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

Verdict 2973 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-14

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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%?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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

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

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- Current findings: Post-treatment persistent protection requires the risk population/observation and direct effects/CI for that interval; during-treatment signals do not substitute.
- 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.
- 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.
- 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.
- 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

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

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- Current findings: These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.
- 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.
- 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.
- 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.
- Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
- Related sources: R01

## Evidence and sources

### R01

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

[PubMed](https://pubmed.ncbi.nlm.nih.gov/23635049/)

Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread  
Findings recorded in the 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.  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/21910701/)

Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread  
Findings recorded in the 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.  
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.

| 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.