Accelerated iTBS in Smoking Cessation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Accelerated iTBS in Smoking Cessation (NCT05271175), a randomized na study. The primary outcome is Self-reported Nicotine Consumption.

2. Clinical Question

The study concerns adults with nicotine dependence and smoking cessation as its clinical context. Its stated aim was to evaluate accelerated intermittent theta burst stimulation (iTBS) for smoking cessation and to investigate whether exposure to smoking-related rather than neutral cues during treatment affected cigarette craving. The registry record does not report further eligibility details, so the characteristics of the target population beyond the listed conditions are not reported in the registry record.

3. Trial Design

The registry describes a randomized, double-blind, parallel-group study sponsored by Cyprus rTMS Center. The listed phase is NA. Enrollment is 104, and the record status is completed. The study began on 2019-04-19, with primary completion on 2020-09-07.

Three arms are described. Participants in Active TMS & Neutral Videos received active iTBS while watching neutral videos. Participants in Active TMS & Smoking Videos received active iTBS while watching smoking-related videos. Participants in Sham TMS & Smoking Videos received sham stimulation while watching smoking-related videos. The posted baseline primary-outcome group sizes are 29.0, 30.0, and 30.0, respectively. These are group-level counts for that measure; other posted measures have their own group counts.

The study summary characterizes the protocol as 4 iTBS sessions per day during 5 consecutive days over the left DLPFC. The record does not report further details of the randomization sequence, allocation concealment, masking procedures, treatment adherence, or whether participants and outcome assessors were masked separately. It also does not report the original design assumptions or the rationale for the enrollment target.

Although the study aim refers to treatment efficacy and cue-related effects on craving, the posted primary outcome is a baseline measure, taken before treatment. The posted secondary measures described in the outcome data are also baseline measures. Post-treatment smoking, cessation, and craving results are not reported in the registry record. The available outcome summaries consequently describe the recorded starting values and unadjusted comparisons between arms, not the effect of treatment over time.

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.

Treatment

One Week Follow up

Reasons for not completing this period:

One Month Follow up

Reasons for not completing this period:

Six Months Follow up

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Self-reported Nicotine Consumption, measured over Baseline.

The primary outcome is self-reported nicotine consumption, measured as the mean number of cigarettes participants usually smoke per day at baseline. The registry describes it as the number of cigarettes usually smoked before treatment. It is a continuous measure: each participant’s reported daily consumption contributes to a group mean, and the posted spread is identified as a standard error.

As a general statistical point, a baseline smoking measure can describe the starting level of cigarette use in each randomized group and help readers understand what the study groups looked like before treatment. It is not, by itself, a measure of quitting, change in consumption, or treatment response. To evaluate change, a post-treatment measure or a comparison of change over time would be needed. Such a result is not reported in the registry record.

The registry record does not report why this particular baseline measure was designated primary, nor does it report a post-treatment primary endpoint for cessation. The baseline group means are 27.55 cigarettes/day for Active TMS & Neutral Videos, 26.83 cigarettes/day for Active TMS & Smoking Videos, and 30.0 cigarettes/day for Sham TMS & Smoking Videos. These values describe the recorded baseline consumption in the respective groups; they do not establish whether any group later smoked less or quit.

7. Results Posted in the Registry

• Active TMS & Neutral Videos: mean 27.55 versus 30.00 on control; difference -2.45 (95% CI -42.39 to 37.49), standardized effect d = -0.03; z-test p = 0.904.
• Active TMS & Smoking Videos: mean 26.83 versus 30.00 on control; difference -3.17 (95% CI -39.54 to 33.20), standardized effect d = -0.04; z-test p = 0.864.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Perceived Stress

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Active TMS & Neutral Videos: mean 5.97 versus 5.60 on control; difference 0.37 (95% CI -0.69 to 1.43), standardized effect d = 0.18; z-test p = 0.495.
  • Active TMS & Smoking Videos: mean 6.53 versus 5.60 on control; difference 0.93 (95% CI -0.18 to 2.04), standardized effect d = 0.42; z-test p = 0.102.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active TMS & Neutral Videos and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active TMS & Smoking Videos and the control. The interval gives the range of effects that remain compatible with the data.

Motivation to Quit Smoking

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Active TMS & Neutral Videos: mean 77.78 versus 80.83 on control; difference -3.05 (95% CI -13.88 to 7.78), standardized effect d = -0.15; z-test p = 0.581.
  • Active TMS & Smoking Videos: mean 82.41 versus 80.83 on control; difference 1.58 (95% CI -8.42 to 11.58), standardized effect d = 0.08; z-test p = 0.757.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active TMS & Neutral Videos and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Active TMS & Smoking Videos and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes are perceived stress and motivation to quit smoking, both reported as baseline scale measures. Their arm summaries show variation in the starting values, but their recalculated comparison intervals include zero. The registry does not list reported analyses for these outcomes, and it does not report post-treatment values or changes. The secondary data therefore describe baseline scores rather than evidence about how stress or motivation responded to treatment.

These summaries are consistent with the primary outcome’s central limitation: the available results concern baseline characteristics, not outcomes after the intervention. They cannot establish whether stimulation, video cues, or their combination changed smoking behavior, stress, or motivation. The stated interest in cue-related craving is not answered by the posted secondary results, because craving results are not reported in the registry record.

In general, multiple outcomes create a multiplicity issue: the more comparisons examined, the greater the chance that at least one result may appear unusual by chance. Unadjusted secondary p-values do not account for the number of outcomes or analyses considered. This does not invalidate descriptive summaries, but it means isolated secondary findings would carry less weight than a prespecified, appropriately analyzed primary result. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting the secondary outcomes.

There are 10 secondary outcomes posted and 37 outcome measures listed overall, while no analyses are listed as reported analyses. The record does not explain how the posted measures relate to the full outcome set or identify which secondary comparisons were prespecified. The safest reading is therefore descriptive and cautious: the baseline secondary measures add context about the recorded groups, but they do not provide independent evidence of treatment-related change or resolve the primary question.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Perceived Stress
• Perceived Stress
• Perceived Stress
• Perceived Stress
• Perceived Stress
• Motivation to Quit Smoking
• Motivation to Quit Smoking
• Motivation to Quit Smoking

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, and the registry reports group means with standard errors. A mean summarizes the group’s average reported cigarettes per day. A standard error describes the precision of that estimated mean; it is not the same as the standard deviation, which describes variation among individual participants. General statistical interpretation should keep these quantities distinct, especially because the primary outcome lists standard error as its dispersion measure.

What does a mean difference represent?

For each active-treatment arm, the recalculated comparison subtracts the sham-arm mean from the active-arm mean. A negative estimate means the active arm’s posted baseline mean is lower than the sham arm’s posted baseline mean; a positive estimate would mean it is higher. This direction describes the baseline summaries only. It does not describe a change caused by treatment, because the measure is recorded before treatment.

The two primary comparison estimates are -2.45 and -3.17 cigarettes/day. The calculation is unadjusted: it uses the posted arm-level summary statistics and does not account for other participant characteristics or a model of repeated measurements. No adjusted analysis or sponsor-reported primary analysis is listed in the registry record. These recalculated comparisons should therefore be read as descriptive statistical contrasts, not as the trial’s reported treatment-effect analysis.

How should a confidence interval be read?

In general, a confidence interval describes the range of estimates compatible with the observed data under the assumptions of the calculation. A wide interval indicates substantial uncertainty about the magnitude and direction of the estimate. An interval that includes zero is compatible with no mean difference as well as with differences in either direction. It does not prove that the true difference is zero, nor does it assign a probability to the true value lying inside that particular interval.

For the primary comparisons, the intervals are wide and include zero. Their breadth means the posted baseline summaries do not precisely identify the difference between groups. Because these are baseline comparisons, even a narrow interval would not establish a treatment effect; it would only estimate the difference in starting means with greater precision.

What do p-values add?

A p-value measures how unusual the observed statistic, or a more extreme one, would be under a specified null model. The unadjusted values for the primary comparisons are 0.904 and 0.864. They do not quantify the probability that a treatment works, the probability that the null hypothesis is true, or the size of any clinical effect. Considered alongside the wide intervals, they do not indicate a clear baseline difference. The registry’s planning illustration specifies a two-sided significance level of 0.05; that is a planning assumption and does not change the baseline nature of these comparisons.

Why does the distinction between baseline and follow-up matter?

A randomized trial usually evaluates treatment by comparing outcomes measured after treatment, or by comparing how outcomes change from baseline. This is a general design principle, not a claim about an analysis performed in this study. Here, the posted primary measure is explicitly at baseline, and post-treatment primary values or change estimates are not reported in the registry record. Without those outcome data, the reported baseline estimates cannot answer whether active iTBS reduced smoking or whether smoking-related cues affected craving.

The same caution applies to the secondary measures. Perceived stress and motivation to quit are posted as baseline measures, and no reported analyses are listed for them. Baseline summaries can describe the groups, but they do not establish changes in stress or motivation after intervention. Statistical significance of a baseline contrast, if present, would not on its own demonstrate a treatment effect.

What is the role of planning illustrations?

In general, a sample-size calculation links a target effect, variability, significance level, allocation, and desired power to a planning count. The registry’s illustration uses the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and the stated fractions of the observed effect. It is not the trial’s original design justification; that justification is not reported in the registry record. The resulting counts are planning illustrations, not evidence about the trial’s observed ability to detect an effect. Smaller target effects require more participants because they are harder to distinguish from background variation.

All these calculations depend on assumptions. In general, departures from the assumed variability, allocation, analysis method, or target effect can change the planning requirement. The registry record does not report whether the original design used those assumptions or whether an original sample-size calculation was performed. The posted illustrations therefore provide context for hypothetical future planning, not a retrospective judgment that the completed trial was adequately powered.

11. Confidence Intervals and Precision

The precision of an estimate is reflected in the width of its confidence interval: narrower intervals indicate less uncertainty, while wider intervals indicate more. For baseline self-reported cigarette consumption, the interval for Active TMS & Neutral Videos versus Sham TMS & Smoking Videos runs from -42.39 to 37.49. The interval for Active TMS & Smoking Videos versus Sham TMS & Smoking Videos runs from -39.54 to 33.2. Both include zero and allow for differences in either direction.

These intervals are wide relative to the estimates, so the recalculated contrasts do not precisely establish the size or direction of baseline differences. The corresponding unadjusted p-values are 0.904 and 0.864. Read together, the estimates and intervals do not provide a clear baseline separation between the active and sham groups. They do not demonstrate equivalence: establishing equivalence would require a prespecified margin and an analysis designed to assess whether the full uncertainty interval stays within that margin. Such a margin and analysis are not reported in the registry record.

In general, a confidence interval describes sampling uncertainty under the calculation’s assumptions. It does not account automatically for every source of uncertainty, such as measurement error, missing observations, choice of analysis, or unreported outcome selection. The primary measure is self-reported, and the registry record does not report further details about its measurement properties or missing-data handling.

Most importantly, these intervals concern baseline group means. Their precision cannot answer whether smoking changed after the intervention. Post-treatment primary results and treatment-effect intervals are not reported in the registry record. The baseline estimates therefore offer an imprecise description of starting consumption, not a precise estimate of treatment efficacy.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total participant counts or event totals. The registry’s stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The original trial’s own design assumptions and sample-size justification are not reported in the registry record.

In general, 80% power means that, if the assumed effect and other calculation assumptions were true, a study planned at that size would have an 80% chance of detecting the effect using the specified test. The 90% power column reflects a higher target chance under those same assumptions and therefore calls for more participants. These are planning targets, not a guarantee of a result. Smaller effects are harder to distinguish from random variation and require more participants; the figures for planning for 75% or 50% of the observed effect illustrate that pattern alongside planning for 100% of the observed effect.

The observed effects used in these illustrations come from the posted baseline summaries, not from a reported post-treatment outcome. The calculated sample sizes are hypothetical planning illustrations and are not observed power. They should not be read as the trial’s actual planned enrollment or as proof that the completed study could or could not detect an effect.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.450; pooled standard deviation σ = 78.089.
2. n = 2 × (1.96 + 0.842)² × 78.089² / -2.450² = 15,947.0, rounded up to 15,948 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -2.45                      # observed difference in means
sigma <- 78.0885227319364                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5271175)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 15,948 (80% power), 21,349 (90% power)
 75% of observed effect: n per arm = 28,351 (80% power), 37,953 (90% power)
 50% of observed effect: n per arm = 63,789 (80% power), 85,395 (90% power)
power.t.test: 15948 
Simulated power at n = 15,948 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 37 outcome measures, with 10 secondary outcomes posted, but it does not list reported analyses. It does not report a statistical analysis plan, a hierarchy of primary and secondary hypotheses, or a procedure for controlling multiplicity. When several outcomes or comparisons are examined, general statistical reasoning indicates that unadjusted p-values can overstate the strength of evidence if readers focus on whichever results appear most notable. Without a reported plan, it is difficult to distinguish confirmatory analyses from exploratory ones.

Missing-data methods and analysis populations are not reported in the registry record. The record does not state whether results were based on all randomized participants, participants who received treatment, participants who completed treatment, or another population. It also does not report reasons for missing measurements, handling of incomplete questionnaires, or whether any participants were excluded from particular analyses. Those details matter because missingness and exclusions can affect both group summaries and comparisons.

The posted group counts vary by outcome. For example, the primary baseline summaries list 29.0, 30.0, and 30.0 participants across the three arms, while the motivation-to-quit summaries list 27.0, 27.0, and 30.0. The registry record does not explain the difference in those outcome-specific counts. It would be inappropriate to infer why observations are absent or whether any count reflects withdrawal, nonresponse, or an analysis exclusion.

These reporting gaps limit assessment of how the results were selected, how uncertainty was handled across outcomes, and which participants contributed to each measure. They do not prove that the trial methods were inadequate; they mean that the relevant procedures are not reported in the registry record.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for each listed arm. The at-risk counts are 29, 30, and 30; the reported serious-event counts are zero in all three arms. Deaths are also reported as zero in each arm. These figures mean that no serious adverse events or deaths are recorded in the posted results for the stated at-risk groups.

Other adverse events affected 11 participants in Active TMS & Neutral Videos, 5 in Active TMS & Smoking Videos, and 7 in Sham TMS & Smoking Videos. These are separate from the serious-event counts. The registry does not provide event descriptions in the posted summary, and no top serious-event terms are listed. The record does not report further information about event definitions, severity grading, timing, or the method used to assess attribution.

Zero reported serious events should not be interpreted as proof that serious harms are impossible or that the interventions have no risks. These are descriptive safety counts from the registry record, and their interpretation is limited by the available reporting and the groups observed.

16. What the Result Does, and Does Not, Mean

The posted results establish what was recorded at baseline: mean self-reported cigarette consumption and baseline scores for perceived stress and motivation to quit in the listed arms. The unadjusted baseline comparisons have wide confidence intervals that include zero. They are compatible with differences in either direction and do not precisely identify the size of any starting-value contrast.

They do not establish that active iTBS reduced cigarette consumption, increased cessation, or affected craving. The primary endpoint is described as a before-treatment measure, while post-treatment smoking results and craving results are not reported in the registry record. Baseline comparisons cannot substitute for a treatment-versus-sham comparison of follow-up outcomes or change from baseline.

The record also cannot establish that the groups were equivalent at baseline. A non-significant unadjusted comparison is not an equivalence test, and no equivalence margin or suitable analysis is reported. Nor can the posted estimates determine why group counts vary across outcome measures, how missing data were handled, or whether the displayed summaries capture every prespecified analysis.

The study’s randomized, double-blind description and its treatment and cue conditions identify the question the investigators intended to examine. However, the results available in the registry record do not answer that clinical question. The appropriate conclusion is limited: the recorded baseline summaries offer imprecise descriptive comparisons, while treatment effects on smoking cessation, cigarette consumption after treatment, and cue-related craving remain unreported in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically informative because its stated clinical aim and its posted primary outcome do not align in time. The study summary describes smoking cessation and cue-related craving, while the primary measure reported in the results is usual cigarette consumption before treatment. That distinction is fundamental: baseline measurements characterize starting conditions, whereas efficacy requires outcomes measured after the intervention or an analysis of change.

The contrast illustrates why statistical interpretation should begin with the endpoint’s definition and timeframe, rather than with a p-value alone. A randomized, double-blind design can support a causal treatment comparison when relevant post-treatment outcomes are collected and analyzed appropriately. The design label alone does not turn a baseline difference into an estimate of treatment effect. Here, the available primary comparisons are unadjusted contrasts of starting means, and their intervals are broad.

The record also highlights the importance of outcome reporting. The summary identifies smoking cessation and craving as aims, but the posted outcome data are baseline consumption, stress, and motivation. Without post-treatment results, readers cannot assess whether the intended clinical outcomes changed. Reporting the analysis population, missing-data procedures, and multiplicity plan would also help readers evaluate how the results were generated and how much confidence to place in any one comparison.

Finally, the planning illustrations show how sample-size requirements depend on the assumed effect size and power target. Because they use observed baseline effects, they are not a substitute for the original design rationale or evidence about the trial’s actual power. The broader statistical lesson is that endpoint timing, uncertainty, planning assumptions, and completeness of outcome reporting all matter alongside the randomized design.

18. 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.

A central limitation of the available record is that the primary outcome is measured at baseline, before treatment. No post-treatment primary result or change estimate is reported, despite the study summary’s focus on smoking cessation. The posted data therefore cannot quantify treatment efficacy. Similarly, the stated investigation of cue-related craving is not represented by a reported craving result.

The available comparisons are unadjusted recalculations from group summaries. No sponsor-reported analyses are listed, and no statistical analysis plan, covariate adjustment, or repeated-measures approach is reported in the registry record. The confidence intervals are wide, limiting the precision of the baseline contrasts. The registry also does not explain why outcome-specific group counts differ or how missing measurements were handled.

The listed arms include active stimulation paired with neutral videos, active stimulation paired with smoking-related videos, and sham stimulation paired with smoking-related videos. A sham group paired with neutral videos is not listed. The posted arms therefore do not provide every possible combination of stimulation and cue type, limiting what can be inferred about separate cue and stimulation effects from the listed comparisons alone.

Further limitations include the absence of reported participant characteristics and detailed eligibility criteria, analysis populations, multiplicity procedures, and the original sample-size justification. The registry does not report enough information to assess adherence, treatment fidelity, or the completeness of follow-up. These are reporting limitations; the record does not establish whether the underlying study collected information that is not posted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Accelerated iTBS in Smoking Cessation — NCT05271175.
• Registry record last updated 2022-09-26; status last verified 2022-09.
• Results first posted 2022-09-13.
• 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.

22. Record Summary

NCT05271175, Accelerated iTBS in Smoking Cessation, is recorded as a completed randomized, double-blind, parallel-group study sponsored by Cyprus rTMS Center. Enrollment is 104. The study summary describes active or sham iTBS paired with video cues, with active stimulation delivered over the left DLPFC.

The posted primary outcome is mean self-reported cigarettes/day at baseline. Its unadjusted comparisons with the sham, smoking-video arm are imprecise and do not provide post-treatment evidence about smoking cessation. Posted secondary measures concern baseline perceived stress and motivation to quit. Post-treatment results for the stated smoking and craving aims, the analysis plan, missing-data methods, and original sample-size justification are not reported in the registry record.