up, HbA1c times, complication windows and post-intervention follow-up", "role": "Required", "role_reason": "This condition connects Long-term exposure/follow-up, HbA1c times, complication windows and post-intervention follow-up with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Long-term exposure/follow-up, HbA1c times, complication windows and post-intervention follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only exposure/follow-up, assessment times and event windows are unverified. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How is long-term HbA1c defined?", "needed": "HbA1c units, baseline/end/change, times, measurement and model", "role": "Required", "role_reason": "This condition connects HbA1c units, baseline/end/change, times, measurement and model with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for HbA1c units, baseline/end/change, times, measurement and model must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Whey-only HbA1c definitions/units, baseline/change, times and models are unverified. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is a between-group long-term whey-only HbA1c effect preserved?", "needed": "Long-term whey-only arm values, between-group effect, adjustment/CI and control", "role": "Required", "role_reason": "This condition connects Long-term whey-only arm values, between-group effect, adjustment/CI and control with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Long-term whey-only arm values, between-group effect, adjustment/CI and control must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only arm values, effects/CIs, adjustment and comparator are unverified. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are long-term HbA1c populations, denominators and missing data?", "needed": "Allocation/completion/analysis, arm-specific sample sizes, medication, missing data and ITT/PP", "role": "Required", "role_reason": "This condition connects Allocation/completion/analysis, arm-specific sample sizes, medication, missing data and ITT/PP with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Allocation/completion/analysis, arm-specific sample sizes, medication, missing data and ITT/PP must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only arm-specific analysis/denominators, missing data/attrition and target effects are unverified. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which complications and follow-up windows are being asked about?", "needed": "Complication definitions, collection/adjudication, occurrence/progression and follow-up", "role": "Required", "role_reason": "This condition connects Complication definitions, collection/adjudication, occurrence/progression and follow-up with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Complication definitions, collection/adjudication, occurrence/progression and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct complication definitions, collection/adjudication, occurrence/progression and follow-up are unverified. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are direct complication effects, denominators and CIs available?", "needed": "Whey-only arm-specific events/denominators, effects/CIs, losses and comparator/medication", "role": "Required", "role_reason": "This condition connects Whey-only arm-specific events/denominators, effects/CIs, losses and comparator/medication with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Whey-only arm-specific events/denominators, effects/CIs, losses and comparator/medication must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct complication events/denominators, effects/CIs, follow-up losses and comparator are unverified. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "At what level is whey-plus-guar material identified?", "needed": "Original combination mention, bibliography/identity, composition, duration, comparator and results", "role": "Required", "role_reason": "This condition connects Original combination mention, bibliography/identity, composition, duration, comparator and results with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original combination mention, bibliography/identity, composition, duration, comparator and results must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Whey-plus-guar bibliography/registration, composition, duration, population and effects are unverified. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How does MCT plus WPI differ from whey alone?", "needed": "Zameer combination components, formulation/dose, comparator/duration and adherence", "role": "Required", "role_reason": "This condition connects Zameer combination components, formulation/dose, comparator/duration and adherence with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Zameer combination components, formulation/dose, comparator/duration and adherence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Component amounts/calories, comparator, exposure/duration and isolated contribution are unverified. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What is the scope of null primary 24-hour/daytime iAUC?", "needed": "Zameer endpoints/results, original hierarchy, exact effects/intervals and denominators", "role": "Required", "role_reason": "This condition connects Zameer endpoints/results, original hierarchy, exact effects/intervals and denominators with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Zameer endpoints/results, original hierarchy, exact effects/intervals and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original iAUC effects/CIs, units/denominators and registered plans/analysis are unverified. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What was the acute 50 g/30-minute-premeal exposure?", "needed": "Jakubowicz acute 50 g, 30 minutes before a meal, 180 minutes and actual formulation/control", "role": "Required", "role_reason": "This condition connects Jakubowicz acute 50 g, 30 minutes before a meal, 180 minutes and actual formulation/control with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Jakubowicz acute 50 g, 30 minutes before a meal, 180 minutes and actual formulation/control must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Formulation/manufacturing, control/meal and actual exposure are unverified. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What are the original 28% glucose and 105% insulin findings?", "needed": "Original response percentages, 180 minutes, scale/model, denominators and intervals", "role": "Required", "role_reason": "This condition connects Original response percentages, 180 minutes, scale/model, denominators and intervals with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original response percentages, 180 minutes, scale/model, denominators and intervals must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Response definitions, absolute values/denominators, CIs and exact GLP-1 values are unverified. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Do insulin and GLP-1 answer the long-term clinical question?", "needed": "Mechanistic measures versus separate direct HbA1c, complication and medication outcomes", "role": "Required", "role_reason": "This condition connects Mechanistic measures versus separate direct HbA1c, complication and medication outcomes with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Mechanistic measures versus separate direct HbA1c, complication and medication outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Links between mechanisms and direct long-term outcomes, mediation and clinical analyses are unverified. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is the scope of the 15.6 g protein drink and 7-day study?", "needed": "Smith's 7 days, premeal drink, original 15.6 g, product/control and actual exposure", "role": "Required", "role_reason": "This condition connects Smith's 7 days, premeal drink, original 15.6 g, product/control and actual exposure with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Smith's 7 days, premeal drink, original 15.6 g, product/control and actual exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Product composition, net content, actual adherence and identical long-term exposure are unverified. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What does iAUC 1.6±0.6 versus 2.1±0.9 describe?", "needed": "Original iAUC values, P=.003, units/time, meaning of ± and denominator/model", "role": "Required", "role_reason": "This condition connects Original iAUC values, P=.003, units/time, meaning of ± and denominator/model with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original iAUC values, P=.003, units/time, meaning of ± and denominator/model must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: iAUC units/time, the meaning of ±, denominators/models and CIs are unverified. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What does approximately 100 kcal versus 34 kcal limit?", "needed": "Smith drink calories, calorie imbalance, control composition, meals and other nutrients", "role": "Required", "role_reason": "This condition connects Smith drink calories, calorie imbalance, control composition, meals and other nutrients with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Smith drink calories, calorie imbalance, control composition, meals and other nutrients must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Composition, meal/total-intake changes and between-condition nutrient contributions are unverified. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What is known about Smith's registered/published primary mismatch?", "needed": "Original hierarchy mismatch, ISRCTN and registered/protocol/published endpoints", "role": "Required", "role_reason": "This condition connects Original hierarchy mismatch, ISRCTN and registered/protocol/published endpoints with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original hierarchy mismatch, ISRCTN and registered/protocol/published endpoints must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registered/published primary names, analysis/times and registration chronology/amendments are unverified. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How are long-term whey-only controls and shared treatment established?", "needed": "Long-term whey-only controls, calories/contact, meals/lifestyle/medication and rescue treatment", "role": "Required", "role_reason": "This condition connects Long-term whey-only controls, calories/contact, meals/lifestyle/medication and rescue treatment with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Long-term whey-only controls, calories/contact, meals/lifestyle/medication and rescue treatment must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term whey-only controls/shared care, meal/medication changes and contact are unverified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What stages do 15, 18 and nonnumeric sample wording represent?", "needed": "Original samples, allocation/completion/analysis, crossover/endpoint-specific counts and missing data", "role": "Required", "role_reason": "This condition connects Original samples, allocation/completion/analysis, crossover/endpoint-specific counts and missing data with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original samples, allocation/completion/analysis, crossover/endpoint-specific counts and missing data must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Allocation/completion, endpoint/crossover denominators and missing data/attrition are unverified. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What are crossover sequence, carryover, period effects and analysis?", "needed": "Acute/7-day/MCT crossover, sequence/washout and within-person repeated analysis", "role": "Required", "role_reason": "This condition connects Acute/7-day/MCT crossover, sequence/washout and within-person repeated analysis with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Acute/7-day/MCT crossover, sequence/washout and within-person repeated analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Allocation/concealment, sequence/washout, carryover/period effects and repeated analysis are unverified. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How do glucose, hormone and long-term outcome measurements differ?", "needed": "Outcome-specific devices, units/times, blinding, collection/adjudication and repeats", "role": "Required", "role_reason": "This condition connects Outcome-specific devices, units/times, blinding, collection/adjudication and repeats with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Outcome-specific devices, units/times, blinding, collection/adjudication and repeats must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Measurement/calculation, blinding and long-term measurement/adjudication are unverified. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How do shared medication/meals connect with long-term analysis?", "needed": "Medication, meals/total intake, changes, adherence and comparator/analysis", "role": "Required", "role_reason": "This condition connects Medication, meals/total intake, changes, adherence and comparator/analysis with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Medication, meals/total intake, changes, adherence and comparator/analysis must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Medication/meals, changes/adherence and long-term analysis are unverified. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are long-term target effects, baseline and missing data known?", "needed": "ITT/PP, baseline/covariates, missing data/attrition, adjustment, repeats and sensitivity", "role": "Required", "role_reason": "This condition connects ITT/PP, baseline/covariates, missing data/attrition, adjustment, repeats and sensitivity with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for ITT/PP, baseline/covariates, missing data/attrition, adjustment, repeats and sensitivity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term baseline/models, ITT/PP, adjustment and missing-data/sensitivity analyses are unverified. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What are actual long-term whey exposure, discontinuation and adherence?", "needed": "Product/dose, actual intake, discontinuation, tolerability, follow-up and exposure models", "role": "Required", "role_reason": "This condition connects Product/dose, actual intake, discontinuation, tolerability, follow-up and exposure models with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Product/dose, actual intake, discontinuation, tolerability, follow-up and exposure models must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term actual intake, discontinuation/maintenance and exposure/outcome links are unverified. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What intervals and plans exist for long-term HbA1c or complications?", "needed": "Direct effects/CIs, prespecified plans/power, importance and events/denominators", "role": "Required", "role_reason": "This condition connects Direct effects/CIs, prespecified plans/power, importance and events/denominators with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Direct effects/CIs, prespecified plans/power, importance and events/denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Long-term effects/intervals, prespecified plans/power and importance are unverified. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How are shared reports, populations and outcomes linked?", "needed": "Report/registration/cohort, crossover periods, glucose/hormones and combination/whey-only relationships", "role": "Required", "role_reason": "This condition connects Report/registration/cohort, crossover periods, glucose/hormones and combination/whey-only relationships with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Report/registration/cohort, crossover periods, glucose/hormones and combination/whey-only relationships must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Related reports/cohorts, unique-trial/participant counts and outcome-specific relationships are unverified. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "How much direct replication of the same long-term whey-only question is preserved?", "needed": "Whey formulation/alone, population, duration, comparator, HbA1c/complications and identity", "role": "Required", "role_reason": "This condition connects Whey formulation/alone, population, duration, comparator, HbA1c/complications and identity with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Whey formulation/alone, population, duration, comparator, HbA1c/complications and identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct material for the same long-term whey-only question, conditions/identities and independence are unverified. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are NCT/ISRCTN identifiers separate from actual registration content?", "needed": "NCT01571622, ISRCTN17563146, NCT04905589 and content/dates/hierarchy", "role": "Required", "role_reason": "This condition connects NCT01571622, ISRCTN17563146, NCT04905589 and content/dates/hierarchy with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for NCT01571622, ISRCTN17563146, NCT04905589 and content/dates/hierarchy must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Registry content/dates, timing relative to recruitment, endpoints/analysis and amendments are unverified. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "At what level is industry/product involvement known?", "needed": "Original ministry/Milk Council, Smith product/industry/investigator involvement and Zameer mixed support", "role": "Required", "role_reason": "This condition connects Original ministry/Milk Council, Smith product/industry/investigator involvement and Zameer mixed support with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original ministry/Milk Council, Smith product/industry/investigator involvement and Zameer mixed support must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Support/COI details, roles, analysis involvement and related-study independence are unverified. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Which material was actually read for this table?", "needed": "Complete stored summary versus external abstracts, full texts, registration, plans and support", "role": "Required", "role_reason": "This condition connects Complete stored summary versus external abstracts, full texts, registration, plans and support with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Complete stored summary versus external abstracts, full texts, registration, plans and support must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: External material is unread; access failure or unavailability has not been established either. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are original evidence date, production and current review separate?", "needed": "Original date, empty corrections/deliberation and historical cross-check wording", "role": "Required", "role_reason": "This condition connects Original date, empty corrections/deliberation and historical cross-check wording with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Original date, empty corrections/deliberation and historical cross-check wording must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Current content-review date and new clinical-verification date are unrecorded. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are selected long-term wording and original parent English preserved together?", "needed": "Long-term claim/notes in both languages versus acute/combination/long-term boundaries", "role": "Required", "role_reason": "This condition connects Long-term claim/notes in both languages versus acute/combination/long-term boundaries with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Long-term claim/notes in both languages versus acute/combination/long-term boundaries must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Detailed original-paper, Korean/English translation and correction comparisons are unverified. This records needed materials; no new research was executed." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "How are parent axes and absent subclaim values retained?", "needed": "Parent axes and unrecorded precision versus absent selected score/status/axes", "role": "Required", "role_reason": "This condition connects Parent axes and unrecorded precision versus absent selected score/status/axes with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Parent axes and unrecorded precision versus absent selected score/status/axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Subclaim score/status/axes fields are absent; long-term precision is unverified. This records needed materials; no new research was executed." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are allergy/hypoglycemia cautions actual event data?", "needed": "Harm definitions, original allergy/medication cautions, collection/assessment and event tables", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Harm definitions, original allergy/medication cautions, collection/assessment and event tables with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Harm definitions, original allergy/medication cautions, collection/assessment and event tables must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm definitions/collection, assessors and actual event tables are unverified. This records needed materials; no new research was executed." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What are exposure, symptoms/discontinuation and long-term harm follow-up?", "needed": "Actual intake/meals, medication, event/recovery times and short-/long-term follow-up", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Actual intake/meals, medication, event/recovery times and short-/long-term follow-up with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Actual intake/meals, medication, event/recovery times and short-/long-term follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm onset/recovery, discontinuation and long-term/post-intervention follow-up are unverified. This records needed materials; no new research was executed." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Which comparator defines whey-only or combination harm comparisons?", "needed": "Arm-specific collection/timing, control drinks/calories, meals/medication and event tables", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Arm-specific collection/timing, control drinks/calories, meals/medication and event tables with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Arm-specific collection/timing, control drinks/calories, meals/medication and event tables must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm comparators, identical collection/follow-up and original comparative outcomes are unverified. This records needed materials; no new research was executed." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are harm counts and actual exposure/observation denominators available?", "needed": "Exposure/observation/arm denominators, harm counts, discontinuation and duration", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Exposure/observation/arm denominators, harm counts, discontinuation and duration with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Exposure/observation/arm denominators, harm counts, discontinuation and duration must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Harm counts, actual exposure/observation denominators and duration are unverified. This records needed materials; no new research was executed." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "Are medication, meals, allergy and combination components distinguished?", "needed": "Shared medication/meals, baseline risk, whey/guar/MCT and event chronology", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Shared medication/meals, baseline risk, whey/guar/MCT and event chronology with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Shared medication/meals, baseline risk, whey/guar/MCT and event chronology must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual events, shared factors, baseline risks and causal assessments are unverified. This records needed materials; no new research was executed." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "What are discontinuation/attrition and loss of harm reporting?", "needed": "Discomfort/discontinuation reasons, arm-specific attrition, missing/selective harm reporting and later follow-up", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Discomfort/discontinuation reasons, arm-specific attrition, missing/selective harm reporting and later follow-up with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Discomfort/discontinuation reasons, arm-specific attrition, missing/selective harm reporting and later follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Discontinuation/attrition, missing/selective harm reporting and later follow-up are unverified. This records needed materials; no new research was executed." }, { "item_id": "N43", "question_type": "Evidence condition", "question": "How much is known about independent, vulnerable-population or long-term whey-only harms?", "needed": "Same-formulation/whey-only harms, independent reports, treatment/disease populations and follow-up", "role": "Supplementary; required for extending long-term safety conclusions", "role_reason": "This condition connects Same-formulation/whey-only harms, independent reports, treatment/disease populations and follow-up with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Same-formulation/whey-only harms, independent reports, treatment/disease populations and follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Independent harms, vulnerable/treatment populations and long-term whey-only follow-up are unverified. This records needed materials; no new research was executed." }, { "item_id": "N44", "question_type": "Evidence condition", "question": "Are material versions, application and review status separate?", "needed": "Preserved methodological material, condition versions and production/application records", "role": "Required", "role_reason": "This condition connects Preserved methodological material, condition versions and production/application records with long-term whey alone, separate direct HbA1c and complication outcomes, populations and denominators, duration, actual comparators and exposure, short-term/combination background, support and harms.", "application_exception": "Preserve original subclaim ?, the note that longer combination trials cannot isolate whey, and absent score, status and axes. Acute/several-day glucose and hormones, calorie imbalance and combination iAUC are not direct long-term whey-only HbA1c/complication results. Unverified does not mean no effect, established safety or absence of all research; create no new effects, CIs, totals, grades, independence certification, dosing, medication reduction/replacement or treatment guidance.", "criterion": "Material for Preserved methodological material, condition versions and production/application records must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Completed content review or new official-method/external clinical certification is not established. This records needed materials; no new research was executed." } ] }