{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3082-main", "verdict_number": "3082", "title": "Nicotinic acid (prescription NIASPAN ER tablets added to LDL-targeted statin therapy) × Two-year triglyceride percentage change", "view_version": "1.0", "view_created_date": "2026-10-28", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-14", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." }, "claim_context": { "population": "Adults ≥45 with established ASCVD and low-HDL/residual dyslipidaemia tolerating niacin run-in. Entry TG >150 and <400 mg/dL off statins or >100 and <400 on statins. Not a nutrient-deficiency treatment cohort.", "intervention": "Nicotinic acid (prescription NIASPAN ER tablets added to LDL-targeted statin therapy)", "dose": "1500–2000 mg/day; control includes IR niacin 100–150 mg/day", "comparator": "Both groups used simvastatin 40–80 mg/day±ezetimibe 10 mg/day for LDL-C 40–80 mg/dL. Control contained IR niacin 50 mg/tablet (100–150 mg/day). Actual background doses were titrated, so this is a treatment-strategy contrast, not identical fixed background dosing.", "endpoint": "Reported TG percentage change from baseline at 2 years: page endpoint. Trial 1st (primary): cardiovascular composite; lipids were a protocol 3rd (tertiary) objective.", "duration": "2-year lipid assessment; trial stopped early after approximately 3 years; 4–8-week run-in before randomization", "excluded_extensions": [ "At 2 years in AIM-HIGH, reported triglyceride changes were −28.6% with the ER-niacin strategy and −8.1% with control, an arithmetic contrast of −20.5 percentage points. This is not cardiovascular-event prevention or evidence for every formulation and dose in all hypertriglyceridaemia. [S15; S17]", "3414 participants and 1718/1696 are randomized counts; the 2-year TG analysis denominator is unverified. The historical arithmetic contrast −20.5 percentage points is not a formal adjusted mean difference, mg/dL difference, ARR or NNT. The mean/median estimator, TG CI, SD and missing-data handling also remain unverified.", "This pharmacological regimen has flushing, liver-enzyme, glucose/urate and specific laboratory-interference risks. Study-drug discontinuation of 25.4% versus 20.1% is not loss to follow-up. The 4–8-week tolerability run-in limits safety generalization to all starters. Safety details are from the fixed 2020 FDA source, not new current prescribing guidance. Research doses are not personal dosing instructions. [S15:safety; S15:interference; S17:discontinuation; S18:runin]", "Retain original C, 46, Caution, B/S/R1/I1/EX/B1/CX and the historical grade-revalidation record. No new scoring was performed. Do not extend to generic B3, other formulations, deficiency correction, all high-TG populations, optimal dose, persistence beyond 2 years or personal prescribing." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Is the independent claim specifically the 2-year TG percentage change?", "needed": "The original claim linked to the AIM-HIGH question elements.", "role": "Required", "role_reason": "Needed to keep a surrogate decrease separate from clinical-event prevention and other lipid results.", "application_exception": "Korean/English are languages of the same question; an empty subclaim list does not create new claims.", "criterion": "Link the original effect claim, actual intervention, population, comparator and time to the TG question.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare manuscript and trial identities; separate independent claims when question elements differ.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim is “2-year triglyceride percentage change”. It concerns TG changes with NIASPAN ER added to LDL-targeted treatment versus a low-dose IR-niacin control strategy. The subclaim list is empty.", "condition_status": "Met", "status_reason": "The original manuscript and claim conditions identify the TG question. Clinical events, LDL and other formulations are outside it.", "missingness": "No gap in the identity of this narrow question.", "uncertainty": "No gap in the identity of this narrow question. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original claim linked to the AIM-HIGH question elements." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Is the chemical form, formulation and route actually oral NIASPAN ER tablets?", "needed": "Product formulation, ingredient and route records.", "role": "Required", "role_reason": "Needed to avoid treating generic vitamin B3 or other derivatives as the same intervention.", "application_exception": "Nicotinamide, inositol hexanicotinate and no-flush products are different interventions.", "criterion": "Link nicotinic acid, NIASPAN ER tablets and the oral route to the retained source identity.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Match product name, chemical form and formulation across drug documents and trial records; analyze other products separately.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained material specifies oral nicotinic-acid NIASPAN extended-release tablets. It excludes nicotinamide and inositol hexanicotinate; the intervention is not a B-complex product.", "condition_status": "Met", "status_reason": "Chemical form, formulation and oral route are specified. This does not establish the same effect for generic B3 products.", "missingness": "Manufacturing origin is addressed separately in N09.", "uncertainty": "Manufacturing origin is addressed separately in N09. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product formulation, ingredient and route records." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the target dose of the selected add-on strategy verified?", "needed": "Target titration plan and individual actual dosing/adherence records.", "role": "Required", "role_reason": "Needed to distinguish target dosing from individually achieved dosing and optimal dose.", "application_exception": "The 1500–2000 mg/day target range is not a single fixed dose or the achieved dose of every participant.", "criterion": "Verify the selected NIASPAN ER target dose and limit extensions to actual achieved or optimal dose.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Trace arm-specific doses, titration and dosing histories to distinguish target from actual dose.", "current_reports": [ "S15", "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The NIASPAN ER target was 1500–2000 mg/day. This is the add-on strategy range in selected tolerators, not a verified individual actual dose or optimal dose.", "condition_status": "Met", "status_reason": "The target dose is specified in the claim conditions and original scope. Individually achieved dosing is not thereby verified.", "missingness": "Individual dosing/adherence histories and optimal dose remain unverified.", "uncertainty": "Individual dosing/adherence histories and optimal dose remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Target titration plan and individual actual dosing/adherence records." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Does the control strategy contain low-dose IR niacin?", "needed": "Control-tablet composition, dose and masking plan.", "role": "Required", "role_reason": "Needed to avoid misreading a low-dose active masking ingredient as no treatment or a wholly inactive placebo.", "application_exception": "The presence of low-dose IR does not establish equivalent dosing/formulation to ER or a monotherapy comparison.", "criterion": "Include IR niacin 50 mg/tablet and 100–150 mg/day in the selected comparison.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare control composition, tablet count and dose with the original plan and intervention records.", "current_reports": [ "S15", "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The control contained IR niacin 50 mg/tablet, totaling 100–150 mg/day. This is not NIASPAN monotherapy versus no treatment.", "condition_status": "Met", "status_reason": "Control composition and dose identify the actual comparison. Do not relabel it a wholly inactive placebo.", "missingness": "No current gap in this control identity.", "uncertainty": "No current gap in this control identity. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Control-tablet composition, dose and masking plan." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Was background treatment titrated to the same LDL target in both groups?", "needed": "Background-drug targets, arm-specific titration and actual doses.", "role": "Required", "role_reason": "Needed to avoid attributing statin/ezetimibe titration differences solely to fixed-dose NIASPAN.", "application_exception": "A common target does not imply identical actual arm doses or require every treatment change to match.", "criterion": "Verify simvastatin/ezetimibe ranges and the LDL target; distinguish identical fixed-dose treatment.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare target treatment, co-treatment changes and adherence by arm; define the effect as a strategy contrast.", "current_reports": [ "S15", "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Both groups titrated simvastatin 40–80 mg/day±ezetimibe 10 mg/day to LDL-C 40–80 mg/dL. Actual background dosing was not fixed identically, so this is a strategy comparison.", "condition_status": "Met", "status_reason": "The manuscript clearly describes target-treatment strategies. It does not establish identical individual fixed background doses.", "missingness": "Individual and arm-specific actual-dose distributions remain unverified in the retained material.", "uncertainty": "Individual and arm-specific actual-dose distributions remain unverified in the retained material. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Background-drug targets, arm-specific titration and actual doses." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the selected ASCVD/low-HDL population and entry TG criteria verified?", "needed": "Eligibility/exclusion criteria and actual recruited-population characteristics.", "role": "Required", "role_reason": "Needed to avoid extending the findings to all people with high triglycerides or nutrient deficiency.", "application_exception": "Do not merge entry TG criteria for people taking and not taking statins.", "criterion": "Verify age 45 and older, established ASCVD/low HDL and statin-dependent entry TG ranges.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare eligibility with baseline characteristics and assess directness for other high-TG populations.", "current_reports": [ "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Participants were adults age 45 and older with established ASCVD and low-HDL/residual dyslipidaemia. Entry TG was >150 and <400 mg/dL off statins, or >100 and <400 mg/dL on statins.", "condition_status": "Met", "status_reason": "The sources distinguish population and entry TG ranges. Do not generalize to all adults with high TG.", "missingness": "Additional details of the full baseline-characteristics table remain unverified.", "uncertainty": "Additional details of the full baseline-characteristics table remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusion criteria and actual recruited-population characteristics." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is selection through a prerandomization tolerability run-in verified?", "needed": "Run-in participation, reasons for exclusion and flow into randomization.", "role": "Required", "role_reason": "Needed to avoid extending selected-tolerator findings to efficacy/safety in all first-time starters.", "application_exception": "Do not add the 4–8-week prerandomization run-in to randomized treatment or long-term safety follow-up.", "criterion": "Verify the 4–8-week niacin tolerability run-in and its prerandomization timing.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Review prerandomization flow and exclusion reasons to distinguish selected participants from all starters.", "current_reports": [ "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Randomization selected people who tolerated a 4–8-week niacin run-in. This is not the same safety population as all people starting treatment.", "condition_status": "Met", "status_reason": "The population, duration and safety records verify tolerator selection. Numbers excluded during selection are not thereby verified.", "missingness": "Run-in entry/exclusion denominators and reason-specific counts remain unverified.", "uncertainty": "Run-in entry/exclusion denominators and reason-specific counts remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Run-in participation, reasons for exclusion and flow into randomization." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are baseline diagnostic values for nutritional niacin deficiency reported?", "needed": "Baseline niacin-deficiency diagnostic criteria and measurements.", "role": "Supplementary; required for deficiency-subgroup interpretation", "role_reason": "Needed to distinguish disease/lipid eligibility from nutritional deficiency status.", "application_exception": "Not selecting for deficiency does not establish that testing confirmed every participant was nondeficient.", "criterion": "Check whether deficiency tests, criteria and participant-specific values are reported.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If deficiency was defined and measured, link it to prespecified effect-modification analyses.", "current_reports": [ "S17", "S18" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "This was not a trial selected for nutritional niacin deficiency. The historical record states that deficiency diagnostic values were not reported within the source material used.", "condition_status": "Not reported", "status_reason": "Nonreporting is limited to the accessed scope. It does not establish universal nondeficiency, no subgroup benefit or worldwide absence of data.", "missingness": "Baseline deficiency test values and subgroup comparisons are unavailable in this retained scope.", "uncertainty": "Baseline deficiency test values and subgroup comparisons are unavailable in this retained scope. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline niacin-deficiency diagnostic criteria and measurements." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is the chemical ingredient’s manufacturing origin verified?", "needed": "Product raw-material and manufacturing-origin documents.", "role": "Supplementary; required for claims of identical manufacturing origin", "role_reason": "Needed to distinguish an inapplicable botanical part from unverified manufacturing information.", "application_exception": "A botanical part is inapplicable to nicotinic acid, but this does not verify manufacturing origin.", "criterion": "Check for direct documentation of the NIASPAN ingredient’s manufacturing origin.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Trace ingredient identity and trial product through manufacturing records; separate claims of equivalent products.", "current_reports": [ "S15" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Nicotinic acid is a chemical entity, so a botanical part is inapplicable. Actual manufacturing origin remains unverified in the original claim conditions.", "condition_status": "Unverified", "status_reason": "Chemical identity is verified, but evidence establishing manufacturing origin is unavailable in the retained scope.", "missingness": "Manufacturing-origin documentation is unverified.", "uncertainty": "Manufacturing-origin documentation is unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product raw-material and manufacturing-origin documents." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Is total niacin exposure, including diet and tryptophan equivalents, verified?", "needed": "Measurements of diet, concomitant products and tryptophan equivalents.", "role": "Supplementary; required for total-exposure interpretation", "role_reason": "Needed to avoid treating the trial add-on dose as total exposure including diet.", "application_exception": "Do not substitute the product target dose for total intake or infer deficiency status.", "criterion": "Check for total-exposure data linking diet, concomitant niacin and tryptophan equivalents.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separate individual add-on dosing from other intake sources; trace total exposure and compare co-treatment differences.", "current_reports": [ "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The trial add-on dose is verified, but total niacin intake including diet and tryptophan equivalents is unconfirmed.", "condition_status": "Unverified", "status_reason": "An add-on strategy dose alone cannot establish total nutritional exposure.", "missingness": "Total-intake measurements and conversion inputs are unverified.", "uncertainty": "Total-intake measurements and conversion inputs are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurements of diet, concomitant products and tryptophan equivalents." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are randomization and masking details sufficiently verified for the TG comparison?", "needed": "Sequence generation, central allocation, masking procedures and masking-success assessments.", "role": "Required", "role_reason": "Needed to avoid treating an RCT label as verification of every randomization/masking detail.", "application_exception": "A low-dose active control alone does not establish failed masking.", "criterion": "Verify actual central allocation/masking methods and retain gaps in sequence generation and concealment.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare planned and reported allocation/masking procedures at the level of the outcome.", "current_reports": [ "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Historical body-text extraction records central Internet allocation and double blinding, using low-dose IR niacin for masking. The summary does not verify all sequence-generation/concealment details or masking success.", "condition_status": "Partly verified", "status_reason": "Some allocation/masking methods are verified, but details and actual success assessments remain incomplete.", "missingness": "Sequence-generation/concealment details and masking assessments are unverified.", "uncertainty": "Sequence-generation/concealment details and masking assessments are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, central allocation, masking procedures and masking-success assessments." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are TG measurement procedures and conditions sufficiently verified?", "needed": "TG sampling, fasting, laboratory, reagents and measurement procedures.", "role": "Required", "role_reason": "Needed to avoid assuming objective testing removes differences in timing, sampling or laboratories.", "application_exception": "Do not substitute clinical-event measurement for the TG biomarker.", "criterion": "Verify 2-year TG procedures, sampling conditions, laboratory and comparability between groups.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare measurement timing and methods across groups using the original laboratory plan and records.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "An objective blood-TG marker and 2-year percentage change from baseline are verified. Fasting sampling, reagent/laboratory versions and detailed standardization were not verified in this retained summary.", "condition_status": "Partly verified", "status_reason": "Outcome type and time are verified, but measurement procedures remain incompletely specified.", "missingness": "Sampling, laboratory, reagent and measurement-condition details remain unverified.", "uncertainty": "Sampling, laboratory, reagent and measurement-condition details remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "TG sampling, fasting, laboratory, reagents and measurement procedures." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are the 2-year TG assessment, approximately 3-year trial and prerandomization period distinguished?", "needed": "Assessment, trial-stopping and run-in timelines.", "role": "Required", "role_reason": "Needed to avoid mixing outcome time with overall study duration and creating unsupported persistence claims.", "application_exception": "Do not replace the 2-year TG assessment with the 4–8-week run-in or approximately 3-year trial duration.", "criterion": "Distinguish the 2-year selected outcome from prerandomization and overall trial periods.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link each outcome visit to its timeline and compare changes for that visit only.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The page concerns 2-year TG percentage change. Trial stopping after approximately 3 years and the 4–8-week prerandomization run-in are separate periods.", "condition_status": "Met", "status_reason": "Claim conditions and results distinguish the periods. Persistence outside 2 years is not established.", "missingness": "Persistence of the same TG effect beyond 2 years remains separately unverified.", "uncertainty": "Persistence of the same TG effect beyond 2 years remains separately unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Assessment, trial-stopping and run-in timelines." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are the page TG endpoint and the trial’s 1st (primary)/3rd (tertiary) hierarchy distinguished?", "needed": "Endpoint hierarchy in the original protocol and actual reports.", "role": "Required", "role_reason": "Needed to avoid presenting the page endpoint as success on the trial 1st (primary) endpoint.", "application_exception": "Lipids being 3rd (tertiary) objectives does not justify deleting the observed TG decrease.", "criterion": "Link the 1st (primary) cardiovascular composite and 3rd (tertiary) lipid objectives to retained plans/reports.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare protocol-version hierarchies with reports while keeping markers and events as separate questions.", "current_reports": [ "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The page endpoint is 2-year TG percentage change. The trial 1st (primary) was a cardiovascular composite; lipids were 3rd (tertiary) protocol objectives.", "condition_status": "Met", "status_reason": "The source explicitly distinguishes the marker and trial hierarchy. Do not turn TG into 1st (primary) clinical-event success.", "missingness": "Complete reconciliation with initial registration is a gap addressed in N22.", "uncertainty": "Complete reconciliation with initial registration is a gap addressed in N22. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint hierarchy in the original protocol and actual reports." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are the reported changes and direction verified for the same 2-year TG outcome?", "needed": "Concurrent arm-level TG values from the original table/body text.", "role": "Required", "role_reason": "Needed to avoid merging within-arm changes, other lipids or different times.", "application_exception": "Verified reported decreases do not establish the mean/median estimator or a formal between-group interval.", "criterion": "Attribute ER −28.6% and control −8.1% to the same 2-year TG report.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Match arm values to the same outcome, time and population; retain opposing findings as well.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained AIM-HIGH2-year TG changes from baseline were ER −28.6% and control −8.1%. Retain the reported decreases without importing another lipid’s figures.", "condition_status": "Met", "status_reason": "The arm-level values match the retained calculation and core evidence for the same 2-year TG outcome. This differs from verification of a precise between-group estimate.", "missingness": "TG percentage-change estimator, dispersion and analysis denominator remain separately unverified.", "uncertainty": "TG percentage-change estimator, dispersion and analysis denominator remain separately unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent arm-level TG values from the original table/body text." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is a formal adjusted between-group TG estimate verified?", "needed": "TG analysis model, adjustment variables, formal estimate and dispersion.", "role": "Required", "role_reason": "Needed to avoid upgrading historical descriptive arithmetic into an adjusted causal mean difference.", "application_exception": "Do not recalculate the retained −20.5 percentage points or convert it to mg/dL, ARR or NNT.", "criterion": "Verify the formal model, estimator and effect of interest; distinguish arithmetic subtraction of reported arm values.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Define the model’s strategy contrast and review it separately from descriptive arithmetic.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Historical −20.5 percentage points subtracts reported −28.6% and −8.1%. The calculation record explicitly excludes an adjusted causal mean difference, mg/dL difference, ARR or NNT; a formal adjusted TG effect remains unverified.", "condition_status": "Unverified", "status_reason": "Descriptive arithmetic is recorded, but the formal adjusted between-group effect asked about remains unverified.", "missingness": "The formal TG model, adjusted estimate and corresponding dispersion remain unverified.", "uncertainty": "The formal TG model, adjusted estimate and corresponding dispersion remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "TG analysis model, adjustment variables, formal estimate and dispersion." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is the mean/median estimator for TG percentage change verified?", "needed": "The original definition of aggregation/estimation for TG percentage change.", "role": "Required", "role_reason": "Needed to avoid assuming a mean effect merely because the result is a percentage.", "application_exception": "Do not fill an unconfirmed estimator with either mean or median.", "criterion": "Verify the reported percentage-change aggregation/estimation method and its definition.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare arm-level calculation and aggregation definitions in the original statistics section and tables.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original calculation records the mean or median estimator for TG percentage change as unconfirmed.", "condition_status": "Unverified", "status_reason": "Percentage-change values are available, but evidence defining their mean/median estimator is unavailable.", "missingness": "The percentage-change estimator is unverified.", "uncertainty": "The percentage-change estimator is unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original definition of aggregation/estimation for TG percentage change." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the actual arm-specific analysis denominators verified for 2-year TG?", "needed": "Arm-specific 2-year TG analysis n, visit attendance, exclusions and flow.", "role": "Required", "role_reason": "Needed to avoid using randomized counts as the lipid-analysis sample.", "application_exception": "Do not substitute 3414,1718/1696 or event-ITT wording for the TG analysis n.", "criterion": "Verify valid arm-specific 2-year TG analysis n and its relationship to exclusions/missingness.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Trace randomization, outcome visits, valid measurements and model-analysis denominators as separate steps.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Randomization included 3414 participants,1718 versus 1696. The original denominator explanation and evidence explicitly state that these are not verified 2-year TG analysis counts.", "condition_status": "Unverified", "status_reason": "Randomized denominators are known, but the actual 2-year TG analysis denominators cannot be established.", "missingness": "Arm-specific 2-year TG analysis n remains unverified.", "uncertainty": "Arm-specific 2-year TG analysis n remains unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific 2-year TG analysis n, visit attendance, exclusions and flow." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are TG missing-data handling, analysis population and effect of interest verified?", "needed": "TG missing-data methods, model, analysis population and sensitivity analyses.", "role": "Required", "role_reason": "Needed to avoid turning event-ITT wording into proof of a TG analysis without missing data.", "application_exception": "Medication stopping, follow-up loss and missing tests differ; do not fill missing TG with 0.", "criterion": "Verify how TG missingness, exclusions and imputation connect the analysis population to the strategy effect.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link missing/post-discontinuation outcomes to models and examine interpretations under different missingness assumptions.", "current_reports": [ "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Details of 2-year TG missing-data handling remain unconfirmed. The source states that event-ITT wording does not prove a lipid ITT analysis without missing data.", "condition_status": "Unverified", "status_reason": "Event-analysis terminology alone cannot identify the TG analysis population or missing-data handling.", "missingness": "TG missingness, exclusions, imputation and sensitivity analyses are unverified.", "uncertainty": "TG missingness, exclusions, imputation and sensitivity analyses are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "TG missing-data methods, model, analysis population and sensitivity analyses." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are the TG between-group CI, change-score SD/SE and precision inputs verified?", "needed": "TG between-group CI, change-score SD/SE, degrees of freedom, confidence level and analysis n.", "role": "Required", "role_reason": "Needed to avoid replacing TG precision with sample size, significance or a different event HR interval.", "application_exception": "Do not replace unrecorded values with 0 or reconstruct CI/SD from IQR or a threshold P value.", "criterion": "Link the TG interval and matching dispersion/confidence level to the corresponding estimator and denominator.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Match TG estimators to dispersion in original tables/statistical methods; reject intervals from different outcomes as substitutes.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original calculation’s standard error, change-score SD, degrees of freedom, confidence level and interval are all unrecorded. A bounded record notes absent matching dispersion/TG between-group CI in the accessed regulatory tables; do not substitute a cardiovascular HR CI.", "condition_status": "Unverified", "status_reason": "The relevant TG interval/dispersion inputs are unverified. This does not claim nonreporting throughout an unread original paper.", "missingness": "The relevant TG CI, SD/SE, degrees of freedom and confidence level are unverified.", "uncertainty": "The relevant TG CI, SD/SE, degrees of freedom and confidence level are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "TG between-group CI, change-score SD/SE, degrees of freedom, confidence level and analysis n." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can TG importance thresholds be compared with a reported interval?", "needed": "Context-specific TG importance criteria, a formal effect interval and clinical-outcome links.", "role": "Supplementary; required for importance/clinical-benefit interpretation", "role_reason": "Needed to avoid equating an observed decrease with MCID attainment or event prevention.", "application_exception": "If importance criteria/CI are unverified, do not relabel the decrease as 0 or below MCID.", "criterion": "Check for a prespecified TG importance threshold and corresponding interval in this population/strategy.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare importance criteria and intervals separately; assess clinical events through direct event-trial findings.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The source retains the TG decrease with EX(a) because its between-group CI/SD were unconfirmed; it did not relabel it E0 or below MCID. No context-validated TG importance threshold/interval is newly established here.", "condition_status": "Unverified", "status_reason": "Reported decreases alone cannot establish importance-threshold attainment or clinical-event benefit. The original EX/grade are historical quotations.", "missingness": "A direct comparison of TG importance criteria and a reported interval remains unverified.", "uncertainty": "A direct comparison of TG importance criteria and a reported interval remains unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Context-specific TG importance criteria, a formal effect interval and clinical-outcome links." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is TG plan/analysis/timing agreement verified from initial registration to final report?", "needed": "Initial registration history, all relevant protocol/SAP versions and final TG reporting.", "role": "Required", "role_reason": "Needed to avoid treating an archived amended protocol as verification of all initial registration records.", "application_exception": "A historical registry rendering failure does not establish nonregistration or selective reporting.", "criterion": "Verify the scope of comparison and reasons for changes across initial registration, protocol versions and final TG analyses.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare endpoint, time and analysis changes chronologically across versions to assess agreement.", "current_reports": [ "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The archived protocol is Amendment 6 dated 2011-06-01. Lipids are 3rd (tertiary) objectives and the event 1st (primary) has an amendment history. The historical ClinicalTrials.gov record did not render; complete reconciliation with initial registration is not claimed.", "condition_status": "Partly verified", "status_reason": "The amended protocol and some hierarchy are verified; complete comparison from initial registration through final TG analysis remains incomplete.", "missingness": "Complete initial registration history, TG SAP and reasons for changes are unverified.", "uncertainty": "Complete initial registration history, TG SAP and reasons for changes are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial registration history, all relevant protocol/SAP versions and final TG reporting." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are cardiovascular 1st (primary) failure and early stopping kept within their interpretation boundaries?", "needed": "1st (primary)-event findings, reasons for early stopping and links to TG results.", "role": "Supplementary; required for clinical-event interpretation", "role_reason": "Needed to avoid hiding unfavorable clinical findings/early stopping behind favorable TG decreases.", "application_exception": "Cardiovascular 1st (primary) failure does not negate the TG decrease; a TG decrease does not establish event prevention.", "criterion": "Verify reported cardiovascular 1st (primary) failure/early stopping separately from the TG endpoint.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Review each outcome, analysis and time separately; do not merge discordant marker/event findings.", "current_reports": [ "S15", "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained manuscript states cardiovascular 1st (primary) failure and early stopping. Keep the TG decrease as a separate marker observation without turning it into clinical-event prevention.", "condition_status": "Met", "status_reason": "Retain unfavorable 1st (primary) findings/stopping separately from the selected TG question. No new clinical-event effect size is calculated.", "missingness": "Detailed cardiovascular-event estimates are outside this TG table’s scope.", "uncertainty": "Detailed cardiovascular-event estimates are outside this TG table’s scope. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "1st (primary)-event findings, reasons for early stopping and links to TG results." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Do 25.4% versus 20.1% refer to study-drug discontinuation?", "needed": "Original arm-specific drug-discontinuation reasons, follow-up retention and missing-test tables.", "role": "Supplementary; required for adherence/safety interpretation", "role_reason": "Needed to avoid presenting medication stopping as TG analysis attrition, follow-up loss or every-AE incidence.", "application_exception": "Do not derive TG missingness counts or specific adverse-event rates from drug-discontinuation percentages.", "criterion": "Verify that the percentages describe study-drug discontinuation and separate them from follow-up loss.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link follow-up/measurements after drug stopping; examine adherence and missingness separately.", "current_reports": [ "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The reported 25.4% versus 20.1% concern study-drug discontinuation. They are not follow-up attrition,2-year TG missingness or specific adverse-event rates.", "condition_status": "Met", "status_reason": "The safety record and C17 correction clearly classify the percentages. They do not establish complete follow-up status.", "missingness": "Actual reason-specific stopping counts, lipid follow-up retention and missing tests remain unverified.", "uncertainty": "Actual reason-specific stopping counts, lipid follow-up retention and missing tests remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm-specific drug-discontinuation reasons, follow-up retention and missing-test tables." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are harm-collection methods and event-specific denominators verified for the same exposure/population?", "needed": "Trial AE collection plan, event-specific arm counts, duration, discontinuation reasons and regulatory documents.", "role": "Supplementary; required for comparative-harm/frequency interpretation", "role_reason": "Needed to distinguish general drug warnings from trial event frequencies and collection data.", "application_exception": "Do not count FDA warnings as independent clinical trials or as all-AE incidence.", "criterion": "Distinguish original definitions, collection, exposure and denominators for flushing, liver enzymes, glucose/urate and other harms.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare event definitions, active ascertainment and valid follow-up denominators to distinguish signals from comparative frequencies.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The FDA 2020 source records pharmacological-regimen harms including flushing and increased liver enzymes, glucose and urate. The current summary does not provide every AIM-HIGH event definition, arm count, time denominator or collection procedure.", "condition_status": "Partly verified", "status_reason": "General harm types and source are verified, but within-trial event-specific comparisons/denominators remain insufficiently verified.", "missingness": "AE definitions, collection, arm counts, exposure time and valid denominators are unverified.", "uncertainty": "AE definitions, collection, arm counts, exposure time and valid denominators are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial AE collection plan, event-specific arm counts, duration, discontinuation reasons and regulatory documents." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the specific tests and conditions for laboratory interference verified?", "needed": "Section 7.6 tests, interference direction, exposure and measurement conditions.", "role": "Supplementary; required for laboratory-interference interpretation", "role_reason": "Needed to avoid treating an interference warning as every abnormal laboratory result or a treatment effect.", "application_exception": "If test methods are unverified, do not invent interference across every platform or a universal stopping interval.", "criterion": "Distinguish the FDA 2020 interference location from actual verification of methods/exposure conditions.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare test-specific interference by platform, reagent and exposure; separate interference from biological change.", "current_reports": [ "S15" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The manuscript records specific laboratory interference in FDA 2020 Section 7.6. This retained summary does not verify specific tests, every platform, interference magnitude or a universal stopping interval.", "condition_status": "Partly verified", "status_reason": "The interference source/location is verified, but specific measurement conditions remain unverified.", "missingness": "Test-, platform- and exposure-specific interference details remain unverified.", "uncertainty": "Test-, platform- and exposure-specific interference details remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Section 7.6 tests, interference direction, exposure and measurement conditions." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is safety directly verified for all starters, long-term use or other doses?", "needed": "Direct harm data for run-in exclusions, unselected populations, other doses and long-term use.", "role": "Supplementary; required for safety-scope extensions", "role_reason": "Needed to avoid turning selected-tolerator/limited-study findings into a safety guarantee for all starters.", "application_exception": "Unverified safety does not justify deleting TG findings or giving personal dosing instructions.", "criterion": "Check direct harm data for run-in nontolerators, other doses, long-term use and vulnerable populations.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Study exposure, follow-up and harms in unselected starters separately and compare them with the selected population.", "current_reports": [ "S15", "S17", "S18" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 4–8-week tolerability run-in limits generalization to all starters. Fixed FDA 2020 warnings do not establish safety across every dose, long-term use or vulnerable population.", "condition_status": "Unverified", "status_reason": "Selected-population records and general warnings cannot establish the extended safety scope.", "missingness": "Direct safety data for nontolerators, long-term use, other doses and vulnerable populations are unverified.", "uncertainty": "Direct safety data for nontolerators, long-term use, other doses and vulnerable populations are unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harm data for run-in exclusions, unselected populations, other doses and long-term use." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are the reports linked to the same AIM-HIGH study family?", "needed": "Trial identity, registration number, report titles and links between trial materials.", "role": "Required", "role_reason": "Needed to avoid counting the regulatory document, trial paper, official archive and protocol as independent trials.", "application_exception": "Different access routes do not establish independent clinical studies.", "criterion": "Link S15 AIM-HIGH data, S17,S18 and S19 to the NCT00120289 family.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Map reports to studies, outcomes, times and analyses to avoid double-counting citations within the same family.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The direct core evidence is AIM-HIGH-NCT00120289. S15’s AIM-HIGH section, S17 trial paper, S18 official archive and S19 protocol are different materials from the same family.", "condition_status": "Met", "status_reason": "Study name, registration, titles and used locations identify the same family. Do not count the reports as independent replications.", "missingness": "Do not derive an independent participant total from the number of reports.", "uncertainty": "Do not derive an independent participant total from the number of reports. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial identity, registration number, report titles and links between trial materials." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Is there an independent study family replicating this exact TG strategy comparison?", "needed": "Independent trial identities, arm-specific TG findings, population and funding records.", "role": "Supplementary; required for independent-replication claims", "role_reason": "Needed to avoid treating other lipids/doses or repeated citations within one family as independent TG replication.", "application_exception": "One currently identified family does not mean 0 studies worldwide, R0 or no effect.", "criterion": "Verify independent families for the same population, ER add-on/IR control and 2-year TG comparison.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Classify directness by study family, separate different comparisons and assess replication/heterogeneity.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The direct evidence and references concern the same AIM-HIGH family. Trials in manufacturer tables are not R2 without verified independent authors/funding; other lipids or durations are not replications of this TG comparison.", "condition_status": "Unverified", "status_reason": "A separate independent family for the exact TG comparison was not verified within the retained scope.", "missingness": "Independent replication and independence for the exact TG strategy remain unverified.", "uncertainty": "Independent replication and independence for the exact TG strategy remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent trial identities, arm-specific TG findings, population and funding records." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are funding, product supply and reported analysis involvement identified?", "needed": "Funding, product supply, author interests and analysis-role documents.", "role": "Supplementary; required for independence interpretation", "role_reason": "Needed to avoid treating reported analysis non-involvement as proof of public-only funding or independent replication.", "application_exception": "Interests do not automatically exclude results; absence of interests does not establish absence of bias.", "criterion": "Link NHLBI/Abbott mixed support and product supply to the reported level of involvement.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separate funding, drug supply, design, analysis and publication roles when comparing independence.", "current_reports": [ "S17", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained record identifies mixed NHLBI/Abbott support and product supply. Reported sponsor analysis non-involvement does not imply I2. I1 quotes the historical verdict.", "condition_status": "Met", "status_reason": "The bounded reported support, supply and analysis involvement can be identified. Complete independence is not newly certified.", "missingness": "Independent audit of every author’s interests and all roles was not performed.", "uncertainty": "Independent audit of every author’s interests and all roles was not performed. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product supply, author interests and analysis-role documents." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Does comprehensive searching, including unpublished trials, rule out selection/publication gaps?", "needed": "Original search strategy, selection records and unpublished/registered-result lists.", "role": "Supplementary; required for claims of overall evidence completeness", "role_reason": "Needed to avoid relabelling historical indexed searches as a current systematic search or absence of publication bias.", "application_exception": "No new search in this work does not mean no research or a failed search.", "criterion": "Verify the compared scope of sources, strategy, dates, unpublished material and selected outcomes.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Use reproducible question-specific searching, family linkage and selection to review missing reports/selected results.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 2026-09-14 review used web indexes, a provided 3081-record index, related originals and direct publisher/FDA/NHLBI material. Exhaustive PubMed/unpublished-trial searching is not claimed. New searches in this work:0.", "condition_status": "Unverified", "status_reason": "A bounded search record exists, but comprehensive searching or exclusion of publication bias is unverified.", "missingness": "Comprehensive search strategies, unpublished trials and complete selection records remain unverified.", "uncertainty": "Comprehensive search strategies, unpublished trials and complete selection records remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search strategy, selection records and unpublished/registered-result lists." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are original search/review dates distinguished from the retained-record review?", "needed": "Original date fields, individual access histories and current reading receipts.", "role": "Required (verification-scope record)", "role_reason": "Needed to avoid backdating material-specific original access to a global historical date.", "application_exception": "Do not present an absent dedicated evidence-cutoff field as an existing original record.", "criterion": "Link the original search-cutoff/review dates and retained-record review date to their actual records separately.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Distinguish search, review, access, freeze and application as different dated events.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original search cutoff is 2026-09-14 and the original verdict review date is also 2026-09-14. The retained-record review date is 2026-10-05. Dedicated evidence-cutoff and reference-specific access-date records are absent.", "condition_status": "Met", "status_reason": "Actual date records and their absence establish the event-specific scope. Do not fill report-specific access dates from a global date.", "missingness": "Actual access dates for individual references remain unverified and unrecorded.", "uncertainty": "Actual access dates for individual references remain unverified and unrecorded. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original date fields, individual access histories and current reading receipts." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are retained-summary reading, unread external originals and historical access levels distinguished?", "needed": "Current reading receipts and reference-specific material types, URLs and historical access records.", "role": "Required (reading record)", "role_reason": "Needed to avoid upgrading a URL or historical full-text record into current external reading.", "application_exception": "External access not attempted now is not inaccessibility; retain each historical material type/scope.", "criterion": "Separate actual retained-summary reading from current external access/acquisition/reading not attempted.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Match access, acquisition, reading and locations to accurate reader badges and links.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Actual reading concerns the retained summary. Historical records describe S15 regulatory PDF/selected-table screenshots, S17 publisher-indexed body text with unrendered tables, S18 official archive HTML and S19 protocol PDF. External materials were all unattempted, unacquired and unread in this work.", "condition_status": "Met", "status_reason": "The narrow reading-record condition reflects actual actions. Current external content verification is not thereby complete.", "missingness": "External-original comparison was not performed in this work; historical material-specific access dates remain unverified.", "uncertainty": "External-original comparison was not performed in this work; historical material-specific access dates remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current reading receipts and reference-specific material types, URLs and historical access records." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are direct TG locations distinguished from other lipids and unavailable shared-correction references?", "needed": "Actual TG locations, full shared corrections and reference-specific identity records.", "role": "Required", "role_reason": "Needed to avoid inheriting LDL/Table 3,S16 or L128 in shared corrections as evidence for this TG value.", "application_exception": "Do not present references absent from the bibliography or old unavailable files as materials actually read.", "criterion": "Identify Section 5.1 as the direct TG location; separate other endpoints and unavailable references.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare correction-specific endpoint, time and source attribution; retain other-question values/unverified references separately.", "current_reports": [ "S15", "S17" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Direct TG locations are S15 Section 5.1/AIM-HIGH, printed pages 4–5, and S17 Lipid Levels. C11 combines TG/LDL arithmetic; C12 has shared Table 3 wording. C14’s L128 and C16’s S16/LDL −14%/duration discrepancy are not inherited as the direct TG bibliography’s 4 sources.", "condition_status": "Met", "status_reason": "The boundary between direct TG locations, other lipids and unavailable references is identified. Do not substitute another LDL/Table 3 analysis as this TG result’s location.", "missingness": "Separate shared-correction,S16 and L128 materials were not read in this work.", "uncertainty": "Separate shared-correction,S16 and L128 materials were not read in this work. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual TG locations, full shared corrections and reference-specific identity records." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are the latest current prescribing document and recommendations verified?", "needed": "Current prescribing-document version, amendment history and prescribing guidance.", "role": "Supplementary; required for current-prescribing interpretation", "role_reason": "Needed to avoid presenting a fixed 2020 document as the latest label or personal prescribing advice.", "application_exception": "Approval differs from proof of clinical efficacy; unverified currency does not erase historical records.", "criterion": "Distinguish whether current label versions/recommendations have actually been verified.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare versions while separately recording actual access/dates, administrative facts and clinical results.", "current_reports": [ "S15" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The FDA document used was revised 09/2020. The latest label/current prescribing guidance was not verified in this work; research doses are not personal dosing instructions.", "condition_status": "Unverified", "status_reason": "A fixed historical document does not establish verification of the current version.", "missingness": "Direct verification of current labels/recommendations was not performed.", "uncertainty": "Direct verification of current labels/recommendations was not performed. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current prescribing-document version, amendment history and prescribing guidance." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are other formulations, high-TG populations, persistence beyond 2 years and optimal dosing directly verified?", "needed": "Original comparative TG studies by formulation, population, dose and long-term duration.", "role": "Supplementary; required for extension claims", "role_reason": "Needed to avoid extending a fixed-question result across all formulations, populations, doses and durations.", "application_exception": "Do not require every extension study for the narrow TG question.", "criterion": "Check direct comparisons for formulations, populations, doses and times outside the selected question.", "basis": "Existing method principles distinguish population, formulation, dose, time, target-treatment comparator, lipid measurement, denominators, missingness, between-group estimates, intervals, plans, report relationships, funding and harms. Detailed conditions are Chamgap’s own application; they do not impose adjusted analysis on every randomized comparison.", "condition_origin": "Conditions for the NIASPAN ER add-on, low-dose IR control and 2-year TG strategy comparison were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Define each extension question separately; review direct comparisons, effect modification and persistence.", "current_reports": [ "S15", "S17", "S18", "S19" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The findings are limited to AIM-HIGH tolerators, NIASPAN ER add-on versus low-dose IR control and 2-year TG. Generic B3, other formulations, all high-TG populations, optimal dose and persistence beyond 2 years are not directly established.", "condition_status": "Unverified", "status_reason": "The source limits generalization outside its scope. Do not delete the selected-question decrease or reclassify it as effect 0.", "missingness": "Comparative extensions by formulation, population, dose and long-term duration remain unverified.", "uncertainty": "Comparative extensions by formulation, population, dose and long-term duration remain unverified. No new effects, intervals, denominators, incidence rates or grades are calculated or adjudicated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original comparative TG studies by formulation, population, dose and long-term duration." } ], "reports": [ { "report_id": "S15", "title": "NIASPAN (niacin extended-release tablets), FDA prescribing information revised 09/2020", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020381s054lbl.pdf", "report_type": "Historical FDA NIASPAN 2020 prescribing-information PDF and selected table screenshots", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "study_family": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided.", "observed_result": "Retained historical record: FDA revised 09/2020 Section 5.1/AIM-HIGH, printed pages 4–5, was used for TG. Retain 2-year TG −28.6% versus −8.1%, randomized 1718/1696 and historical arithmetic −20.5 percentage points. Actual 2-year TG analysis n, formal between-group CI and dispersion are unverified. Sections 2/3 formulation and Sections 5/6 and 7.6 safety/laboratory interference have separate fixed-document scopes. Section 14 Table 3–5 records do not replace this TG location.", "result_level": "Retained records of the same study. External originals were not revalidated in this work; retain each material’s historical access limitations.", "source_evidence_date": "2026-09-14", "materials": [ { "material_type": "Retained bibliographic/linked summary and historical review record", "public_status": "Internally retained summary", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was acquired and read. This is not an original-byte copy of a clinical full text. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." }, { "material_type": "Historical FDA NIASPAN 2020 prescribing-information PDF and selected table screenshots", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained external URL is provided. Access, acquisition and reading were not attempted in this work. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." } ], "links": [ { "label": "Official source", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020381s054lbl.pdf" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided." }, { "report_id": "S17", "title": "AIM-HIGH Investigators. Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1107579", "report_type": "Historical NEJM publisher-indexed body text; tables and supplementary dispersion not rendered", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "study_family": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided.", "observed_result": "Retained historical record: AIM-HIGH was a multicentre randomized double-blind target-treatment strategy comparison; 3414 randomized, 1718/1696, with actual 2-year TG analysis n unconfirmed. NIASPAN ER 1500–2000 mg/day versus control containing low-dose IR 100–150 mg/day was added to LDL-targeted statin±ezetimibe titration. The reported 2-year TG −28.6% versus −8.1% is not a formal adjusted effect or CI. Retain cardiovascular 1st (primary) failure, early stopping and study-drug discontinuation 25.4% versus 20.1% separately. NHLBI/Abbott mixed support and product supply do not become independent funding because sponsor analysis non-involvement was reported. Tables and supplementary dispersion did not render during historical indexed-body access.", "result_level": "Retained records of the same study. External originals were not revalidated in this work; retain each material’s historical access limitations.", "source_evidence_date": "2026-09-14", "materials": [ { "material_type": "Retained bibliographic/linked summary and historical review record", "public_status": "Internally retained summary", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was acquired and read. This is not an original-byte copy of a clinical full text. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." }, { "material_type": "Historical NEJM publisher-indexed body text; tables and supplementary dispersion not rendered", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained external URL is provided. Access, acquisition and reading were not attempted in this work. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." } ], "links": [ { "label": "Official source", "url": "https://www.nejm.org/doi/full/10.1056/NEJMoa1107579" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided." }, { "report_id": "S18", "title": "NHLBI BioLINCC AIM-HIGH study archive", "url": "https://biolincc.nhlbi.nih.gov/studies/aimhigh/", "report_type": "Historical NHLBI BioLINCC official AIM-HIGH archive HTML", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "study_family": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided.", "observed_result": "Retained historical record: Study Population, Study Design and Outcomes in the official BioLINCC AIM-HIGH archive supported age 45 and older, ASCVD/low-HDL residual dyslipidaemia, a 4–8-week tolerability run-in and statin-dependent entry TG ranges. This is a description of the same AIM-HIGH family, not a new independent TG trial or reading of ClinicalTrials.gov registry results.", "result_level": "Retained records of the same study. External originals were not revalidated in this work; retain each material’s historical access limitations.", "source_evidence_date": "2026-09-14", "materials": [ { "material_type": "Retained bibliographic/linked summary and historical review record", "public_status": "Internally retained summary", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was acquired and read. This is not an original-byte copy of a clinical full text. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." }, { "material_type": "Historical NHLBI BioLINCC official AIM-HIGH archive HTML", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained external URL is provided. Access, acquisition and reading were not attempted in this work. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." } ], "links": [ { "label": "Official source", "url": "https://biolincc.nhlbi.nih.gov/studies/aimhigh/" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided." }, { "report_id": "S19", "title": "AIM-HIGH Protocol, Amendment 6, 1 June 2011", "url": "https://biolincc.nhlbi.nih.gov/media/studies/aimhigh/Protocol.pdf", "report_type": "Historical AIM-HIGH 2011-06-01 Amendment6 protocol PDF and selected-page screenshots", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "study_family": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided.", "observed_result": "Retained historical record: the protocol is Amendment 6, 2011-06-01. Retain the locations used for lipids as 3rd (tertiary) objectives, entry lipid criteria, low-dose IR-niacin control, treatment/product supply and stopping plans. The historical ClinicalTrials.gov record did not render. Access to this protocol does not establish successful registry access or complete agreement from initial registration through final TG analysis.", "result_level": "Retained records of the same study. External originals were not revalidated in this work; retain each material’s historical access limitations.", "source_evidence_date": "2026-09-14", "materials": [ { "material_type": "Retained bibliographic/linked summary and historical review record", "public_status": "Internally retained summary", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was acquired and read. This is not an original-byte copy of a clinical full text. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." }, { "material_type": "Historical AIM-HIGH 2011-06-01 Amendment6 protocol PDF and selected-page screenshots", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The retained external URL is provided. Access, acquisition and reading were not attempted in this work. A summary of historical access records. This does not establish direct external full-text, table, registry or protocol reading, or independent clinical certification in this work. The original search/verdict review date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access dates for individual references are unrecorded. Access levels below are historical records; external access, acquisition and reading were not attempted in this work." } ], "links": [ { "label": "Official source", "url": "https://biolincc.nhlbi.nih.gov/media/studies/aimhigh/Protocol.pdf" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided." } ], "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; distinguish intervention variants.", "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": "Link studies and reports separately; do not omit studies 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": "Fix the result and effect of interest when examining randomization, deviations, missingness, 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.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The narrow fact, identity, numerical attribution or explicit record asked about is verified within retained material; this is not certification of clinical efficacy, precision or overall safety.", "Partly verified": "Some required information is verified, but analysis, measurement or version details remain incomplete.", "Unverified": "The fact or analysis cannot be established from retained material; this does not mean effect0, no research worldwide or a current access failure.", "Not reported": "Not reported within the specified historical material/section actually accessed; do not extend this to entire unread originals.", "Conflicting data": "Used for inconsistent reports of the same fact. Different lipids or times are not automatically conflicting TG results.", "Not applicable": "Used when a specific reason makes the condition inapplicable; not a substitute for unverified or unread.", "Inaccessible": "A failed actual access attempt must be recorded by material and event; not assigned to external material unattempted in this work.", "Review incomplete": "Limited to external-original comparison not performed in this work; does not undo completed retained-summary review." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S15 AIM-HIGH regulatory clinical data, S17 direct trial report, S18 official archive and S19 amended protocol belong to the same AIM-HIGH-NCT00120289 family. Do not count the reports as independent replications or sum participants. No new overall unique-study or participant total is provided." }, "history": [ { "date": "2026-10-28", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 36 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-28" }