Glyburide × superiority conclusion of significantly greater harm than insulin: evidence checklist

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 harm and production from preserved materialWhat existing verdict accompanies the selected harm-superiority question?Required	The selected question is “Superiority conclusion that glyburide is significantly more harmful”; D and “INDAO did not confirm that conclusion” are preserved. Sibling noninferiority C and parent C54 are separate contexts. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm. The original content review remains incomplete.	Exact claim, subclaim D/note, and separation from parent C54	Maintain the two questions’ pointers and verdict contexts separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
2	Partly verified	Full text not readStored summary read	N02 · Comparative harm and production from preserved materialWhich events and population are compared by “more harmful”?Required	The original context is a glyburide-versus-insulin perinatal comparison in gestational diabetes requiring medication. The INDAO composite and individual maternal/neonatal events are separated. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations. The original content review remains incomplete.	Fixed harm-event definitions, population, comparator, and period	Attribute harm questions separately to the perinatal composite and individual events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
3	Partly verified	Full text not readStored summary read	N03 · Comparative harm and production from preserved materialAre population, pregnancy timing, and baseline risk known?Required	The original scope of 13 French university hospitals and gestational diabetes requiring medication even after 10 days of dietary treatment is preserved. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified. The original content review remains incomplete.	Actual recruitment conditions, medication requirement, and baseline risk	Separate the scope for other pregnancy/diabetes populations and vulnerable groups. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
4	Partly verified	Full text not readStored summary read	N04 · Comparative harm and production from preserved materialWhat are actual exposure, comparator, and concomitant treatment?Required	The manuscript records oral glyburide versus injected insulin. Only original study conditions are described; no administration/substitution instructions are created. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified. The original content review remains incomplete.	Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care	Separate nominal assignment, actual exposure, and other causes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
5	Partly verified	Full text not readStored summary read	N05 · Comparative harm and production from preserved materialWas INDAO designed to test superiority in harm?Required	INDAO is an open-label randomized noninferiority trial. The selected note records that the superiority-in-harm conclusion was not confirmed. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design. The original content review remains incomplete.	Noninferiority/superiority hypotheses, prespecified tests, and analysis plan	Distinguish results for different statistical questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
6	Partly verified	Full text not readStored summary read	N06 · Comparative harm and production from preserved materialWhat were actual randomization, open-label procedures, and measurement operations?Required	The original description is open-label randomization of 914 participants (460/454) at 13 hospitals. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design. The original content review remains incomplete.	Allocation, concealment, baseline balance, event measurement, and blinding	Link design to limitations of actual event measurement. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
7	Partly verified	Full text not readStored summary read	N07 · Comparative harm and production from preserved materialWhat are perinatal-composite event definitions and counting units?Required	INDAO’s primary composite is at least one of three components. Maternal hypoglycemia is not moved into this explicitly stated composite. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified. The original content review remains incomplete.	Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling	Record composite person/event units and each harm separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
8	Partly verified	Full text not readStored summary read	N08 · Comparative harm and production from preserved materialAre original event rates/difference interpreted directly as superiority in harm?Required	The original composite rates of 27.6% versus 23.4% and absolute difference of +4.2 percentage points are preserved. Observed direction and confirmation of significant superiority in harm do not mean the same thing. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated. The original content review remains incomplete.	Original rates, absolute difference, denominators, and testing framework	Separate observed direction from testing conclusions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
9	Partly verified	Full text not readStored summary read	N09 · Comparative harm and production from preserved materialIs the one-sided noninferiority interval a harm-superiority interval?Required	Supplied values are a one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=.19. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P. The original content review remains incomplete.	Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics	Maintain the hypothesis and interval definition of the original statistics. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
10	Partly verified	Full text not readStored summary read	N10 · Comparative harm and production from preserved materialHow does failure at the +7-percentage-point threshold differ from significant harm?Required	The manuscript says the +10.5-percentage-point upper bound exceeded the prespecified +7-percentage-point margin, so being within the acceptable margin was not demonstrated. It explicitly states this was not proof of significantly worse outcomes. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created. The original content review remains incomplete.	Distinction between the noninferiority margin and superiority conclusion	Separate the failed question from the distinct unconfirmed conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
11	Partly verified	Full text not readStored summary read	N11 · Comparative harm and production from preserved materialAre assignment, PP, exposure, and neonatal denominators separated?Required	914 randomized (460/454) and the prespecified PP 809 (367/442) are preserved separately. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated. The original content review remains incomplete.	Person/neonatal units and assignment/exposure/observation/analysis units	Link exposed participants, people with events, and analysis units separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
12	Partly verified	Full text not readStored summary read	N12 · Comparative harm and production from preserved materialDo other analysis populations confirm the superiority conclusion?Required	The manuscript records only that other analysis populations were used to assess consistency. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation. The original content review remains incomplete.	Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses	Maintain PP, supplementary analyses, and harm superiority as distinct records. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
13	Unverified	Full text not readStored summary read	N13 · Comparative harm and production from preserved materialAre harm-observation timing, missed tests, and discontinuation known?Required	Only the historical study context of the perinatal composite and medication assignment is available. S01	Currently required information in the stored summary is unverified. Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified. The original content review remains incomplete.	Exposure start/end, event timing, testing/follow-up, and discontinuation	Distinguish unreported/unverified information from absence of events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
14	Unverified	Full text not readStored summary read	N14 · Comparative harm and production from preserved materialWere concurrent treatment and alternative explanations reviewed?Required	The original descriptions of an open-label randomized comparison and medication requirement after dietary treatment are preserved. S01	Currently required information in the stored summary is unverified. Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted. The original content review remains incomplete.	Baseline risk, concomitant treatment, switching, confounding, and adjustment	Distinguish observed harm from causal attribution to a single medication. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
15	Partly verified	Full text not readStored summary read	N15 · Comparative harm and production from preserved materialWhat is the actual reading level for registration and the superiority plan?Required	NCT01731431 is preserved as originally recorded. The number does not mean the superiority plan was read. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established. The original content review remains incomplete.	NCT identifier, hypotheses, change history, and protocol/SAP	If corresponding material is supplied, record differences among hypotheses, changes, and reporting. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
16	Partly verified	Full text not readStored summary read	N16 · Comparative harm and production from preserved materialWhat verification scope applies to public funding and unreported commercial support?Required	The original description of French Ministry of Health PHRC and AP-HP public sponsor support, and unreported commercial pharmaceutical funding/free study medication, is preserved. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made. The original content review remains incomplete.	PHRC/AP-HP, commercial support, medication, authors/COI, and roles	Distinguish disclosed information from unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
17	Partly verified	Full text not readStored summary read	N17 · Comparative harm and production from preserved materialIs INDAO maternal hypoglycemia evidence of composite superiority?Required	The manuscript describes more frequent maternal hypoglycemia in the glyburide arm. It is not transferred to significant superiority in harm for the entire perinatal composite. S01	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance. The original content review remains incomplete.	Maternal-event definition, arm-specific values, denominators, and harm analysis	Attribute maternal harms and the neonatal composite separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
18	Unverified	Full text not readStored summary read	N18 · Comparative harm and production from preserved materialAre INDAO’s individual neonatal-component results known?Required	The pivotal report supplies composite results for three components. S01	Currently required information in the stored summary is unverified. Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates. The original content review remains incomplete.	Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia	Separate comparison conclusions for the composite and each component. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
19	Partly verified	Full text not readStored summary read	N19 · Comparative harm and production from preserved materialHow are Helal’s overall synthesis and RCT subgroup analysis distinguished?Required	The review records 24 studies with 24,517 participants overall and an 11-RCT subgroup. S02	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets. The original content review remains incomplete.	24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators	Separate synthesis reports from actual original-trial/population units. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
20	Partly verified	Full text not readStored summary read	N20 · Comparative harm and production from preserved materialWhat are the review’s RCT maternal hypoglycemia/LGA results?Required	S02’s evidence/citation entries record more maternal hypoglycemia and LGA in the RCT subgroup. S02	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite. The original content review remains incomplete.	Subgroup endpoints, effects/intervals, arms/denominators, and definitions	Attribute results individually by analysis level, event, and material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
21	Partly verified	Full text not readStored summary read	N21 · Comparative harm and production from preserved materialWhich result does the overall pooled neonatal hypoglycemia OR describe?Required	S02’s evidence entry supplies overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95). S02	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms. The original content review remains incomplete.	Overall pooling, neonatal events, OR/CI, and original analysis scope	Link the original OR/interval only to its corresponding overall analysis. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
22	Partly verified	Full text not readStored summary read	N22 · Comparative harm and production from preserved materialWhat is the difference between stored-summary descriptions of the review’s analysis levels?Required	The Korean/English safety explanation records increased neonatal hypoglycemia and LGA in the RCT subgroup. The evidence list distinguishes RCT maternal hypoglycemia/LGA from the overall neonatal hypoglycemia OR. S02	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made. The original content review remains incomplete.	Outcome attribution in evidence/safety explanations and external-verification scope	If the original paper is supplied, record explanations/correction events for the wording difference separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
23	Unverified	Full text not readStored summary read	N23 · Comparative harm and production from preserved materialWhat information do Helal’s support and registration entries actually provide?Required	The funding entry is “systematic review; included-trial funding mixed”, and nct is “not applicable”. The actual registration identifier remains null. S02	Currently required information in the stored summary is unverified. The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification. The original content review remains incomplete.	Review/included-trial funding, COI, plans, and registration	Separate material types, review roles, and original-trial support. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
24	Partly verified	Full text not readStored summary read	N24 · Comparative harm and production from preserved materialWhat were the earlier Langer trial’s opposing results?Required	The 404-participant RCT had primary glycemic control and secondary individual perinatal outcomes. LGA 12/13%, neonatal hypoglycemia 9/6%, no significant difference, and the “clinically effective alternative” conclusion are preserved as originally recorded. S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success. The original content review remains incomplete.	Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion	Record opposing results together with limitations from different questions/designs. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
25	Unverified	Full text not readStored summary read	N25 · Comparative harm and production from preserved materialWhat level do Langer’s funding/registration wordings represent?Required	Funding “reported in the original paper” and nct “not applicable” are preserved as originally recorded. These wordings are not an actual funding provider or registration number. S03	Currently required information in the stored summary is unverified. External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established. The original content review remains incomplete.	Actual supporter, product/COI, registration, and plans	Distinguish original wording from newly supplied actual identity material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
26	Partly verified	Full text not readStored summary read	N26 · Comparative harm and production from preserved materialAre the same events, trials, and review counted as independent replications?Required	INDAO, the Helal review, and Langer are linked as separate report slots and shared with the sibling noninferiority sheet. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals. The original content review remains incomplete.	Report-to-trial-to-event links, recitation, and review-inclusion relationships	Maintain relationships among original trials, review recitations, and the same people/timepoints. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
27	Partly verified	Full text not readStored summary read	N27 · Comparative harm and production from preserved materialDoes the current record establish comparison direction, a signal, or causality?Required	INDAO’s failure to demonstrate noninferiority/unconfirmed superiority are distinguished from individual maternal/neonatal harm contexts. Selected D is the original-data verdict, not a new harm grade. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created. The original content review remains incomplete.	Design, intervals, alternatives, and original-conclusion scope of each material	Maintain each original report’s comparison/interpretation scope separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
28	Partly verified	Full text not readStored summary read	N28 · Comparative harm and production from preserved materialIs the result extended to other drugs, vulnerable groups, or long-term harms?Required	The manuscript records that sulfonylurea placental-transfer characteristics vary by drug and are not generalized to the whole class. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created. The original content review remains incomplete.	Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk	Separate the narrow comparative-harm question from questions outside its scope. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
29	Partly verified	Full text not readStored summary read	N29 · Comparative harm and production from preserved materialWhat historical context do parent values, languages, empty values, dates, and corrections provide?Required	Parent C54, unrecorded precision, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, historical cross-checking, and selected D/note are preserved in the full stored summary. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review. The original content review remains incomplete.	Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections	Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.
30	Partly verified	Full text not readStored summary read	N30 · Comparative harm and production from preserved materialAre actual summary reading and unread external material distinguished?Required	The full JSON with three evidence entries and three citations was read for production, and original links are preserved. Summaries are labeled “summary read”; external material is labeled “unread”. S01 S02 S03	Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access. The original content review remains incomplete.	Access status for preserved material, papers, registration, protocol, SAP, and disclosures	Update each material’s existence, acquisition, and reading level separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.

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30 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: Original gestational-diabetes population requiring medication; shared with the sibling noninferiority sheet
Ingredient, formulation and route: Original study: glyburide; assignment/actual exposure/concomitant treatment/switching unverified
Dose: Not recorded
Comparator: Insulin; observed direction separated from harm-superiority testing
Measured outcome: Superiority conclusion that glyburide is significantly more harmful; INDAO note: unconfirmed; composite/individual harms distinguished
Duration: Perinatal context; exact event period/long-term outcomes unverified
Questions outside this scope: Changing failure to demonstrate noninferiority into significant superiority in harm, equivalence, an exactly zero effect, or confirmation of all safety outcomes; Repurposing the one-sided 97.5% upper bound of +10.5 percentage points/noninferiority P=.19 as a full two-sided CI/harm-superiority P, or calculating new values; Replacing 914 randomized (460/454), PP 809 (367/442), and maternal/neonatal/event denominators as the same unit, or calculating new exclusion/event/risk counts; Treating the composite, macrosomia, LGA, neonatal hypoglycemia, hyperbilirubinemia, and maternal hypoglycemia as the same outcome; Substituting Helal’s overall 24,517 participants, 11 RCTs, and endpoint-specific subset denominators, or repurposing the overall neonatal OR as an RCT-only/INDAO/composite value; Automatically resolving or reassessing the review-attribution difference between the stored summary’s evidence list and safety explanation while the original paper remains unread; Changing Langer’s 404 participants, primary glycemic control/secondary individual perinatal outcomes, or nonsignificance into passing composite NI at +7 percentage points, reversing INDAO, or zero harm; Summing the review, original trial, subsequent reports, sibling tables, people/arms/events/timepoints as new independent trials, participants, or replications; Changing funding reported in the original paper/systematic review, nct not applicable, or unreported commercial support into an actual provider, absence, registration identifier, or independence certification; Inheriting parent C54, original axes, or historical cross-checking as selected C/D scores/axes, current content review, or external reading; New calculations, invented values, new effects/CIs, reassessment, independence certification, or instructions to implement medication selection/substitution/administration/treatment/monitoring for pregnant women

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.

S01 · Sénat MV et al. 2018 INDAO

PubMed

Material type: Multicenter open-label randomized noninferiority trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: The original note that INDAO did not confirm the superiority conclusion of significantly greater harm is preserved. 27.6% versus 23.4%, difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, and noninferiority P=0.19 are noninferiority results; that CI upper bound/P is not repurposed as a superiority interval/test. Observed composite direction, maternal-hypoglycemia descriptions, and superiority confirmation are distinct.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Helal KF et al. 2020 systematic review and meta-analysis

PubMed

Material type: 11-RCT subgroup analysis within 24 studies
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: More maternal hypoglycemia and LGA with glyburide in the RCT subgroup, and overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95). Wording at a different analysis level in the stored summary’s safety explanation is also preserved. The overall OR is not repurposed as RCT-only/INDAO/composite data; no new effects/CIs/totals/reassessment are created.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Langer O et al. 2000

PubMed

Material type: Randomized glyburide-versus-insulin trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%; no significant difference in individual complications; “clinically effective alternative” conclusion. Individual values and the original alternative conclusion are attributed to that earlier trial. Gaps in denominators/original CI/P/plans remain; no new judgment of passing NI, significant harm, or an exactly zero effect is made.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.

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 · What existing verdict accompanies the selected harm-superiority question?

Required materials and conditions: Exact claim, subclaim D/note, and separation from parent C54
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exact claim, subclaim D/note, and separation from parent C54. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Exact claim, subclaim D/note, and separation from parent C54.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N02 · Which events and population are compared by “more harmful”?

Required materials and conditions: Fixed harm-event definitions, population, comparator, and period
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Fixed harm-event definitions, population, comparator, and period. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Fixed harm-event definitions, population, comparator, and period.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N03 · Are population, pregnancy timing, and baseline risk known?

Required materials and conditions: Actual recruitment conditions, medication requirement, and baseline risk
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual recruitment conditions, medication requirement, and baseline risk. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Actual recruitment conditions, medication requirement, and baseline risk.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation

N04 · What are actual exposure, comparator, and concomitant treatment?

Required materials and conditions: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design

N05 · Was INDAO designed to test superiority in harm?

Required materials and conditions: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N06 · What were actual randomization, open-label procedures, and measurement operations?

Required materials and conditions: Allocation, concealment, baseline balance, event measurement, and blinding
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Allocation, concealment, baseline balance, event measurement, and blinding. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Allocation, concealment, baseline balance, event measurement, and blinding.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

N07 · What are perinatal-composite event definitions and counting units?

Required materials and conditions: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation

N08 · Are original event rates/difference interpreted directly as superiority in harm?

Required materials and conditions: Original rates, absolute difference, denominators, and testing framework
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original rates, absolute difference, denominators, and testing framework. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Original rates, absolute difference, denominators, and testing framework.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation

N09 · Is the one-sided noninferiority interval a harm-superiority interval?

Required materials and conditions: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

N10 · How does failure at the +7-percentage-point threshold differ from significant harm?

Required materials and conditions: Distinction between the noninferiority margin and superiority conclusion
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Distinction between the noninferiority margin and superiority conclusion. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Distinction between the noninferiority margin and superiority conclusion.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation

N11 · Are assignment, PP, exposure, and neonatal denominators separated?

Required materials and conditions: Person/neonatal units and assignment/exposure/observation/analysis units
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Person/neonatal units and assignment/exposure/observation/analysis units. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Person/neonatal units and assignment/exposure/observation/analysis units.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

N12 · Do other analysis populations confirm the superiority conclusion?

Required materials and conditions: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N13 · Are harm-observation timing, missed tests, and discontinuation known?

Required materials and conditions: Exposure start/end, event timing, testing/follow-up, and discontinuation
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exposure start/end, event timing, testing/follow-up, and discontinuation. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Exposure start/end, event timing, testing/follow-up, and discontinuation.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

N14 · Were concurrent treatment and alternative explanations reviewed?

Required materials and conditions: Baseline risk, concomitant treatment, switching, confounding, and adjustment
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Baseline risk, concomitant treatment, switching, confounding, and adjustment. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Baseline risk, concomitant treatment, switching, confounding, and adjustment.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N15 · What is the actual reading level for registration and the superiority plan?

Required materials and conditions: NCT identifier, hypotheses, change history, and protocol/SAP
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: NCT identifier, hypotheses, change history, and protocol/SAP. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: NCT identifier, hypotheses, change history, and protocol/SAP.
Referenced methods: M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N16 · What verification scope applies to public funding and unreported commercial support?

Required materials and conditions: PHRC/AP-HP, commercial support, medication, authors/COI, and roles
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC/AP-HP, commercial support, medication, authors/COI, and roles. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: PHRC/AP-HP, commercial support, medication, authors/COI, and roles.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N17 · Is INDAO maternal hypoglycemia evidence of composite superiority?

Required materials and conditions: Maternal-event definition, arm-specific values, denominators, and harm analysis
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal-event definition, arm-specific values, denominators, and harm analysis. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Maternal-event definition, arm-specific values, denominators, and harm analysis.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N18 · Are INDAO’s individual neonatal-component results known?

Required materials and conditions: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N19 · How are Helal’s overall synthesis and RCT subgroup analysis distinguished?

Required materials and conditions: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

N20 · What are the review’s RCT maternal hypoglycemia/LGA results?

Required materials and conditions: Subgroup endpoints, effects/intervals, arms/denominators, and definitions
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Subgroup endpoints, effects/intervals, arms/denominators, and definitions.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N21 · Which result does the overall pooled neonatal hypoglycemia OR describe?

Required materials and conditions: Overall pooling, neonatal events, OR/CI, and original analysis scope
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Overall pooling, neonatal events, OR/CI, and original analysis scope. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Overall pooling, neonatal events, OR/CI, and original analysis scope.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation

N22 · What is the difference between stored-summary descriptions of the review’s analysis levels?

Required materials and conditions: Outcome attribution in evidence/safety explanations and external-verification scope
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Outcome attribution in evidence/safety explanations and external-verification scope. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Outcome attribution in evidence/safety explanations and external-verification scope.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

N23 · What information do Helal’s support and registration entries actually provide?

Required materials and conditions: Review/included-trial funding, COI, plans, and registration
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Review/included-trial funding, COI, plans, and registration. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Review/included-trial funding, COI, plans, and registration.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

N24 · What were the earlier Langer trial’s opposing results?

Required materials and conditions: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N25 · What level do Langer’s funding/registration wordings represent?

Required materials and conditions: Actual supporter, product/COI, registration, and plans
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual supporter, product/COI, registration, and plans. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Actual supporter, product/COI, registration, and plans.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N26 · Are the same events, trials, and review counted as independent replications?

Required materials and conditions: Report-to-trial-to-event links, recitation, and review-inclusion relationships
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Report-to-trial-to-event links, recitation, and review-inclusion relationships. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Report-to-trial-to-event links, recitation, and review-inclusion relationships.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

N27 · Does the current record establish comparison direction, a signal, or causality?

Required materials and conditions: Design, intervals, alternatives, and original-conclusion scope of each material
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Design, intervals, alternatives, and original-conclusion scope of each material. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Design, intervals, alternatives, and original-conclusion scope of each material.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

N28 · Is the result extended to other drugs, vulnerable groups, or long-term harms?

Required materials and conditions: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

N29 · What historical context do parent values, languages, empty values, dates, and corrections provide?

Required materials and conditions: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

N30 · Are actual summary reading and unread external material distinguished?

Required materials and conditions: Access status for preserved material, papers, registration, protocol, SAP, and disclosures
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Access status for preserved material, papers, registration, protocol, SAP, and disclosures.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-11 · Public page/material version 1.0

The public page and data were prepared from the existing 30 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 · What existing verdict accompanies the selected harm-superiority question?

Current findings: The selected question is “Superiority conclusion that glyburide is significantly more harmful”; D and “INDAO did not confirm that conclusion” are preserved. Sibling noninferiority C and parent C54 are separate contexts.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm. The original content review remains incomplete.
Reason for missing information: Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm.
Required materials and conditions: Exact claim, subclaim D/note, and separation from parent C54
Materials to obtain first: Correction records for the selected claim and parent assessment
Further research: Maintain the two questions’ pointers and verdict contexts separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exact claim, subclaim D/note, and separation from parent C54. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Exact claim, subclaim D/note, and separation from parent C54.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01 S02 S03

N02 · Which events and population are compared by “more harmful”?

Current findings: The original context is a glyburide-versus-insulin perinatal comparison in gestational diabetes requiring medication. The INDAO composite and individual maternal/neonatal events are separated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations. The original content review remains incomplete.
Reason for missing information: The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations.
Required materials and conditions: Fixed harm-event definitions, population, comparator, and period
Materials to obtain first: Prespecified superiority-question definition and event-specific results
Further research: Attribute harm questions separately to the perinatal composite and individual events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Fixed harm-event definitions, population, comparator, and period. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Fixed harm-event definitions, population, comparator, and period.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N03 · Are population, pregnancy timing, and baseline risk known?

Current findings: The original scope of 13 French university hospitals and gestational diabetes requiring medication even after 10 days of dietary treatment is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified. The original content review remains incomplete.
Reason for missing information: Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified.
Required materials and conditions: Actual recruitment conditions, medication requirement, and baseline risk
Materials to obtain first: Recruitment, baseline-characteristic, and risk tables
Further research: Separate the scope for other pregnancy/diabetes populations and vulnerable groups. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual recruitment conditions, medication requirement, and baseline risk. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Actual recruitment conditions, medication requirement, and baseline risk.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation

Related sources S01

N04 · What are actual exposure, comparator, and concomitant treatment?

Current findings: The manuscript records oral glyburide versus injected insulin. Only original study conditions are described; no administration/substitution instructions are created.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified. The original content review remains incomplete.
Reason for missing information: Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified.
Required materials and conditions: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care
Materials to obtain first: Arm-specific intervention, exposure, and concomitant-treatment/change records
Further research: Separate nominal assignment, actual exposure, and other causes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design

Related sources S01

N05 · Was INDAO designed to test superiority in harm?

Current findings: INDAO is an open-label randomized noninferiority trial. The selected note records that the superiority-in-harm conclusion was not confirmed.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design. The original content review remains incomplete.
Reason for missing information: A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design.
Required materials and conditions: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan
Materials to obtain first: Hypothesis/testing plans in the protocol and SAP
Further research: Distinguish results for different statistical questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N06 · What were actual randomization, open-label procedures, and measurement operations?

Current findings: The original description is open-label randomization of 914 participants (460/454) at 13 hospitals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design. The original content review remains incomplete.
Reason for missing information: Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design.
Required materials and conditions: Allocation, concealment, baseline balance, event measurement, and blinding
Materials to obtain first: Allocation, measurement, and blinding-operation material
Further research: Link design to limitations of actual event measurement. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Allocation, concealment, baseline balance, event measurement, and blinding. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Allocation, concealment, baseline balance, event measurement, and blinding.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

Related sources S01

N07 · What are perinatal-composite event definitions and counting units?

Current findings: INDAO’s primary composite is at least one of three components. Maternal hypoglycemia is not moved into this explicitly stated composite.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified. The original content review remains incomplete.
Reason for missing information: Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified.
Required materials and conditions: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling
Materials to obtain first: Composite/component definitions and event tables
Further research: Record composite person/event units and each harm separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation

Related sources S01

N08 · Are original event rates/difference interpreted directly as superiority in harm?

Current findings: The original composite rates of 27.6% versus 23.4% and absolute difference of +4.2 percentage points are preserved. Observed direction and confirmation of significant superiority in harm do not mean the same thing.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated. The original content review remains incomplete.
Reason for missing information: Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated.
Required materials and conditions: Original rates, absolute difference, denominators, and testing framework
Materials to obtain first: Event/denominator result tables and superiority analysis
Further research: Separate observed direction from testing conclusions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original rates, absolute difference, denominators, and testing framework. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Original rates, absolute difference, denominators, and testing framework.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation

Related sources S01

N09 · Is the one-sided noninferiority interval a harm-superiority interval?

Current findings: Supplied values are a one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=.19.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P. The original content review remains incomplete.
Reason for missing information: The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P.
Required materials and conditions: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics
Materials to obtain first: Prespecified superiority plan and corresponding original analysis table
Further research: Maintain the hypothesis and interval definition of the original statistics. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

Related sources S01

N10 · How does failure at the +7-percentage-point threshold differ from significant harm?

Current findings: The manuscript says the +10.5-percentage-point upper bound exceeded the prespecified +7-percentage-point margin, so being within the acceptable margin was not demonstrated. It explicitly states this was not proof of significantly worse outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created. The original content review remains incomplete.
Reason for missing information: No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created.
Required materials and conditions: Distinction between the noninferiority margin and superiority conclusion
Materials to obtain first: Original noninferiority/superiority plans and conclusions
Further research: Separate the failed question from the distinct unconfirmed conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Distinction between the noninferiority margin and superiority conclusion. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Distinction between the noninferiority margin and superiority conclusion.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation

Related sources S01

N11 · Are assignment, PP, exposure, and neonatal denominators separated?

Current findings: 914 randomized (460/454) and the prespecified PP 809 (367/442) are preserved separately.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated. The original content review remains incomplete.
Reason for missing information: Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated.
Required materials and conditions: Person/neonatal units and assignment/exposure/observation/analysis units
Materials to obtain first: Flow diagram, PP definition, and endpoint-specific denominator tables
Further research: Link exposed participants, people with events, and analysis units separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Person/neonatal units and assignment/exposure/observation/analysis units. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Person/neonatal units and assignment/exposure/observation/analysis units.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

Related sources S01

N12 · Do other analysis populations confirm the superiority conclusion?

Current findings: The manuscript records only that other analysis populations were used to assess consistency.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation. The original content review remains incomplete.
Reason for missing information: Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation.
Required materials and conditions: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses
Materials to obtain first: Supplementary analyses/SAP and effect-of-interest material
Further research: Maintain PP, supplementary analyses, and harm superiority as distinct records. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N13 · Are harm-observation timing, missed tests, and discontinuation known?

Current findings: Only the historical study context of the perinatal composite and medication assignment is available.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently required information in the stored summary is unverified. Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified. The original content review remains incomplete.
Reason for missing information: Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified.
Required materials and conditions: Exposure start/end, event timing, testing/follow-up, and discontinuation
Materials to obtain first: Event-collection, follow-up, and discontinuation records
Further research: Distinguish unreported/unverified information from absence of events. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Exposure start/end, event timing, testing/follow-up, and discontinuation. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Exposure start/end, event timing, testing/follow-up, and discontinuation.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

Related sources S01

N14 · Were concurrent treatment and alternative explanations reviewed?

Current findings: The original descriptions of an open-label randomized comparison and medication requirement after dietary treatment are preserved.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently required information in the stored summary is unverified. Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted. The original content review remains incomplete.
Reason for missing information: Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted.
Required materials and conditions: Baseline risk, concomitant treatment, switching, confounding, and adjustment
Materials to obtain first: Baseline/concomitant treatment, actual exposure, and adjusted-analysis tables
Further research: Distinguish observed harm from causal attribution to a single medication. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Baseline risk, concomitant treatment, switching, confounding, and adjustment. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Baseline risk, concomitant treatment, switching, confounding, and adjustment.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

Related sources S01

N15 · What is the actual reading level for registration and the superiority plan?

Current findings: NCT01731431 is preserved as originally recorded. The number does not mean the superiority plan was read.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established. The original content review remains incomplete.
Reason for missing information: External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established.
Required materials and conditions: NCT identifier, hypotheses, change history, and protocol/SAP
Materials to obtain first: Registration history, protocol, and SAP
Further research: If corresponding material is supplied, record differences among hypotheses, changes, and reporting. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: NCT identifier, hypotheses, change history, and protocol/SAP. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: NCT identifier, hypotheses, change history, and protocol/SAP.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N16 · What verification scope applies to public funding and unreported commercial support?

Current findings: The original description of French Ministry of Health PHRC and AP-HP public sponsor support, and unreported commercial pharmaceutical funding/free study medication, is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made. The original content review remains incomplete.
Reason for missing information: Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made.
Required materials and conditions: PHRC/AP-HP, commercial support, medication, authors/COI, and roles
Materials to obtain first: Original funding, product, author/COI, and role material
Further research: Distinguish disclosed information from unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC/AP-HP, commercial support, medication, authors/COI, and roles. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: PHRC/AP-HP, commercial support, medication, authors/COI, and roles.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N17 · Is INDAO maternal hypoglycemia evidence of composite superiority?

Current findings: The manuscript describes more frequent maternal hypoglycemia in the glyburide arm. It is not transferred to significant superiority in harm for the entire perinatal composite.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance. The original content review remains incomplete.
Reason for missing information: Arm-specific values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance.
Required materials and conditions: Maternal-event definition, arm-specific values, denominators, and harm analysis
Materials to obtain first: Maternal hypoglycemia result table and analysis plan
Further research: Attribute maternal harms and the neonatal composite separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal-event definition, arm-specific values, denominators, and harm analysis. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Maternal-event definition, arm-specific values, denominators, and harm analysis.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N18 · Are INDAO’s individual neonatal-component results known?

Current findings: The pivotal report supplies composite results for three components.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently required information in the stored summary is unverified. Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates. The original content review remains incomplete.
Reason for missing information: Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates.
Required materials and conditions: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia
Materials to obtain first: Component results, definitions, and testing plan
Further research: Separate comparison conclusions for the composite and each component. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01

N19 · How are Helal’s overall synthesis and RCT subgroup analysis distinguished?

Current findings: The review records 24 studies with 24,517 participants overall and an 11-RCT subgroup.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets. The original content review remains incomplete.
Reason for missing information: RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets.
Required materials and conditions: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators
Materials to obtain first: Included-trial and design/endpoint-specific analysis tables
Further research: Separate synthesis reports from actual original-trial/population units. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

Related sources S02

N20 · What are the review’s RCT maternal hypoglycemia/LGA results?

Current findings: S02’s evidence/citation entries record more maternal hypoglycemia and LGA in the RCT subgroup.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite. The original content review remains incomplete.
Reason for missing information: Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite.
Required materials and conditions: Subgroup endpoints, effects/intervals, arms/denominators, and definitions
Materials to obtain first: Original endpoint-specific RCT subgroup analysis tables
Further research: Attribute results individually by analysis level, event, and material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Subgroup endpoints, effects/intervals, arms/denominators, and definitions.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S02

N21 · Which result does the overall pooled neonatal hypoglycemia OR describe?

Current findings: S02’s evidence entry supplies overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95).
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms. The original content review remains incomplete.
Reason for missing information: Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms.
Required materials and conditions: Overall pooling, neonatal events, OR/CI, and original analysis scope
Materials to obtain first: Endpoint/design-specific result tables for the overall pooling
Further research: Link the original OR/interval only to its corresponding overall analysis. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Overall pooling, neonatal events, OR/CI, and original analysis scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Overall pooling, neonatal events, OR/CI, and original analysis scope.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation

Related sources S02

N22 · What is the difference between stored-summary descriptions of the review’s analysis levels?

Current findings: The Korean/English safety explanation records increased neonatal hypoglycemia and LGA in the RCT subgroup. The evidence list distinguishes RCT maternal hypoglycemia/LGA from the overall neonatal hypoglycemia OR.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made. The original content review remains incomplete.
Reason for missing information: Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made.
Required materials and conditions: Outcome attribution in evidence/safety explanations and external-verification scope
Materials to obtain first: Endpoint-specific overall/RCT tables in the original review
Further research: If the original paper is supplied, record explanations/correction events for the wording difference separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Outcome attribution in evidence/safety explanations and external-verification scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Outcome attribution in evidence/safety explanations and external-verification scope.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design

Related sources S02

N23 · What information do Helal’s support and registration entries actually provide?

Current findings: The funding entry is “systematic review; included-trial funding mixed”, and nct is “not applicable”. The actual registration identifier remains null.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently required information in the stored summary is unverified. The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification. The original content review remains incomplete.
Reason for missing information: The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification.
Required materials and conditions: Review/included-trial funding, COI, plans, and registration
Materials to obtain first: Review plan, disclosures, and included-trial support table
Further research: Separate material types, review roles, and original-trial support. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Review/included-trial funding, COI, plans, and registration. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Review/included-trial funding, COI, plans, and registration.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

Related sources S02

N24 · What were the earlier Langer trial’s opposing results?

Current findings: The 404-participant RCT had primary glycemic control and secondary individual perinatal outcomes. LGA 12/13%, neonatal hypoglycemia 9/6%, no significant difference, and the “clinically effective alternative” conclusion are preserved as originally recorded.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success. The original content review remains incomplete.
Reason for missing information: Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success.
Required materials and conditions: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion
Materials to obtain first: Langer plan and individual-event result tables
Further research: Record opposing results together with limitations from different questions/designs. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S03

N25 · What level do Langer’s funding/registration wordings represent?

Current findings: Funding “reported in the original paper” and nct “not applicable” are preserved as originally recorded. These wordings are not an actual funding provider or registration number.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Currently required information in the stored summary is unverified. External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established. The original content review remains incomplete.
Reason for missing information: External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established.
Required materials and conditions: Actual supporter, product/COI, registration, and plans
Materials to obtain first: Original plan, support, and COI material
Further research: Distinguish original wording from newly supplied actual identity material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Actual supporter, product/COI, registration, and plans. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Actual supporter, product/COI, registration, and plans.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S03

N26 · Are the same events, trials, and review counted as independent replications?

Current findings: INDAO, the Helal review, and Langer are linked as separate report slots and shared with the sibling noninferiority sheet.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals. The original content review remains incomplete.
Reason for missing information: Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals.
Required materials and conditions: Report-to-trial-to-event links, recitation, and review-inclusion relationships
Materials to obtain first: Related/included-trial and event-linking tables
Further research: Maintain relationships among original trials, review recitations, and the same people/timepoints. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Report-to-trial-to-event links, recitation, and review-inclusion relationships. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Report-to-trial-to-event links, recitation, and review-inclusion relationships.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design

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N27 · Does the current record establish comparison direction, a signal, or causality?

Current findings: INDAO’s failure to demonstrate noninferiority/unconfirmed superiority are distinguished from individual maternal/neonatal harm contexts. Selected D is the original-data verdict, not a new harm grade.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created. The original content review remains incomplete.
Reason for missing information: No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created.
Required materials and conditions: Design, intervals, alternatives, and original-conclusion scope of each material
Materials to obtain first: Original hypothesis/interval and event-specific conclusions, plus alternative material
Further research: Maintain each original report’s comparison/interpretation scope separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Design, intervals, alternatives, and original-conclusion scope of each material. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Design, intervals, alternatives, and original-conclusion scope of each material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design

Related sources S01 S02 S03

N28 · Is the result extended to other drugs, vulnerable groups, or long-term harms?

Current findings: The manuscript records that sulfonylurea placental-transfer characteristics vary by drug and are not generalized to the whole class.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created. The original content review remains incomplete.
Reason for missing information: Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created.
Required materials and conditions: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk
Materials to obtain first: Separate medication/population and long-term-harm material
Further research: Separate the narrow comparative-harm question from questions outside its scope. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S01 S02 S03

N29 · What historical context do parent values, languages, empty values, dates, and corrections provide?

Current findings: Parent C54, unrecorded precision, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, historical cross-checking, and selected D/note are preserved in the full stored summary.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review. The original content review remains incomplete.
Reason for missing information: Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review.
Required materials and conditions: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections
Materials to obtain first: Correction records, user comments, and supplied original material
Further research: Distinguish the original record from production and amendment events. This is a proposal; no new investigation, calculation or trial was performed.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

Related sources S01 S02 S03

N30 · Are actual summary reading and unread external material distinguished?

Current findings: The full JSON with three evidence entries and three citations was read for production, and original links are preserved. Summaries are labeled “summary read”; external material is labeled “unread”.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access. The original content review remains incomplete.
Reason for missing information: External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access.
Required materials and conditions: Access status for preserved material, papers, registration, protocol, SAP, and disclosures
Materials to obtain first: Each material and actual reading record
Further research: Update each material’s existence, acquisition, and reading level separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed: A production item connecting required and available material for the selected question by distinguishing: Access status for preserved material, papers, registration, protocol, SAP, and disclosures.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03