Low-dose penicillin × Reduced first recurrence during 12 months of treatment

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionSelected first recurrence during treatment and original gradeRequired	Selected subclaim: reduced first recurrence during 12 months, grade B, with the original 22% versus 37%/NNT 5 note. Subclaim score/status/axes are absent; parent B with 76 points does not fill the subclaim score. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence. Existing content review remains incomplete.	Original wording/grade/note versus parent values and post-treatment results	Proposed follow-up comparative research specifying first-recurrence endpoints by period; no new investigation, calculation or trial was performed in this production.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionRecurrence risk, eligibility and populationRequired	Original PATCH I population: adults with at least two leg-cellulitis episodes in the previous three years. Do not extend to prevention after a first episode or other sites/populations. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified. Existing content review remains incomplete.	Recent recurrence, age/eligibility, baseline risk and applicability	Proposed follow-up research specifying recurrence risk and population scope; no new investigation, calculation or trial was performed in this production.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionPenicillin V study exposureRequired	Original study exposure was penicillin V 250 mg twice daily for 12 months. Preserve study exposure only; do not convert it to intake/prevention/cellulitis-management instructions. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified. Existing content review remains incomplete.	Original antibiotic, dose/frequency/duration and formulation identity	Proposed follow-up research separating drug/duration from applicability; no new investigation, calculation or trial was performed in this production.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionPlacebo and comparison specificationsRequired	S01 was a multicentre double-blind randomized placebo-controlled trial. The placebo name does not verify matching of all composition/contact/concurrent management. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified. Existing content review remains incomplete.	Actual placebo composition/sensory features, contact and concurrent treatment matching	Proposed follow-up trial specifying actual comparison conditions; no new investigation, calculation or trial was performed in this production.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionCentral pharmacy and allocation concealmentRequired	The original records central-pharmacy dispensing as allocation-concealment evidence. This is not current verification of original text/allocation records or certification of the whole randomization process. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.	Original allocation/drug-supply descriptions versus actual original-text verification	Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionDouble masking and assessorsRequired	Original double-blind design and clinician-confirmed recurrence are preserved. Maintained masking of every role or exclusion of expectation effects are not treated as newly verified. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread. Existing content review remains incomplete.	Actual masking/maintenance of participants, clinicians and analysts	Proposed follow-up research specifying endpoint adjudication and masking; no new investigation, calculation or trial was performed in this production.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionClinician-confirmed recurrence definitionRequired	Original recurrence was clinician-confirmed, not based only on participant reports. It is not treated as the same endpoint as suspected self-reported symptoms, other infections/sites or all repeated events. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified. Existing content review remains incomplete.	Reporting, diagnostic confirmation, first/all recurrences and site definitions	Proposed research specifying first clinical recurrence definitions/adjudication; no new investigation, calculation or trial was performed in this production.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionTime to first recurrenceRequired	The primary endpoint was time to first clinician-confirmed recurrence. HR, proportions of people within a period, all recurrences and total observation time are not combined as the same estimand. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified. Existing content review remains incomplete.	Prespecified primary time endpoint versus proportions/total events	Proposed follow-up research distinguishing time endpoints from period proportions/repeated events; no new investigation, calculation or trial was performed in this production.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionDuring treatment: 30/136 and 51/138Required	First recurrence during treatment was 30/136 (22%) versus 51/138 (37%). Distinguish recurrent participants, all repeated events, observation time and randomized populations; no new proportions/event totals are calculated. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified. Existing content review remains incomplete.	Original first-recurrence people/denominators and 22%/37%	Proposed research reporting people/event/time denominators separately; no new investigation, calculation or trial was performed in this production.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHR 0.55·CI·PRequired	Original HR 0.55 (95% CI 0.35–0.86), P=.01 is preserved. No new RR/OR, HR, CI or individual risks are calculated from 22%/37%. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread. Existing content review remains incomplete.	Original first-recurrence time effect/CI versus proportions	Proposed follow-up research reporting time effects and uncertainty; no new investigation, calculation or trial was performed in this production.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionOriginal absolute difference and NNTRequired	Original absolute difference −15 percentage points and NNT 5 (4–9) are preserved unchanged. They are not recalculated/corrected through new arithmetic or transferred to other periods/populations/drugs. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original estimation/period/model, CI methods and risk-reference details for each number remain unread. Existing content review remains incomplete.	Original absolute difference/NNT and period/analysis/estimation specifications	Proposed follow-up research separating absolute/time effects and calculation specifications; no new investigation, calculation or trial was performed in this production.
12	Partly verified	Full text not readStored summary read	N12 · Evidence condition27% after stopping and persistenceRequired	Original off-treatment follow-up had 27% recurrence in both arms and no persistent protection. This is not new proof of the during-treatment HR/proportions, permanent prevention or exactly zero effect/equivalence. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified. Existing content review remains incomplete.	During-treatment versus post-treatment results, denominators/estimation	Proposed follow-up research distinguishing persistence during/after treatment; no new investigation, calculation or trial was performed in this production.
13	Partly verified	Full text not readStored summary read	N13 · Evidence condition12 months, exposure, adherence/discontinuationRequired	Original 12-month study exposure is preserved. It does not establish full-period complete intake/actual exposure in everyone or continued protection afterwards. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified. Existing content review remains incomplete.	Planned treatment duration versus actual exposure/stopping/changes	Proposed research distinguishing planned/actual exposure and period-specific effects; no new investigation, calculation or trial was performed in this production.
14	Partly verified	Full text not readStored summary read	N14 · Evidence condition274 participants, 28 hospitals and 136/138Required	PATCH I assigned 274 participants at 28 hospitals, 136/138. Hospitals, arms, time, events and citations are not added as new independent trials/participants. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified. Existing content review remains incomplete.	Recruitment/randomization denominators versus endpoint observation/at-risk populations	Proposed research distinguishing recruitment/observation/risk denominators; no new investigation, calculation or trial was performed in this production.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionITT principle and actual analysis populationsRequired	The original records historical wording that all analyses followed ITT. This does not newly verify complete observation or detailed denominators/models for every result. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread. Existing content review remains incomplete.	Original ITT versus inclusion/exclusion, estimation populations and censoring specifications	Proposed research separately disclosing assignment/exposure/observation analyses; no new investigation, calculation or trial was performed in this production.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionMissingness, withdrawals and observation timeRequired	Original randomized denominators and ITT descriptions are preserved. No assumption of zero missingness/withdrawal or no effects from infection reporting/confirmation/follow-up differences is filled in. S01	Required current information remains unverified in the preserved summary. Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified. Existing content review remains incomplete.	Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation	Proposed research reporting follow-up and its effects on first-event estimation; no new investigation, calculation or trial was performed in this production.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionTwo registrations and prespecified plansRequired	Original evidence registration identifier: ISRCTN34716921 · EudraCT 2006-000381-36. Pre-recruitment registration and matching first-recurrence endpoint descriptions are preserved; full registration/plans remain unread. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread. Existing content review remains incomplete.	ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions	Proposed research linking and disclosing prespecified plans and actual period-specific analyses; no new investigation, calculation or trial was performed in this production.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionPrimary/secondary outcomes, periods and multiple testsRequired	Original primary endpoint was time to first recurrence. Post-treatment, all-recurrence, safety and other analyses are not upgraded to new primary endpoints or independent confirmation. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified. Existing content review remains incomplete.	First-recurrence primary endpoint versus other events/periods/subgroup hierarchy	Proposed research distinguishing primary from period-specific/secondary results; no new investigation, calculation or trial was performed in this production.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionConcurrent treatment and recurrence-risk managementRequired	This was a placebo-controlled trial in adults at risk of recurrent leg cellulitis. The original summary is not extended to confirm identical concurrent treatment/management or no influence on effects. S01	Required current information remains unverified in the preserved summary. Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified. Existing content review remains incomplete.	Concurrent medications/conditions/lifestyle management and contact by arm	Proposed follow-up research distinguishing concurrent management from study-drug effects; no new investigation, calculation or trial was performed in this production.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionPATCH II companion report and directnessRequired	Original S02 PATCH II: 123 participants, HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. The same 12-month/recurrence-risk/exposure specifications are not automatically filled in. S02	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified. Existing content review remains incomplete.	Separate-cohort results versus PATCH I specifications	Proposed follow-up research specifying separate cohorts/specifications; no new investigation, calculation or trial was performed in this production.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionTwo estimates, nonsignificance and conflict scopeRequired	Original interpretation that PATCH II’s CI includes PATCH I’s 0.55 and is not statistically conflicting is preserved. No new pooled effects, CI, significance or equivalence/conflict verdicts are calculated. S01 S02	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified. Existing content review remains incomplete.	PATCH II CI and the original verdict’s relationship interpretation	Proposed research distinguishing matching specifications from result relationships; no new investigation, calculation or trial was performed in this production.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionReports, cohorts, network and independenceRequired	PATCH I/II were separate cohorts in the same network, so the original verdict did not count independent replication. 274/123, hospitals, arms, time points, citations/related sheets are not added as new participant/trial totals. S01 S02	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. No new unique-clinical-trial/participant or independent-replication totals are established. Existing content review remains incomplete.	PATCH I/II separate cohorts versus the same network	Proposal for later independent comparative research on the same selected question; no new investigation, calculation or trial was performed in that production.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAction Medical Research fundingRequired	Original PATCH I funding was nonprofit support from Action Medical Research. This does not become new certification of no support/COI or independence. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Funder roles, contracts, other support and original data/publication authority remain unread. Existing content review remains incomplete.	Nonprofit funding versus support roles/other relationships	Proposed follow-up research disclosing support roles; no new investigation, calculation or trial was performed in this production.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionNottingham sponsorship and pharmaceutical supportRequired	The original records University of Nottingham as sponsor and pharmaceutical cash/product/analysis support as not identified. Unverified does not mean actually absent or no author relationships. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread. Existing content review remains incomplete.	Research sponsor and verification of cash/product/analysis support	Proposed research separately disclosing research roles and item-specific support; no new investigation, calculation or trial was performed in this production.
25	Partly verified	Full text not readStored summary read	N25 · Harm-information gaps supplementing the efficacy tableAdverse-event reporters and PSupplementary	Original adverse-event reporters numbered 37 versus 48, P=.50. Person counts are not converted to total events, related reactions, no harm or equivalent safety. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified. Existing content review remains incomplete.	People versus event counts/denominators and nonsignificance versus safety	Proposed harm research distinguishing people/events and uncertainty; no new investigation, calculation or trial was performed in this production.
26	Partly verified	Full text not readStored summary read	N26 · Harm-information gaps supplementing the efficacy tableAllergy, gastrointestinal and resistance gapsSupplementary	Original parent caution and allergy/gastrointestinal/antimicrobial-resistance burdens are preserved. Warnings are not made into actual event rates/resistance measurements or intake/prevention instructions. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified. Existing content review remains incomplete.	Parent caution wording versus actual harm/resistance measurement	Proposed follow-up research specifying harm/resistance collection scope; no new investigation, calculation or trial was performed in this production.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionOther drugs/populations and persistent applicationRequired	The original excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and permanent protection. Preserve research results only; no management/treatment-replacement instructions. S01	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified. Existing content review remains incomplete.	Original recurrence risk, drug/route/duration versus long-term generalization	Proposed follow-up research distinguishing specifications/period from persistent protection; no new investigation, calculation or trial was performed in this production.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionParent/subclaim, bilingual text and historyRequired	Parent B with 76 points, B/H/R1/I2/E+/B0, unrecorded precision, true large-hard-endpoint-RCT and two false indicators, empty grade-override reasons and subclaim B/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim scores. S01 S02	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification. Existing content review remains incomplete.	Separate original score/axes, evidence date, corrections and verification descriptions	Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this production.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionActual summary reading and material linksRequired	The entire preserved summary/citations were used for production and PATCH I/II links retained. Original papers/registration/protocol/SAP/support/COI remain unread, access unattempted and external links untested. S01 S02	Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact denominators/duration/models and accessibility remain unverified. Existing content review remains incomplete.	Reading preserved summaries versus external papers/two registrations/plans	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 with at least two leg-cellulitis episodes in the previous three years. Original PATCH I: 28 hospitals, 274 participants, 136/138. Detailed eligibility/baseline risk, time-specific observation/risk denominators and withdrawal/missingness remain unverified. PATCH I conditions are not automatically applied to the separate 123-person PATCH II cohort.
Ingredient, formulation and route: Only original PATCH I study exposure is preserved: penicillin V 250 mg twice daily for 12 months. Actual adherence/discontinuation and product/formulation remain unverified; no intake/prevention/cellulitis-management or other-drug/dose/route instructions.
Dose: Separate 12 months during treatment from off-treatment follow-up afterwards. Actual intake/duration, discontinuation/re-exposure and post-treatment windows remain unverified; no new dose/frequency/duration conversion.
Comparator: Multicentre double-blind randomized placebo comparison. Central-pharmacy dispensing, ITT and pre-recruitment registration/matching-endpoint descriptions are preserved history, not current original-text/procedural verification. Actual placebo/contact, concurrent treatment and masking/allocation details remain unread/unverified.
Measured outcome: Time to first clinician-confirmed recurrence; during treatment 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86)/P=.01, original absolute difference −15 percentage points and NNT 5 (4–9) are preserved as separate original estimands. People/first events/all repeated events/time are not combined; no new arithmetic/effects/CI. Post-treatment 27% in both arms is a separate-period result.
Duration: Distinguish original PATCH I first recurrence during 12 months from lost protection after stopping. PATCH II HR 0.53 (0.26–1.07)/P=.08, 123 participants, concerns a separate cohort in the same network; exact exposure/duration/eligibility remain unverified.
Questions outside this scope: Calculating new effects/CI, proportions/events, observation time or repeated totals from 30/136, 51/138 or 22%/37%; Recalculating/correcting original absolute difference −15 percentage points, NNT 5 (4–9) or HR 0.55, or transferring them to other periods/populations; Turning post-treatment 27% in both arms into new proof of during-treatment effects, permanent protection or exactly zero effect/equivalence; Adding/mixing first-recurrence time, recurrent people within a period and all repeated events/people/time; Applying PATCH I eligibility, 12-month exposure, registration/denominators/plans to PATCH II’s 123 participants/HR 0.53/CI/P=.08; Turning original PATCH I/II relationships into independent replication, new pooled effects or clinical-participant/trial totals; Repurposing adverse-event reporters 37/48/P=.50 as total related events, no harm, resistance measurements or equivalent safety; Inheriting original parent values/axes and historical cross-checking/registration/allocation/masking/analysis descriptions as subclaim scores or current clinical-content review/full-text reading; New arithmetic, invented quantities, effects/CI, grades/independence certification or antibiotic-use/prevention/cellulitis-management/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 · Thomas KS et al. 2013 PATCH I

PubMed

Material type: Multicentre double-blind randomized placebo-controlled trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 30/136 (22%) vs 51/138 (37%); HR 0.55 (0.35–0.86), P=.01; NNT 5 (4–9). Grade B. PATCH I first recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (95% CI 0.35–0.86), P=.01, absolute difference −15 percentage points and NNT 5 (4–9). After stopping, 27% in both arms recurred and protection did not persist.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed.

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

S02 · UK Dermatology Clinical Trials Network. PATCH II. Br J Dermatol. 2012. PMID: 21910701.

PubMed

Material type: Citation-only PATCH II companion report of a separate cohort; no original evidence-list row
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: PATCH II’s 123 participants had HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. Its interval includes PATCH I’s 0.55 estimate and was described as not statistically conflicting. It was a separate cohort in the same network and was not counted as independent replication.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed.

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

Report counts versus independent study counts

PATCH I and PATCH II are separate cohorts in the same network. PATCH I reports time to first clinician-confirmed recurrence at 28 hospitals, 274 participants, 136/138, comparing penicillin V 250 mg twice daily for 12 months with placebo. Original 30/136 (22%) versus 51/138 (37%), HR 0.55 (0.35–0.86)/P=.01 and absolute difference −15 percentage points/NNT 5 (4–9) are preserved. Post-treatment 27% in both arms concerns a separate period. PATCH II is a companion report of 123 participants, HR 0.53 (0.26–1.07)/P=.08; eligibility, exposure/duration, registration/denominators/models are not filled from PATCH I. The original same-network relationship and decision not to count independent replication are preserved; no new clinical totals, pooled effects or independence certification. Reports/cohorts, people, arms, events, time and related sheets are not summed.

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 first recurrence during treatment and original grade

Required materials and conditions: Original wording/grade/note versus parent values and post-treatment results
Conditions for verification: Relevant originals and analysis scope for Original wording/grade/note versus parent values and post-treatment results should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original wording/grade/note versus parent values and post-treatment results to connect materials needed for the selected question with available 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 · Recurrence risk, eligibility and population

Required materials and conditions: Recent recurrence, age/eligibility, baseline risk and applicability
Conditions for verification: Relevant originals and analysis scope for Recent recurrence, age/eligibility, baseline risk and applicability should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Recent recurrence, age/eligibility, baseline risk and applicability to connect materials needed for the selected question with available 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 · Penicillin V study exposure

Required materials and conditions: Original antibiotic, dose/frequency/duration and formulation identity
Conditions for verification: Relevant originals and analysis scope for Original antibiotic, dose/frequency/duration and formulation identity should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original antibiotic, dose/frequency/duration and formulation identity to connect materials needed for the selected question with available 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 · Placebo and comparison specifications

Required materials and conditions: Actual placebo composition/sensory features, contact and concurrent treatment matching
Conditions for verification: Relevant originals and analysis scope for Actual placebo composition/sensory features, contact and concurrent treatment matching should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Actual placebo composition/sensory features, contact and concurrent treatment matching to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application

N05 · Central pharmacy and allocation concealment

Required materials and conditions: Original allocation/drug-supply descriptions versus actual original-text verification
Conditions for verification: Relevant originals and analysis scope for Original allocation/drug-supply descriptions versus actual original-text verification should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original allocation/drug-supply descriptions versus actual original-text verification to connect materials needed for the selected question with available materials.
Referenced methods: M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed

N06 · Double masking and assessors

Required materials and conditions: Actual masking/maintenance of participants, clinicians and analysts
Conditions for verification: Relevant originals and analysis scope for Actual masking/maintenance of participants, clinicians and analysts should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Actual masking/maintenance of participants, clinicians and analysts to connect materials needed for the selected question with available materials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP

N07 · Clinician-confirmed recurrence definition

Required materials and conditions: Reporting, diagnostic confirmation, first/all recurrences and site definitions
Conditions for verification: Relevant originals and analysis scope for Reporting, diagnostic confirmation, first/all recurrences and site definitions should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Reporting, diagnostic confirmation, first/all recurrences and site definitions to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

N08 · Time to first recurrence

Required materials and conditions: Prespecified primary time endpoint versus proportions/total events
Conditions for verification: Relevant originals and analysis scope for Prespecified primary time endpoint versus proportions/total events should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Prespecified primary time endpoint versus proportions/total events to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

N09 · During treatment: 30/136 and 51/138

Required materials and conditions: Original first-recurrence people/denominators and 22%/37%
Conditions for verification: Relevant originals and analysis scope for Original first-recurrence people/denominators and 22%/37% should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original first-recurrence people/denominators and 22%/37% to connect materials needed for the selected question with available 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

N10 · HR 0.55·CI·P

Required materials and conditions: Original first-recurrence time effect/CI versus proportions
Conditions for verification: Relevant originals and analysis scope for Original first-recurrence time effect/CI versus proportions should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original first-recurrence time effect/CI versus proportions to connect materials needed for the selected question with available materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

N11 · Original absolute difference and NNT

Required materials and conditions: Original absolute difference/NNT and period/analysis/estimation specifications
Conditions for verification: Relevant originals and analysis scope for Original absolute difference/NNT and period/analysis/estimation specifications should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original absolute difference/NNT and period/analysis/estimation specifications to connect materials needed for the selected question with available materials.
Referenced methods: M15 §15.3.1–15.3.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed

N12 · 27% after stopping and persistence

Required materials and conditions: During-treatment versus post-treatment results, denominators/estimation
Conditions for verification: Relevant originals and analysis scope for During-treatment versus post-treatment results, denominators/estimation should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing During-treatment versus post-treatment results, denominators/estimation to connect materials needed for the selected question with available materials.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; 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/effect-modification details are internally designed

N13 · 12 months, exposure, adherence/discontinuation

Required materials and conditions: Planned treatment duration versus actual exposure/stopping/changes
Conditions for verification: Relevant originals and analysis scope for Planned treatment duration versus actual exposure/stopping/changes should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Planned treatment duration versus actual exposure/stopping/changes to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

N14 · 274 participants, 28 hospitals and 136/138

Required materials and conditions: Recruitment/randomization denominators versus endpoint observation/at-risk populations
Conditions for verification: Relevant originals and analysis scope for Recruitment/randomization denominators versus endpoint observation/at-risk populations should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Recruitment/randomization denominators versus endpoint observation/at-risk populations to connect materials needed for the selected question with available materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

N15 · ITT principle and actual analysis populations

Required materials and conditions: Original ITT versus inclusion/exclusion, estimation populations and censoring specifications
Conditions for verification: Relevant originals and analysis scope for Original ITT versus inclusion/exclusion, estimation populations and censoring specifications should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original ITT versus inclusion/exclusion, estimation populations and censoring specifications to connect materials needed for the selected question with available materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed

N16 · Missingness, withdrawals and observation time

Required materials and conditions: Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation
Conditions for verification: Relevant originals and analysis scope for Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation to connect materials needed for the selected question with available 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 · Two registrations and prespecified plans

Required materials and conditions: ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions
Conditions for verification: Relevant originals and analysis scope for ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions to connect materials needed for the selected question with available 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

N18 · Primary/secondary outcomes, periods and multiple tests

Required materials and conditions: First-recurrence primary endpoint versus other events/periods/subgroup hierarchy
Conditions for verification: Relevant originals and analysis scope for First-recurrence primary endpoint versus other events/periods/subgroup hierarchy should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing First-recurrence primary endpoint versus other events/periods/subgroup hierarchy to connect materials needed for the selected question with available materials.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N19 · Concurrent treatment and recurrence-risk management

Required materials and conditions: Concurrent medications/conditions/lifestyle management and contact by arm
Conditions for verification: Relevant originals and analysis scope for Concurrent medications/conditions/lifestyle management and contact by arm should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Concurrent medications/conditions/lifestyle management and contact by arm to connect materials needed for the selected question with available 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

N20 · PATCH II companion report and directness

Required materials and conditions: Separate-cohort results versus PATCH I specifications
Conditions for verification: Relevant originals and analysis scope for Separate-cohort results versus PATCH I specifications should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Separate-cohort results versus PATCH I specifications to connect materials needed for the selected question with available materials.
Referenced methods: M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

N21 · Two estimates, nonsignificance and conflict scope

Required materials and conditions: PATCH II CI and the original verdict’s relationship interpretation
Conditions for verification: Relevant originals and analysis scope for PATCH II CI and the original verdict’s relationship interpretation should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing PATCH II CI and the original verdict’s relationship interpretation to connect materials needed for the selected question with available materials.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N22 · Reports, cohorts, network and independence

Required materials and conditions: PATCH I/II separate cohorts versus the same network
Conditions for verification: Relevant originals and analysis scope for PATCH I/II separate cohorts versus the same network should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing PATCH I/II separate cohorts versus the same network to connect materials needed for the selected question with available materials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N23 · Action Medical Research funding

Required materials and conditions: Nonprofit funding versus support roles/other relationships
Conditions for verification: Relevant originals and analysis scope for Nonprofit funding versus support roles/other relationships should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Nonprofit funding versus support roles/other relationships to connect materials needed for the selected question with available 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.

N24 · Nottingham sponsorship and pharmaceutical support

Required materials and conditions: Research sponsor and verification of cash/product/analysis support
Conditions for verification: Relevant originals and analysis scope for Research sponsor and verification of cash/product/analysis support should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Research sponsor and verification of cash/product/analysis support to connect materials needed for the selected question with available 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 · Adverse-event reporters and P

Required materials and conditions: People versus event counts/denominators and nonsignificance versus safety
Conditions for verification: Relevant originals and analysis scope for People versus event counts/denominators and nonsignificance versus safety should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
Why this condition is needed: An application item distinguishing People versus event counts/denominators and nonsignificance versus safety to connect materials needed for the selected question with available materials.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application

N26 · Allergy, gastrointestinal and resistance gaps

Required materials and conditions: Parent caution wording versus actual harm/resistance measurement
Conditions for verification: Relevant originals and analysis scope for Parent caution wording versus actual harm/resistance measurement should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
Why this condition is needed: An application item distinguishing Parent caution wording versus actual harm/resistance measurement to connect materials needed for the selected question with available materials.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M19 §19.1.2–19.2.4; CHAMGAP adaptation

N27 · Other drugs/populations and persistent application

Required materials and conditions: Original recurrence risk, drug/route/duration versus long-term generalization
Conditions for verification: Relevant originals and analysis scope for Original recurrence risk, drug/route/duration versus long-term generalization should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Original recurrence risk, drug/route/duration versus long-term generalization to connect materials needed for the selected question with available materials.
Referenced methods: M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

N28 · Parent/subclaim, bilingual text and history

Required materials and conditions: Separate original score/axes, evidence date, corrections and verification descriptions
Conditions for verification: Relevant originals and analysis scope for Separate original score/axes, evidence date, corrections and verification descriptions should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Separate original score/axes, evidence date, corrections and verification descriptions to connect materials needed for the selected question with available 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: Reading preserved summaries versus external papers/two registrations/plans
Conditions for verification: Relevant originals and analysis scope for Reading preserved summaries versus external papers/two registrations/plans should be available, with unverified items distinguished. Preserved wording is linked 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: An application item distinguishing Reading preserved summaries versus external papers/two registrations/plans to connect materials needed for the selected question with available 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 first recurrence during treatment and original grade

Current findings: Selected subclaim: reduced first recurrence during 12 months, grade B, with the original 22% versus 37%/NNT 5 note. Subclaim score/status/axes are absent; parent B with 76 points does not fill the subclaim score.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence. Existing content review remains incomplete.
Reason for missing information: Subclaim score/status/axes are absent; distinguish protection after stopping from first recurrence.
Required materials and conditions: Original wording/grade/note versus parent values and post-treatment results
Materials to obtain first: Original selected-subclaim/parent records and user correction comments
Further research: Proposed follow-up comparative research specifying first-recurrence endpoints by period; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original wording/grade/note versus parent values and post-treatment results should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original wording/grade/note versus parent values and post-treatment results to connect materials needed for the selected question with available 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 · Recurrence risk, eligibility and population

Current findings: Original PATCH I population: adults with at least two leg-cellulitis episodes in the previous three years. Do not extend to prevention after a first episode or other sites/populations.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified. Existing content review remains incomplete.
Reason for missing information: Detailed eligibility, baseline conditions/recurrence frequency, diagnosis/exclusions, recruitment and arm balance remain unverified.
Required materials and conditions: Recent recurrence, age/eligibility, baseline risk and applicability
Materials to obtain first: Eligibility/recruitment and baseline risk/characteristic tables
Further research: Proposed follow-up research specifying recurrence risk and population scope; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Recent recurrence, age/eligibility, baseline risk and applicability should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Recent recurrence, age/eligibility, baseline risk and applicability to connect materials needed for the selected question with available 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 · Penicillin V study exposure

Current findings: Original study exposure was penicillin V 250 mg twice daily for 12 months. Preserve study exposure only; do not convert it to intake/prevention/cellulitis-management instructions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified. Existing content review remains incomplete.
Reason for missing information: Study product/formulation, manufacture/quality, actual exposure and correspondence to other antibiotics/doses/routes remain unverified.
Required materials and conditions: Original antibiotic, dose/frequency/duration and formulation identity
Materials to obtain first: Study-drug ingredients/formulation, manufacture and exposure data
Further research: Proposed follow-up research separating drug/duration from applicability; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original antibiotic, dose/frequency/duration and formulation identity should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original antibiotic, dose/frequency/duration and formulation identity to connect materials needed for the selected question with available 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 · Placebo and comparison specifications

Current findings: S01 was a multicentre double-blind randomized placebo-controlled trial. The placebo name does not verify matching of all composition/contact/concurrent management.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified. Existing content review remains incomplete.
Reason for missing information: Placebo ingredients/appearance, supply, contact/instructions, concurrent treatment and distinguishability remain unverified.
Required materials and conditions: Actual placebo composition/sensory features, contact and concurrent treatment matching
Materials to obtain first: Placebo/contact and concurrent-exposure/masking materials
Further research: Proposed follow-up trial specifying actual comparison conditions; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Actual placebo composition/sensory features, contact and concurrent treatment matching should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Actual placebo composition/sensory features, contact and concurrent treatment matching to connect materials needed for the selected question with available 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 testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01

N05 · Central pharmacy and allocation concealment

Current findings: The original records central-pharmacy dispensing as allocation-concealment evidence. This is not current verification of original text/allocation records or certification of the whole randomization process.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread. Existing content review remains incomplete.
Reason for missing information: Sequence generation, concealment/implementation, exceptions, baseline balance and original protocol remain unread.
Required materials and conditions: Original allocation/drug-supply descriptions versus actual original-text verification
Materials to obtain first: Original allocation/drug supply, baseline and protocol materials
Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original allocation/drug-supply descriptions versus actual original-text verification should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original allocation/drug-supply descriptions versus actual original-text verification to connect materials needed for the selected question with available 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; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed

Related sources S01

N06 · Double masking and assessors

Current findings: Original double-blind design and clinician-confirmed recurrence are preserved. Maintained masking of every role or exclusion of expectation effects are not treated as newly verified.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread. Existing content review remains incomplete.
Reason for missing information: Adjudicator/analyst roles, maintained masking/unmasking and assessment procedures remain unread.
Required materials and conditions: Actual masking/maintenance of participants, clinicians and analysts
Materials to obtain first: Original masking roles and adjudication/assessment materials
Further research: Proposed follow-up research specifying endpoint adjudication and masking; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Actual masking/maintenance of participants, clinicians and analysts should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Actual masking/maintenance of participants, clinicians and analysts to connect materials needed for the selected question with available 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; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP

Related sources S01

N07 · Clinician-confirmed recurrence definition

Current findings: Original recurrence was clinician-confirmed, not based only on participant reports. It is not treated as the same endpoint as suspected self-reported symptoms, other infections/sites or all repeated events.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified. Existing content review remains incomplete.
Reason for missing information: Diagnostic/confirmation criteria, assessment timing/committee, same/other leg and event overlap/adjudication details remain unverified.
Required materials and conditions: Reporting, diagnostic confirmation, first/all recurrences and site definitions
Materials to obtain first: Recurrence definitions, clinician confirmation and event adjudication data
Further research: Proposed research specifying first clinical recurrence definitions/adjudication; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Reporting, diagnostic confirmation, first/all recurrences and site definitions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Reporting, diagnostic confirmation, first/all recurrences and site definitions to connect materials needed for the selected question with available 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 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

Related sources S01

N08 · Time to first recurrence

Current findings: The primary endpoint was time to first clinician-confirmed recurrence. HR, proportions of people within a period, all recurrences and total observation time are not combined as the same estimand.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified. Existing content review remains incomplete.
Reason for missing information: Time origin, events/censoring, repeated recurrence, at-risk population/analysis windows and estimation models remain unverified.
Required materials and conditions: Prespecified primary time endpoint versus proportions/total events
Materials to obtain first: Time/censoring, first-event and model/at-risk population data
Further research: Proposed follow-up research distinguishing time endpoints from period proportions/repeated events; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Prespecified primary time endpoint versus proportions/total events should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Prespecified primary time endpoint versus proportions/total events to connect materials needed for the selected question with available 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 our own design; M08 §8.2.2, M15 §15.3.1; our own application

Related sources S01

N09 · During treatment: 30/136 and 51/138

Current findings: First recurrence during treatment was 30/136 (22%) versus 51/138 (37%). Distinguish recurrent participants, all repeated events, observation time and randomized populations; no new proportions/event totals are calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified. Existing content review remains incomplete.
Reason for missing information: Visit/observation/risk denominators, first-recurrence confirmation/censoring and individual recurrence times remain unverified.
Required materials and conditions: Original first-recurrence people/denominators and 22%/37%
Materials to obtain first: Original recurrence/at-risk populations and observations/events
Further research: Proposed research reporting people/event/time denominators separately; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original first-recurrence people/denominators and 22%/37% should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original first-recurrence people/denominators and 22%/37% to connect materials needed for the selected question with available 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

N10 · HR 0.55·CI·P

Current findings: Original HR 0.55 (95% CI 0.35–0.86), P=.01 is preserved. No new RR/OR, HR, CI or individual risks are calculated from 22%/37%.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread. Existing content review remains incomplete.
Reason for missing information: Exact models/adjustment, time assumptions, censoring/at-risk populations and original sensitivity results remain unread.
Required materials and conditions: Original first-recurrence time effect/CI versus proportions
Materials to obtain first: Time models, adjustment/CI and assumption/sensitivity data
Further research: Proposed follow-up research reporting time effects and uncertainty; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original first-recurrence time effect/CI versus proportions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original first-recurrence time effect/CI versus proportions to connect materials needed for the selected question with available 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; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap's own design

Related sources S01

N11 · Original absolute difference and NNT

Current findings: Original absolute difference −15 percentage points and NNT 5 (4–9) are preserved unchanged. They are not recalculated/corrected through new arithmetic or transferred to other periods/populations/drugs.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Original estimation/period/model, CI methods and risk-reference details for each number remain unread. Existing content review remains incomplete.
Reason for missing information: Original estimation/period/model, CI methods and risk-reference details for each number remain unread.
Required materials and conditions: Original absolute difference/NNT and period/analysis/estimation specifications
Materials to obtain first: Original absolute difference/NNT and period/method/CI materials
Further research: Proposed follow-up research separating absolute/time effects and calculation specifications; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original absolute difference/NNT and period/analysis/estimation specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original absolute difference/NNT and period/analysis/estimation specifications to connect materials needed for the selected question with available 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; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed

Related sources S01

N12 · 27% after stopping and persistence

Current findings: Original off-treatment follow-up had 27% recurrence in both arms and no persistent protection. This is not new proof of the during-treatment HR/proportions, permanent prevention or exactly zero effect/equivalence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified. Existing content review remains incomplete.
Reason for missing information: Post-treatment follow-up duration, denominators/event counts, effects/CI, re-exposure and censoring remain unverified.
Required materials and conditions: During-treatment versus post-treatment results, denominators/estimation
Materials to obtain first: Post-treatment results, follow-up/denominators and effects/CI
Further research: Proposed follow-up research distinguishing persistence during/after treatment; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for During-treatment versus post-treatment results, denominators/estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing During-treatment versus post-treatment results, denominators/estimation to connect materials needed for the selected question with available 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 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; 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/effect-modification details are internally designed

Related sources S01

N13 · 12 months, exposure, adherence/discontinuation

Current findings: Original 12-month study exposure is preserved. It does not establish full-period complete intake/actual exposure in everyone or continued protection afterwards.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified. Existing content review remains incomplete.
Reason for missing information: Actual intake/adherence, temporary stopping, drug changes and period-specific observation/contact remain unverified.
Required materials and conditions: Planned treatment duration versus actual exposure/stopping/changes
Materials to obtain first: Exposure/adherence, discontinuation/changes and period records
Further research: Proposed research distinguishing planned/actual exposure and period-specific effects; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Planned treatment duration versus actual exposure/stopping/changes should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Planned treatment duration versus actual exposure/stopping/changes to connect materials needed for the selected question with available 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; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

Related sources S01

N14 · 274 participants, 28 hospitals and 136/138

Current findings: PATCH I assigned 274 participants at 28 hospitals, 136/138. Hospitals, arms, time, events and citations are not added as new independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified. Existing content review remains incomplete.
Reason for missing information: Effective/at-risk denominators by endpoint/time, hospital-specific/analysis inclusion and completion/follow-up remain unverified.
Required materials and conditions: Recruitment/randomization denominators versus endpoint observation/at-risk populations
Materials to obtain first: Flow, hospital/arm-specific and endpoint/time denominators
Further research: Proposed research distinguishing recruitment/observation/risk denominators; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Recruitment/randomization denominators versus endpoint observation/at-risk populations should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Recruitment/randomization denominators versus endpoint observation/at-risk populations to connect materials needed for the selected question with available 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 custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

Related sources S01

N15 · ITT principle and actual analysis populations

Current findings: The original records historical wording that all analyses followed ITT. This does not newly verify complete observation or detailed denominators/models for every result.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread. Existing content review remains incomplete.
Reason for missing information: Analysis-population definitions, inclusion/exclusion, discontinuation/missingness, censoring and PPS/sensitivity originals remain unread.
Required materials and conditions: Original ITT versus inclusion/exclusion, estimation populations and censoring specifications
Materials to obtain first: Original ITT, censoring/inclusion and sensitivity materials
Further research: Proposed research separately disclosing assignment/exposure/observation analyses; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original ITT versus inclusion/exclusion, estimation populations and censoring specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original ITT versus inclusion/exclusion, estimation populations and censoring specifications to connect materials needed for the selected question with available 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; internal application; M04 §4.5–4.6 collection/selection principles; access/reading separation and hyperlink specifications are internally designed

Related sources S01

N16 · Missingness, withdrawals and observation time

Current findings: Original randomized denominators and ITT descriptions are preserved. No assumption of zero missingness/withdrawal or no effects from infection reporting/confirmation/follow-up differences is filled in.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required current information remains unverified in the preserved summary. Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified. Existing content review remains incomplete.
Reason for missing information: Deviations/missingness by arm, confirmation delays, observation time/censoring and missing-data handling/sensitivity remain unverified.
Required materials and conditions: Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation
Materials to obtain first: Flow, observation time/censoring and missingness/sensitivity data
Further research: Proposed research reporting follow-up and its effects on first-event estimation; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Deviations/unobserved data, reasons by arm and effects on time/first-recurrence estimation to connect materials needed for the selected question with available 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 · Two registrations and prespecified plans

Current findings: Original evidence registration identifier: ISRCTN34716921 · EudraCT 2006-000381-36. Pre-recruitment registration and matching first-recurrence endpoint descriptions are preserved; full registration/plans remain unread.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread. Existing content review remains incomplete.
Reason for missing information: Registration dates/amendments, protocol/SAP and full period/hierarchy/analysis specifications remain unread.
Required materials and conditions: ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions
Materials to obtain first: Both registration histories, protocol and SAP
Further research: Proposed research linking and disclosing prespecified plans and actual period-specific analyses; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing ISRCTN/EudraCT identifiers and pre-recruitment/matching-endpoint descriptions to connect materials needed for the selected question with available 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

N18 · Primary/secondary outcomes, periods and multiple tests

Current findings: Original primary endpoint was time to first recurrence. Post-treatment, all-recurrence, safety and other analyses are not upgraded to new primary endpoints or independent confirmation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified. Existing content review remains incomplete.
Reason for missing information: All secondary/period/subgroup analyses, multiplicity, prespecified order and amendment history remain unverified.
Required materials and conditions: First-recurrence primary endpoint versus other events/periods/subgroup hierarchy
Materials to obtain first: SAP, all results and endpoint/period hierarchies
Further research: Proposed research distinguishing primary from period-specific/secondary results; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for First-recurrence primary endpoint versus other events/periods/subgroup hierarchy should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing First-recurrence primary endpoint versus other events/periods/subgroup hierarchy to connect materials needed for the selected question with available 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; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources S01

N19 · Concurrent treatment and recurrence-risk management

Current findings: This was a placebo-controlled trial in adults at risk of recurrent leg cellulitis. The original summary is not extended to confirm identical concurrent treatment/management or no influence on effects.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Required current information remains unverified in the preserved summary. Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified. Existing content review remains incomplete.
Reason for missing information: Concurrent drugs/conditions, recurrence management, other antibiotic exposures, contact and their analyses remain unverified.
Required materials and conditions: Concurrent medications/conditions/lifestyle management and contact by arm
Materials to obtain first: Concurrent exposure/management, contact and analysis materials
Further research: Proposed follow-up research distinguishing concurrent management from study-drug effects; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Concurrent medications/conditions/lifestyle management and contact by arm should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Concurrent medications/conditions/lifestyle management and contact by arm to connect materials needed for the selected question with available 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

Related sources S01

N20 · PATCH II companion report and directness

Current findings: Original S02 PATCH II: 123 participants, HR 0.53 (0.26–1.07), P=.08, individually nonsignificant. The same 12-month/recurrence-risk/exposure specifications are not automatically filled in.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified. Existing content review remains incomplete.
Reason for missing information: PATCH II eligibility, exposure/duration, denominators/events, registration/hierarchy and exact analysis correspondence remain unverified.
Required materials and conditions: Separate-cohort results versus PATCH I specifications
Materials to obtain first: PATCH II original text/plans and correspondence between both trials
Further research: Proposed follow-up research specifying separate cohorts/specifications; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Separate-cohort results versus PATCH I specifications should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Separate-cohort results versus PATCH I specifications to connect materials needed for the selected question with available 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 distinguishes studies from reports; cohort/outcome links are an internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

Related sources S02

N21 · Two estimates, nonsignificance and conflict scope

Current findings: Original interpretation that PATCH II’s CI includes PATCH I’s 0.55 and is not statistically conflicting is preserved. No new pooled effects, CI, significance or equivalence/conflict verdicts are calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified. Existing content review remains incomplete.
Reason for missing information: Matching analysis/population specifications, between-study comparison/pooling models and full independence remain unverified.
Required materials and conditions: PATCH II CI and the original verdict’s relationship interpretation
Materials to obtain first: Both results/specifications and comparison/pooling methods
Further research: Proposed research distinguishing matching specifications from result relationships; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for PATCH II CI and the original verdict’s relationship interpretation should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing PATCH II CI and the original verdict’s relationship interpretation to connect materials needed for the selected question with available 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 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M15 §15.3.1–15.3.3; internal application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources S01 S02

N22 · Reports, cohorts, network and independence

Current findings: PATCH I/II were separate cohorts in the same network, so the original verdict did not count independent replication. 274/123, hospitals, arms, time points, citations/related sheets are not added as new participant/trial totals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. No new unique-clinical-trial/participant or independent-replication totals are established. Existing content review remains incomplete.
Reason for missing information: No new unique-clinical-trial/participant or independent-replication totals are established.
Required materials and conditions: PATCH I/II separate cohorts versus the same network
Materials to obtain first: Cohort/network and report/registration relationships, plus 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: Relevant originals and analysis scope for PATCH I/II separate cohorts versus the same network should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing PATCH I/II separate cohorts versus the same network to connect materials needed for the selected question with available 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: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02

N23 · Action Medical Research funding

Current findings: Original PATCH I funding was nonprofit support from Action Medical Research. This does not become new certification of no support/COI or independence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Funder roles, contracts, other support and original data/publication authority remain unread. Existing content review remains incomplete.
Reason for missing information: Funder roles, contracts, other support and original data/publication authority remain unread.
Required materials and conditions: Nonprofit funding versus support roles/other relationships
Materials to obtain first: Original funding, support/authority and COI materials
Further research: Proposed follow-up research disclosing support roles; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Nonprofit funding versus support roles/other relationships should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Nonprofit funding versus support roles/other relationships to connect materials needed for the selected question with available 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.

Related sources S01

N24 · Nottingham sponsorship and pharmaceutical support

Current findings: The original records University of Nottingham as sponsor and pharmaceutical cash/product/analysis support as not identified. Unverified does not mean actually absent or no author relationships.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread. Existing content review remains incomplete.
Reason for missing information: Sponsor roles, in-kind/product supply, analysis, author/writing/publication support and original COI remain unread.
Required materials and conditions: Research sponsor and verification of cash/product/analysis support
Materials to obtain first: Sponsor, cash/product/analysis and author/writing support disclosures
Further research: Proposed research separately disclosing research roles and item-specific support; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Research sponsor and verification of cash/product/analysis support should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Research sponsor and verification of cash/product/analysis support to connect materials needed for the selected question with available 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

Related sources S01

N25 · Adverse-event reporters and P

Current findings: Original adverse-event reporters numbered 37 versus 48, P=.50. Person counts are not converted to total events, related reactions, no harm or equivalent safety.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified. Existing content review remains incomplete.
Reason for missing information: Arm-specific safety-analysis denominators, event types/counts, causality/severity, collection/adjudication and CI remain unverified.
Required materials and conditions: People versus event counts/denominators and nonsignificance versus safety
Materials to obtain first: Adverse-event tables, denominators/collection and causality/severity data
Further research: Proposed harm research distinguishing people/events and uncertainty; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for People versus event counts/denominators and nonsignificance versus safety should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing People versus event counts/denominators and nonsignificance versus safety to connect materials needed for the selected question with available materials.
Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
Referenced methods: M19 §19.1.2–19.2.4; detailed discrimination is internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application

Related sources S01

N26 · Allergy, gastrointestinal and resistance gaps

Current findings: Original parent caution and allergy/gastrointestinal/antimicrobial-resistance burdens are preserved. Warnings are not made into actual event rates/resistance measurements or intake/prevention instructions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified. Existing content review remains incomplete.
Reason for missing information: Each harm’s measurement/frequencies/denominators, microbiology/resistance and long-term/vulnerable-population follow-up remain unverified.
Required materials and conditions: Parent caution wording versus actual harm/resistance measurement
Materials to obtain first: Harm-specific collection and resistance/long-term follow-up data
Further research: Proposed follow-up research specifying harm/resistance collection scope; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Parent caution wording versus actual harm/resistance measurement should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Parent caution wording versus actual harm/resistance measurement to connect materials needed for the selected question with available materials.
Application exceptions: Supplements safety-information gaps for the selected subclaim. First-recurrence/post-treatment results or parent safety wording do not yield safety verdicts, harm incidence or new use instructions.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP; M19 §19.1.2–19.2.4; CHAMGAP adaptation; CHAMGAP’s interpretation boundary, informed by M19 principles; no official causality tool was run; M19 §19.1.2–19.2.4; CHAMGAP adaptation

Related sources S01

N27 · Other drugs/populations and persistent application

Current findings: The original excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and permanent protection. Preserve research results only; no management/treatment-replacement instructions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified. Existing content review remains incomplete.
Reason for missing information: Direct comparisons for other conditions, exposure/persistence beyond 12 months and long-term harms remain unverified.
Required materials and conditions: Original recurrence risk, drug/route/duration versus long-term generalization
Materials to obtain first: Direct population/drug/duration-specific trials and follow-up data
Further research: Proposed follow-up research distinguishing specifications/period from persistent protection; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Original recurrence risk, drug/route/duration versus long-term generalization should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Original recurrence risk, drug/route/duration versus long-term generalization to connect materials needed for the selected question with available 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/duration/effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed

Related sources S01

N28 · Parent/subclaim, bilingual text and history

Current findings: Parent B with 76 points, B/H/R1/I2/E+/B0, unrecorded precision, true large-hard-endpoint-RCT and two false indicators, empty grade-override reasons and subclaim B/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and cross-checking are not completed clinical review now or subclaim scores.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification. Existing content review remains incomplete.
Reason for missing information: Missing subclaim score/status/axes are not filled with parent values. No new efficacy/method certification.
Required materials and conditions: Separate original score/axes, evidence date, corrections and verification descriptions
Materials to obtain first: Original corrections, versions and user correction comments
Further research: Proposed research distinguishing original values/history from new-update scope; no new investigation, calculation or trial was performed in this 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: Relevant originals and analysis scope for Separate original score/axes, evidence date, corrections and verification descriptions should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Separate original score/axes, evidence date, corrections and verification descriptions to connect materials needed for the selected question with available 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

Related sources S01 S02

N29 · Actual summary reading and material links

Current findings: The entire preserved summary/citations were used for production and PATCH I/II links retained. Original papers/registration/protocol/SAP/support/COI remain unread, access unattempted and external links untested.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information is recorded; detailed originals remain unread and existing content review incomplete. External original content, exact denominators/duration/models and accessibility remain unverified. Existing content review remains incomplete.
Reason for missing information: External original content, exact denominators/duration/models and accessibility remain unverified.
Required materials and conditions: Reading preserved summaries versus external papers/two registrations/plans
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: Relevant originals and analysis scope for Reading preserved summaries versus external papers/two registrations/plans should be available, with unverified items distinguished. Preserved wording is linked here; existing content review remains incomplete.
Why this condition is needed: An application item distinguishing Reading preserved summaries versus external papers/two registrations/plans to connect materials needed for the selected question with available 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

Related sources S01 S02