{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral Nigella sativa seed or seed-oil supplementation × Body-weight reduction in adults with overweight or obesity", "language": "en", "translation_date": "2026-10-24", "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": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which body-weight question is addressed?", "needed": "Oral seed/seed oil and weight change in kg in adults with overweight or obesity", "role": "Required", "role_reason": "Material on Oral seed/seed oil and weight change in kg in adults with overweight or obesity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Oral seed/seed oil and weight change in kg in adults with overweight or obesity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: An eligibility table for population, formulation, control and timing of the single weight endpoint is needed. Composite glycemia/blood-pressure/lipid claims are excluded. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are seed powder and seed oil kept separate?", "needed": "Original trials and product/constituent tables by powder/oil formulation", "role": "Required", "role_reason": "Material on Original trials and product/constituent tables by powder/oil formulation is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original trials and product/constituent tables by powder/oil formulation must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product, extraction, standardized constituent quantities and inclusion tables by formulation are needed. A mixed pooled mean does not establish efficacy or equivalence for each formulation. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Can doses and active quantities be converted into equivalents?", "needed": "Trial-specific dose, frequency, actual exposure and active constituents", "role": "Required", "role_reason": "Material on Trial-specific dose, frequency, actual exposure and active constituents is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific dose, frequency, actual exposure and active constituents must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original doses, constituents/units, adherence and actual administration are needed. Powder/oil dose equivalence is unverified. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are overall durations distinguished from 8 weeks or less?", "needed": "Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less", "role": "Required", "role_reason": "Material on Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original treatment, measurement, follow-up/post-discontinuation timing and tables by duration group are needed. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are overweight/obesity and mixed-disease studies distinguished?", "needed": "Inclusion composition by diagnosis, baseline weight/BMI and comorbidity", "role": "Required", "role_reason": "Material on Inclusion composition by diagnosis, baseline weight/BMI and comorbidity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Inclusion composition by diagnosis, baseline weight/BMI and comorbidity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial tables of diagnosis, selection, age, baseline weight and comorbidity are needed. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are placebo and control-condition arrangements the same?", "needed": "Trial-specific control constituents, management and cointerventions by arm", "role": "Required", "role_reason": "Material on Trial-specific control constituents, management and cointerventions by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific control constituents, management and cointerventions by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original records of control composition, masking, lifestyle management and adherence are needed. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Can the effects of concomitant diet and exercise be distinguished?", "needed": "Matching dietary restriction, exercise, management and concomitant use by arm", "role": "Required", "role_reason": "Material on Matching dietary restriction, exercise, management and concomitant use by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Matching dietary restriction, exercise, management and concomitant use by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original diet/exercise arrangements, arm-specific adherence, energy/weight changes and additional interventions are needed. The effect is not isolated as that of seed oil alone. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are medication, other treatment and weight changes distinguished?", "needed": "Baseline medications, disease treatment, changes and arm-specific management", "role": "Required", "role_reason": "Material on Baseline medications, disease treatment, changes and arm-specific management is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Baseline medications, disease treatment, changes and arm-specific management must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Records of medications for glycemia/blood pressure, other treatment, weight-related changes and arm-specific maintenance are needed. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the 2018 and 2023 reviews retained as separate reports?", "needed": "Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews", "role": "Required", "role_reason": "Material on Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Search dates, eligibility criteria, included trials and correspondence with additional reports/registration are needed. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What is the scope of the 13 trials and 875 participants in 2018?", "needed": "R01 included trials/participants and weight-endpoint denominators", "role": "Required", "role_reason": "Material on R01 included trials/participants and weight-endpoint denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R01 included trials/participants and weight-endpoint denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Inclusion tables and original trials/arm-specific randomized, analyzed and completion denominators by weight endpoint are needed. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the updated review’s 21 trials distinguished from 15 studies and 16 weight comparisons?", "needed": "Study/comparison/participant units for the whole review and weight analysis", "role": "Required", "role_reason": "Material on Study/comparison/participant units for the whole review and weight analysis is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Study/comparison/participant units for the whole review and weight analysis must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Multi-arm, shared-control and sample correspondence for the 15 studies/16 comparisons and original extraction tables are needed. The 21 trials are not converted into a count of unique weight trials. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What analysis denominator does approximately 995 participants describe?", "needed": "Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description", "role": "Required", "role_reason": "Material on Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original extraction, randomization, analysis, completion and missing-data tables, with overlapping-sample links, are needed. No new total is calculated. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Can original trials shared by the reviews be linked?", "needed": "Review–original-trial–additional-report and same-participant correspondence", "role": "Required", "role_reason": "Material on Review–original-trial–additional-report and same-participant correspondence is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review–original-trial–additional-report and same-participant correspondence must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Each review’s included articles, registration, institution/time and sample correspondence are needed. Final unique-trial and unique-participant totals remain null. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What is the 2018 weight estimate?", "needed": "R01 weight in kg, 95% CI, heterogeneity and analysis arrangements", "role": "Required", "role_reason": "Material on R01 weight in kg, 95% CI, heterogeneity and analysis arrangements is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R01 weight in kg, 95% CI, heterogeneity and analysis arrangements must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original pooling tables, inclusions/weights, final values versus changes and models are needed. Effects are not recalculated. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What is the 2023 overall weight estimate?", "needed": "R02 weight in kg, 95% CI and original analysis scope", "role": "Required", "role_reason": "Material on R02 weight in kg, 95% CI and original analysis scope is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R02 weight in kg, 95% CI and original analysis scope must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original weight-pooling tables, weights, variance, models and extraction/timing material are needed. Values are not replicated as results for each formulation/population. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is extreme heterogeneity retained alongside the mean?", "needed": "Overall heterogeneity and formulation/disease/duration/cointervention explanations", "role": "Required", "role_reason": "Material on Overall heterogeneity and formulation/disease/duration/cointervention explanations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Overall heterogeneity and formulation/disease/duration/cointervention explanations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Heterogeneity, sensitivity/classification, model and original-trial material are needed. Prediction intervals or causal proportions are not invented, and effects are not generalized to everyone. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is the null obesity-subgroup finding distinguished from the positive overall result?", "needed": "Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups", "role": "Required", "role_reason": "Material on Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original subgroup definitions, effects/CIs, denominators, interactions and prospective plans are needed. The overall −1.46 kg is not replicated as the subgroup value. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is the null finding at 8 weeks or less retained?", "needed": "Duration-subgroup definitions, effects, CIs and denominators", "role": "Required", "role_reason": "Material on Duration-subgroup definitions, effects, CIs and denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Duration-subgroup definitions, effects, CIs and denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original duration tables, prespecification, interactions and formulation/population differences are needed. The overall estimate is not substituted for a short-duration subgroup value. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are powder/oil subgroups equivalent to a direct superiority comparison?", "needed": "Effects/CIs, denominators and prespecification by formulation, and direct comparisons", "role": "Required", "role_reason": "Material on Effects/CIs, denominators and prespecification by formulation, and direct comparisons is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Effects/CIs, denominators and prespecification by formulation, and direct comparisons must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original formulation-subgroup tables, prospective plans, interactions and direct comparisons are needed. Seed/oil superiority or equivalence is not established. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are earlier favorable directions kept distinct from independent replication?", "needed": "Links between earlier reviews mentioned in the narrative, structured reports and original trials", "role": "Supplementary", "role_reason": "Material on Links between earlier reviews mentioned in the narrative, structured reports and original trials is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Links between earlier reviews mentioned in the narrative, structured reports and original trials must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Corresponding citations, years and included trials for each narrative statement are needed. Agreement in review directions does not certify independent replication of an identical formulation. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are weight in kg, BMI and waist circumference separate endpoints?", "needed": "Definitions, units, denominators and timing for weight in kg versus BMI/waist", "role": "Required", "role_reason": "Material on Definitions, units, denominators and timing for weight in kg versus BMI/waist is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Definitions, units, denominators and timing for weight in kg versus BMI/waist must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original effects/CIs, units, denominators and hierarchy are requested separately for each endpoint. BMI is not converted into kg. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What are the weight-measurement, baseline-adjustment and change-score arrangements?", "needed": "Measurement procedures, baseline weight, final values versus changes, variance and analysis populations", "role": "Required", "role_reason": "Material on Measurement procedures, baseline weight, final values versus changes, variance and analysis populations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Measurement procedures, baseline weight, final values versus changes, variance and analysis populations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original measurement, timing, baseline values, extraction tables, variance handling/models and analysis plans are needed. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What supports allocation, masking and risk assessment?", "needed": "Original-RCT allocation, concealment, masking and individual assessment grounds", "role": "Required", "role_reason": "Material on Original-RCT allocation, concealment, masking and individual assessment grounds is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original-RCT allocation, concealment, masking and individual assessment grounds must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial methods, registration/plans and the reviews’ assessment grounds are needed. No formal RoB2/GRADE or new suitability judgment is produced. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is known about missing data, withdrawals, analysis exclusions and selective reporting?", "needed": "Missing weight data, withdrawals, analysis sets and all time points by arm", "role": "Required", "role_reason": "Material on Missing weight data, withdrawals, analysis sets and all time points by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Missing weight data, withdrawals, analysis sets and all time points by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific flows, exclusion reasons, missing-data handling, original results at all time points and sensitivity material are needed. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are PROSPERO review registration and original-trial registration distinguished?", "needed": "Review plans for CRD42022358471 and registration for each original trial", "role": "Required", "role_reason": "Material on Review plans for CRD42022358471 and registration for each original trial is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review plans for CRD42022358471 and registration for each original trial must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original review registration, versions/dates and plans, plus individual-trial registrations, are needed. A recorded identifier is not promoted to current reading or certification of adherence to plans. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is a prospective hierarchy for the main weight analysis and subgroups confirmed?", "needed": "Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity", "role": "Required", "role_reason": "Material on Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Review/original-trial protocols, SAPs, registration versions and all result tables are needed. No new conclusion that subgroups were post hoc is made. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are importance, sustained loss and clinical effects kept within the retained scope?", "needed": "Original weight-importance criteria, responders and long-term/post-discontinuation course", "role": "Supplementary", "role_reason": "Material on Original weight-importance criteria, responders and long-term/post-discontinuation course is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original weight-importance criteria, responders and long-term/post-discontinuation course must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct material on prospective importance/responders, body composition, persistence/regain and clinical events is needed. A mean in kg is not converted into individual success rates or large/sustained loss. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are independent replication and optimal dosing of an identical formulation confirmed?", "needed": "Original-trial families and independent teams for an identical product/population/comparator/duration", "role": "Supplementary", "role_reason": "Material on Original-trial families and independent teams for an identical product/population/comparator/duration is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original-trial families and independent teams for an identical product/population/comparator/duration must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct studies linking trial families, products, teams/funding and dose/timing are needed. Final unique-trial and participant numbers remain null. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are the four channels of company involvement known?", "needed": "Review/trial-specific funding, product support, employee authorship and COI", "role": "Required", "role_reason": "Material on Review/trial-specific funding, product support, employee authorship and COI is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review/trial-specific funding, product support, employee authorship and COI must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding, product provision, author affiliations and COI are needed. Unverified information is not converted into a strength for independence. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are harm collection, events and discontinuations known?", "needed": "Adverse-event definitions, active/passive collection, severity and discontinuations", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, active/passive collection, severity and discontinuations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Adverse-event definitions, active/passive collection, severity and discontinuations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original harm methods, events, discontinuations and missing-data material are needed. Unread material is not converted into an absence of events. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What are the harm denominators and exposure durations?", "needed": "Arm-specific safety sets, actual administration, exposure and events/controls", "role": "Supplementary", "role_reason": "Material on Arm-specific safety sets, actual administration, exposure and events/controls is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Arm-specific safety sets, actual administration, exposure and events/controls must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Safety denominators, arm-specific event counts, exposure, control groups and withdrawal records are needed. Incidence or participant totals are not calculated. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What is known about concomitant medicines, alternative causes and event timing?", "needed": "Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course", "role": "Supplementary", "role_reason": "Material on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original concomitant use, baseline disease, changes, event timing, controls and dechallenge/rechallenge records are needed. No new causality judgment is made. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are long-term, rare and vulnerable-population harms certified?", "needed": "Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators", "role": "Supplementary", "role_reason": "Material on Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term, rare and vulnerable-population material, independent event reports, exposure and denominators are needed. No new harm search or reassessment is executed. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are actual stored-summary reading and external-source links distinguished?", "needed": "Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs", "role": "Required", "role_reason": "Material on Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External material remains unread before user-provided acquisition and review. A URL/registration number alone does not establish reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are generic English wording, corrections and Korean/English expressions preserved?", "needed": "Original Korean/English records and limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "Material on Original Korean/English records and limits of the 2026-09-14 correction is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original Korean/English records and limits of the 2026-09-14 correction must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Earlier correction targets and external English-source comparison are not revisited here. The original correction is not presented as newly completed QA. This records needed materials; no new research was executed." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are original grades, axes, evidence date and production kept separate?", "needed": "Original C46, Caution, axes, evidence date and correction values", "role": "Required", "role_reason": "Material on Original C46, Caution, axes, evidence date and correction values is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original C46, Caution, axes, evidence date and correction values must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events after user review. The original evidence date is not converted into a current search end date or external-reading date. This records needed materials; no new research was executed." } ] }