{ "schema_version": "chamgap-public-criteria-1.0", "title": "Phytosomal Curcumin 250 mg/day × Migraine-Attack Frequency at 8 Weeks in Adults With Migraine Without Aura", "language": "en", "translation_date": "2026-10-25", "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 migraine-attack frequency question is covered?", "needed": "An 8-week phytosomal-curcumin add-on comparison for migraine without aura", "role": "Required", "role_reason": "Material on An 8-week phytosomal-curcumin add-on comparison for migraine without aura is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on An 8-week phytosomal-curcumin add-on comparison for migraine without aura must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct original paper, protocol and registration. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which adults with migraine are represented?", "needed": "Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment", "role": "Required", "role_reason": "Material on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the phytosomal formulation interchangeable with other curcumin?", "needed": "Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations", "role": "Required", "role_reason": "Material on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Formulation, product, batch and quantification material. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the dose and actual intake?", "needed": "Phytosomal curcumin 250 mg/day and actual adherence", "role": "Required", "role_reason": "Material on Phytosomal curcumin 250 mg/day and actual adherence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Phytosomal curcumin 250 mg/day and actual adherence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Product amount, ingredient amount and adherence records. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the treatment and follow-up times?", "needed": "Treatment/follow-up over 8 weeks and persistence after stopping", "role": "Required", "role_reason": "Material on Treatment/follow-up over 8 weeks and persistence after stopping is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Treatment/follow-up over 8 weeks and persistence after stopping must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Measurement schedule and follow-up plan. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What was the contribution of standard treatment and concurrent medication?", "needed": "Continuation/changes in standard treatment, preventive medication and rescue medication in both groups", "role": "Required", "role_reason": "Material on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Concurrent, preventive and rescue medication tables. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What was the maltodextrin-placebo comparison?", "needed": "Conditions of maltodextrin placebo added to standard treatment", "role": "Required", "role_reason": "Material on Conditions of maltodextrin placebo added to standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Conditions of maltodextrin placebo added to standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo and concurrent-treatment specifications. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How is the direct report identified?", "needed": "Shojaei report title, PMID, DOI and retained result", "role": "Required", "role_reason": "Material on Shojaei report title, PMID, DOI and retained result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Shojaei report title, PMID, DOI and retained result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct original paper and bibliographic record. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is an IRCT number the same as actual registration verification?", "needed": "IRCT20201129049534N2, registration timing, endpoints and history", "role": "Required", "role_reason": "Material on IRCT20201129049534N2, registration timing, endpoints and history is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on IRCT20201129049534N2, registration timing, endpoints and history must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration and change history. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Was attack frequency the single prespecified primary endpoint (1st in the hierarchy)?", "needed": "Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints", "role": "Required", "role_reason": "Material on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Protocol, SAP and registered endpoints. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What were the randomization and concealment methods?", "needed": "Randomization procedures, concealment and recruitment flow", "role": "Required", "role_reason": "Material on Randomization procedures, concealment and recruitment flow is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Randomization procedures, concealment and recruitment flow must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods and participant flow diagram. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How were blinding and outcome measurement maintained?", "needed": "Participant/assessor blinding and placebo matching", "role": "Required", "role_reason": "Material on Participant/assessor blinding and placebo matching is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Participant/assessor blinding and placebo matching must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Blinding, placebo and outcome-recording methods. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How are 70 randomized participants and 65 completers distinguished?", "needed": "The 70 randomized participants, 65 completers and group correspondence for 33 versus 32", "role": "Required", "role_reason": "Material on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Group-specific allocation, completion and analysis flow and result tables. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What was the exact ITT analysis population?", "needed": "ITT, completer analyses and inclusion criteria for the frequency result", "role": "Required", "role_reason": "Material on ITT, completer analyses and inclusion criteria for the frequency result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on ITT, completer analyses and inclusion criteria for the frequency result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Analysis-population definitions, ITT, SAP and result tables. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What effects could missingness and withdrawal have?", "needed": "Group-specific withdrawal reasons, missing-data handling and sensitivity analyses", "role": "Required", "role_reason": "Material on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Missing-data and withdrawal reasons and analysis material. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "In which units was attack frequency measured?", "needed": "Attack definition, frequency per period, diaries and baseline values", "role": "Required", "role_reason": "Material on Attack definition, frequency per period, diaries and baseline values is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Attack definition, frequency per period, diaries and baseline values must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Frequency definition, diaries, baseline values and result tables. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What was the exact between-group effect on frequency?", "needed": "Frequency-specific between-group change and analysis model", "role": "Required", "role_reason": "Material on Frequency-specific between-group change and analysis model is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Frequency-specific between-group change and analysis model must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original frequency-specific group values and between-group estimate tables. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is there a confidence interval for the frequency effect?", "needed": "Exact frequency-specific between-group 95% CI", "role": "Required", "role_reason": "Material on Exact frequency-specific between-group 95% CI is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Exact frequency-specific between-group 95% CI must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Between-group 95% CI and analysis output. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What was the P value in the direct phytosomal trial?", "needed": "Exact frequency-specific between-group P value, distinguished from values in another trial", "role": "Required", "role_reason": "Material on Exact frequency-specific between-group P value, distinguished from values in another trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Exact frequency-specific between-group P value, distinguished from values in another trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Frequency-specific analysis tables and SAP. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are other clinical endpoints distinguished from frequency?", "needed": "Separate results for frequency, duration, intensity, quality of life and sleep", "role": "Required", "role_reason": "Material on Separate results for frequency, duration, intensity, quality of life and sleep is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Separate results for frequency, duration, intensity, quality of life and sleep must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Prespecified plans and result tables for all endpoints. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Was the change in attack count important to patients?", "needed": "Minimum important difference, responders, medication use and patient-important outcomes", "role": "Required", "role_reason": "Material on Minimum important difference, responders, medication use and patient-important outcomes is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Minimum important difference, responders, medication use and patient-important outcomes must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Responder, important-difference and patient-outcome material. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is the conventional-curcumin trial in 44 people the same intervention?", "needed": "A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks", "role": "Required", "role_reason": "Material on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Separate original paper, result tables and intervention specifications. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What differences separate the trials?", "needed": "Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day", "role": "Required", "role_reason": "Material on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific intervention, population and analysis specifications. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are mechanistic, omega-3 and CoQ10 reports counted as clinical replication?", "needed": "Directness of mechanistic markers and combination trials", "role": "Required", "role_reason": "Material on Directness of mechanistic markers and combination trials is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Directness of mechanistic markers and combination trials must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Related-report lists, cohorts, interventions and endpoint material. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How far are unique trials and independent replications established?", "needed": "Report-trial-endpoint relationships and independence", "role": "Required", "role_reason": "Material on Report-trial-endpoint relationships and independence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Report-trial-endpoint relationships and independence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Report-trial mapping and specifications of replication-study interventions. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What information is retained on research funding?", "needed": "Funding for the direct trial and the separate academic-institution trial", "role": "Required", "role_reason": "Material on Funding for the direct trial and the separate academic-institution trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Funding for the direct trial and the separate academic-institution trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding and institutional-role statements. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are product supply and manufacturer involvement known?", "needed": "Free product support, manufacturer, batches and institutional roles", "role": "Required", "role_reason": "Material on Free product support, manufacturer, batches and institutional roles is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Free product support, manufacturer, batches and institutional roles must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Product-supply and manufacturer-role material. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Does no-conflict wording answer employee-authorship and support questions?", "needed": "Distinction among COI declarations, affiliations, employee authors and individual support", "role": "Required", "role_reason": "Material on Distinction among COI declarations, affiliations, employee authors and individual support is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Distinction among COI declarations, affiliations, employee authors and individual support must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original COI, affiliation and support statements. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Does no reported adverse reaction establish safety?", "needed": "Adverse-event definitions, collection, group-specific events and exposure denominators", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, collection, group-specific events and exposure denominators is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Adverse-event definitions, collection, group-specific events and exposure denominators must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event collection methods and group-specific tables. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are harms beyond 8 weeks and concurrent-treatment risks answered?", "needed": "Follow-up of long-term/rare harms, concurrent medication and vulnerable groups", "role": "Supplementary", "role_reason": "Material on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term follow-up, concurrent-medication and harm-denominator material. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can findings be extended to replacing preventive medication or other products?", "needed": "Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations", "role": "Required", "role_reason": "Material on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons for replacement treatment and other formulations. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the current English wording and historical language correction?", "needed": "Retained Korean/English wording, generic English text and the correction event of 2026-09-14", "role": "Required", "role_reason": "Material on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original wording before/after correction and language-mapping material. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How are the original C score of 50, axes and historical verification retained?", "needed": "Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check", "role": "Required", "role_reason": "Material on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What dates, unrecorded information and actual reading scope are retained?", "needed": "Original verdict date, correction date, empty detailed-claim list and external material unread", "role": "Required", "role_reason": "Material on Original verdict date, correction date, empty detailed-claim list and external material unread is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.", "application_exception": "Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.", "criterion": "Original material and analysis scope on Original verdict date, correction date, empty detailed-claim list and external material unread must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Required originals and planning material when provided. This records needed materials; no new research was executed." } ] }