{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Single-ingredient garlic tablets 900 mg/day; powder, processing, and active-constituent specifications unverified × Reduction of HbA1c in adults with type 2 diabetes",
  "language": "en",
  "translation_date": "2026-10-26",
  "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": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.",
    "Unverified": "Direct information is unverified in the retained record. This does not establish an effect of 0, no studies or absence of harm.",
    "Review incomplete": "Reading of the material or review of a condition is incomplete. This does not establish absence of studies or efficacy.",
    "Not reported": "The needed information was not found in material actually read. This is distinguished from unread material.",
    "Inaccessible": "Access was actually attempted but the material was not acquired. This is distinguished from access not attempted.",
    "Insufficient evidence matching the conditions": "Evidence directly matching the defined question and conditions is insufficient. This does not establish absence of all research.",
    "Not applicable": "A specific condition does not apply to the question. This does not substitute for unread or unverified material.",
    "Conflicting data": "This covers discrepancies in material about the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicts.",
    "Met": "The retained identity, observation or scope required by this item was checked within stated limits. This does not establish efficacy or full-text certification."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Is the selected 900 mg tablet, 24-week HbA1c comparison with placebo distinguished from other garlic claims?",
      "needed": "Original locations for the current claim, formulation/route, selected dose, population, endpoint, comparator and timing",
      "role": "Required",
      "role_reason": "The specific HbA1c question with evidence gaps must first be fixed.",
      "application_exception": "Verifying the question’s identity does not verify the absolute effect or formulation specifications.",
      "criterion": "Link the current article’s selected 900 mg/day, 24-week HbA1c and placebo question to excluded endpoints.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Review separate boundaries only when adding a new question. A new clinical trial is not required to identify this question."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Have the 7-arm primary trial and two meta-analyses been kept from being double-counted as independent trials?",
      "needed": "Links among primary reports, reviews, included-trial tables, registrations and report families",
      "role": "Required",
      "role_reason": "Counting multiple arms and reviews as additional independent replications inflates the evidence.",
      "application_exception": "Retain null values and unverified states when original family tables and unique-participant relationships are unavailable.",
      "criterion": "Separate the roles of 1 primary-trial report and 2 meta-analysis reports, the same 7 arms, and unresolved included-trial overlap.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "First construct a study-level results table by comparing included-trial tables with registration numbers, authors and recruitment periods."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are the summaries actually read in this conversion distinguished from reading external papers, supplements and registrations?",
      "needed": "Material identity, public/access status, acquisition, actual reading level, date, original location and identity",
      "role": "Required",
      "role_reason": "External links and retained summaries must not be represented as reading a paper’s full text.",
      "application_exception": "Access not attempted differs from inaccessible, failed access and 0 results.",
      "criterion": "Show actual reading of the local retained summary separately from external material unread in this conversion, and link summaries to their exact original locations.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "For lawfully acquired material, record the sections/tables read and file identity in a separate event."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are adults with type 2 diabetes and the actual selection/baseline status in the selected primary trial verified?",
      "needed": "Diagnosis, age, baseline HbA1c, inclusion/exclusion, baseline medication/disease and balance between arms",
      "role": "Required",
      "role_reason": "Sharing the label diabetes does not make a meta-analysis’s mixed populations applicable to this population.",
      "application_exception": "Do not transfer figures from other populations or formulations to the selected arms.",
      "criterion": "Explain the match between the primary trial’s actual population and the selected question, and unverified baseline/selection details.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve the primary trial’s Methods and baseline table to review population matching, separating direct population-specific studies when needed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the source, specifications and active constituents of the selected single-ingredient garlic tablet verified?",
      "needed": "Exact product name, manufacturing/processing, powder/extraction method, batch, alliin/allicin assays and single-ingredient composition",
      "role": "Required",
      "role_reason": "Food, oil, AGE and black garlic must not be mixed with the tablet’s actual exposure.",
      "application_exception": "The source Allium sativum cloves alone does not establish processing or active-constituent specifications.",
      "criterion": "Distinguish the verified scope of an oral single-ingredient tablet from unverified specifications, and exclude other garlic formulations.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "First check the primary trial’s product documents and constituent assays; design formulation-specific effect studies as separate comparisons."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are the per-dose amount, divided schedule and actual intake of 900 mg/day verified?",
      "needed": "Dosing table for the 900 mg arm, per-dose amount/frequency, actual intake, adherence and product content",
      "role": "Required",
      "role_reason": "Nominal daily dose must be distinguished from actual administered exposure to attribute the selected dose accurately.",
      "application_exception": "Do not import other dose arms or meta-analysis dose-response results as the selected 900 mg schedule.",
      "criterion": "Preserve the original 900 mg/day and record unverified divided dosing, intake and active-constituent amounts.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve the primary trial’s dosing table and adherence data. Review direct dose comparisons separately for an optimal-dose claim."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are common glucose-lowering medication, changes and adherence in the placebo and 900 mg arms verified?",
      "needed": "Common glucose-lowering drugs by arm, stable-treatment period, changes/rescue treatment, adherence and analytical handling",
      "role": "Required",
      "role_reason": "Contributions from other glucose-lowering treatment must not be attributed to the selected garlic effect.",
      "application_exception": "Metformin is a separate active arm and is not assumed to be common maintenance medication.",
      "criterion": "Distinguish common treatment in both arms from a separate active arm, recording the impact of unverified concomitant treatment/changes.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "First check the primary trial’s Methods, concomitant-medication table, treatment changes and SAP to clarify the effect of interest."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are the actual roles of placebo tablets and the separate metformin active arm verified?",
      "needed": "Allocation table for the 7 arms, placebo composition/appearance, active-arm dose, common treatment and selected contrast",
      "role": "Required",
      "role_reason": "Garlic versus placebo and garlic versus an active drug are different questions.",
      "application_exception": "Do not substitute the separate active drug for placebo or common background treatment in both arms.",
      "criterion": "Fix the selected contrast as 900 mg versus placebo, explaining unverified placebo details and actual active-arm composition.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve arm-composition/allocation tables and define a separate question before adding an active-drug comparison."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are the actual schedules of 24-week treatment and measurements at 12 and 24 weeks verified?",
      "needed": "Treatment/testing schedules by arm, baseline/12-week/24-week measurements, completion/stopping and follow-up duration",
      "role": "Required",
      "role_reason": "A 12-week interim value must not become the selected 24-week effect or a sustained effect after treatment stops.",
      "application_exception": "Distinguish measurement times from actual completed follow-up and long-term maintenance duration.",
      "criterion": "Preserve the selected 24-week endpoint and 12-week interim measurement, leaving actual schedules/losses by arm unverified.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve original schedules and time-specific measurement/completion data; effects after stopping require separate follow-up."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the definition and units of absolute between-group HbA1c change verified?",
      "needed": "Units, baseline/final values/change, contrast of interest, direction and analytical definition for 24-week HbA1c",
      "role": "Required",
      "role_reason": "Significance, glucose values and pooled means must not be mixed with the selected absolute HbA1c effect.",
      "application_exception": "Do not interchange % and %p, within-group before/after and between-group comparisons, or final values and changes.",
      "criterion": "Distinguish the question of absolute between-group HbA1c change at 24 weeks from the level of actually reported results and unverified information.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve baseline/final/change values and contrast definitions from the original results table to link them to the selected effect."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are HbA1c assay methods, collection times and assessment procedures verified?",
      "needed": "Laboratory method/standardization, blood-collection timing, identical procedures by arm, assessor blinding and error handling",
      "role": "Required",
      "role_reason": "Actual procedures are needed to examine whether differences in measurement conditions could explain result differences.",
      "application_exception": "The objective-marker name HbA1c alone does not establish absence of measurement bias.",
      "criterion": "Explain the actual scope and unverified aspects of testing, collection, standardization and blinding.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Acquire the original Methods, laboratory procedures and measurement-quality data."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Can the described 210 participants and 30 per arm be distinguished from actual 900 mg/placebo analysis denominators at 24 weeks?",
      "needed": "Recruitment/allocation, completion by arm, 24-week measurements, ITT/PP analysis n and participant flow diagram",
      "role": "Required",
      "role_reason": "A described sample size must not be established as a completed/analysis denominator.",
      "application_exception": "Do not substitute 30 in each of 7 arms for an analysis of 210 in the 900 mg/placebo contrast.",
      "criterion": "Preserve the original description of 210 participants and 30 per arm, distinguishing recruitment/allocation/completion/analysis roles and unverified information.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve original flow diagrams and arm-by-time/analysis tables to link the actual denominators for the selected contrast."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are missingness, dropout, exclusions and analytical handling in the selected two arms verified?",
      "needed": "Missingness/dropout by arm, exclusion reasons, imputed values, ITT/PP and sensitivity analyses",
      "role": "Required",
      "role_reason": "Original sample size alone cannot establish that no analysis losses occurred.",
      "application_exception": "Do not fill losses absent from the current summary with 0 or 100% completion.",
      "criterion": "Verify actual losses/handling for the selected 900 mg/placebo arms or explain that they remain unverified within the current material.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Acquire participant flow diagrams, analysis plans and sensitivity-analysis material."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are randomization methods, concealment and baseline balance in the 7-arm controlled trial verified?",
      "needed": "Original random sequence, allocation concealment, arm composition, baseline tables and recruitment process",
      "role": "Required",
      "role_reason": "Controlled-trial/review-RCT labels must not be inherited as adequate allocation in the primary trial.",
      "application_exception": "An unverified randomization method does not establish that the trial was nonrandomized.",
      "criterion": "Distinguish the 7-arm single-blind controlled-trial wording from unverified allocation/concealment/balance.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve original Methods, allocation and baseline data to examine design limitations for the selected contrast."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are the people blinded, placebo appearance and assessment blinding verified?",
      "needed": "Who was blinded, placebo appearance, blinding assessment/unblinding and tester procedures",
      "role": "Required",
      "role_reason": "The single-blind label must not be read as resolving all performance/measurement bias.",
      "application_exception": "An objective endpoint does not erase unverified performance/concomitant-treatment differences or measurement procedures.",
      "criterion": "Distinguish original blinding wording from unverified people and actual procedures for each outcome.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Acquire the primary trial’s blinding Methods and placebo/measurement procedures."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are ITT/PP, adjustment, between-group contrasts and analytical models for the selected result verified?",
      "needed": "Original SAP, ITT/PP analysis populations, baseline adjustment, between-/within-group comparisons and multi-arm contrast definitions",
      "role": "Required",
      "role_reason": "Without knowing which effect is estimated, the P value cannot be read as the selected absolute between-group effect.",
      "application_exception": "Do not arbitrarily fill the analysis as ITT or turn within-group improvement into an additional effect.",
      "criterion": "Compare the absolute between-group effect of interest at 24 weeks with actual analytical definitions and unverified aspects.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve the selected results table and analysis plan/model to link contrasts, denominators and adjustment."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are the attribution of P<.005 for each garlic arm versus placebo and the selected effect’s limitations distinguished?",
      "needed": "Original 24-week results table, contrasts by arm, tests, multiple comparisons and effect definition",
      "role": "Required",
      "role_reason": "P values and effect size/precision provide different information.",
      "application_exception": "Do not convert each dose arm’s P value into the selected absolute %p or CI, or pool them as identical effects.",
      "criterion": "Attribute P<.005 to the original statement and show alongside it that the 900 mg absolute effect and CI remain unverified.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Acquire the original results table and handling of multiple arms in testing, linking only the selected contrast separately."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are the absolute 24-week HbA1c effect and 95%CI for the selected 900 mg tablet verified?",
      "needed": "Baseline/final/change HbA1c in the selected/placebo arms, absolute between-group %p, variance, 95%CI and evidence for an important difference",
      "role": "Required",
      "role_reason": "Primary-trial counts, significance and pooled means cannot determine the selected effect’s size or adequacy.",
      "application_exception": "Do not calculate and fill missing effects or CIs from P values or meta-analysis WMDs for other formulations.",
      "criterion": "Link the selected 900 mg absolute effect, interval and evidence for importance, or leave them precisely unverified.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve the primary trial’s selected results table, variance and denominators. If unavailable, quantitative replication research needs prespecified outcome reporting."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Can the primary trial’s prespecified 24-week HbA1c rank 1 outcome hierarchy and analysis plan be compared with actual reporting?",
      "needed": "Contemporaneous primary-trial registration versions, protocol, SAP, endpoints/times and multi-arm change history",
      "role": "Required",
      "role_reason": "Comparing prespecified plans with reports is needed to examine favorable selection of endpoints, times or arms.",
      "application_exception": "Unable to verify registration does not establish nonregistration; do not use review PROSPERO as a primary-trial NCT.",
      "criterion": "Explicitly state that a prespecified single rank 1 primary endpoint is unverified and registration/SAP were not compared, separating review registration.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve contemporaneous registration, protocol and SAP to compare the prespecified hierarchy for 24-week HbA1c and the selected 900 mg contrast."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Is material available to distinguish the pooled HbA1c value from 3 trials and 7 effects from the selected tablet’s effect?",
      "needed": "HbA1c included trials, formulations/doses, populations, background treatments, times and effect/shared-control tables in the first meta-analysis",
      "role": "Required (applying pooled evidence)",
      "role_reason": "Multi-arm effects from the same trial and varied formulations/concomitant treatments must not be pooled as the selected 900 mg effect.",
      "application_exception": "Do not substitute 7 independent trials for 3 trials and 7 effects.",
      "criterion": "Explain the reported WMD/CI, roles of 3 trials and 7 effects, mixed formulations/background treatments and indirectness for the selected effect.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve included-trial tables and original results to link exposure, timing and shared controls for each HbA1c effect."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Is the overall scale of 27 RCTs and 1,619 participants across all endpoints distinguished from the HbA1c analysis scale?",
      "needed": "Endpoint-specific trials/participants, products, populations, times, background treatments and HbA1c analysis tables in the second meta-analysis",
      "role": "Required (applying pooled evidence)",
      "role_reason": "Reading all-endpoint scale as the sample size for HbA1c or the selected 900 mg comparison overstates precision.",
      "application_exception": "The 27 RCTs and 1,619 participants describe all endpoints; do not transfer them as unique HbA1c analysis n.",
      "criterion": "Preserve overall scale and HbA1c WMD/CI separately, marking endpoint-specific denominators and directness unverified.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve endpoint-specific included-trial/effect tables, products and durations to separate the relevant HbA1c analysis."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are included-trial and unique-participant overlaps between the primary trial and the two reviews verified?",
      "needed": "Included-trial tables for both reviews, primary/multi-arm reports, registration numbers, recruitment sites/periods and unique-participant links",
      "role": "Required (independent replication)",
      "role_reason": "Different reviews citing the same primary trial do not add independent replication evidence.",
      "application_exception": "Different bibliographic DOIs for reviews alone do not establish independent included trials/participants.",
      "criterion": "Explain the verified scope of primary-trial inclusion, overlap between reviews and unique-study/participant counts.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "First construct a report-family table, comparing recruitment periods, sites and registrations to verify overlap."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are the scope and causes of I²96.4% and a positive publication-bias test in the first meta-analysis verified?",
      "needed": "HbA1c effect distributions, I²/variance, heterogeneity/bias-test methods, prespecified hypotheses and missing results",
      "role": "Required (interpreting pooled evidence)",
      "role_reason": "The positive pooled mean and extreme heterogeneity must both be retained.",
      "application_exception": "A positive test alone must not generate a missing-trial count or corrected effect, or invalidate all trials.",
      "criterion": "Link reported heterogeneity, the positive test and unverified methods/causes to limitations in applying results to the selected formulation.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve original forest plots, tests and formulation/background-treatment/time-specific results to review explanations for heterogeneity."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Have −0.50%p and −0.53%p been kept from being forced into the same analysis or an actual conflict?",
      "needed": "Results/CIs, analysis scope, products/background treatments and endpoint-specific inclusion differences between the two reviews",
      "role": "Required",
      "role_reason": "Differences between means with different analytical scopes must neither be ignored nor declared conflicts about the same question.",
      "application_exception": "Differences between review estimates alone do not establish conflicting data, equivalence or an effect of 0.",
      "criterion": "Attribute both original reported values/CIs, heterogeneity and the need for additional high-quality RCTs to their respective sources without combining them.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Compare analytical scopes/included trials before separately reviewing whether an actual conflict concerns the same question."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are an optimal 900 mg dose, persistence after stopping and effects in specific subgroups verified?",
      "needed": "Direct dose contrasts, cessation/long-term follow-up, prespecified subgroups, interactions and separate estimates",
      "role": "Supplementary; required for extension claims",
      "role_reason": "The selected 24-week result must not be extended to an optimal dose, long-term maintenance or effects in special populations.",
      "application_exception": "Do not require all extension research as mandatory for the current narrow 24-week HbA1c question.",
      "criterion": "Distinguish the 7-arm/review dose-response labels from unverified direct extension results for 900 mg.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Claims of an optimal dose, maintenance or subgroups require product-fixed direct contrasts and prespecified subgroup/follow-up studies."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Has an HbA1c difference been kept from being extended to replacing diabetes medication or preventing complications?",
      "needed": "Original boundaries between the HbA1c surrogate and questions about medication replacement, complications and events",
      "role": "Supplementary; required for clinical extensions",
      "role_reason": "A surrogate-marker change does not automatically answer questions about other treatments or clinical events.",
      "application_exception": "Do not require event trials as mandatory to verify the numerical HbA1c question.",
      "criterion": "Explicitly prohibit extensions to medication replacement, complications and effects from all garlic foods.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Separate claims of replacement treatment or complication prevention require direct comparisons/event data for those clinical questions."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are funding, product provision and conflicts of interest for the primary trial and both reviews actually verified?",
      "needed": "Funding, product provision, author employment/patents, declared COI and institutional/independent-family relationships by report",
      "role": "Supplementary; required for independence claims",
      "role_reason": "Unverified funding must not be credited as independent funding or absence of conflicts.",
      "application_exception": "Do not inherit an academic-research label or original I1 as independent funding or replication certification.",
      "criterion": "Separate unverified primary-trial funding/product provision from the reviews’ wording of academic research and mixed primary-trial funding.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve funding, provision, COI, author and institutional information separately for primary papers/reviews, recording the actual scope."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are hypoglycemic, gastrointestinal and bleeding events and collection methods for the selected formulation verified?",
      "needed": "Event definitions, active/spontaneous collection, severity, events/stopping by arm and missingness/dropout",
      "role": "Supplementary; required for safety claims",
      "role_reason": "General caution wording must not become actual primary-trial adverse-event counts or absence of harm.",
      "application_exception": "Unverified harm data do not delete HbA1c reports; record separate states.",
      "criterion": "Separate caution wording from actual events/collection and the boundaries between not reported and not read.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Acquire primary-trial AE, stopping and collection tables; review safety questions separately with suitable harm designs."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are harm timing, denominators, follow-up and comparative risks in the selected two arms verified?",
      "needed": "Exposure/events, stopping/recovery times, exposed people/people with events/event counts by arm, follow-up time and comparative estimates",
      "role": "Supplementary; required for comparative harms/incidence",
      "role_reason": "The scale of 210 participants/30 per arm and the 24-week schedule must not automatically become harm incidence or causal denominators.",
      "application_exception": "Do not calculate harm risk from efficacy times/sample sizes or extrapolate background rates.",
      "criterion": "Link reporting of actual harm timing, controls, denominators/duration to currently unverified information.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Retrieve original arm-specific AE/stopping/exposure-time tables; long-term and rare harms need suitable follow-up data."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are glucose-lowering medication, baseline disease, other exposures and alternative explanations for harms reviewed?",
      "needed": "Concomitant medication by arm, baseline hypoglycemia/bleeding/disease, other exposures, changes and alternatives/adjustment",
      "role": "Supplementary; required for causal harms",
      "role_reason": "A concomitant-use caution alone must not attribute actual events solely to garlic.",
      "application_exception": "Missing alternative-explanation information does not establish that no other causes existed.",
      "criterion": "Distinguish the warning context from the verified scope of actual co-exposure, underlying disease and alternatives.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Link original concomitant-medication, baseline and event records to review alternative explanations for harm and temporal relationships."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Is the scope of other independent harm records, long-term/rare risks and vulnerable groups verified?",
      "needed": "Unique harm families, regulatory reports versus recitations, long-term/rare events, special-population exposure and interactions",
      "role": "Supplementary; required for replication/overall safety",
      "role_reason": "Short-term efficacy trials/reviews must not be promoted to independent harm replications or overall safety.",
      "application_exception": "Do not require every rare-harm study for the current HbA1c question or add together repeated citations of the same event.",
      "criterion": "Separate direct harm replications and unverified long-term/vulnerable-group information from original efficacy material.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Review separate harm questions through unique-event links and suitable long-term follow-up/registration data."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are positive signals, the unverified selected effect and cautions explained at distinct levels?",
      "needed": "Boundaries between P/pooled direction, selected quantitative gaps, original cautions and incidence/causality/individual prescribing",
      "role": "Required (current wording scope)",
      "role_reason": "Positive efficacy signals must not become safety, medication replacement or an established selected quantitative effect.",
      "application_exception": "Do not revise uncertainty and caution into a new safety grade or individual intake instructions.",
      "criterion": "Retain positive statements alongside unverified selected effects/harms, explicitly explaining limits on causal/incidence extensions.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Revisit each question/row if actual quantitative or harm data are added; retain original boundaries until then."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are the original 2026-09-08 reference date, 09-14 correction history, generic English wording and current scope distinguished?",
      "needed": "Original verdict-review date, corrections, original Korean/English/evidence/citation fields and current reading/search/publication-status scope",
      "role": "Required",
      "role_reason": "Historical access/correction labels must not be backdated into full-text reading, a current search or specific English verification in this conversion.",
      "application_exception": "Preserve original generic English principles; no translation correction or historical reconstruction is performed in this conversion.",
      "criterion": "Link original dates, corrections/English wording and actual reading of the retained summary to the absence of searching/external reading; do not label no response as 0 studies.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If original-data correction/evidence updating is separately requested, preserve the whole original and handle original locations/version changes as an event."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Have original C46, Caution, all axes and empty subclaims been kept from being inherited as new condition states/grades?",
      "needed": "Original typed grade/score/safety, bilingual synthesis/grade decisions, axes, corrections and empty subclaims",
      "role": "Required (historical preservation)",
      "role_reason": "Conversion-table states preserve information by condition and must not automatically recalculate the original efficacy verdict.",
      "application_exception": "Do not display original verification labels or C46 as independent clinical certification, a new efficacy score or a condition-fulfillment rate.",
      "criterion": "Link original values/types unchanged, explaining that no new score/grade or subclaim index is generated.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Correcting the original verdict requires a separate request and version/change event. It is not rescoring in this sheet conversion."
    }
  ]
}