Insulin degludec × Overall symptomatic hypoglycemia — patient-time and affected-patient evidence sheet

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyAre subclaim C/D, original notes and parent C50/axes distinguished?Required	Selected overall symptomatic hypoglycemia subclaim C has a note of patient-proportion absolute difference −9.1%p. It is distinguished from parent C50, safety caution and the original overall symptomatic verdict. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.	Separate preservation of the selected claim, grade, note, absent values and parent values	Additional material is linked with each selected question and parent context distinguished.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyWhat are the actual population and baseline characteristics of type 2 diabetes with hypoglycemia risk?Required	SWITCH2 is an insulin comparison trial in type 2 diabetes with hypoglycemia risk. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.	Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators	Acquire original eligibility, baseline characteristics, risk criteria, concurrent exposure and denominators.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyWhat is the direct comparison between degludec and glargine U100?Required	The existing citation compares insulin degludec with insulin glargine U100; each patient received both insulins sequentially. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.	Original drugs, formulations, active control, shared treatment and actual exposure	Acquire original drugs, formulations, active control, concurrent treatment, changes and actual exposure.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyWhat are the sequence, same-person and analysis relationships in the two-period crossover?Required	The original randomized double-blind two-period crossover design gives both treatments to the same people. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.	Assigned sequences, each period, treatment-specific contributions, correlation and denominators	Acquire original sequence allocation, period/treatment contributions, correlations, models and denominators.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyAre each 32-week period, 16-week titration and 16-week maintenance windows distinguished?Required	The existing summary says the initial 16 weeks of each 32-week period were for titration, with only maintenance used in primary analysis. The evidence entry concerns the 16-week maintenance endpoint. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.	Original periods, titration, maintenance, primary window and actual exposure	Acquire original period-specific plans, actual exposure, observation windows, denominators and analyses.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyAre carryover-mitigation plans distinguished from gaps on residual effects?Required	The existing summary describes crossover’s reduction of between-person variation, possible carryover and a 16-week titration plan to reduce it. It records that crossover itself was not a listed defect. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.	Original titration plans, period effects, residual effects, sequence and sensitivity	Acquire original period/sequence, carryover, titration and sensitivity plans/results.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyAre 721 randomized, 720 FAS, 580 completed and treatment-specific 632/618 distinguished?Required	The existing evidence list gives 721 randomized, 720 FAS and 580 completed. The original Korean article records treatment-specific primary contributors of 632 and 618. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.	Randomized, FAS, completers, contributors and each treatment/period denominator	Acquire original flow, treatment/period contributions, sequences, population definitions and denominators.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyWhat are the limits of completed 80.4%, not completed 19.6% and original missing-data handling?Required	580/721 completed, 80.4%; not completed, 19.6%; and ITT/missingness-sensitivity analyses are retained as described in the original article. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.	Completion, discontinuation reasons, treatment/period missingness, models and sensitivity	Acquire original discontinuation, missingness, imputation/sensitivity assumptions, populations, effects and intervals.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacyWhat is the overall symptomatic endpoint definition involving severe or glucose-confirmed events?Required	The original primary endpoint is externally adjudicated severe events requiring third-party assistance, or events combining glucose <56mg/dL with symptoms. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.	Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment	Acquire original definitions, external adjudication, combined symptoms/testing, people/recurrent events and periods.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyWhat scales do 185.6/265.4 events, 0.70 and the 95% CI represent?Required	Overall symptomatic hypoglycemia during 16-week maintenance was 185.6 versus 265.4 events/100 patient-years; rate ratio 0.70 (95% CI 0.61–0.80). R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.	Patient-time, event rates, original ratio, model, interval and denominator	Acquire original event/time tables, rate models, adjustment, group exposure, CIs and tests.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacyWas the original absolute rate difference −23.66 retained without recalculation as a simple difference?Required	The existing summary and evidence list separately record an absolute rate difference of −23.66 events/100 patient-years. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.	Original rate difference, model, scale, denominator and uncertainty	Acquire original rate-difference calculation, model, denominator, period and interval.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyAre affected-patient proportions 22.5%/31.6% and original −9.1%p distinguished?Required	Patients experiencing overall symptomatic events were 22.5% versus 31.6%; the original absolute difference was −9.1%p. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.	Affected patients, at least one event, denominator, period, difference and interval	Acquire original affected-patient definitions, group denominators, event mapping, original difference/interval and tests.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyAre severe 1.6%/2.4%, −0.8%p, CI and P retained in their original scope?Required	Patients experiencing severe events during maintenance were 1.6% versus 2.4%; difference −0.8%p (95% CI −2.2–0.5; P=.35). R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.	Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P	Acquire original severe events, affected patients, denominators, periods, difference/interval and tests.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyAre overall-endpoint improvement and severe-only uncertainty separated?Required	The existing summary says overall symptomatic outcomes improved but the severe maintenance-period difference was not significant. Subclaim C/D are distinguished. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.	Overall/components, hierarchy, denominators, original effects, tests and interpretation	Acquire original component-specific plans, effects, intervals, hierarchy and precision.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyAre secondary HbA1c noninferiority and primary hypoglycemia separated?Required	The existing summary records HbA1c as a secondary efficacy endpoint, noninferior in both periods. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.	Original secondary efficacy, noninferiority plans, periods, denominators and margins	Separately acquire original HbA1c plans, margins, group values, denominators, periods and tests.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacyWhat are the clinical scope, individual effects and long-term confirmation of overall symptomatic improvement?Required	Subclaim C’s original note gives patient-proportion difference −9.1%p; the parent records C50 for one manufacturer-run crossover trial. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This average between-group result is not transferred to prevention of hypoglycemia in every individual, severe improvement or long-term mortality/function improvement.	Original symptomatic endpoints, recurrent events, average/individual effects and direct long-term material	Acquire original direct long-term outcomes, independent-report relationships and new population/exposure material.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyWhat is actual access to primary/secondary hierarchy, multiplicity, registration and SAP?Required	The original registration identifier is NCT02030600; the primary endpoint is the 16-week maintenance overall symptomatic hypoglycemia rate. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.	Original registration, protocol, SAP, primary/secondary outcomes, changes and models	Acquire original registration, plans, hierarchy, multiplicity, models and changes.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre identical vials/syringes, double blinding and actual assessment distinguished?Required	The existing summary records double blinding, identical vials/syringes, ITT and missingness sensitivity as historical reasons for not counting additional defects. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.	Allocation, concealment, masking, identical tools, adjudication and analysis	Acquire original allocation, masking, external adjudication, analysis and missingness.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacyAre Novo support, two employees and design/data/writing roles each preserved?Required	Novo Nordisk support, 2 employee authors and involvement in design, data and medical writing are preserved as in the existing summary. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.	Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing	Separately acquire original cash, drug/in-kind support, affiliations and design/data/analysis/writing disclosures.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyWere one trial, two periods, recurrent events and two tables kept from independent addition?Required	One Wysham2017 SWITCH2 report and the same crossover population share two existing questions. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.	Bibliography, trial, same people, periods and sibling-question relationships	Link added reports to original registration, the same population, outcomes and period relationships.
21	Unverified	Full text not readStored summary read	N21 · Comparative efficacyDo gaps remain for nocturnal, other-period, baseline-risk-subgroup and individual effects?Required	Core values in the designated existing summary concern overall symptomatic and severe outcomes during 16-week maintenance. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.	Original prespecified subgroups, timepoints, outcomes, interactions and denominators	Acquire original period/subgroup plans, outcomes, denominators, interactions and multiplicity.
22	Partly verified	Full text not readStored summary read	N22 · Supplementary harm evidenceAre hypoglycemia outcomes separated from other drug harms and safety denominators?Required	The existing summary records patient-experienced hypoglycemia as a treatment harm. Both treatments are insulins and parent safety is caution. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.	Harm definitions, people/events, actual exposure, denominators and relatedness	Acquire original other harms, group people/events, safety denominators, exposure and relatedness.
23	Unverified	Full text not readStored summary read	N23 · Supplementary harm evidenceWhat are the gaps in rare/long-term harms, discontinuation, actual exposure and treatment application?Required	Original completion/contribution limitations and the severe-proportion CI are preserved; long-term/rare-harm tables were not provided. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.	Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships	Acquire original exposure, harm-related discontinuation, collection, rare/long-term outcomes and direct material for new populations/drugs.
24	Partly verified	Full text not readStored summary read	N24 · Comparative efficacyAre stored summaries, bibliographic URLs, registration identifiers and external access distinguished?Required	The complete stored parent-verdict summary was read for production; Wysham2017 PubMed PMID28672317, registration identifier NCT02030600 and the original source URL were linked. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.	Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans	Link user-provided individual source material to its type and access status.
25	Partly verified	Full text not readStored summary read	N25 · Comparative efficacyAre Korean/English, axes, the reference date, corrections, empty values, candidate history and current production preserved?Supplementary	2026-08-26, empty correction/deliberation values, parent C50, safety caution, axes, Korean/English articles, selected subclaim C/D and notes are preserved in their original form. R01	Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.	Distinguishing the selected verdict record, complete parent, original languages, history and current production	Only user-added material/decisions are linked as separate events after preserving the complete original.

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25 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Type 2 diabetes with hypoglycemia risk; detailed eligibility, baseline characteristics and risk subgroups remain unread
Ingredient, formulation and route: Historical crossover-trial exposure to insulin degludec; not a recommendation on selection or use
Dose: Original detailed doses, titration and administration times remain unread; no individual regimen, injection or dose-adjustment instructions
Comparator: Active insulin glargine U100 control; two-period crossover in the same patients; detailed shared concurrent treatment remains unread
Measured outcome: Overall symptomatic hypoglycemia rate and proportion of affected patients during 16-week maintenance; severe-only outcomes distinguished
Duration: Each 32-week period: initial 16-week titration and 16-week maintenance primary analysis; other periods/long-term follow-up remain separate gaps
Questions outside this scope: Transferring the overall symptomatic composite effect to severe-only, HbA1c or long-term outcomes; Mixing event rates, patient proportions, contributors, FAS and completers; Correcting the original rate difference −23.66 using simple arithmetic; Adding two periods, the same people or recurrent events as new independent observations; Recommendations on insulin, doses, titration, injections, treatment choice, coverage or costs

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Wysham C, Bhargava A, Chaykin L, et al. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes. JAMA. 2017;318(1):45-56. PMID: 28672317.

PubMed

Material type: Randomized crossover superiority-trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 185.6 versus 265.4 events/100 patient-years; rate ratio 0.70 (0.61–0.80), absolute difference -23.66 events/100 patient-years; patient-proportion difference -9.1%p
Record level: Stored review summary; not a result of comparing the original external report here
Study overlap and independent replication: Family IDs link relationships and do not certify unique trial counts; added reports, sibling questions, the same participants and outcomes are not added independently. F01: the same SWITCH2 crossover report, patients, two periods, recurrent events and overall/severe hypoglycemia are shared by both subquestions

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Original URL preserved	Summary read	Summary read	Stored parent-verdict summary
External abstract	Original URL preserved	Not read	Not read	External material unread; a URL does not mean acquisition, reading or completed review
External full paper	No separate URL in the original material	Not read	Not read	External material unread; a URL does not mean acquisition, reading or completed review
External registration	No separate URL in the original material	Not read	Not read	External material unread; a URL does not mean acquisition, reading or completed review
External protocol and SAP	No separate URL in the original material	Not read	Not read	External material unread; a URL does not mean acquisition, reading or completed review

Report counts versus independent study counts

Family IDs link relationships and do not certify unique trial counts; added reports, sibling questions, the same participants and outcomes are not added independently. F01: the same SWITCH2 crossover report, patients, two periods, recurrent events and overall/severe hypoglycemia are shared by both subquestions

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Are subclaim C/D, original notes and parent C50/axes distinguished?

Required materials and conditions: Separate preservation of the selected claim, grade, note, absent values and parent values
Conditions for verification: Separate preservation of the selected claim, grade, note, absent values and parent values
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N02 · What are the actual population and baseline characteristics of type 2 diabetes with hypoglycemia risk?

Required materials and conditions: Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators
Conditions for verification: Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N03 · What is the direct comparison between degludec and glargine U100?

Required materials and conditions: Original drugs, formulations, active control, shared treatment and actual exposure
Conditions for verification: Original drugs, formulations, active control, shared treatment and actual exposure
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N04 · What are the sequence, same-person and analysis relationships in the two-period crossover?

Required materials and conditions: Assigned sequences, each period, treatment-specific contributions, correlation and denominators
Conditions for verification: Assigned sequences, each period, treatment-specific contributions, correlation and denominators
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N05 · Are each 32-week period, 16-week titration and 16-week maintenance windows distinguished?

Required materials and conditions: Original periods, titration, maintenance, primary window and actual exposure
Conditions for verification: Original periods, titration, maintenance, primary window and actual exposure
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N06 · Are carryover-mitigation plans distinguished from gaps on residual effects?

Required materials and conditions: Original titration plans, period effects, residual effects, sequence and sensitivity
Conditions for verification: Original titration plans, period effects, residual effects, sequence and sensitivity
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N07 · Are 721 randomized, 720 FAS, 580 completed and treatment-specific 632/618 distinguished?

Required materials and conditions: Randomized, FAS, completers, contributors and each treatment/period denominator
Conditions for verification: Randomized, FAS, completers, contributors and each treatment/period denominator
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N08 · What are the limits of completed 80.4%, not completed 19.6% and original missing-data handling?

Required materials and conditions: Completion, discontinuation reasons, treatment/period missingness, models and sensitivity
Conditions for verification: Completion, discontinuation reasons, treatment/period missingness, models and sensitivity
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N09 · What is the overall symptomatic endpoint definition involving severe or glucose-confirmed events?

Required materials and conditions: Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment
Conditions for verification: Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N10 · What scales do 185.6/265.4 events, 0.70 and the 95% CI represent?

Required materials and conditions: Patient-time, event rates, original ratio, model, interval and denominator
Conditions for verification: Patient-time, event rates, original ratio, model, interval and denominator
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N11 · Was the original absolute rate difference −23.66 retained without recalculation as a simple difference?

Required materials and conditions: Original rate difference, model, scale, denominator and uncertainty
Conditions for verification: Original rate difference, model, scale, denominator and uncertainty
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N12 · Are affected-patient proportions 22.5%/31.6% and original −9.1%p distinguished?

Required materials and conditions: Affected patients, at least one event, denominator, period, difference and interval
Conditions for verification: Affected patients, at least one event, denominator, period, difference and interval
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N13 · Are severe 1.6%/2.4%, −0.8%p, CI and P retained in their original scope?

Required materials and conditions: Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P
Conditions for verification: Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N14 · Are overall-endpoint improvement and severe-only uncertainty separated?

Required materials and conditions: Overall/components, hierarchy, denominators, original effects, tests and interpretation
Conditions for verification: Overall/components, hierarchy, denominators, original effects, tests and interpretation
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N15 · Are secondary HbA1c noninferiority and primary hypoglycemia separated?

Required materials and conditions: Original secondary efficacy, noninferiority plans, periods, denominators and margins
Conditions for verification: Original secondary efficacy, noninferiority plans, periods, denominators and margins
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N16 · What are the clinical scope, individual effects and long-term confirmation of overall symptomatic improvement?

Required materials and conditions: Original symptomatic endpoints, recurrent events, average/individual effects and direct long-term material
Conditions for verification: Original symptomatic endpoints, recurrent events, average/individual effects and direct long-term material
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N17 · What is actual access to primary/secondary hierarchy, multiplicity, registration and SAP?

Required materials and conditions: Original registration, protocol, SAP, primary/secondary outcomes, changes and models
Conditions for verification: Original registration, protocol, SAP, primary/secondary outcomes, changes and models
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N18 · Are identical vials/syringes, double blinding and actual assessment distinguished?

Required materials and conditions: Allocation, concealment, masking, identical tools, adjudication and analysis
Conditions for verification: Allocation, concealment, masking, identical tools, adjudication and analysis
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N19 · Are Novo support, two employees and design/data/writing roles each preserved?

Required materials and conditions: Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing
Conditions for verification: Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N20 · Were one trial, two periods, recurrent events and two tables kept from independent addition?

Required materials and conditions: Bibliography, trial, same people, periods and sibling-question relationships
Conditions for verification: Bibliography, trial, same people, periods and sibling-question relationships
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N21 · Do gaps remain for nocturnal, other-period, baseline-risk-subgroup and individual effects?

Required materials and conditions: Original prespecified subgroups, timepoints, outcomes, interactions and denominators
Conditions for verification: Original prespecified subgroups, timepoints, outcomes, interactions and denominators
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N22 · Are hypoglycemia outcomes separated from other drug harms and safety denominators?

Required materials and conditions: Harm definitions, people/events, actual exposure, denominators and relatedness
Conditions for verification: Harm definitions, people/events, actual exposure, denominators and relatedness
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N23 · What are the gaps in rare/long-term harms, discontinuation, actual exposure and treatment application?

Required materials and conditions: Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships
Conditions for verification: Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N24 · Are stored summaries, bibliographic URLs, registration identifiers and external access distinguished?

Required materials and conditions: Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans
Conditions for verification: Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans
Requirement and applicability: Required
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

N25 · Are Korean/English, axes, the reference date, corrections, empty values, candidate history and current production preserved?

Required materials and conditions: Distinguishing the selected verdict record, complete parent, original languages, history and current production
Conditions for verification: Distinguishing the selected verdict record, complete parent, original languages, history and current production
Requirement and applicability: Supplementary
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing

What the statuses mean

Partly verified: Some information is in the stored summary; detailed original material remains unverified. This does not certify passed review or clinical efficacy
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Awaiting user review
Met: Use only within the relevant condition's scope after user review; no automatic display in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-10 · Public page/material version 1.0

The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Are subclaim C/D, original notes and parent C50/axes distinguished?

Current findings: Selected overall symptomatic hypoglycemia subclaim C has a note of patient-proportion absolute difference −9.1%p. It is distinguished from parent C50, safety caution and the original overall symptomatic verdict.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.
Reason for missing information: Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.
Required materials and conditions: Separate preservation of the selected claim, grade, note, absent values and parent values
Materials to obtain first: Absent subclaim scores, status and axes are not filled with parent values. There is no new split, verdict, grade or independent certification.
Further research: Additional material is linked with each selected question and parent context distinguished.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate preservation of the selected claim, grade, note, absent values and parent values
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N02 · What are the actual population and baseline characteristics of type 2 diabetes with hypoglycemia risk?

Current findings: SWITCH2 is an insulin comparison trial in type 2 diabetes with hypoglycemia risk.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.
Reason for missing information: Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.
Required materials and conditions: Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators
Materials to obtain first: Detailed risk eligibility, previous hypoglycemia, baseline medication, renal/age/comorbidity characteristics and group/sequence composition are absent from the summary. Results are not automatically extended to other populations.
Further research: Acquire original eligibility, baseline characteristics, risk criteria, concurrent exposure and denominators.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Eligibility, risk criteria, baseline insulin, concurrent drugs and denominators
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N03 · What is the direct comparison between degludec and glargine U100?

Current findings: The existing citation compares insulin degludec with insulin glargine U100; each patient received both insulins sequentially.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.
Reason for missing information: This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.
Required materials and conditions: Original drugs, formulations, active control, shared treatment and actual exposure
Materials to obtain first: This is not changed to other concentrations, other insulins, treatment discontinuation or no-insulin comparison. Product, dose, shared concurrent treatment and treatment-change details remain unread; no selection or regimen instructions are given.
Further research: Acquire original drugs, formulations, active control, concurrent treatment, changes and actual exposure.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original drugs, formulations, active control, shared treatment and actual exposure
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N04 · What are the sequence, same-person and analysis relationships in the two-period crossover?

Current findings: The original randomized double-blind two-period crossover design gives both treatments to the same people.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.
Reason for missing information: Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.
Required materials and conditions: Assigned sequences, each period, treatment-specific contributions, correlation and denominators
Materials to obtain first: Two periods, treatment-specific analyses and two questions are not added as new people or independent trials. Original sequence counts, period/sequence models, treatment changes and censoring remain unread.
Further research: Acquire original sequence allocation, period/treatment contributions, correlations, models and denominators.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Assigned sequences, each period, treatment-specific contributions, correlation and denominators
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N05 · Are each 32-week period, 16-week titration and 16-week maintenance windows distinguished?

Current findings: The existing summary says the initial 16 weeks of each 32-week period were for titration, with only maintenance used in primary analysis. The evidence entry concerns the 16-week maintenance endpoint.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.
Reason for missing information: Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.
Required materials and conditions: Original periods, titration, maintenance, primary window and actual exposure
Materials to obtain first: Time in the two periods is not newly added, and titration/full-period values are not moved into maintenance results. No titration method, usage instruction or actual period/exposure is invented.
Further research: Acquire original period-specific plans, actual exposure, observation windows, denominators and analyses.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original periods, titration, maintenance, primary window and actual exposure
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N06 · Are carryover-mitigation plans distinguished from gaps on residual effects?

Current findings: The existing summary describes crossover’s reduction of between-person variation, possible carryover and a 16-week titration plan to reduce it. It records that crossover itself was not a listed defect.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.
Reason for missing information: A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.
Required materials and conditions: Original titration plans, period effects, residual effects, sequence and sensitivity
Materials to obtain first: A titration plan alone does not newly certify zero carryover or complete resolution. Washout, period/sequence tests and sensitivity details remain unread.
Further research: Acquire original period/sequence, carryover, titration and sensitivity plans/results.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original titration plans, period effects, residual effects, sequence and sensitivity
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N07 · Are 721 randomized, 720 FAS, 580 completed and treatment-specific 632/618 distinguished?

Current findings: The existing evidence list gives 721 randomized, 720 FAS and 580 completed. The original Korean article records treatment-specific primary contributors of 632 and 618.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.
Reason for missing information: 632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.
Required materials and conditions: Randomized, FAS, completers, contributors and each treatment/period denominator
Materials to obtain first: 632/618 are not newly mapped to treatment names absent from the existing summary or added as different people. FAS720, completed580 and primary contributors do not substitute for the same population.
Further research: Acquire original flow, treatment/period contributions, sequences, population definitions and denominators.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Randomized, FAS, completers, contributors and each treatment/period denominator
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N08 · What are the limits of completed 80.4%, not completed 19.6% and original missing-data handling?

Current findings: 580/721 completed, 80.4%; not completed, 19.6%; and ITT/missingness-sensitivity analyses are retained as described in the original article.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.
Reason for missing information: No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.
Required materials and conditions: Completion, discontinuation reasons, treatment/period missingness, models and sensitivity
Materials to obtain first: No new dropout rate, group missingness or imputed values are calculated. Original missing-data analysis wording does not certify resolution of all missingness bias or complete follow-up.
Further research: Acquire original discontinuation, missingness, imputation/sensitivity assumptions, populations, effects and intervals.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Completion, discontinuation reasons, treatment/period missingness, models and sensitivity
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N09 · What is the overall symptomatic endpoint definition involving severe or glucose-confirmed events?

Current findings: The original primary endpoint is externally adjudicated severe events requiring third-party assistance, or events combining glucose <56mg/dL with symptoms.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.
Reason for missing information: This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.
Required materials and conditions: Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment
Materials to obtain first: This is not changed to a lab value alone, all asymptomatic hypoglycemia or severe events alone. Recurrent-event distinctions, ascertainment schedules and collection details remain unread.
Further research: Acquire original definitions, external adjudication, combined symptoms/testing, people/recurrent events and periods.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Severe events, third-party assistance, external adjudication, glucose/symptoms and event ascertainment
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N10 · What scales do 185.6/265.4 events, 0.70 and the 95% CI represent?

Current findings: Overall symptomatic hypoglycemia during 16-week maintenance was 185.6 versus 265.4 events/100 patient-years; rate ratio 0.70 (95% CI 0.61–0.80).
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.
Reason for missing information: Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.
Required materials and conditions: Patient-time, event rates, original ratio, model, interval and denominator
Materials to obtain first: Event rates are not changed into patient proportions, risk ratios or total people. Recurrent events, patient-time, adjustment and detailed test P values are not invented.
Further research: Acquire original event/time tables, rate models, adjustment, group exposure, CIs and tests.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Patient-time, event rates, original ratio, model, interval and denominator
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N11 · Was the original absolute rate difference −23.66 retained without recalculation as a simple difference?

Current findings: The existing summary and evidence list separately record an absolute rate difference of −23.66 events/100 patient-years.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. 185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.
Reason for missing information: 185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.
Required materials and conditions: Original rate difference, model, scale, denominator and uncertainty
Materials to obtain first: 185.6/265.4 are not subtracted again to replace/correct this original value. Calculation model, adjustment, CI and P value are not filled in if unspecified.
Further research: Acquire original rate-difference calculation, model, denominator, period and interval.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original rate difference, model, scale, denominator and uncertainty
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N12 · Are affected-patient proportions 22.5%/31.6% and original −9.1%p distinguished?

Current findings: Patients experiencing overall symptomatic events were 22.5% versus 31.6%; the original absolute difference was −9.1%p.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.
Reason for missing information: This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.
Required materials and conditions: Affected patients, at least one event, denominator, period, difference and interval
Materials to obtain first: This proportion is not converted to a recurrent-event rate, severe proportion or new patient count. No new NNT, difference CI, P value or absolute-event example is created.
Further research: Acquire original affected-patient definitions, group denominators, event mapping, original difference/interval and tests.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Affected patients, at least one event, denominator, period, difference and interval
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N13 · Are severe 1.6%/2.4%, −0.8%p, CI and P retained in their original scope?

Current findings: Patients experiencing severe events during maintenance were 1.6% versus 2.4%; difference −0.8%p (95% CI −2.2–0.5; P=.35).
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.
Reason for missing information: This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.
Required materials and conditions: Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P
Materials to obtain first: This value is not changed to events/patient-year, overall symptomatic effects or severe effects in other periods. No new people/event counts, rate ratios, CIs or P values are created.
Further research: Acquire original severe events, affected patients, denominators, periods, difference/interval and tests.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Severe definition requiring third-party assistance, patient proportions, original denominators, difference, CI and P
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N14 · Are overall-endpoint improvement and severe-only uncertainty separated?

Current findings: The existing summary says overall symptomatic outcomes improved but the severe maintenance-period difference was not significant. Subclaim C/D are distinguished.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.
Reason for missing information: Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.
Required materials and conditions: Overall/components, hierarchy, denominators, original effects, tests and interpretation
Materials to obtain first: Overall effects, average glucose or mechanisms do not establish severe reduction; P=.35 is not judged as an exact zero effect or equivalence.
Further research: Acquire original component-specific plans, effects, intervals, hierarchy and precision.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Overall/components, hierarchy, denominators, original effects, tests and interpretation
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N15 · Are secondary HbA1c noninferiority and primary hypoglycemia separated?

Current findings: The existing summary records HbA1c as a secondary efficacy endpoint, noninferior in both periods.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.
Reason for missing information: HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.
Required materials and conditions: Original secondary efficacy, noninferiority plans, periods, denominators and margins
Materials to obtain first: HbA1c is not promoted to primary hypoglycemia; values, margins, CIs, P values or overall/severe effects absent from the existing summary are not filled in.
Further research: Separately acquire original HbA1c plans, margins, group values, denominators, periods and tests.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original secondary efficacy, noninferiority plans, periods, denominators and margins
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N16 · What are the clinical scope, individual effects and long-term confirmation of overall symptomatic improvement?

Current findings: Subclaim C’s original note gives patient-proportion difference −9.1%p; the parent records C50 for one manufacturer-run crossover trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This average between-group result is not transferred to prevention of hypoglycemia in every individual, severe improvement or long-term mortality/function improvement.
Reason for missing information: This average between-group result is not transferred to prevention of hypoglycemia in every individual, severe improvement or long-term mortality/function improvement.
Required materials and conditions: Original symptomatic endpoints, recurrent events, average/individual effects and direct long-term material
Materials to obtain first: This average between-group result is not transferred to prevention of hypoglycemia in every individual, severe improvement or long-term mortality/function improvement.
Further research: Acquire original direct long-term outcomes, independent-report relationships and new population/exposure material.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original symptomatic endpoints, recurrent events, average/individual effects and direct long-term material
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N17 · What is actual access to primary/secondary hierarchy, multiplicity, registration and SAP?

Current findings: The original registration identifier is NCT02030600; the primary endpoint is the 16-week maintenance overall symptomatic hypoglycemia rate.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.
Reason for missing information: Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.
Required materials and conditions: Original registration, protocol, SAP, primary/secondary outcomes, changes and models
Materials to obtain first: Registration, full text and plans were not newly read. Exact hierarchy, α, multiplicity, prespecified subgroups or changes for severe/other periods are not newly established.
Further research: Acquire original registration, plans, hierarchy, multiplicity, models and changes.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original registration, protocol, SAP, primary/secondary outcomes, changes and models
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N18 · Are identical vials/syringes, double blinding and actual assessment distinguished?

Current findings: The existing summary records double blinding, identical vials/syringes, ITT and missingness sensitivity as historical reasons for not counting additional defects.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.
Reason for missing information: This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.
Required materials and conditions: Allocation, concealment, masking, identical tools, adjudication and analysis
Materials to obtain first: This does not certify new completed review or absence of all bias. Successful masking, allocation concealment and analyst/adjudicator details remain unread.
Further research: Acquire original allocation, masking, external adjudication, analysis and missingness.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Allocation, concealment, masking, identical tools, adjudication and analysis
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N19 · Are Novo support, two employees and design/data/writing roles each preserved?

Current findings: Novo Nordisk support, 2 employee authors and involvement in design, data and medical writing are preserved as in the existing summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.
Reason for missing information: Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.
Required materials and conditions: Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing
Materials to obtain first: Two employees are not certified as independent authors, and funding alone does not fill trial-drug provision or external-analysis roles. Parent I0 is also preserved.
Further research: Separately acquire original cash, drug/in-kind support, affiliations and design/data/analysis/writing disclosures.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Funding, drugs/in-kind support, employees, external analysis and design/data/medical writing
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N20 · Were one trial, two periods, recurrent events and two tables kept from independent addition?

Current findings: One Wysham2017 SWITCH2 report and the same crossover population share two existing questions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.
Reason for missing information: Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.
Required materials and conditions: Bibliography, trial, same people, periods and sibling-question relationships
Materials to obtain first: Periods, treatment contributions, recurrent events and overall/severe components are not added as new trials/participants. Final independent counts and participant totals are null.
Further research: Link added reports to original registration, the same population, outcomes and period relationships.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Bibliography, trial, same people, periods and sibling-question relationships
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N21 · Do gaps remain for nocturnal, other-period, baseline-risk-subgroup and individual effects?

Current findings: Core values in the designated existing summary concern overall symptomatic and severe outcomes during 16-week maintenance.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.
Reason for missing information: No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.
Required materials and conditions: Original prespecified subgroups, timepoints, outcomes, interactions and denominators
Materials to obtain first: No nocturnal, titration, full-period, baseline-risk-specific effect, individual suitability or drug choice is invented.
Further research: Acquire original period/subgroup plans, outcomes, denominators, interactions and multiplicity.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original prespecified subgroups, timepoints, outcomes, interactions and denominators
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N22 · Are hypoglycemia outcomes separated from other drug harms and safety denominators?

Current findings: The existing summary records patient-experienced hypoglycemia as a treatment harm. Both treatments are insulins and parent safety is caution.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.
Reason for missing information: Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.
Required materials and conditions: Harm definitions, people/events, actual exposure, denominators and relatedness
Materials to obtain first: Reduced overall hypoglycemia is not extended to absence of other harms or overall drug safety. Other-harm tables, relatedness and safety populations remain unread.
Further research: Acquire original other harms, group people/events, safety denominators, exposure and relatedness.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Harm definitions, people/events, actual exposure, denominators and relatedness
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N23 · What are the gaps in rare/long-term harms, discontinuation, actual exposure and treatment application?

Current findings: Original completion/contribution limitations and the severe-proportion CI are preserved; long-term/rare-harm tables were not provided.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.
Reason for missing information: No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.
Required materials and conditions: Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships
Materials to obtain first: No dose-adjustment, monitoring, injection, treatment choice/substitution, coverage or cost guidance is created. Nonreporting/nonsignificance is not used as long-term safety or zero rare events.
Further research: Acquire original exposure, harm-related discontinuation, collection, rare/long-term outcomes and direct material for new populations/drugs.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original harm collection, exposure, discontinuation, follow-up, periods and independent relationships
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N24 · Are stored summaries, bibliographic URLs, registration identifiers and external access distinguished?

Current findings: The complete stored parent-verdict summary was read for production; Wysham2017 PubMed PMID28672317, registration identifier NCT02030600 and the original source URL were linked.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.
Reason for missing information: External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.
Required materials and conditions: Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans
Materials to obtain first: External abstracts, full texts, registration, protocols and SAPs remain unread. No new URL/DOI is constructed from identifiers and no separate link test was run.
Further research: Link user-provided individual source material to its type and access status.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original bibliography, URLs, identifiers and access to abstracts/full texts/registration/plans
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01

N25 · Are Korean/English, axes, the reference date, corrections, empty values, candidate history and current production preserved?

Current findings: 2026-08-26, empty correction/deliberation values, parent C50, safety caution, axes, Korean/English articles, selected subclaim C/D and notes are preserved in their original form.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only relevant stored-summary information is recorded; detailed original material and user review remain outstanding. Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.
Reason for missing information: Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.
Required materials and conditions: Distinguishing the selected verdict record, complete parent, original languages, history and current production
Materials to obtain first: Original design/missingness and prescription/cost explanations are historical, not current review, lookup or recommendations. Absent subclaim values are not filled; candidate review-pending/production-eligible indicators are historical.
Further research: Only user-added material/decisions are linked as separate events after preserving the complete original.
Remaining uncertainty: Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Distinguishing the selected verdict record, complete parent, original languages, history and current production
Why this condition is needed: Individual production conditions recording original selected claims, comparisons, denominators, periods and interpretive limits
Application exceptions: Unread external material, other questions or out-of-scope outcomes do not substitute for satisfied conditions, zero effect or safety.
Referenced methods: Selected claim: Reduced overall symptomatic hypoglycemia

Related sources R01