CHAMGAP

Surgical-mask recommendation × Infection in the wearer at one month

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionSelected wearer question and original gradeRequired
The selected subclaim is “Reduced infection in the wearer at one month,” grade D with the null OR 0.82(0.54–1.23) note. Subclaim score/status/axes are absent; parent D34 is not used to fill a subclaim score.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are distinguished from transmission-to-others and mandate effects. Existing content review remains incomplete.
Existing question, grade/note, parent values and separate transmission question
Proposal for later research specifying the wearer endpoint/timepoint; no new investigation, calculation or trial was performed in that production.
2 Partly verified Full text not readStored summary read N02 · Evidence condition2020 Denmark and community settingRequired
DANMASK-19 studied adults in 2020 Denmark where community mask use was uncommon. Results are not extended to current/other epidemics, healthcare settings or protection of all populations.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Age/eligibility, baseline infection/risk, exposure/occupation, recruitment/group balance and test access remain unverified. Existing content review remains incomplete.
Time/setting, actual population, recruitment and baseline risk
Proposal for later comparative research specifying the setting/population; no new investigation, calculation or trial was performed in that production.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionRecommendation, 50 masks and instructionsRequired
The intervention supplied a surgical-mask recommendation, 50 masks and instructions. It is not relabeled as full actual wearing, filtration/product effects alone or a mandate trial.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Product specifications/batches, actual supply/instructions, additional contacts and wearing conditions/exposure remain unverified. Existing content review remains incomplete.
Assigned recommendation/support versus actual wearing and product effects
Proposal for later research distinguishing recommendation/support from actual wearing; no new investigation, calculation or trial was performed in that production.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionActual wearing and self-reported adherenceRequired
Preserve self-reported adherence: 46% as recommended, 47% predominantly as recommended, 7% not as recommended. These do not fill objective wearing-time/precise exposure records for all participants.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adherence-questionnaire denominators/timing/definitions, objective wearing/use, missingness and group crossover remain unverified. Existing content review remains incomplete.
46/47/7% categories/periods, measurement and exposure
Proposal specifying differences between reported adherence and actual exposure; no new investigation, calculation or trial was performed in that production.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionRecommendation effects and adherence-based analysisRequired
The original trial compares assigned recommendations. The original low-full-adherence context is retained without newly estimating actual-wearer/full-adherence effects or certifying benefits.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified adherence-based plans, inclusion/exposure, adjustment/confounding and related sensitivity results remain unverified. Existing content review remains incomplete.
Assigned recommendation versus actual-wearer/full-adherence effects
Proposal distinguishing assignment strategies and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.
6 Partly verified Full text not readStored summary read N06 · Evidence conditionControl and concurrent public-health measuresRequired
Both groups followed prevailing public-health advice. This does not verify a no-action/no-contact control or identical prevention/lifestyle/exposure conditions.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Control mask wearing/additional support, concurrent measures, lifestyle/exposure, contacts and differences/analyses remain unverified. Existing content review remains incomplete.
Actual measures and contact/exposure differences across groups
Proposal specifying actual comparisons/concurrent conditions; no new investigation, calculation or trial was performed in that production.
7 Partly verified Full text not readStored summary read N07 · Evidence conditionRandomization and lack of maskingRequired
The original design is a nationwide unblinded randomized controlled trial. The randomization label does not verify all sequence/concealment or test/adjudicator/analyst masking details.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original sequence generation/concealment, implementation/exceptions, role-specific masking and baseline balance remain unread. Existing content review remains incomplete.
Design label and scope of allocation/measurement/analysis procedures
Proposal disclosing allocation and outcome measurement/adjudication; no new investigation, calculation or trial was performed in that production.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionComposite infection ascertainmentRequired
The primary endpoint is the wearer’s own SARS-CoV-2 infection at one month, ascertained through antibody testing, PCR or hospital diagnosis. It is not relabeled as PCR alone, self-reported symptoms or transmission to others.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component definitions/tests, accepted results, overlap/adjudication and event timing remain unverified. Existing content review remains incomplete.
Antibody testing, PCR, hospital diagnosis and component/adjudication rules
Proposal distinguishing component ascertainment from the composite endpoint; no new investigation, calculation or trial was performed in that production.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionTesting time, baseline infection and missingnessRequired
Preserve the original ascertainment methods and one-month period without claiming verified test counts, baseline status, assessment windows or identical ascertainment of all events.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Baseline infection, test/sample timing, implementation/nonimplementation, access, adjudication/errors and confirmation delays remain unverified. Existing content review remains incomplete.
Correspondence of one-month infection with tests/baseline/assessment windows
Proposal specifying testing/baseline conditions and infection-adjudication timing; no new investigation, calculation or trial was performed in that production.
10 Partly verified Full text not readStored summary read N10 · Evidence conditionOne month and duration/exposure scopeRequired
Follow-up was one month. The same recommendation is not expanded to sustained long-term/other-epidemic/healthcare/other-mask effects, and no use/testing instructions are produced.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual observation/wearing periods, start/end/censoring and later follow-up/exposure remain unverified. Existing content review remains incomplete.
Original period, actual observation/wearing and long-term/other-epidemic boundaries
Proposal distinguishing timepoint/duration and setting-specific applicability; no new investigation, calculation or trial was performed in that production.
11 Partly verified Full text not readStored summary read N11 · Evidence conditionOriginal events and complete-case denominatorsRequired
Primary results were 42/2,392(1.8%) versus 53/2,470(2.1%). They are not relabeled with all-randomized denominators, test counts or total repeated infections; no new proportions/event totals are calculated.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component-specific event counts, test/person overlap, risk/observation denominators and ascertainment-method correspondence remain unverified. Existing content review remains incomplete.
42/2,392 and 53/2,470 versus people/test units
Proposal reporting people/events/tests and denominators separately; no new investigation, calculation or trial was performed in that production.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionOriginal absolute difference, CI and PRequired
Preserve absolute difference −0.3 percentage points (95% CI −1.2–0.4), P=.38. Do not newly subtract 1.8%/2.1% or calculate a new effect, CI or NNT.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Exact contrasts/models, adjustment, CI methods and original plans/sensitivity remain unread. Existing content review remains incomplete.
Original absolute effect/CI versus rounded proportions and models
Proposal for later research disclosing effect measures and precision; no new investigation, calculation or trial was performed in that production.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionOR, CI and separate PRequired
OR 0.82(0.54–1.23), P=.33 is the original result. It is retained separately from absolute-difference P=.38; OR is not converted to RR, individual risk or a new relative reduction.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. OR models/adjustment, precise contrasts, tests/CI methods and correspondence to absolute effects remain unread. Existing content review remains incomplete.
Original OR/CI versus the different absolute-difference estimand
Proposal reporting effect measures/tests separately; no new investigation, calculation or trial was performed in that production.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionNonsignificance, wide CI and importanceRequired
The original manuscript records no established primary benefit and a CI retaining substantial benefit/harm possibilities. It is not changed to zero effect, equivalence or confirmed general mask ineffectiveness/harm.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and sufficient precision for exact effects remain unverified. Existing content review remains incomplete.
Null verdict versus possible benefit/harm, exactly zero and equivalence
Proposal specifying effects/precision and question scope; no new investigation, calculation or trial was performed in that production.
15 Partly verified Full text not readStored summary read N15 · Evidence condition6,024 randomized and 4,862 complete casesRequired
Preserve 6,024 randomized (3,030/2,994) and 4,862 primary complete cases (2,392/2,470). These populations/group counts are not combined or filled as complete observation/ITT for everyone.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case inclusion/exclusion, test/component-specific valid denominators and baseline/visit correspondence remain unverified. Existing content review remains incomplete.
Randomized/complete-case populations and group denominators
Proposal distinguishing allocated/observed/analyzed denominators; no new investigation, calculation or trial was performed in that production.
16 Partly verified Full text not readStored summary read N16 · Evidence condition19.3% missingness and dropoutRequired
Primary missingness 19.3% is the original record. No new missing counts/rates or best/worst effects are calculated, and absence of missing-data effects is not certified.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original group missingness/dropout reasons, baseline risk, test/contact differences and handling/sensitivity remain unverified. Existing content review remains incomplete.
Group missingness/deviations, testing/reporting and outcome effects
Proposal reporting effects of missingness and observation selection; no new investigation, calculation or trial was performed in that production.
17 Partly verified Full text not readStored summary read N17 · Evidence conditionComplete-case estimands and within/between-group comparisonsRequired
The original primary analysis is complete-case. It is not relabeled as ITT for all randomized participants or actual full-wearing effects, and within-group improvements are not made into new between-group benefits.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case models/adjustment, observation selection, missingness/adherence sensitivity and other analyses remain unverified. Existing content review remains incomplete.
Analysis populations/models, assigned effects and observation selection
Proposal distinguishing assignment, observation and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.
18 Partly verified Full text not readStored summary read N18 · Evidence conditionRegistration, retrospective dates and plansRequired
Original wording records NCT04337541 first posted 2020-04-08 after the 2020-04-02 start, six-day retrospective registration. It is not changed to prospective registration, verified complete prespecification or definite outcome switching.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration history, prerecruitment protocols/SAP, changes and complete endpoint/analysis contracts remain unread. Existing content review remains incomplete.
Preserved NCT/dates and prespecified endpoint/analysis contracts
Proposal linking and disclosing plan/registration timing and actual analyses; no new investigation, calculation or trial was performed in that production.
19 Partly verified Full text not readStored summary read N19 · Evidence conditionPrimary/secondary outcomes and multiplicityRequired
The selected result is the wearer’s own one-month infection primary endpoint. Multiple tests, effect measures, adherence groups or other outcomes are not counted as independent trials or new primary successes.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete secondary/timepoint, multiplicity, testing-order, prespecified hierarchy and reporting changes remain unverified. Existing content review remains incomplete.
Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy
Proposal separating primary, component and secondary outcomes; no new investigation, calculation or trial was performed in that production.
20 Partly verified Full text not readStored summary read N20 · Evidence conditionTransmission to others and mandates were unmeasuredRequired
The original manuscript records that transmission prevention to others and mask-mandate effects were not tested. The selected wearer result is not transferred to their effects/null results or policy/procedural guidance.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct transmission-to-others, mandate, healthcare/other-epidemic results are not connected by this trial. Existing content review remains incomplete.
Wearer protection versus source control, policy and setting
Proposal for later research separating wearer/others/policy questions; no new investigation, calculation or trial was performed in that production.
21 Unverified Full text not readStored summary read N21 · Evidence conditionConcurrent measures, exposure and lifestyleRequired
Preserve the original prevailing-public-health-advice record for both groups without filling in identical/no-effect exposure, lifestyle/prevention or disease/medication conditions.
Information currently required is unverified in the preserved summary. Concurrent measures, outside contacts/exposures, other masks/products, diseases/medications and group differences/analyses remain unverified. Existing content review remains incomplete.
Group concurrent prevention/exposure, diseases/medications and contacts
Proposal distinguishing concurrent conditions from recommendation/wearing effects; no new investigation, calculation or trial was performed in that production.
22 Partly verified Full text not readStored summary read N22 · Evidence conditionSalling funding and RigshospitaletRequired
Salling Foundations funding and Rigshospitalet leadership are original records. Institution/leadership names are not changed to absence of all support/relationships or new independence certification.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original support/leadership roles, contracts, data/analysis/publication control and author COI remain unread. Existing content review remains incomplete.
Support/sponsorship, roles and independence
Proposal for later research disclosing support/research roles; no new investigation, calculation or trial was performed in that production.
23 Partly verified Full text not readStored summary read N23 · Evidence conditionStudy mask supply and donated supportRequired
Original records state that study masks were supplied within the research and manufacturer donation was not verified. This is not changed to definite manufacturer supply, no support or actual receipt of 50 masks by everyone.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Manufacture/specifications, actual distribution, purchase/supply contracts and support scope/roles remain unverified. Existing content review remains incomplete.
Study supply versus manufacturer support/products and actual receipt
Proposal separating study supply from manufacturer support; no new investigation, calculation or trial was performed in that production.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionMedical writing, publication costs and author relationshipsRequired
Original records state that medical-writing/publication-cost support was not verified. Unverified is not changed to absent, and funding/leadership names do not fill all author COI.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete original writing/publication, outside analysis, author relationships/contributions and support remain unread. Existing content review remains incomplete.
Unverified support items and author/analysis roles
Proposal disclosing support items separately; no new investigation, calculation or trial was performed in that production.
25 Partly verified Full text not readStored summary read N25 · Evidence conditionOne trial, bibliographic years and sibling sheetsRequired
Preserve Bundgaard 2020 DANMASK-19 in the evidence list and 2021 publication bibliography in the citation list. These do not become separate trials/replications or new participant totals across groups/tests/events/timepoints/sibling sheets.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Unique clinical-trial/participant totals or independent replication of the same question are not newly established. Existing content review remains incomplete.
Evidence-list 2020, citation-list 2021 and the same DANMASK relationship
Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.
26 Partly verified Full text not readStored summary read N26 · Evidence conditionGeneralization across duration, setting and productsRequired
The scope is 2020 Denmark, low community mask use, a surgical-mask recommendation and one month. Effects are not extended to healthcare, other variants/epidemics, long-term use, mandates or other masks/products.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct comparisons, sustained/discontinued exposure and long-term outcomes in other situations/products remain unverified. Existing content review remains incomplete.
Original recommendation/setting versus other situations and long-term effects
Proposal distinguishing question/situation/duration applicability; no new investigation, calculation or trial was performed in that production.
27 Partly verified Full text not readStored summary read N27 · Harm-information gaps supplementing the efficacy tableUnknown safety and unquantified harmsSupplementary
The original parent safety is Unknown and mask-related harms were not quantified. Infection results/P are not used as evidence of no discomfort/skin irritation or of safety.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adverse-event collection/types/frequency/denominators, discontinuation and long-term/vulnerable-population harms remain unverified. Existing content review remains incomplete.
Discomfort/skin irritation and harms collection/denominator/follow-up scope
Proposal for later research specifying harms collection/scope; no new investigation, calculation or trial was performed in that production.
28 Partly verified Full text not readStored summary read N28 · Evidence conditionOriginal values, both languages, dates, corrections and historyRequired
Preserve parent D34, B/H/R1/I2/E0/B2/C0, the large hard-endpoint RCT true marker, two false markers, empty override reasons and subclaim D/note. Both languages, 2026-08-26, empty corrections/deliberation and cross-validation are not current review or a subclaim score.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled with parent values; no new methodological/efficacy certification. Existing content review remains incomplete.
Parent/subclaim scores/axes versus historical verification/dates
Proposal separating original values/history from new-material application; no new investigation, calculation or trial was performed in that production.
29 Partly verified Full text not readStored summary read N29 · Evidence conditionActual summary reading and material linksRequired
The complete preserved summary/bibliography were used for production and links retained. External paper/registration/protocol/SAP/support/COI originals remain unread/unaccessed; external link testing was not performed.
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External original content, exact contracts/denominators/models and access availability remain unverified. Existing content review remains incomplete.
Preserved-summary reading versus external paper/registration/plan access
Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.
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29 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
Adults in 2020 Denmark where community mask use was uncommon. Distinguish 6,024 randomized (3,030/2,994) from 4,862 primary complete cases (2,392/2,470), with 19.3% missingness. Baseline risk/infection, recruitment/testing and missingness/dropout details remain unverified.
Ingredient, formulation and route
Research intervention supplying a surgical-mask recommendation, 50 masks and instructions. Actual supply/wearing, specifications/batches and exposure/contacts remain unverified. It is not relabeled as filtration/product effects alone or mandate effects. No new wearing/testing/infection-prevention instructions.
Dose
One-month recommendation/follow-up. Preserve self-reported 46% adherence as recommended, 47% predominantly as recommended and 7% nonadherence; do not fill objective wearing time, complete follow-up for all or other-period/long-term exposure.
Comparator
Unblinded randomized comparison with both groups following prevailing public-health advice. Control is not relabeled as no action/contact or identical conditions. Actual control wearing/concurrent exposure and allocation/adjudication/analysis details remain unverified.
Measured outcome
Primary composite of the wearer’s own SARS-CoV-2 infection at one month by antibody testing, PCR or hospital diagnosis. Preserve separate original estimands: 42/2,392(1.8%) versus 53/2,470(2.1%); absolute difference −0.3 percentage points (95% CI −1.2–0.4)/P=.38; OR 0.82(0.54–1.23)/P=.33. Component counts/tests, overlap, baseline/assessment windows and models remain unverified. No new RR/effects/CI or event/proportion totals.
Duration
One-month wearer outcome. Individual actual exposure/observations, testing windows/repetition, later follow-up, other epidemics/healthcare settings and long-term effects remain unverified.
Questions outside this scope
New differences/RR/NNT/CI or event/denominator totals from 42/2,392, 53/2,470 or 1.8/2.1%; Combining the original absolute-difference/OR P values and intervals as one estimand, or converting OR to RR/individual risk; Replacing recommendation/50 masks/instructions or 46/47/7% reports with objective full wearing or product/filtration effects alone; Relabeling 4,862 complete cases/19.3% missingness as ITT for all 6,024 or no missing-data effects; Transferring antibody/PCR/hospital-diagnosis composite infection to PCR alone, self-reported symptoms, transmission to others or mandates; Generalizing 2020 Danish one-month recommendations to current epidemics, healthcare, long-term use or all masks; Changing original six-day retrospective registration into prospective registration, fully verified prespecification or definite outcome switching; Summing people/groups/tests/events/timepoints/bibliographies, registrations or sibling sheets as new independent trials/participants; Inheriting original parent values/axes or historical verification/registration/allocation/masking/analysis wording as subclaim scores or current content review/full-text reading; New calculations, invented quantities, effects/CI, grades, independence certification or mask/testing/infection-prevention/respiratory-care/treatment-replacement instructions

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 · Bundgaard H et al. 2020 DANMASK-19

PubMed

Material type
Nationwide unblinded randomized controlled trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
42/2,392(1.8%) versus 53/2,470(2.1%); difference −0.3 percentage points (−1.2–0.4), P=.38; OR 0.82(0.54–1.23), P=.33
Record level
Outcome wording in the stored summary
Study overlap and independent replication
S01 DANMASK-19 compares a surgical-mask recommendation/50 masks/instructions with concurrent public-health advice in 2020 Denmark, where community wearing was uncommon. Distinguish 6,024 allocated (3,030/2,994) from 4,862 primary complete cases (2,392/2,470), with 19.3% missingness. Self-reported wearing 46/47/7%, one-month wearer infection by antibody/PCR/hospital diagnosis, 42/2,392 versus 53/2,470, original absolute difference −0.3 percentage points/CI −1.2–0.4/P=.38 and OR 0.82/CI 0.54–1.23/P=.33 are separate exposures/endpoints/estimands. Transmission to others/mandates were unmeasured. Complete-case results are not relabeled as ITT for all, full wearing, generally zero effects or safety. Evidence-list 2020 and citation-list 2021 concern the same report identity. People/groups/tests/events/timepoints, bibliographies/registrations and sibling sheets are not summed as new independent trials/participants. Report entries are not unique clinical totals; no new calculations, independence certification or procedural guidance.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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 materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo 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 DANMASK-19 compares a surgical-mask recommendation/50 masks/instructions with concurrent public-health advice in 2020 Denmark, where community wearing was uncommon. Distinguish 6,024 allocated (3,030/2,994) from 4,862 primary complete cases (2,392/2,470), with 19.3% missingness. Self-reported wearing 46/47/7%, one-month wearer infection by antibody/PCR/hospital diagnosis, 42/2,392 versus 53/2,470, original absolute difference −0.3 percentage points/CI −1.2–0.4/P=.38 and OR 0.82/CI 0.54–1.23/P=.33 are separate exposures/endpoints/estimands. Transmission to others/mandates were unmeasured. Complete-case results are not relabeled as ITT for all, full wearing, generally zero effects or safety. Evidence-list 2020 and citation-list 2021 concern the same report identity. People/groups/tests/events/timepoints, bibliographies/registrations and sibling sheets are not summed as new independent trials/participants. Report entries are not unique clinical totals; no new calculations, independence certification or procedural guidance.

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 · Selected wearer question and original grade
Required materials and conditions
Existing question, grade/note, parent values and separate transmission question
Conditions for verification
Corresponding original materials and analysis scope for existing question, grade/note, parent values and separate transmission question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing existing question, grade/note, parent values and separate transmission question and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
N02 · 2020 Denmark and community setting
Required materials and conditions
Time/setting, actual population, recruitment and baseline risk
Conditions for verification
Corresponding original materials and analysis scope for time/setting, actual population, recruitment and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing time/setting, actual population, recruitment and baseline risk and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design
N03 · Recommendation, 50 masks and instructions
Required materials and conditions
Assigned recommendation/support versus actual wearing and product effects
Conditions for verification
Corresponding original materials and analysis scope for assigned recommendation/support versus actual wearing and product effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing assigned recommendation/support versus actual wearing and product effects and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N04 · Actual wearing and self-reported adherence
Required materials and conditions
46/47/7% categories/periods, measurement and exposure
Conditions for verification
Corresponding original materials and analysis scope for 46/47/7% categories/periods, measurement and exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing 46/47/7% categories/periods, measurement and exposure and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M03 §3.2.4; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed
N05 · Recommendation effects and adherence-based analysis
Required materials and conditions
Assigned recommendation versus actual-wearer/full-adherence effects
Conditions for verification
Corresponding original materials and analysis scope for assigned recommendation versus actual-wearer/full-adherence effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing assigned recommendation versus actual-wearer/full-adherence effects and connecting materials needed for the selected question with current materials.
Referenced methods
M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application
N06 · Control and concurrent public-health measures
Required materials and conditions
Actual measures and contact/exposure differences across groups
Conditions for verification
Corresponding original materials and analysis scope for actual measures and contact/exposure differences across groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing actual measures and contact/exposure differences across groups and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N07 · Randomization and lack of masking
Required materials and conditions
Design label and scope of allocation/measurement/analysis procedures
Conditions for verification
Corresponding original materials and analysis scope for design label and scope of allocation/measurement/analysis procedures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing design label and scope of allocation/measurement/analysis procedures and connecting materials needed for the selected question with current materials.
Referenced methods
M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed
N08 · Composite infection ascertainment
Required materials and conditions
Antibody testing, PCR, hospital diagnosis and component/adjudication rules
Conditions for verification
Corresponding original materials and analysis scope for antibody testing, PCR, hospital diagnosis and component/adjudication rules should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing antibody testing, PCR, hospital diagnosis and component/adjudication rules and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application
N09 · Testing time, baseline infection and missingness
Required materials and conditions
Correspondence of one-month infection with tests/baseline/assessment windows
Conditions for verification
Corresponding original materials and analysis scope for correspondence of one-month infection with tests/baseline/assessment windows should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing correspondence of one-month infection with tests/baseline/assessment windows and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed
N10 · One month and duration/exposure scope
Required materials and conditions
Original period, actual observation/wearing and long-term/other-epidemic boundaries
Conditions for verification
Corresponding original materials and analysis scope for original period, actual observation/wearing and long-term/other-epidemic boundaries should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing original period, actual observation/wearing and long-term/other-epidemic boundaries and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
N11 · Original events and complete-case denominators
Required materials and conditions
42/2,392 and 53/2,470 versus people/test units
Conditions for verification
Corresponding original materials and analysis scope for 42/2,392 and 53/2,470 versus people/test units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing 42/2,392 and 53/2,470 versus people/test units and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application
N12 · Original absolute difference, CI and P
Required materials and conditions
Original absolute effect/CI versus rounded proportions and models
Conditions for verification
Corresponding original materials and analysis scope for original absolute effect/CI versus rounded proportions and models should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing original absolute effect/CI versus rounded proportions and models and connecting materials needed for the selected question with current materials.
Referenced methods
M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.
N13 · OR, CI and separate P
Required materials and conditions
Original OR/CI versus the different absolute-difference estimand
Conditions for verification
Corresponding original materials and analysis scope for original OR/CI versus the different absolute-difference estimand should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing original OR/CI versus the different absolute-difference estimand and connecting materials needed for the selected question with current materials.
Referenced methods
M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.
N14 · Nonsignificance, wide CI and importance
Required materials and conditions
Null verdict versus possible benefit/harm, exactly zero and equivalence
Conditions for verification
Corresponding original materials and analysis scope for null verdict versus possible benefit/harm, exactly zero and equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing null verdict versus possible benefit/harm, exactly zero and equivalence and connecting materials needed for the selected question with current materials.
Referenced methods
M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries
N15 · 6,024 randomized and 4,862 complete cases
Required materials and conditions
Randomized/complete-case populations and group denominators
Conditions for verification
Corresponding original materials and analysis scope for randomized/complete-case populations and group denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing randomized/complete-case populations and group denominators and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N16 · 19.3% missingness and dropout
Required materials and conditions
Group missingness/deviations, testing/reporting and outcome effects
Conditions for verification
Corresponding original materials and analysis scope for group missingness/deviations, testing/reporting and outcome effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing group missingness/deviations, testing/reporting and outcome effects and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application
N17 · Complete-case estimands and within/between-group comparisons
Required materials and conditions
Analysis populations/models, assigned effects and observation selection
Conditions for verification
Corresponding original materials and analysis scope for analysis populations/models, assigned effects and observation selection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing analysis populations/models, assigned effects and observation selection and connecting materials needed for the selected question with current materials.
Referenced methods
M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed
N18 · Registration, retrospective dates and plans
Required materials and conditions
Preserved NCT/dates and prespecified endpoint/analysis contracts
Conditions for verification
Corresponding original materials and analysis scope for preserved NCT/dates and prespecified endpoint/analysis contracts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing preserved NCT/dates and prespecified endpoint/analysis contracts and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
N19 · Primary/secondary outcomes and multiplicity
Required materials and conditions
Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy
Conditions for verification
Corresponding original materials and analysis scope for wearer primary endpoint, test components and effect-measure/other-outcome hierarchy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing wearer primary endpoint, test components and effect-measure/other-outcome hierarchy and connecting materials needed for the selected question with current materials.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed
N20 · Transmission to others and mandates were unmeasured
Required materials and conditions
Wearer protection versus source control, policy and setting
Conditions for verification
Corresponding original materials and analysis scope for wearer protection versus source control, policy and setting should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing wearer protection versus source control, policy and setting and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 on clarifying questions; detailed separation rules are independently designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are independently designed
N21 · Concurrent measures, exposure and lifestyle
Required materials and conditions
Group concurrent prevention/exposure, diseases/medications and contacts
Conditions for verification
Corresponding original materials and analysis scope for group concurrent prevention/exposure, diseases/medications and contacts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing group concurrent prevention/exposure, diseases/medications and contacts and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design
N22 · Salling funding and Rigshospitalet
Required materials and conditions
Support/sponsorship, roles and independence
Conditions for verification
Corresponding original materials and analysis scope for support/sponsorship, roles and independence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing support/sponsorship, roles and independence and connecting materials needed for the selected question with current materials.
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.
N23 · Study mask supply and donated support
Required materials and conditions
Study supply versus manufacturer support/products and actual receipt
Conditions for verification
Corresponding original materials and analysis scope for study supply versus manufacturer support/products and actual receipt should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing study supply versus manufacturer support/products and actual receipt and connecting materials needed for the selected question with current materials.
Referenced methods
Chamgap’s own independence/attribution conditions; the official method sections used in the pilot do not validate every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are independently designed; M03 §3.2.3, M08 §8.2.2–8.2.3; own application
N24 · Medical writing, publication costs and author relationships
Required materials and conditions
Unverified support items and author/analysis roles
Conditions for verification
Corresponding original materials and analysis scope for unverified support items and author/analysis roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing unverified support items and author/analysis roles and connecting materials needed for the selected question with current materials.
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
N25 · One trial, bibliographic years and sibling sheets
Required materials and conditions
Evidence-list 2020, citation-list 2021 and the same DANMASK relationship
Conditions for verification
Corresponding original materials and analysis scope for evidence-list 2020, citation-list 2021 and the same DANMASK relationship should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing evidence-list 2020, citation-list 2021 and the same DANMASK relationship and connecting materials needed for the selected question with current materials.
Referenced methods
M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design
N26 · Generalization across duration, setting and products
Required materials and conditions
Original recommendation/setting versus other situations and long-term effects
Conditions for verification
Corresponding original materials and analysis scope for original recommendation/setting versus other situations and long-term effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing original recommendation/setting versus other situations and long-term effects and connecting materials needed for the selected question with current materials.
Referenced methods
M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed
N27 · Unknown safety and unquantified harms
Required materials and conditions
Discomfort/skin irritation and harms collection/denominator/follow-up scope
Conditions for verification
Corresponding original materials and analysis scope for discomfort/skin irritation and harms collection/denominator/follow-up scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplement the selected subclaim’s safety-material gaps. Wearer-infection results or parent safety wording do not establish safety or create harms rates or new usage instructions.
Why this condition is needed
Applicability item distinguishing discomfort/skin irritation and harms collection/denominator/follow-up scope and connecting materials needed for the selected question with current materials.
Referenced methods
M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application
N28 · Original values, both languages, dates, corrections and history
Required materials and conditions
Parent/subclaim scores/axes versus historical verification/dates
Conditions for verification
Corresponding original materials and analysis scope for parent/subclaim scores/axes versus historical verification/dates should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing parent/subclaim scores/axes versus historical verification/dates and connecting materials needed for the selected question with current materials.
Referenced methods
M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed
N29 · Actual summary reading and material links
Required materials and conditions
Preserved-summary reading versus external paper/registration/plan access
Conditions for verification
Corresponding original materials and analysis scope for preserved-summary reading versus external paper/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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
Applicability item distinguishing preserved-summary reading versus external paper/registration/plan access and connecting materials needed for the selected question with current materials.
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

2026-10-14 · Public page/material version 1.0

Public pages and materials were created from the existing 29 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 · Selected wearer question and original grade

Current findings
The selected subclaim is “Reduced infection in the wearer at one month,” grade D with the null OR 0.82(0.54–1.23) note. Subclaim score/status/axes are absent; parent D34 is not used to fill a subclaim score.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are distinguished from transmission-to-others and mandate effects. Existing content review remains incomplete.
Reason for missing information
Absent subclaim score/status/axes are distinguished from transmission-to-others and mandate effects.
Required materials and conditions
Existing question, grade/note, parent values and separate transmission question
Materials to obtain first
Original selected-subclaim/parent records and user correction comments
Further research
Proposal for later research specifying the wearer endpoint/timepoint; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for existing question, grade/note, parent values and separate transmission question should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing existing question, grade/note, parent values and separate transmission question and connecting materials needed for the selected question with current materials.
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 custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01

N02 · 2020 Denmark and community setting

Current findings
DANMASK-19 studied adults in 2020 Denmark where community mask use was uncommon. Results are not extended to current/other epidemics, healthcare settings or protection of all populations.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Age/eligibility, baseline infection/risk, exposure/occupation, recruitment/group balance and test access remain unverified. Existing content review remains incomplete.
Reason for missing information
Age/eligibility, baseline infection/risk, exposure/occupation, recruitment/group balance and test access remain unverified.
Required materials and conditions
Time/setting, actual population, recruitment and baseline risk
Materials to obtain first
Population/recruitment, baseline-risk and setting tables
Further research
Proposal for later comparative research specifying the setting/population; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for time/setting, actual population, recruitment and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing time/setting, actual population, recruitment and baseline risk and connecting materials needed for the selected question with current materials.
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; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S01

N03 · Recommendation, 50 masks and instructions

Current findings
The intervention supplied a surgical-mask recommendation, 50 masks and instructions. It is not relabeled as full actual wearing, filtration/product effects alone or a mandate trial.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Product specifications/batches, actual supply/instructions, additional contacts and wearing conditions/exposure remain unverified. Existing content review remains incomplete.
Reason for missing information
Product specifications/batches, actual supply/instructions, additional contacts and wearing conditions/exposure remain unverified.
Required materials and conditions
Assigned recommendation/support versus actual wearing and product effects
Materials to obtain first
Recommendation/supply/instruction, product and contact records
Further research
Proposal for later research distinguishing recommendation/support from actual wearing; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for assigned recommendation/support versus actual wearing and product effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing assigned recommendation/support versus actual wearing and product effects and connecting materials needed for the selected question with current materials.
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 assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · Actual wearing and self-reported adherence

Current findings
Preserve self-reported adherence: 46% as recommended, 47% predominantly as recommended, 7% not as recommended. These do not fill objective wearing-time/precise exposure records for all participants.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adherence-questionnaire denominators/timing/definitions, objective wearing/use, missingness and group crossover remain unverified. Existing content review remains incomplete.
Reason for missing information
Adherence-questionnaire denominators/timing/definitions, objective wearing/use, missingness and group crossover remain unverified.
Required materials and conditions
46/47/7% categories/periods, measurement and exposure
Materials to obtain first
Adherence questionnaires/denominators and actual wearing/exposure
Further research
Proposal specifying differences between reported adherence and actual exposure; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for 46/47/7% categories/periods, measurement and exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing 46/47/7% categories/periods, measurement and exposure and connecting materials needed for the selected question with current materials.
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 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M03 §3.2.4; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed

Related sources S01

N05 · Recommendation effects and adherence-based analysis

Current findings
The original trial compares assigned recommendations. The original low-full-adherence context is retained without newly estimating actual-wearer/full-adherence effects or certifying benefits.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified adherence-based plans, inclusion/exposure, adjustment/confounding and related sensitivity results remain unverified. Existing content review remains incomplete.
Reason for missing information
Prespecified adherence-based plans, inclusion/exposure, adjustment/confounding and related sensitivity results remain unverified.
Required materials and conditions
Assigned recommendation versus actual-wearer/full-adherence effects
Materials to obtain first
Recommendation/adherence analysis plans, models and original results
Further research
Proposal distinguishing assignment strategies and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for assigned recommendation versus actual-wearer/full-adherence effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing assigned recommendation versus actual-wearer/full-adherence effects and connecting materials needed for the selected question with current materials.
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; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application

Related sources S01

N06 · Control and concurrent public-health measures

Current findings
Both groups followed prevailing public-health advice. This does not verify a no-action/no-contact control or identical prevention/lifestyle/exposure conditions.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Control mask wearing/additional support, concurrent measures, lifestyle/exposure, contacts and differences/analyses remain unverified. Existing content review remains incomplete.
Reason for missing information
Control mask wearing/additional support, concurrent measures, lifestyle/exposure, contacts and differences/analyses remain unverified.
Required materials and conditions
Actual measures and contact/exposure differences across groups
Materials to obtain first
Control/concurrent measures, wearing/exposure and contact records
Further research
Proposal specifying actual comparisons/concurrent conditions; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for actual measures and contact/exposure differences across groups should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing actual measures and contact/exposure differences across groups and connecting materials needed for the selected question with current materials.
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 assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N07 · Randomization and lack of masking

Current findings
The original design is a nationwide unblinded randomized controlled trial. The randomization label does not verify all sequence/concealment or test/adjudicator/analyst masking details.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original sequence generation/concealment, implementation/exceptions, role-specific masking and baseline balance remain unread. Existing content review remains incomplete.
Reason for missing information
Original sequence generation/concealment, implementation/exceptions, role-specific masking and baseline balance remain unread.
Required materials and conditions
Design label and scope of allocation/measurement/analysis procedures
Materials to obtain first
Original allocation/concealment, masking roles, baseline and protocol materials
Further research
Proposal disclosing allocation and outcome measurement/adjudication; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for design label and scope of allocation/measurement/analysis procedures should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing design label and scope of allocation/measurement/analysis procedures and connecting materials needed for the selected question with current materials.
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 and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01

N08 · Composite infection ascertainment

Current findings
The primary endpoint is the wearer’s own SARS-CoV-2 infection at one month, ascertained through antibody testing, PCR or hospital diagnosis. It is not relabeled as PCR alone, self-reported symptoms or transmission to others.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component definitions/tests, accepted results, overlap/adjudication and event timing remain unverified. Existing content review remains incomplete.
Reason for missing information
Component definitions/tests, accepted results, overlap/adjudication and event timing remain unverified.
Required materials and conditions
Antibody testing, PCR, hospital diagnosis and component/adjudication rules
Materials to obtain first
Composite-endpoint definitions, testing/adjudication and component/overlap materials
Further research
Proposal distinguishing component ascertainment from the composite endpoint; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for antibody testing, PCR, hospital diagnosis and component/adjudication rules should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing antibody testing, PCR, hospital diagnosis and component/adjudication rules and connecting materials needed for the selected question with current materials.
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 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application

Related sources S01

N09 · Testing time, baseline infection and missingness

Current findings
Preserve the original ascertainment methods and one-month period without claiming verified test counts, baseline status, assessment windows or identical ascertainment of all events.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Baseline infection, test/sample timing, implementation/nonimplementation, access, adjudication/errors and confirmation delays remain unverified. Existing content review remains incomplete.
Reason for missing information
Baseline infection, test/sample timing, implementation/nonimplementation, access, adjudication/errors and confirmation delays remain unverified.
Required materials and conditions
Correspondence of one-month infection with tests/baseline/assessment windows
Materials to obtain first
Testing/baseline/assessment flow and adjudication/missingness materials
Further research
Proposal specifying testing/baseline conditions and infection-adjudication timing; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for correspondence of one-month infection with tests/baseline/assessment windows should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing correspondence of one-month infection with tests/baseline/assessment windows and connecting materials needed for the selected question with current materials.
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, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed

Related sources S01

N10 · One month and duration/exposure scope

Current findings
Follow-up was one month. The same recommendation is not expanded to sustained long-term/other-epidemic/healthcare/other-mask effects, and no use/testing instructions are produced.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Individual observation/wearing periods, start/end/censoring and later follow-up/exposure remain unverified. Existing content review remains incomplete.
Reason for missing information
Individual observation/wearing periods, start/end/censoring and later follow-up/exposure remain unverified.
Required materials and conditions
Original period, actual observation/wearing and long-term/other-epidemic boundaries
Materials to obtain first
Period/visit, actual exposure and long-term follow-up materials
Further research
Proposal distinguishing timepoint/duration and setting-specific applicability; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for original period, actual observation/wearing and long-term/other-epidemic boundaries should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing original period, actual observation/wearing and long-term/other-epidemic boundaries and connecting materials needed for the selected question with current materials.
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 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources S01

N11 · Original events and complete-case denominators

Current findings
Primary results were 42/2,392(1.8%) versus 53/2,470(2.1%). They are not relabeled with all-randomized denominators, test counts or total repeated infections; no new proportions/event totals are calculated.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Component-specific event counts, test/person overlap, risk/observation denominators and ascertainment-method correspondence remain unverified. Existing content review remains incomplete.
Reason for missing information
Component-specific event counts, test/person overlap, risk/observation denominators and ascertainment-method correspondence remain unverified.
Required materials and conditions
42/2,392 and 53/2,470 versus people/test units
Materials to obtain first
Original events/components, denominators/tests and observations
Further research
Proposal reporting people/events/tests and denominators separately; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for 42/2,392 and 53/2,470 versus people/test units should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing 42/2,392 and 53/2,470 versus people/test units and connecting materials needed for the selected question with current materials.
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 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01

N12 · Original absolute difference, CI and P

Current findings
Preserve absolute difference −0.3 percentage points (95% CI −1.2–0.4), P=.38. Do not newly subtract 1.8%/2.1% or calculate a new effect, CI or NNT.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Exact contrasts/models, adjustment, CI methods and original plans/sensitivity remain unread. Existing content review remains incomplete.
Reason for missing information
Exact contrasts/models, adjustment, CI methods and original plans/sensitivity remain unread.
Required materials and conditions
Original absolute effect/CI versus rounded proportions and models
Materials to obtain first
Original absolute effects/models, CI and prespecified plans
Further research
Proposal for later research disclosing effect measures and precision; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for original absolute effect/CI versus rounded proportions and models should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing original absolute effect/CI versus rounded proportions and models and connecting materials needed for the selected question with current materials.
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
M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.

Related sources S01

N13 · OR, CI and separate P

Current findings
OR 0.82(0.54–1.23), P=.33 is the original result. It is retained separately from absolute-difference P=.38; OR is not converted to RR, individual risk or a new relative reduction.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. OR models/adjustment, precise contrasts, tests/CI methods and correspondence to absolute effects remain unread. Existing content review remains incomplete.
Reason for missing information
OR models/adjustment, precise contrasts, tests/CI methods and correspondence to absolute effects remain unread.
Required materials and conditions
Original OR/CI versus the different absolute-difference estimand
Materials to obtain first
OR/absolute-effect models/tests and original results
Further research
Proposal reporting effect measures/tests separately; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for original OR/CI versus the different absolute-difference estimand should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing original OR/CI versus the different absolute-difference estimand and connecting materials needed for the selected question with current materials.
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
M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.

Related sources S01

N14 · Nonsignificance, wide CI and importance

Current findings
The original manuscript records no established primary benefit and a CI retaining substantial benefit/harm possibilities. It is not changed to zero effect, equivalence or confirmed general mask ineffectiveness/harm.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Prespecified importance/success/equivalence criteria and sufficient precision for exact effects remain unverified. Existing content review remains incomplete.
Reason for missing information
Prespecified importance/success/equivalence criteria and sufficient precision for exact effects remain unverified.
Required materials and conditions
Null verdict versus possible benefit/harm, exactly zero and equivalence
Materials to obtain first
Prespecified criteria, models/CI and estimand materials
Further research
Proposal specifying effects/precision and question scope; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for null verdict versus possible benefit/harm, exactly zero and equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing null verdict versus possible benefit/harm, exactly zero and equivalence and connecting materials needed for the selected question with current materials.
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
M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries

Related sources S01

N15 · 6,024 randomized and 4,862 complete cases

Current findings
Preserve 6,024 randomized (3,030/2,994) and 4,862 primary complete cases (2,392/2,470). These populations/group counts are not combined or filled as complete observation/ITT for everyone.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case inclusion/exclusion, test/component-specific valid denominators and baseline/visit correspondence remain unverified. Existing content review remains incomplete.
Reason for missing information
Complete-case inclusion/exclusion, test/component-specific valid denominators and baseline/visit correspondence remain unverified.
Required materials and conditions
Randomized/complete-case populations and group denominators
Materials to obtain first
Flow, analysis-population definitions and endpoint/test denominators
Further research
Proposal distinguishing allocated/observed/analyzed denominators; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for randomized/complete-case populations and group denominators should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing randomized/complete-case populations and group denominators and connecting materials needed for the selected question with current materials.
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 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N16 · 19.3% missingness and dropout

Current findings
Primary missingness 19.3% is the original record. No new missing counts/rates or best/worst effects are calculated, and absence of missing-data effects is not certified.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original group missingness/dropout reasons, baseline risk, test/contact differences and handling/sensitivity remain unverified. Existing content review remains incomplete.
Reason for missing information
Original group missingness/dropout reasons, baseline risk, test/contact differences and handling/sensitivity remain unverified.
Required materials and conditions
Group missingness/deviations, testing/reporting and outcome effects
Materials to obtain first
Group flow, missingness/contact, missing-data handling and sensitivity
Further research
Proposal reporting effects of missingness and observation selection; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for group missingness/deviations, testing/reporting and outcome effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing group missingness/deviations, testing/reporting and outcome effects and connecting materials needed for the selected question with current materials.
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 adaptation is independently designed; M08 §8.2.2, M15 §15.3.1; own application; M08 Table 8.2.a, M03 §3.2.4; own application

Related sources S01

N17 · Complete-case estimands and within/between-group comparisons

Current findings
The original primary analysis is complete-case. It is not relabeled as ITT for all randomized participants or actual full-wearing effects, and within-group improvements are not made into new between-group benefits.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete-case models/adjustment, observation selection, missingness/adherence sensitivity and other analyses remain unverified. Existing content review remains incomplete.
Reason for missing information
Complete-case models/adjustment, observation selection, missingness/adherence sensitivity and other analyses remain unverified.
Required materials and conditions
Analysis populations/models, assigned effects and observation selection
Materials to obtain first
Analysis populations, models/contrasts and missingness/adherence sensitivity
Further research
Proposal distinguishing assignment, observation and actual-exposure estimands; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for analysis populations/models, assigned effects and observation selection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing analysis populations/models, assigned effects and observation selection and connecting materials needed for the selected question with current materials.
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; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is independently designed

Related sources S01

N18 · Registration, retrospective dates and plans

Current findings
Original wording records NCT04337541 first posted 2020-04-08 after the 2020-04-02 start, six-day retrospective registration. It is not changed to prospective registration, verified complete prespecification or definite outcome switching.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Registration history, prerecruitment protocols/SAP, changes and complete endpoint/analysis contracts remain unread. Existing content review remains incomplete.
Reason for missing information
Registration history, prerecruitment protocols/SAP, changes and complete endpoint/analysis contracts remain unread.
Required materials and conditions
Preserved NCT/dates and prespecified endpoint/analysis contracts
Materials to obtain first
Registration history, protocol, and SAP
Further research
Proposal linking and disclosing plan/registration timing and actual analyses; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for preserved NCT/dates and prespecified endpoint/analysis contracts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing preserved NCT/dates and prespecified endpoint/analysis contracts and connecting materials needed for the selected question with current materials.
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, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01

N19 · Primary/secondary outcomes and multiplicity

Current findings
The selected result is the wearer’s own one-month infection primary endpoint. Multiple tests, effect measures, adherence groups or other outcomes are not counted as independent trials or new primary successes.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete secondary/timepoint, multiplicity, testing-order, prespecified hierarchy and reporting changes remain unverified. Existing content review remains incomplete.
Reason for missing information
Complete secondary/timepoint, multiplicity, testing-order, prespecified hierarchy and reporting changes remain unverified.
Required materials and conditions
Wearer primary endpoint, test components and effect-measure/other-outcome hierarchy
Materials to obtain first
SAP, complete outcomes and testing/hierarchy materials
Further research
Proposal separating primary, component and secondary outcomes; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for wearer primary endpoint, test components and effect-measure/other-outcome hierarchy should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing wearer primary endpoint, test components and effect-measure/other-outcome hierarchy and connecting materials needed for the selected question with current materials.
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, M04 §4.6.3; own application; M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort/outcome linkage is independently applied; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed

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N20 · Transmission to others and mandates were unmeasured

Current findings
The original manuscript records that transmission prevention to others and mask-mandate effects were not tested. The selected wearer result is not transferred to their effects/null results or policy/procedural guidance.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct transmission-to-others, mandate, healthcare/other-epidemic results are not connected by this trial. Existing content review remains incomplete.
Reason for missing information
Direct transmission-to-others, mandate, healthcare/other-epidemic results are not connected by this trial.
Required materials and conditions
Wearer protection versus source control, policy and setting
Materials to obtain first
Separate materials directly measuring those questions/settings
Further research
Proposal for later research separating wearer/others/policy questions; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for wearer protection versus source control, policy and setting should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing wearer protection versus source control, policy and setting and connecting materials needed for the selected question with current materials.
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 on clarifying questions; detailed separation rules are independently designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is independently designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are independently designed

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N21 · Concurrent measures, exposure and lifestyle

Current findings
Preserve the original prevailing-public-health-advice record for both groups without filling in identical/no-effect exposure, lifestyle/prevention or disease/medication conditions.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
Information currently required is unverified in the preserved summary. Concurrent measures, outside contacts/exposures, other masks/products, diseases/medications and group differences/analyses remain unverified. Existing content review remains incomplete.
Reason for missing information
Concurrent measures, outside contacts/exposures, other masks/products, diseases/medications and group differences/analyses remain unverified.
Required materials and conditions
Group concurrent prevention/exposure, diseases/medications and contacts
Materials to obtain first
Concurrent conditions, exposures/contacts and analyses
Further research
Proposal distinguishing concurrent conditions from recommendation/wearing effects; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for group concurrent prevention/exposure, diseases/medications and contacts should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing group concurrent prevention/exposure, diseases/medications and contacts and connecting materials needed for the selected question with current materials.
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 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

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N22 · Salling funding and Rigshospitalet

Current findings
Salling Foundations funding and Rigshospitalet leadership are original records. Institution/leadership names are not changed to absence of all support/relationships or new independence certification.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Original support/leadership roles, contracts, data/analysis/publication control and author COI remain unread. Existing content review remains incomplete.
Reason for missing information
Original support/leadership roles, contracts, data/analysis/publication control and author COI remain unread.
Required materials and conditions
Support/sponsorship, roles and independence
Materials to obtain first
Original funding, investigator/author roles and COI
Further research
Proposal for later research disclosing support/research roles; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for support/sponsorship, roles and independence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing support/sponsorship, roles and independence and connecting materials needed for the selected question with current materials.
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.

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N23 · Study mask supply and donated support

Current findings
Original records state that study masks were supplied within the research and manufacturer donation was not verified. This is not changed to definite manufacturer supply, no support or actual receipt of 50 masks by everyone.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Manufacture/specifications, actual distribution, purchase/supply contracts and support scope/roles remain unverified. Existing content review remains incomplete.
Reason for missing information
Manufacture/specifications, actual distribution, purchase/supply contracts and support scope/roles remain unverified.
Required materials and conditions
Study supply versus manufacturer support/products and actual receipt
Materials to obtain first
Product/distribution, purchase/supply contracts and support disclosures
Further research
Proposal separating study supply from manufacturer support; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for study supply versus manufacturer support/products and actual receipt should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing study supply versus manufacturer support/products and actual receipt and connecting materials needed for the selected question with current materials.
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 method sections used in the pilot do not validate every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are independently designed; M03 §3.2.3, M08 §8.2.2–8.2.3; own application

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N24 · Medical writing, publication costs and author relationships

Current findings
Original records state that medical-writing/publication-cost support was not verified. Unverified is not changed to absent, and funding/leadership names do not fill all author COI.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Complete original writing/publication, outside analysis, author relationships/contributions and support remain unread. Existing content review remains incomplete.
Reason for missing information
Complete original writing/publication, outside analysis, author relationships/contributions and support remain unread.
Required materials and conditions
Unverified support items and author/analysis roles
Materials to obtain first
Writing/publication/analysis, author-contribution and COI disclosures
Further research
Proposal disclosing support items separately; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for unverified support items and author/analysis roles should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing unverified support items and author/analysis roles and connecting materials needed for the selected question with current materials.
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

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N25 · One trial, bibliographic years and sibling sheets

Current findings
Preserve Bundgaard 2020 DANMASK-19 in the evidence list and 2021 publication bibliography in the citation list. These do not become separate trials/replications or new participant totals across groups/tests/events/timepoints/sibling sheets.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Unique clinical-trial/participant totals or independent replication of the same question are not newly established. Existing content review remains incomplete.
Reason for missing information
Unique clinical-trial/participant totals or independent replication of the same question are not newly established.
Required materials and conditions
Evidence-list 2020, citation-list 2021 and the same DANMASK relationship
Materials to obtain first
Report/registration/cohort relationships and separate research materials
Further research
Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for evidence-list 2020, citation-list 2021 and the same DANMASK relationship should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing evidence-list 2020, citation-list 2021 and the same DANMASK relationship and connecting materials needed for the selected question with current materials.
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 linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

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N26 · Generalization across duration, setting and products

Current findings
The scope is 2020 Denmark, low community mask use, a surgical-mask recommendation and one month. Effects are not extended to healthcare, other variants/epidemics, long-term use, mandates or other masks/products.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Direct comparisons, sustained/discontinued exposure and long-term outcomes in other situations/products remain unverified. Existing content review remains incomplete.
Reason for missing information
Direct comparisons, sustained/discontinued exposure and long-term outcomes in other situations/products remain unverified.
Required materials and conditions
Original recommendation/setting versus other situations and long-term effects
Materials to obtain first
Direct setting/product/duration-specific research and follow-up
Further research
Proposal distinguishing question/situation/duration applicability; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for original recommendation/setting versus other situations and long-term effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing original recommendation/setting versus other situations and long-term effects and connecting materials needed for the selected question with current materials.
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 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed

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N27 · Unknown safety and unquantified harms

Current findings
The original parent safety is Unknown and mask-related harms were not quantified. Infection results/P are not used as evidence of no discomfort/skin irritation or of safety.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Adverse-event collection/types/frequency/denominators, discontinuation and long-term/vulnerable-population harms remain unverified. Existing content review remains incomplete.
Reason for missing information
Adverse-event collection/types/frequency/denominators, discontinuation and long-term/vulnerable-population harms remain unverified.
Required materials and conditions
Discomfort/skin irritation and harms collection/denominator/follow-up scope
Materials to obtain first
Harms collection, adverse events/discontinuation and follow-up
Further research
Proposal for later research specifying harms collection/scope; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for discomfort/skin irritation and harms collection/denominator/follow-up scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing discomfort/skin irritation and harms collection/denominator/follow-up scope and connecting materials needed for the selected question with current materials.
Application exceptions
Supplement the selected subclaim’s safety-material gaps. Wearer-infection results or parent safety wording do not establish safety or create harms rates or new usage instructions.
Referenced methods
M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

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N28 · Original values, both languages, dates, corrections and history

Current findings
Preserve parent D34, B/H/R1/I2/E0/B2/C0, the large hard-endpoint RCT true marker, two false markers, empty override reasons and subclaim D/note. Both languages, 2026-08-26, empty corrections/deliberation and cross-validation are not current review or a subclaim score.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. Absent subclaim score/status/axes are not filled with parent values; no new methodological/efficacy certification. Existing content review remains incomplete.
Reason for missing information
Absent subclaim score/status/axes are not filled with parent values; no new methodological/efficacy certification.
Required materials and conditions
Parent/subclaim scores/axes versus historical verification/dates
Materials to obtain first
Original corrections, versions and user correction comments
Further research
Proposal separating original values/history from new-material application; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for parent/subclaim scores/axes versus historical verification/dates should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing parent/subclaim scores/axes versus historical verification/dates and connecting materials needed for the selected question with current materials.
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; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

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N29 · Actual summary reading and material links

Current findings
The complete preserved summary/bibliography were used for production and links retained. External paper/registration/protocol/SAP/support/COI originals remain unread/unaccessed; external link testing was not performed.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only corresponding preserved-summary information is recorded; detailed original materials remain unread and existing content review is incomplete. External original content, exact contracts/denominators/models and access availability remain unverified. Existing content review remains incomplete.
Reason for missing information
External original content, exact contracts/denominators/models and access availability remain unverified.
Required materials and conditions
Preserved-summary reading versus external paper/registration/plan access
Materials to obtain first
Original paper, registration, protocol, SAP and support materials or user comments
Further research
Proposal for updating while distinguishing actual acquisition/timing/scope; no new investigation, calculation or trial was performed in that production.
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 materials and analysis scope for preserved-summary reading versus external paper/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.
Why this condition is needed
Applicability item distinguishing preserved-summary reading versus external paper/registration/plan access and connecting materials needed for the selected question with current materials.
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

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