Penicillin V × Protection after stopping — Time intervals, 27% recurrence and gaps

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 conditionWhich original post-treatment protection claim is selected?Required	The selected claim concerns persistent protection after stopping; its original subclaim grade is D and the note reports 27% in both arms during off-treatment follow-up. Absent subclaim score/status/axes are distinguished from parent B with 76 points and its axes. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Selected wording/subclaim grade and parent effects during treatment	Materials needed: Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich recurrence-history population was studied?Required	The original intervention population comprised adults with at least two recurrent leg-cellulitis episodes in the previous three years. PATCH I involved 28 hospitals and 274 participants. Do not extend to prevention after a first episode, other sites/causes or other antibiotics. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Adults with at least two leg-cellulitis episodes in the previous three years	Materials needed: Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations. Only material-request/research needs are recorded; no search/research was performed in this production.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre study exposure and the post-treatment interval separated?Required	Original study exposure was penicillin V 250 mg twice daily for 12 months. Prevention during treatment and off-treatment follow-up are different intervals. No new cumulative dose, intake, extension/discontinuation or antibiotic-selection guidance. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Penicillin V 250 mg twice daily for 12 months	Materials needed: Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs the scope of actual comparison/concurrent care known?Required	The original design was multicentre, double-blind and randomized with placebo control. Actual concurrent treatment/antibiotics, care after recurrence, exposure changes and adherence after stopping remain unverified. The during-treatment comparator is not represented as identical active exposure afterwards. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Placebo comparison and post-treatment care	Materials needed: Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures. Only material-request/research needs are recorded; no search/research was performed in this production.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat is the direct post-treatment protection result?Required	The selected note and bilingual text record recurrence in 27% of both arms after stopping and protection did not persist. Preserve this original result and subclaim grade D; do not apply during-treatment HR/NNT afterwards. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	27% in both arms during off-treatment follow-up	Materials needed: Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%. Only material-request/research needs are recorded; no search/research was performed in this production.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich interval do the during-treatment numbers concern?Required	First recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (CI 0.35–0.86), P=.01, original absolute difference −15 percentage points and NNT 5 (4–9). These concern comparison during 12 months of treatment, not protection after stopping or permanent effects. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	30/136 versus 51/138, HR/CI/P and NNT	Materials needed: Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
7	Unverified	Full text not readStored summary read	N07 · Evidence conditionAre observation starts and lengths during/after treatment verified?Required	The original separates 12 months during treatment from the off-treatment interval; exact post-treatment length, individual observation/end, follow-up loss/re-exposure are not established by the summary. No new total follow-up years/person-time. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Time intervals and the post-treatment follow-up-duration gap	Materials needed: Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks. Only material-request/research needs are recorded; no search/research was performed in this production.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionWhat is the risk population underlying post-treatment 27%?Required	Original randomization comprised 274 participants, 136/138, and the original post-treatment proportion is 27% in both arms. Arm-specific post-treatment observation/analysis, risk sets after recurrence/among nonrecurring participants, person-time/numerators remain unverified. Do not calculate new post-treatment events from randomized 136/138. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	274 randomized participants and interval-specific denominators	Materials needed: Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition. Only material-request/research needs are recorded; no search/research was performed in this production.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre first recurrence and all repeated events distinguished?Required	The original primary endpoint was time to first clinician-confirmed leg-cellulitis recurrence. Exact post-treatment 27% event aggregation, first/repeated/same-leg and time details remain unverified. Do not repurpose as all repeated events or other sites. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Time to first clinician-confirmed leg recurrence	Materials needed: Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants. Only material-request/research needs are recorded; no search/research was performed in this production.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre clinician confirmation and reporting/adjudication details separated?Required	The original study-product description explains that recurrence was clinician-confirmed rather than solely participant-reported. Interval-specific reporting/confirmation, diagnostic criteria, missingness/adjudication/masking details remain unverified. Do not invent post-treatment confirmation/follow-up methods. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Original confirmation procedures and post-treatment measurement gaps	Materials needed: Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre ITT and actual adherence/follow-up/withdrawal distinguished?Required	The original study description records ITT principles, central-pharmacy dispensing and double-blinding. Actual adherence/discontinuation, interval-specific completion/withdrawal, missingness/censoring are not established by the summary. ITT is not converted into universal completion/observation across all intervals. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Analysis as randomized and actual observed denominators	Materials needed: Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre equal post-treatment proportions newly certified as equivalence/zero effect?Required	Preserve the original verdict of 27% in both arms and loss of persistent protection. Exact post-treatment effects/CI, equivalence/noninferiority/clinical thresholds are absent here; do not newly certify exclusion of all benefit or exactly zero effect. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Original 27%/lost protection and unverified CI	Materials needed: Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment. Only material-request/research needs are recorded; no search/research was performed in this production.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionDoes PATCH II concern the same trial/interval?Required	The original counterview records PATCH II with 123 participants, HR 0.53 (CI 0.26–1.07), P=.08, individually nonsignificant. Preserve the original description that its interval includes PATCH I’s 0.55 estimate and does not statistically conflict, and that it was a separate cohort in the same network. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Separate 123-person cohort with HR 0.53	Materials needed: Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it. Only material-request/research needs are recorded; no search/research was performed in this production.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat is the hierarchy of during-treatment success and post-treatment analysis?Required	Preserve the original primary time-to-first-recurrence and matching pre-recruitment registration descriptions. Prespecification/secondary hierarchy, all testing, amendments and model details for post-treatment analysis were not established through original-plan reading now. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	First recurrence as primary and interval-specific plans	Materials needed: Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory. Only material-request/research needs are recorded; no search/research was performed in this production.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionIs permanent protection extended to a single course/other antibiotics?Required	The original advertising interpretation excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and continuing protection after one course. During-treatment signals are not converted to long-term-management/treatment-replacement instructions. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Applicability boundaries of study population/drug/duration	Materials needed: Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance. Only material-request/research needs are recorded; no search/research was performed in this production.
16	Partly verified	Full text not readStored summary read	N16 · Harm-information gaps supplementing the efficacy tableAre adverse-event reporter counts and event counts distinguished?Supplementary	The original safety description records 37 versus 48 adverse-event reporters, P=.50. People are distinguished from events/severity/types and interval/actual-exposure denominators, which remain unverified. P=.50 is not converted into no harm/equivalence. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	37 versus 48 people, P=.50	Materials needed: Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
17	Unverified	Full text not readStored summary read	N17 · Harm-information gaps supplementing the efficacy tableAre allergy, gastrointestinal and resistance harm boundaries retained?Supplementary	Original counterview/safety descriptions retain allergy, gastrointestinal adverse effects and antimicrobial-resistance burdens. Event counts/causes/duration by type and post-treatment harm/resistance data remain unverified. No new certification of overall study safety/absence of resistance. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Long-term antibiotic burdens and interval-specific data	Materials needed: Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre during-treatment signals transferred to post-treatment mechanism/protection?Required	The original crux limits reduced recurrence to treatment and reports protection disappearing after stopping. During-treatment HR/NNT or mechanistic plausibility do not newly prove permanent/post-treatment protection. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Effect timing and direct persistence data	Materials needed: Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat materials were actually read or acquired?Required	The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citations/URLs do not establish external reading here. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Preserved summary and external original materials	Materials needed: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre historical registration/plans distinguished from current reading?Required	Original PATCH I evidence records ISRCTN34716921 and EudraCT 2006-000381-36; original bilingual text describes registration before recruitment and primary-endpoint matching. No current comparison of official registration URLs/versions/actual public dates. PATCH II registration information is unidentified here. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Original registration identifier and detailed comparison	Materials needed: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification. Only the material request/research need is recorded; no lookup or research is performed now.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionHave protocol/SAP and analysis/missing-data plans been acquired?Required	Original primary-outcome/ITT/registration descriptions and historical cross-checking are preserved. Actual protocol/SAP versions/timing, interval/endpoint-specific models/censoring/missingness and hierarchy/multiplicity were not newly read. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Separate materials for prespecified plans/changes	Materials needed: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent. Only the material request/research need is recorded; no lookup or research is performed now.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre sponsorship, funding, products, authors and research involvement separated?Required	PATCH I had nonprofit Action Medical Research funding and University of Nottingham sponsorship; the original limitation is that pharmaceutical cash/product/analysis support was not identified. Employee authors/design/writing/publication, individual roles and PATCH II funding details remain separately unverified. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Four company-involvement items and nonprofit/public/academic support	Materials needed: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence. Only the material request/research need is recorded; no lookup or research is performed now.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre results by interval/endpoint distinguished from information gaps?Required	Distinguish positive first recurrence during treatment from post-treatment 27% in both arms/original ineffective persistent protection and post-treatment effect/denominator gaps. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Direct results, unverified details and access status	Materials needed: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence. Only the material request/research need is recorded; no lookup or research is performed now.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre reports, trials, people, intervals, events and related sheets separated?Required	Parent 2973 and its selected s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve only the original separate-cohort/same-network PATCH II relationship; no new independent-replication count. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. Linked-report counts are not certified unique trial/participant totals. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Linked records versus unique trials/participants	Materials needed: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre the original single trial and separate independent replication distinguished?Supplementary	Preserve parent R1/I2. Intervals/endpoints/related sheets in the same participants are not certified as new independent replication; PATCH II same-network relationships and manufacturer support remain separate. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Parent R1, independence axis and direct replication	Materials needed: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict. Only the material request/research need is recorded; no lookup or research is performed now.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre the subclaim grade and parent score/axes preserved?Required	Preserve selected grade/note and bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points and safety/axes are parent context. They do not supply selected scores or create new grades/RoB 2/GRADE certification. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Selected D, missing score/status/axes and parent context	Materials needed: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history. Only the material request/research need is recorded; no lookup or research is performed now.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre both languages, citations and absent fields preserved?Required	Preserve parent Korean/English citations/descriptions, evidence/citation lists, axes and selected-subclaim records in the complete summary. Separate classification information in both languages is absent; originals are not filled with new fields. No external English full-text comparison. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Both original languages and absent separate classification information	Materials needed: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records. Only the material request/research need is recorded; no lookup or research is performed now.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre source dates/corrections/history separated from production dates?Required	Original evidence date 2026-08-26, empty corrections/deliberation and grade-decision cross-checking are preserved. Historical citation/registration descriptions differ from current production, condition freezing/application and completed content review. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Original 2026-08-26 and new conditions/application	Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhat direct materials would fill the selected gaps?Supplementary	Post-treatment persistent protection requires the risk population/observation and direct effects/CI for that interval; during-treatment signals do not substitute. R01 R02	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Direct interval/endpoint effects, denominators/CI and follow-up	Materials needed: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research. Only the material request/research need is recorded; no lookup or research is performed now.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre applicability records separated from content review and instructions?Supplementary	These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history. R01	Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.	Applicability records, existing candidate history and content review	Materials needed: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.

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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Adults with at least two leg-cellulitis episodes in the previous three years; PATCH I: 274 participants, 136/138, 28 hospitals. Post-treatment risk populations/follow-up denominators remain unverified.
Ingredient, formulation and route: Distinguish penicillin V preventive study exposure from off-treatment follow-up after stopping.
Dose: Original study exposure: 250 mg twice daily for 12 months. No antibiotic-selection/intake/extension/discontinuation or treatment-replacement instructions.
Comparator: PATCH I placebo; actual post-treatment concurrent care/re-exposure in both arms and PATCH II comparator details remain unverified.
Measured outcome: Selected persistent protection after stopping and original 27% result in both arms, separated from during-treatment time to first clinician-confirmed recurrence/HR/NNT.
Duration: 12 months during treatment versus off-treatment follow-up; exact post-treatment duration/censoring/denominator details remain unverified.
Questions outside this scope: Transferring during-treatment effects to persistent protection after stopping or effects on other endpoints; Adding the same reports/people/arms/periods/events/endpoints, citations, related sheets as new independent trials or participants; Mixing randomized/ITT denominators, endpoint-specific observation/testing, person/time/event denominators and other cohorts; New effects/CI/invented quantities, equivalence/zero effects, reassessment/grades or independence certification from original numbers; Antibiotic/product-use, cellulitis-management/infection-prevention and 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.

R01 · Thomas KS, et al. Penicillin to prevent recurrent leg cellulitis. N Engl J Med. 2013;368:1695-1703. PMID: 23635049.

PubMed

Material type: Multicentre double-blind randomized placebo-controlled trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary: 30/136 (22%) versus 51/138 (37%); HR 0.55 (0.35–0.86), P=.01; NNT 5 (4–9)
Record level: Parent-endpoint summary from original evidence; during/post-treatment intervals and boundaries of other endpoints are distinguished in checklist conditions/roles.
Study overlap and independent replication: Separate PATCH I’s primary during-treatment interval from the selected direct post-treatment proportion; no mixing with other cohorts. Parent 2973 and its s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve the original separate-cohort/same-network PATCH II relationship without newly counting independent replication. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. These are provisional citation-based links, not certification of unique trials/participants or independence. PATCH II is a separate cohort in the same network, with HR 0.53/CI/P=.08 context; do not copy PATCH I post-treatment 27%, exposure/registration/funding into it. The shared original report/cohort and related-sheet relationships remain as described above, without new participant/trial totals or independence certification.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
External abstract	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
External full text	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
Registration material	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
Protocol/SAP	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.

R02 · UK Dermatology Clinical Trials Network. PATCH II. Br J Dermatol. 2012. PMID: 21910701.

PubMed

Material type: Separate PATCH II cohort; design/population/duration details remain unverified in the preserved summary.
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain 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: Original counterview’s individual PATCH II HR/CI/P and cohort relationships, separated from PATCH I results.
Study overlap and independent replication: Separate PATCH I’s primary during-treatment interval from the selected direct post-treatment proportion; no mixing with other cohorts. Parent 2973 and its s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve the original separate-cohort/same-network PATCH II relationship without newly counting independent replication. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. These are provisional citation-based links, not certification of unique trials/participants or independence. PATCH II is a separate cohort in the same network, with HR 0.53/CI/P=.08 context; do not copy PATCH I post-treatment 27%, exposure/registration/funding into it. The shared original report/cohort and related-sheet relationships remain as described above, without new participant/trial totals or independence certification.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
External abstract	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
External full text	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
Registration material	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.
Protocol/SAP	Original identifier/bibliography or required-material entry; public availability/access details remain unverified	Unread; access testing not performed	Not read	Only original PubMed URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met.

Report counts versus independent study counts

Separate PATCH I’s primary during-treatment interval from the selected direct post-treatment proportion; no mixing with other cohorts. Parent 2973 and its s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve the original separate-cohort/same-network PATCH II relationship without newly counting independent replication. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. These are provisional citation-based links, not certification of unique trials/participants or independence. PATCH II is a separate cohort in the same network, with HR 0.53/CI/P=.08 context; do not copy PATCH I post-treatment 27%, exposure/registration/funding into it. The shared original report/cohort and related-sheet relationships remain as described above, without new participant/trial totals or independence certification.

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 · Which original post-treatment protection claim is selected?

Required materials and conditions: Selected wording/subclaim grade and parent effects during treatment
Conditions for verification: Show original materials for selected wording/subclaim grade and parent effects during treatment together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect selected wording/subclaim grade and parent effects during treatment with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N02 · Which recurrence-history population was studied?

Required materials and conditions: Adults with at least two leg-cellulitis episodes in the previous three years
Conditions for verification: Show original materials for adults with at least two leg-cellulitis episodes in the previous three years together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect adults with at least two leg-cellulitis episodes in the previous three years with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N03 · Are study exposure and the post-treatment interval separated?

Required materials and conditions: Penicillin V 250 mg twice daily for 12 months
Conditions for verification: Show original materials for penicillin V 250 mg twice daily for 12 months together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect penicillin V 250 mg twice daily for 12 months with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N04 · Is the scope of actual comparison/concurrent care known?

Required materials and conditions: Placebo comparison and post-treatment care
Conditions for verification: Show original materials for placebo comparison and post-treatment care together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect placebo comparison and post-treatment care with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N05 · What is the direct post-treatment protection result?

Required materials and conditions: 27% in both arms during off-treatment follow-up
Conditions for verification: Show original materials for 27% in both arms during off-treatment follow-up together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 27% in both arms during off-treatment follow-up with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N06 · Which interval do the during-treatment numbers concern?

Required materials and conditions: 30/136 versus 51/138, HR/CI/P and NNT
Conditions for verification: Show original materials for 30/136 versus 51/138, HR/CI/P and NNT together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 30/136 versus 51/138, HR/CI/P and NNT with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N07 · Are observation starts and lengths during/after treatment verified?

Required materials and conditions: Time intervals and the post-treatment follow-up-duration gap
Conditions for verification: Show original materials for time intervals and the post-treatment follow-up-duration gap together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect time intervals and the post-treatment follow-up-duration gap with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N08 · What is the risk population underlying post-treatment 27%?

Required materials and conditions: 274 randomized participants and interval-specific denominators
Conditions for verification: Show original materials for 274 randomized participants and interval-specific denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 274 randomized participants and interval-specific denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N09 · Are first recurrence and all repeated events distinguished?

Required materials and conditions: Time to first clinician-confirmed leg recurrence
Conditions for verification: Show original materials for time to first clinician-confirmed leg recurrence together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect time to first clinician-confirmed leg recurrence with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N10 · Are clinician confirmation and reporting/adjudication details separated?

Required materials and conditions: Original confirmation procedures and post-treatment measurement gaps
Conditions for verification: Show original materials for original confirmation procedures and post-treatment measurement gaps together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original confirmation procedures and post-treatment measurement gaps with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N11 · Are ITT and actual adherence/follow-up/withdrawal distinguished?

Required materials and conditions: Analysis as randomized and actual observed denominators
Conditions for verification: Show original materials for analysis as randomized and actual observed denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect analysis as randomized and actual observed denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N12 · Are equal post-treatment proportions newly certified as equivalence/zero effect?

Required materials and conditions: Original 27%/lost protection and unverified CI
Conditions for verification: Show original materials for original 27%/lost protection and unverified CI together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original 27%/lost protection and unverified CI with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N13 · Does PATCH II concern the same trial/interval?

Required materials and conditions: Separate 123-person cohort with HR 0.53
Conditions for verification: Show original materials for separate 123-person cohort with HR 0.53 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect separate 123-person cohort with HR 0.53 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N14 · What is the hierarchy of during-treatment success and post-treatment analysis?

Required materials and conditions: First recurrence as primary and interval-specific plans
Conditions for verification: Show original materials for first recurrence as primary and interval-specific plans together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect first recurrence as primary and interval-specific plans with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N15 · Is permanent protection extended to a single course/other antibiotics?

Required materials and conditions: Applicability boundaries of study population/drug/duration
Conditions for verification: Show original materials for applicability boundaries of study population/drug/duration together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect applicability boundaries of study population/drug/duration with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N16 · Are adverse-event reporter counts and event counts distinguished?

Required materials and conditions: 37 versus 48 people, P=.50
Conditions for verification: Show original materials for 37 versus 48 people, P=.50 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect 37 versus 48 people, P=.50 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N17 · Are allergy, gastrointestinal and resistance harm boundaries retained?

Required materials and conditions: Long-term antibiotic burdens and interval-specific data
Conditions for verification: Show original materials for long-term antibiotic burdens and interval-specific data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect long-term antibiotic burdens and interval-specific data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N18 · Are during-treatment signals transferred to post-treatment mechanism/protection?

Required materials and conditions: Effect timing and direct persistence data
Conditions for verification: Show original materials for effect timing and direct persistence data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect effect timing and direct persistence data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N19 · What materials were actually read or acquired?

Required materials and conditions: Preserved summary and external original materials
Conditions for verification: Show original materials for preserved summary and external original materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect preserved summary and external original materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N20 · Are historical registration/plans distinguished from current reading?

Required materials and conditions: Original registration identifier and detailed comparison
Conditions for verification: Show original materials for original registration identifier and detailed comparison together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original registration identifier and detailed comparison with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N21 · Have protocol/SAP and analysis/missing-data plans been acquired?

Required materials and conditions: Separate materials for prespecified plans/changes
Conditions for verification: Show original materials for separate prespecified-plan and amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect separate prespecified-plan and amendment materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N22 · Are sponsorship, funding, products, authors and research involvement separated?

Required materials and conditions: Four company-involvement items and nonprofit/public/academic support
Conditions for verification: Show original materials for four company-involvement items and nonprofit/public/academic support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect four company-involvement items and nonprofit/public/academic support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N23 · Are results by interval/endpoint distinguished from information gaps?

Required materials and conditions: Direct results, unverified details and access status
Conditions for verification: Show original materials for direct results, unverified details and access status together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect direct results, unverified details and access status with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N24 · Are reports, trials, people, intervals, events and related sheets separated?

Required materials and conditions: Linked records versus unique trials/participants
Conditions for verification: Show original materials for linked records and unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect linked records and unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N25 · Are the original single trial and separate independent replication distinguished?

Required materials and conditions: Parent R1, independence axis and direct replication
Conditions for verification: Show original materials for parent R1, independence axis and direct replication together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect parent R1, independence axis and direct replication with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N26 · Are the subclaim grade and parent score/axes preserved?

Required materials and conditions: Selected D, missing score/status/axes and parent context
Conditions for verification: Show original materials for selected D, missing score/status/axes and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect selected D, missing score/status/axes and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N27 · Are both languages, citations and absent fields preserved?

Required materials and conditions: Both original languages and absent separate classification information
Conditions for verification: Show original materials for both original languages and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect both original languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N28 · Are source dates/corrections/history separated from production dates?

Required materials and conditions: Original 2026-08-26 and new conditions/application
Conditions for verification: Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Required
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N29 · What direct materials would fill the selected gaps?

Required materials and conditions: Direct interval/endpoint effects, denominators/CI and follow-up
Conditions for verification: Show original materials for direct interval/endpoint effects, denominators/CI and follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect direct interval/endpoint effects, denominators/CI and follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N30 · Are applicability records separated from content review and instructions?

Required materials and conditions: Applicability records, existing candidate history and content review
Conditions for verification: Show original materials for condition records, historical candidates and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Requirement and applicability: Supplementary
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Why this condition is needed: Needed to connect condition records, historical candidates and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

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: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

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

Change history

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

The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which original post-treatment protection claim is selected?

Current findings: The selected claim concerns persistent protection after stopping; its original subclaim grade is D and the note reports 27% in both arms during off-treatment follow-up. Absent subclaim score/status/axes are distinguished from parent B with 76 points and its axes.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score.
Required materials and conditions: Selected wording/subclaim grade and parent effects during treatment
Materials to obtain first: Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score.
Further research: Materials needed: Definitions, start/duration, denominators/estimands for post-treatment follow-up and review of the claim boundary. Parent scores do not fill the subclaim score. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for selected wording/subclaim grade and parent effects during treatment together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect selected wording/subclaim grade and parent effects during treatment with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N02 · Which recurrence-history population was studied?

Current findings: The original intervention population comprised adults with at least two recurrent leg-cellulitis episodes in the previous three years. PATCH I involved 28 hospitals and 274 participants. Do not extend to prevention after a first episode, other sites/causes or other antibiotics.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations.
Required materials and conditions: Adults with at least two leg-cellulitis episodes in the previous three years
Materials to obtain first: Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations.
Further research: Materials needed: Eligibility/exclusions, baseline history/severity, oedema/skin/comorbidities, treatment/follow-up and direct comparisons in other populations. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for adults with at least two leg-cellulitis episodes in the previous three years together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect adults with at least two leg-cellulitis episodes in the previous three years with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N03 · Are study exposure and the post-treatment interval separated?

Current findings: Original study exposure was penicillin V 250 mg twice daily for 12 months. Prevention during treatment and off-treatment follow-up are different intervals. No new cumulative dose, intake, extension/discontinuation or antibiotic-selection guidance.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions.
Required materials and conditions: Penicillin V 250 mg twice daily for 12 months
Materials to obtain first: Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions.
Further research: Materials needed: Original actual-exposure/adherence, discontinuation dates/reasons, concurrent treatment and follow-up time data. No drug/cellulitis-management or treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for penicillin V 250 mg twice daily for 12 months together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect penicillin V 250 mg twice daily for 12 months with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N04 · Is the scope of actual comparison/concurrent care known?

Current findings: The original design was multicentre, double-blind and randomized with placebo control. Actual concurrent treatment/antibiotics, care after recurrence, exposure changes and adherence after stopping remain unverified. The during-treatment comparator is not represented as identical active exposure afterwards.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures.
Required materials and conditions: Placebo comparison and post-treatment care
Materials to obtain first: Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures.
Further research: Materials needed: Actual placebo/care in both arms, treatment completion/withdrawal, post-treatment care/exposure and observation data. Do not repurpose as comparisons of other doses/injections/procedures. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for placebo comparison and post-treatment care together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect placebo comparison and post-treatment care with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N05 · What is the direct post-treatment protection result?

Current findings: The selected note and bilingual text record recurrence in 27% of both arms after stopping and protection did not persist. Preserve this original result and subclaim grade D; do not apply during-treatment HR/NNT afterwards.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%.
Required materials and conditions: 27% in both arms during off-treatment follow-up
Materials to obtain first: Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%.
Further research: Materials needed: Arm-specific post-treatment numerators/denominators, estimands/CI, event/follow-up definitions, observation start/end and original tables. Do not back-calculate new event counts/HR/RR from 27%. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 27% in both arms during off-treatment follow-up together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect 27% in both arms during off-treatment follow-up with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N06 · Which interval do the during-treatment numbers concern?

Current findings: First recurrence during treatment was 30/136 (22%) versus 51/138 (37%), HR 0.55 (CI 0.35–0.86), P=.01, original absolute difference −15 percentage points and NNT 5 (4–9). These concern comparison during 12 months of treatment, not protection after stopping or permanent effects.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations.
Required materials and conditions: 30/136 versus 51/138, HR/CI/P and NNT
Materials to obtain first: Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations.
Further research: Materials needed: Interval-specific estimands, denominators/censoring, models/plans and post-treatment effects/CI. No new absolute difference/RRR/NNT/CI calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 30/136 versus 51/138, HR/CI/P and NNT together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect 30/136 versus 51/138, HR/CI/P and NNT with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N07 · Are observation starts and lengths during/after treatment verified?

Current findings: The original separates 12 months during treatment from the off-treatment interval; exact post-treatment length, individual observation/end, follow-up loss/re-exposure are not established by the summary. No new total follow-up years/person-time.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks.
Required materials and conditions: Time intervals and the post-treatment follow-up-duration gap
Materials to obtain first: Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks.
Further research: Materials needed: Interval-specific observation plans, treatment end/follow-up start, censoring/withdrawal, actual exposure/event-time originals. Do not mix post-treatment cumulative and time-specific risks. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for time intervals and the post-treatment follow-up-duration gap together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect time intervals and the post-treatment follow-up-duration gap with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N08 · What is the risk population underlying post-treatment 27%?

Current findings: Original randomization comprised 274 participants, 136/138, and the original post-treatment proportion is 27% in both arms. Arm-specific post-treatment observation/analysis, risk sets after recurrence/among nonrecurring participants, person-time/numerators remain unverified. Do not calculate new post-treatment events from randomized 136/138.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition.
Required materials and conditions: 274 randomized participants and interval-specific denominators
Materials to obtain first: Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition.
Further research: Materials needed: Interval-specific risk sets/denominators, events/censoring, flow/follow-up loss and analysis data. No new post-treatment events/rates or participant addition. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 274 randomized participants and interval-specific denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect 274 randomized participants and interval-specific denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N09 · Are first recurrence and all repeated events distinguished?

Current findings: The original primary endpoint was time to first clinician-confirmed leg-cellulitis recurrence. Exact post-treatment 27% event aggregation, first/repeated/same-leg and time details remain unverified. Do not repurpose as all repeated events or other sites.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants.
Required materials and conditions: Time to first clinician-confirmed leg recurrence
Materials to obtain first: Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants.
Further research: Materials needed: Original interval-specific event definitions, first/repeated aggregation, person/leg identifiers, post-recurrence care and denominators/analysis plans. The same people/legs are not new participants. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for time to first clinician-confirmed leg recurrence together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect time to first clinician-confirmed leg recurrence with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N10 · Are clinician confirmation and reporting/adjudication details separated?

Current findings: The original study-product description explains that recurrence was clinician-confirmed rather than solely participant-reported. Interval-specific reporting/confirmation, diagnostic criteria, missingness/adjudication/masking details remain unverified. Do not invent post-treatment confirmation/follow-up methods.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production.
Required materials and conditions: Original confirmation procedures and post-treatment measurement gaps
Materials to obtain first: Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production.
Further research: Materials needed: Event diagnosis/reporting, adjudication/masking, confirmation and post-treatment observation/missingness data. No formal RoB assessment in this production. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original confirmation procedures and post-treatment measurement gaps together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect original confirmation procedures and post-treatment measurement gaps with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N11 · Are ITT and actual adherence/follow-up/withdrawal distinguished?

Current findings: The original study description records ITT principles, central-pharmacy dispensing and double-blinding. Actual adherence/discontinuation, interval-specific completion/withdrawal, missingness/censoring are not established by the summary. ITT is not converted into universal completion/observation across all intervals.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations.
Required materials and conditions: Analysis as randomized and actual observed denominators
Materials to obtain first: Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations.
Further research: Materials needed: Original arm-specific flow, actual exposure/adherence, analysis/observation, censoring/withdrawal reasons and sensitivity plans. No new withdrawal counts/rates or adherence-effect calculations. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for analysis as randomized and actual observed denominators together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect analysis as randomized and actual observed denominators with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N12 · Are equal post-treatment proportions newly certified as equivalence/zero effect?

Current findings: Preserve the original verdict of 27% in both arms and loss of persistent protection. Exact post-treatment effects/CI, equivalence/noninferiority/clinical thresholds are absent here; do not newly certify exclusion of all benefit or exactly zero effect.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment.
Required materials and conditions: Original 27%/lost protection and unverified CI
Materials to obtain first: Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment.
Further research: Materials needed: Post-treatment comparative effects/CI, interval/model, prespecified clinical thresholds, original denominators and data. Do not extend original grade D through new calculation/reassessment. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original 27%/lost protection and unverified CI together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect original 27%/lost protection and unverified CI with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N13 · Does PATCH II concern the same trial/interval?

Current findings: The original counterview records PATCH II with 123 participants, HR 0.53 (CI 0.26–1.07), P=.08, individually nonsignificant. Preserve the original description that its interval includes PATCH I’s 0.55 estimate and does not statistically conflict, and that it was a separate cohort in the same network.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it.
Required materials and conditions: Separate 123-person cohort with HR 0.53
Materials to obtain first: Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it.
Further research: Materials needed: Original PATCH II population/intervention/duration/intervals, events/denominators/plans and funding/author relationships. Do not copy PATCH I exposure, post-treatment 27%, funding/registration into it. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for separate 123-person cohort with HR 0.53 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect separate 123-person cohort with HR 0.53 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N14 · What is the hierarchy of during-treatment success and post-treatment analysis?

Current findings: Preserve the original primary time-to-first-recurrence and matching pre-recruitment registration descriptions. Prespecification/secondary hierarchy, all testing, amendments and model details for post-treatment analysis were not established through original-plan reading now.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory.
Required materials and conditions: First recurrence as primary and interval-specific plans
Materials to obtain first: Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory.
Further research: Materials needed: Interval-specific endpoints, censoring/analysis, hierarchy/multiplicity and amendments/publication timing in registration/protocol/SAP. Do not newly designate post-treatment analysis as confirmatory/exploratory. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for first recurrence as primary and interval-specific plans together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect first recurrence as primary and interval-specific plans with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N15 · Is permanent protection extended to a single course/other antibiotics?

Current findings: The original advertising interpretation excludes extension to prevention after a first episode, other antibiotics/doses/injection routes and continuing protection after one course. During-treatment signals are not converted to long-term-management/treatment-replacement instructions.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance.
Required materials and conditions: Applicability boundaries of study population/drug/duration
Materials to obtain first: Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance.
Further research: Materials needed: Direct population/drug/route/duration, during/post-treatment effects/CI and harms for each applicability question. No new antibiotic selection, extension/discontinuation or cellulitis-management guidance. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for applicability boundaries of study population/drug/duration together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect applicability boundaries of study population/drug/duration with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N16 · Are adverse-event reporter counts and event counts distinguished?

Current findings: The original safety description records 37 versus 48 adverse-event reporters, P=.50. People are distinguished from events/severity/types and interval/actual-exposure denominators, which remain unverified. P=.50 is not converted into no harm/equivalence.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions.
Required materials and conditions: 37 versus 48 people, P=.50
Materials to obtain first: Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions.
Further research: Materials needed: Original AE collection, reporter/event aggregation, arm exposure/harm denominators, intervals/discontinuation/relatedness and types. No new harm rates/effects or management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for 37 versus 48 people, P=.50 together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect 37 versus 48 people, P=.50 with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N17 · Are allergy, gastrointestinal and resistance harm boundaries retained?

Current findings: Original counterview/safety descriptions retain allergy, gastrointestinal adverse effects and antimicrobial-resistance burdens. Event counts/causes/duration by type and post-treatment harm/resistance data remain unverified. No new certification of overall study safety/absence of resistance.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions.
Required materials and conditions: Long-term antibiotic burdens and interval-specific data
Materials to obtain first: Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions.
Further research: Materials needed: Harm-specific collection/exposure/denominators, discontinuation/relatedness, resistance measurement and long-term/post-treatment data. No antibiotic/infection-prevention/treatment instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for long-term antibiotic burdens and interval-specific data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect long-term antibiotic burdens and interval-specific data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N18 · Are during-treatment signals transferred to post-treatment mechanism/protection?

Current findings: The original crux limits reduced recurrence to treatment and reports protection disappearing after stopping. During-treatment HR/NNT or mechanistic plausibility do not newly prove permanent/post-treatment protection.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions.
Required materials and conditions: Effect timing and direct persistence data
Materials to obtain first: Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions.
Further research: Materials needed: Direct post-treatment plans, observation/risk populations, re-exposure/concurrent treatment and effects/CI/harms. No invented persistent protection/management instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for effect timing and direct persistence data together with selected-subclaim/parent boundaries, direct intervals/endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect effect timing and direct persistence data with the selected question, actual population/intervention/comparator, intervals/endpoints/estimands, denominators/repetition/exposure and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N19 · What materials were actually read or acquired?

Current findings: The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citations/URLs do not establish external reading here.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.
Required materials and conditions: Preserved summary and external original materials
Materials to obtain first: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.
Further research: Materials needed: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for preserved summary and external original materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect preserved summary and external original materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N20 · Are historical registration/plans distinguished from current reading?

Current findings: Original PATCH I evidence records ISRCTN34716921 and EudraCT 2006-000381-36; original bilingual text describes registration before recruitment and primary-endpoint matching. No current comparison of official registration URLs/versions/actual public dates. PATCH II registration information is unidentified here.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification.
Required materials and conditions: Original registration identifier and detailed comparison
Materials to obtain first: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification.
Further research: Materials needed: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original registration identifier and detailed comparison together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect original registration identifier and detailed comparison with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N21 · Have protocol/SAP and analysis/missing-data plans been acquired?

Current findings: Original primary-outcome/ITT/registration descriptions and historical cross-checking are preserved. Actual protocol/SAP versions/timing, interval/endpoint-specific models/censoring/missingness and hierarchy/multiplicity were not newly read.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent.
Required materials and conditions: Separate materials for prespecified plans/changes
Materials to obtain first: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent.
Further research: Materials needed: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for separate prespecified-plan and amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect separate prespecified-plan and amendment materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N22 · Are sponsorship, funding, products, authors and research involvement separated?

Current findings: PATCH I had nonprofit Action Medical Research funding and University of Nottingham sponsorship; the original limitation is that pharmaceutical cash/product/analysis support was not identified. Employee authors/design/writing/publication, individual roles and PATCH II funding details remain separately unverified.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence.
Required materials and conditions: Four company-involvement items and nonprofit/public/academic support
Materials to obtain first: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence.
Further research: Materials needed: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for four company-involvement items and nonprofit/public/academic support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect four company-involvement items and nonprofit/public/academic support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

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N23 · Are results by interval/endpoint distinguished from information gaps?

Current findings: Distinguish positive first recurrence during treatment from post-treatment 27% in both arms/original ineffective persistent protection and post-treatment effect/denominator gaps.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence.
Required materials and conditions: Direct results, unverified details and access status
Materials to obtain first: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence.
Further research: Materials needed: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for direct results, unverified details and access status together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect direct results, unverified details and access status with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N24 · Are reports, trials, people, intervals, events and related sheets separated?

Current findings: Parent 2973 and its selected s0/s1 claims share the PATCH I report/cohort, during/post-treatment context and PATCH II reference report. Preserve only the original separate-cohort/same-network PATCH II relationship; no new independent-replication count. The same people, legs, periods, events, citations and related sheets are not added as new participants/trials. Linked-report counts are not certified unique trial/participant totals.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded.
Required materials and conditions: Linked records versus unique trials/participants
Materials to obtain first: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded.
Further research: Materials needed: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for linked records and unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect linked records and unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N25 · Are the original single trial and separate independent replication distinguished?

Current findings: Preserve parent R1/I2. Intervals/endpoints/related sheets in the same participants are not certified as new independent replication; PATCH II same-network relationships and manufacturer support remain separate.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict.
Required materials and conditions: Parent R1, independence axis and direct replication
Materials to obtain first: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict.
Further research: Materials needed: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for parent R1, independence axis and direct replication together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect parent R1, independence axis and direct replication with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01 R02

N26 · Are the subclaim grade and parent score/axes preserved?

Current findings: Preserve selected grade/note and bilingual claims; absent subclaim score/status/axes remain unrecorded. Parent B with 76 points and safety/axes are parent context. They do not supply selected scores or create new grades/RoB 2/GRADE certification.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history.
Required materials and conditions: Selected D, missing score/status/axes and parent context
Materials to obtain first: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history.
Further research: Materials needed: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for selected D, missing score/status/axes and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect selected D, missing score/status/axes and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N27 · Are both languages, citations and absent fields preserved?

Current findings: Preserve parent Korean/English citations/descriptions, evidence/citation lists, axes and selected-subclaim records in the complete summary. Separate classification information in both languages is absent; originals are not filled with new fields. No external English full-text comparison.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records.
Required materials and conditions: Both original languages and absent separate classification information
Materials to obtain first: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records.
Further research: Materials needed: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for both original languages and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect both original languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N28 · Are source dates/corrections/history separated from production dates?

Current findings: Original evidence date 2026-08-26, empty corrections/deliberation and grade-decision cross-checking are preserved. Historical citation/registration descriptions differ from current production, condition freezing/application and completed content review.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Required materials and conditions: Original 2026-08-26 and new conditions/application
Materials to obtain first: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here.
Further research: Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N29 · What direct materials would fill the selected gaps?

Current findings: Post-treatment persistent protection requires the risk population/observation and direct effects/CI for that interval; during-treatment signals do not substitute.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research.
Required materials and conditions: Direct interval/endpoint effects, denominators/CI and follow-up
Materials to obtain first: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research.
Further research: Materials needed: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research. Only the material request/research need is recorded; no lookup or research is performed now.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for direct interval/endpoint effects, denominators/CI and follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect direct interval/endpoint effects, denominators/CI and follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

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N30 · Are applicability records separated from content review and instructions?

Current findings: These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified: Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Required materials and conditions: Applicability records, existing candidate history and content review
Materials to obtain first: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Further research: Materials needed: Content review and subsequent actual evidence/correction work. Original content-production scope excludes clinical QA/testing, external-link/access/web/API research, new calculations/grades and antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification: Show original materials for condition records, historical candidates and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.
Why this condition is needed: Needed to connect condition records, historical candidates and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.
Application exceptions: Distinguish during/post-treatment intervals, first/repeated clinician-confirmed recurrence, people/time denominators/censoring, adherence/withdrawal/follow-up, HR/NNT/CI and post-treatment 27%, the separate PATCH II cohort, harms and applicability. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or antibiotic/product-use/cellulitis-management/infection-prevention/treatment-replacement instructions.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01