This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for ProVee Urethral Expander System IDE Study (ProVIDE) (NCT05186740), a randomized na study. The primary outcome is Safety: Adverse Events (Time Frame: Procedure to 12 Months).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05186740 |
| Phase | NA |
| Condition | BPH With Symptomatic Lower Urinary Tract Symptoms |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 221 |
| Arms in the primary outcome | 3 |
| Lead sponsor | ProVerum Medical |
| Results posted | Yes |
2. Clinical Question
Population
People with benign prostatic hyperplasia and symptomatic lower urinary tract symptoms, described in the registry summary as symptomatic urinary obstruction related to BPH. Further eligibility criteria are not reported in the registry record.
Intervention
The treatment arm received the ProVee Urethral Expander System, described as a nitinol Expander implant and a 19Fr Delivery System used to deploy the Expander under direct vision.
Comparator
The sham procedure used an ureteroscope housed within the inner lumen of a urethral access sheath, under direct vision. After the 3 month follow-up visit, participants assigned to sham were offered the opportunity to cross over to the device.
Primary question
The primary safety outcome concerns the rate of device- or procedure-related serious adverse events from the procedure through 12 months. The posted outcome is expressed as a count of participants, while separate safety listings report related serious adverse events. The record does not explain how these entries correspond.
The study is randomized and parallel, with double masking recorded in the registry. Enrollment is 221. The randomized groups are listed as 150 in the device arm and 71 in the sham arm. The record also lists a crossover group of 64 participants; these participants had initially been assigned to sham and crossed over after the 3 month follow-up visit. The record says all participants were to be unblinded following that visit.
The clinical question is therefore not simply whether device and sham outcomes differ throughout a common follow-up period. Crossover changes treatment exposure after the initial comparison period. The registry record does not report an analysis plan clarifying how the primary safety outcome handles participants who crossed over, how relatedness was attributed after crossover, or how follow-up through 12 months was assigned to treatment groups.
3. Trial Design
This is a randomized, double-masked, parallel-group clinical study of the ProVee Urethral Expander System. The registry lists an enrollment of 221 and identifies symptomatic lower urinary tract symptoms associated with BPH as the condition under study. The sponsor is ProVerum Medical. The study started on 2022-06-09, and the primary completion date is listed as 2024-03-15. Its status is active, not recruiting.
The device arm received the ProVee Urethral Expander System. The sham arm underwent a procedure using an ureteroscope and urethral access sheath. The device is described as an implant and delivery system deployed under direct vision; the sham procedure also used direct vision. The record does not report the details of the randomization sequence, allocation concealment, or which parties were masked. It records double masking without specifying its implementation.
After the 3 month follow-up visit, participants were unblinded. Participants originally randomized to sham were offered crossover to the ProVee system, and the record lists 64 people in the crossover group. This means that the randomized comparison and the later treatment exposure are not identical: some participants assigned to sham subsequently received the device. The record does not report how this transition was addressed in the primary analysis.
The primary endpoint is a safety measure covering the procedure through 12 months, described as device- or procedure-related serious adverse events. There are four outcome measures recorded, but no secondary outcomes are posted in the registry record. No statistical analyses are posted. Details of the protocol, sample-size justification, prespecified analysis populations, interim analyses, and handling of crossover are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Device: The ProVee Urethral Expander System | Sham: Ureteroscope and Urethral Access Sheath |
|---|---|---|
| STARTED | 150 | 71 |
| Sham Participants Crossed Over to Device at 3 Month Follow-up | 0 | 64 |
| COMPLETED | 150 | 71 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: At 3 month follow-up visit, 64 subjects were crossed over from Sham (Uretheroscope and urethral access sheath) to Device (The ProVee Urethral Expander System)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: At the 3 month follow up, there were 64 participants crossed over from Sham (Ureteroscope and Urethral Access Sheath) Arm/Group to receive the device (ProVee Urethral Expander System)
| Characteristic | Unit | Device: The ProVee Urethral Expander System | Sham: Ureteroscope and Urethral Access Sheath | Total |
|---|---|---|---|---|
| Participants analysed | 150 | 71 | 221 | |
| Age, Customized: Age | Years | 64.0 (SD 8.7) | 64.5 (SD 8.2) | 64.2 (SD 8.4) |
| Sex/Gender, Customized: Male | Participants | 150 | 71 | 221 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 19 | 6 | 25 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 128 | 63 | 191 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 2 | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 8 | 1 | 9 |
| Race (NIH/OMB): White | Participants | 137 | 68 | 205 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 2 | 4 |
| BMI | kg/m^2 | 28.1 (SD 4.4) | 28.5 (SD 5.8) | 28.2 (SD 4.9) |
6. Primary Endpoint
The registry lists the primary outcome as Safety: Adverse Events (Time Frame: Procedure to 12 Months), measured over Procedure - 12 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Safety: Adverse Events” and has a time frame from the procedure through 12 months. It is recorded as a count of participants. Its description says it includes the rate of device- or procedure-related serious adverse events through 12 months. The outcome therefore focuses on serious harms considered related to the device or the procedure, rather than on every event that may occur during follow-up.
Serious adverse events are important safety outcomes because they capture events classified as serious, while the relatedness criterion narrows attention to events attributed to the device or procedure. In general, safety monitoring considers both the occurrence and nature of events; a count alone does not describe their clinical details, timing, duration, or consequences. The registry record does not report those details for the primary outcome.
The primary outcome entry lists zero participants in each displayed group, and the posted risk differences are 0.0 with interval limits of 0.0 and 0.0. Separately, the adverse-event listing reports 8 serious related events for the device group and none for the sham or crossover groups. These entries are not consistent on their face. The record does not explain whether they use different definitions, analysis populations, or reporting conventions, so they should not be treated as interchangeable estimates of one endpoint.
7. Results Posted in the Registry
- Device: The ProVee Urethral Expander System: 0.0% (0/150) versus 0.0% (0/71) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0); unadjusted two-proportion z-test p = n/a.
- Crossover ProVee Urethral Expander System: 0.0% (0/64) versus 0.0% (0/71) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0); unadjusted two-proportion z-test p = n/a.
Risk difference: Device: The ProVee Urethral Expander System
95% CI: 0.0 to 0.0 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted primary outcome values are zero for the device group and zero for the sham and crossover groups. The posted comparisons consequently report a risk difference of 0.0 for the device-versus-sham comparison and 0.0 for the crossover-versus-sham comparison, with interval limits of 0.0 to 0.0 in each case. These results describe the outcome values entered in that specific outcome record; they do not by themselves establish that no related serious adverse events occurred during the study.
The separate adverse-event listing records 8 serious adverse events marked related in the device group, which has 150 participants at risk, and none in the sham group, which has 71 participants at risk, or the crossover group, which has 64 participants at risk. It also lists 1 other related adverse event in the device group and none in the other groups. One death is listed in the device group, with none in the sham or crossover groups. The record does not state that the death was related to the device or procedure.
Because the primary outcome entry and the adverse-event listing differ, a reader cannot infer from the zero outcome counts that the adverse-event listing is also zero. Nor can the separate safety listing be substituted for the primary endpoint without knowing whether the definitions, time windows, and populations match. The registry record does not explain the relationship between these entries, the handling of participants who crossed over, or the adjudication of relatedness. The posted statistics should therefore be read as distinct record entries rather than reconciled into a single estimate.
The zero risk differences and zero interval limits also require caution. An interval with identical zero limits, based on zero event counts, does not convey the usual uncertainty about an unobserved underlying event rate. The record does not provide the analysis method or confidence level for these intervals. In general, estimates based on sparse or absent events can be highly limited in their ability to distinguish groups, even when the displayed estimate is exactly zero.
No statistical analyses are posted, and there are no posted secondary outcome results. As a result, the registry record does not provide a broader assessment of comparative safety or effectiveness. The observed entries describe what was recorded, but do not resolve how the primary safety measure should be interpreted alongside the separate adverse-event data.
9. Statistical Methods Explained
What does the risk difference describe?
In general, a risk difference compares the proportion of participants with an event in one group with the proportion in another group. A value of zero indicates equal observed proportions under the data and definitions used for that comparison. It does not establish that the underlying risks are exactly equal, and its meaning depends on which participants and events are counted.
The posted comparisons are risk differences for the device group versus sham and for the crossover group versus sham. Both are reported as 0.0, with interval limits of 0.0 and 0.0. The primary outcome summary also records zero participants with the endpoint in the listed groups. Those comparisons reflect the outcome counts used in that entry. The separate adverse-event listing records serious related events in the device group, so the zero comparison cannot be read as a summary of every safety entry in the registry.
Why do definitions and populations matter?
For a binary endpoint, an analysis generally needs an explicit definition of an event and a defined group of participants at risk. The primary endpoint is described as participants with device- or procedure-related serious adverse events from the procedure through 12 months. Elsewhere, the adverse-event listing has separate serious-related and other-related categories, with at-risk counts by group. The record does not report enough detail to determine whether the primary outcome and these listing categories use the same event definition, follow-up window, or population.
Crossover is particularly relevant to group definition. Participants originally randomized to sham were offered the device after the 3 month visit, and 64 are listed as having crossed over. In general, an analysis can classify participants by original randomization or by treatment actually received, but those approaches answer different questions. The registry record does not report which approach was used for the primary endpoint, or how events after crossover were attributed.
What do the interval limits add?
In general, a confidence interval describes uncertainty around an estimated effect under a specified statistical method. Its width is informative: wider intervals indicate less precision, while narrower intervals indicate greater precision under that method. The confidence level and method are needed to interpret the interval formally.
The posted comparisons give interval limits of 0.0 and 0.0, but the record does not report the confidence level or the method used to construct them. With zero events recorded in the outcome entry, these displayed limits do not communicate the uncertainty that would ordinarily be important when estimating a risk difference. Their interpretation is further constrained by the separate adverse-event listing, which reports serious related events in the device group.
What analysis details are missing?
No statistical analyses are posted. The registry record does not report a prespecified statistical analysis plan, a sample-size justification, a method for handling missing outcomes, or an analysis population such as intention-to-treat or per-protocol. It also does not report whether any interim analyses were planned or conducted. These details matter because they determine how observations are classified, how incomplete follow-up is treated, and how uncertainty is quantified.
A sample-size planning illustration is based on a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such illustrations are planning calculations, not observed power, and the record does not identify these assumptions as the trial’s own design rationale. No numerical planning results are reported in the record.
How should the safety listings be handled?
In general, adverse-event listings and a primary endpoint summary can be different reporting structures. A listing may provide event categories and counts, while a primary endpoint may count participants meeting a narrower definition. Repeated events in one participant, relatedness assessments, timing, and crossover can all affect how these quantities correspond. The registry record does not explain these details, so the entries should remain separately described rather than combined or recalculated.
The record also lists one death in the device group and none in the other groups. A death count is not, by itself, evidence of causation or relatedness. The record does not report a relationship between the death and the device or procedure. No causal interpretation should be added to the count.
10. Confidence Intervals and Precision
Precision concerns how much uncertainty surrounds an estimated effect. In general, a confidence interval gives a range of values compatible with the observed data under a specified statistical method and confidence level. A narrow interval may indicate greater precision, while a wide interval indicates that a range of effects remains compatible with the data.
The registry comparisons report risk differences of 0.0, with lower and upper limits both 0.0, for each comparison. The confidence level and interval method are not reported in the registry record. The endpoint entries also report zero participants with the primary outcome in the listed groups, while the separate adverse-event listing records 8 serious related events in the device group. This inconsistency limits how confidently the intervals can be interpreted as a description of safety uncertainty.
Zero observed counts do not generally establish that the true event risk is zero. In general, when events are rare or absent in a dataset, the available observations may be insufficient to estimate small risks precisely. A displayed interval with zero-width limits does not remove that concern, especially when the analysis method and confidence level are unknown. The record does not provide additional uncertainty estimates that could resolve it.
The group sizes differ, and crossover further complicates precision for comparisons based on treatment exposure. The record lists 150 participants in the device group, 71 in the sham group, and 64 in the crossover group. These are not necessarily equivalent analysis populations for a single randomized comparison, particularly after unblinding and crossover. The registry record does not state how follow-up time or post-crossover events were handled.
Consequently, the posted zero risk differences should be read narrowly as the results attached to the primary outcome entry. They should not be used alone to conclude that the study precisely estimated the comparative safety of the device. The conflicting safety counts, absent interval specifications, and missing analysis details leave important aspects of precision unresolved.
11. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study evaluates several outcomes, comparisons, or analyses. In general, testing many questions can increase the chance of finding an apparently notable result by chance unless the analysis plan addresses that issue. The registry record lists four outcome measures, but no secondary outcomes are posted and no statistical analyses are posted. It does not report whether multiplicity adjustments or a hierarchy among outcomes were planned.
The record also does not report interim analyses, stopping rules, or whether the primary endpoint was analyzed at one prespecified time or in more than one way. These features cannot be inferred from the randomized design or from the posted outcome counts. The statistical plan is not reported in the registry record.
Missing data are another unresolved issue. The record does not report the number of participants with incomplete follow-up, how missing primary endpoint values were handled, or whether participants were excluded from any analysis. It also does not report the prespecified analysis populations. Without those details, it is not possible to assess whether all randomized participants were included in the primary comparison or whether outcomes were analyzed according to original assignment.
Participants assigned to sham could cross over to the device after the 3 month follow-up visit; 64 participants are listed in the crossover group. The record does not explain how this affected the primary safety analysis, the treatment-group labels, or the handling of outcomes occurring after crossover. The registry also states that all participants were unblinded following the 3 month visit. The effects of unblinding on outcome assessment are not reported.
These omissions are especially relevant because the primary endpoint covers the procedure through 12 months, while the crossover occurs after the 3 month visit. The record does not explain whether endpoint events after crossover were attributed to the originally assigned group, the treatment received, or another analysis population. The adverse-event listing and primary outcome summary also differ in their reported counts. No explanation of that difference is reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Device: The ProVee Urethral Expander System | 8 | 150 | 5.3% |
| Sham: Ureteroscope and Urethral Access Sheath | 0 | 71 | 0.0% |
| Crossover ProVee Urethral Expander System | 0 | 64 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Device: The ProVee Urethral Expander System | 1 of 150 |
| Sham: Ureteroscope and Urethral Access Sheath | 0 of 71 |
| Crossover ProVee Urethral Expander System | 0 of 64 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Device: The ProVee Urethral Expander System | 1 of 150 |
| Sham: Ureteroscope and Urethral Access Sheath | 0 of 71 |
| Crossover ProVee Urethral Expander System | 0 of 64 |
Most frequent serious adverse event terms
| Event term | Organ system | Device: The ProVee Urethral Expander System | Sham: Ureteroscope and Urethral Access Sheath | Crossover ProVee Urethral Expander System |
|---|---|---|---|---|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 150 | 0 of 71 | 0 of 64 |
| Small bowel obstruction | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 150 | 0 of 71 | 0 of 64 |
| Transient Ischemic Attack | Nervous system disorders | 1 of 150 | 0 of 71 | 0 of 64 |
| Cerebrovascular accident | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 150 | 0 of 71 | 0 of 64 |
| Cellulitis | Infections and infestations | 1 of 150 | 0 of 71 | 0 of 64 |
| Sepsis | Infections and infestations | 1 of 150 | 0 of 71 | 0 of 64 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 150 | 0 of 71 | 0 of 64 |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 150 | 0 of 71 | 0 of 64 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Device: The ProVee Urethral Expander System | Sham: Ureteroscope and Urethral Access Sheath | Crossover ProVee Urethral Expander System |
|---|---|---|---|---|
| Dry Mouth | General disorders | 1 of 150 | 0 of 71 | 0 of 64 |
Serious events with the highest arm-level rate: squamous cell carcinoma (0.7%), small bowel obstruction (0.7%), transient ischemic attack (0.7%), cerebrovascular accident (0.7%), cellulitis (0.7%).
The adverse-event listing reports 8 serious adverse events marked related for the device group, with 150 participants at risk. It reports none in the sham group, with 71 at risk, and none in the crossover group, with 64 at risk. The listing also reports 1 other related adverse event in the device group and none in the other groups. It records 1 death in the device group and none in the sham or crossover groups.
These are counts from the adverse-event listing, not the primary outcome’s posted participant counts. The primary outcome entry records zero participants in each displayed group, and its associated risk differences are 0.0. The registry record does not explain why the two sets of entries differ, or whether their definitions, time windows, and populations are the same. The counts should therefore be read as separate entries rather than combined.
In general, an event count does not establish causation. The listing marks the serious events as related, but the record does not provide event-level descriptions or explain how relatedness was assessed. The death count alone does not indicate that the death was related to the device or procedure. Its relationship is not reported in the registry record.
13. What the Result Does, and Does Not, Mean
The registry record documents a randomized study of the ProVee Urethral Expander System against a sham procedure, with later crossover available to participants assigned to sham. The primary safety question concerns device- or procedure-related serious adverse events through 12 months. The posted primary outcome summary records zero participants with the endpoint and reports risk differences of 0.0 for the listed comparisons.
Those values do not stand alone. The separate adverse-event listing reports 8 serious related events in the device group, as well as 1 other related adverse event and 1 death in that group. It records none of these categories in the sham or crossover groups. Because the outcome summary and the adverse-event listing differ, the record does not support a single reconciled account of the primary safety outcome without additional definitions and analysis details.
The results therefore describe what is entered in different registry components, not a definitive estimate of comparative safety. They do not establish that the underlying risk is zero, nor do they explain whether counts are based on original assignment or treatment received after crossover. The record does not report the statistical analysis plan, missing-data handling, confidence level, or the treatment of post-crossover events.
These limitations also mean that the posted figures should not be interpreted as evidence about treatment effectiveness. The primary endpoint is a safety endpoint, and no secondary outcomes are posted. The record does not provide enough information to determine how the safety entries were adjudicated or reconciled. Any assessment of comparative effects would require a clear endpoint definition, analysis population, and explanation of the differing counts.
14. Why This Trial Matters Statistically
This study raises statistical issues that are common in device trials: how to preserve a randomized comparison when participants can cross over, how to define safety events, and how to align participant-level endpoints with adverse-event listings. These questions matter because each analytic choice can change which observations contribute to a comparison and what the resulting estimate means.
The registry records the primary outcome as a count of participants with related serious adverse events, but its separate safety listing reports serious related events in the device group. The outcome summary and listing cannot be reconciled from the registry record. This makes clear documentation of definitions, populations, and event attribution essential for readers assessing safety results.
The timing of crossover is also relevant. Participants assigned to sham were offered the device after the 3 month follow-up visit, while the primary safety window extends through 12 months. In general, outcomes after crossover may be handled according to original assignment or actual treatment exposure, but these choices answer different questions. The registry record does not state how it handled this issue.
Finally, zero event counts and zero risk differences can appear conclusive while conveying limited information about uncertainty. Interpretation requires a suitable interval method, a defined analysis population, and consistent outcome reporting. The posted record does not report these details, underscoring why numerical estimates must be read alongside their definitions and limitations.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record leaves important details unresolved. It does not report the eligibility criteria beyond the general BPH condition, the randomization procedure, allocation concealment, or which parties were masked. Double masking is recorded, but its implementation is not described.
The primary endpoint summary records zero participants with the endpoint in each displayed group, while the adverse-event listing reports 8 serious related events in the device group. The record does not explain whether the entries differ because of definitions, time windows, participant populations, or reporting conventions. It also does not report event-level details, how relatedness was determined, or whether the listed death was related to the device or procedure.
Follow-up and analysis are difficult to assess because participants assigned to sham could cross over after the 3 month visit, and 64 are listed as having done so. The registry does not report how events after crossover were attributed or which analysis population was used. It also does not report missing-data handling, the number of participants with incomplete follow-up, a statistical analysis plan, or interim analyses.
The posted risk differences have interval limits of 0.0 to 0.0, but the interval method and confidence level are not reported. No statistical analyses or secondary outcome results are posted. The registry record therefore does not establish how the estimates were constructed or provide a fuller assessment of comparative safety. These limitations concern interpretation of the posted record and should not be mistaken for evidence that an unreported procedure was or was not used.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: ProVee Urethral Expander System IDE Study (ProVIDE) — NCT05186740.
- Registry record last updated 2026-07-28; status last verified 2026-07.
- Results first posted 2025-12-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
The registry record describes the ProVee Urethral Expander System IDE Study, a randomized, double-masked, parallel-group study sponsored by ProVerum Medical. It lists enrollment of 221 and a population with BPH and symptomatic lower urinary tract symptoms. The sham group used an ureteroscope and urethral access sheath; participants assigned to sham could cross over to the device after the 3 month follow-up visit.
The primary endpoint concerns device- or procedure-related serious adverse events from the procedure through 12 months. The primary outcome entry records zero participants in the listed groups, while the separate adverse-event listing reports 8 serious related events in the device group. The registry record does not explain this difference. No statistical analyses or secondary outcome results are posted, and details of the analysis plan, missing data, and post-crossover attribution are not reported in the registry record.