Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity (NCT00460655), a randomized phase 3 study. The primary outcome is Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12).

2. Clinical Question

The clinical question concerns people with post-stroke lower limb spasticity and equinus deformity. The registry describes a Phase 3 study designed to confirm whether GSK1358820 had superior efficacy to placebo, assessed through change in the Modified Ashworth Scale (MAS) ankle score during the double-blind phase.

The registry lists 120 participants as enrollment. The posted primary outcome results include 58 participants in the BTX 300U group and 62 in the placebo group. These are the analysis-group counts reported for this outcome, not a statement about how many participants completed every part of the study.

3. Trial Design

This was a Phase 3, randomized, quadruple-masked, parallel-group study with placebo control. Its official title describes a multicenter, double-blind, placebo-controlled treatment phase followed by an open-label GSK1358820 phase. The record lists GlaxoSmithKline as sponsor and the study status as completed. The start is recorded as 2007-05, and primary completion as 2008-12.

The primary comparison is the double-blind phase comparison of BTX 300U with placebo. Although the registry lists GSK1358820 as an intervention, the primary results identify the active group as “BTX 300U.” The arm descriptions are blank, and the registry record does not report further detail to reconcile the names. The comparator group is identified as placebo.

Randomization assigns participants to study groups by chance, while masking is intended to limit knowledge of assigned treatment among the masked parties. “Quadruple” is the registry’s masking classification; the identities of the parties included in that classification are not reported in the registry record. A parallel design means the groups are compared as separate treatment groups, rather than all participants crossing through both arms during the primary comparison.

The study also included open-label treatment and secondary outcome assessments. Listed secondary measures include MAS ankle score, Physician’s Rating Score, walking time over 10 meters, and functional disability ratings by the investigator, participant, and physiotherapist or occupational therapist. The record lists follow-up assessments during the open-label phase as well. These additional outcomes provide context for the scope of data collection, but the posted primary result concerns the MAS ankle-score AUC through Week 12 of the double-blind phase.

The registry does not report the randomization procedure, allocation concealment details, the identities covered by masking, the treatment schedule, or the original design assumptions for determining enrollment. Those details should not be inferred from the study label or the outcome results.

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.

Double-Blind Phase (12 Weeks)

Reasons for not completing this period:

Open-Label Phase (36 Weeks)

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS): all participants randomized, with the exception of those who did not receive any investigational product and those with no assessment of post-treatment MAS ankle score

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 Area Under the Curve (AUC) for the Change From Baseline in Modified Ashworth Scale (MAS) Ankle Score to the End of the DB Phase (Week 12), measured over Baseline, Week 12.

The primary endpoint is the area under the curve (AUC) for change from baseline in the MAS ankle score through the end of the double-blind phase at Week 12. The MAS is described as a 6-point scale with scores 0, 1, 1+ (regarded as 1.5), 2, 3, and 4. The registry describes 0 as no increase in muscle tone and 4 as the affected part or parts being rigid in flexion or extension.

For each time point in the double-blind phase, change from baseline was calculated. The AUC summarizes the course of those changes over time as the area between the change curve and the horizontal axis. It is reported in score*week units. In this registry’s interpretation, negative changes from baseline indicate improvement, so the AUC has a negative sign when the change curve is negative.

An AUC can capture the pattern of change across the assessment period rather than relying on a single measurement at the final visit. It combines the amount and duration of change into one summary measure. That can be useful when the study question concerns the course of a continuous outcome over time. However, the summary does not show every individual time point or the range of participant-level responses. The registry’s endpoint description does not report the exact calculation details, such as the numerical integration rule.

The measure is a continuous outcome summarized as a mean and standard deviation. Its interpretation depends on the defined MAS scoring and the endpoint’s time window; it should not be read as a count of participants or as a direct measure of every aspect of function.

7. Results Posted in the Registry

• BTX 300U: mean -8.51 versus -5.08 on control; difference -3.43 (95% CI -5.82 to -1.04), standardized effect d = -0.51; z-test p = 0.005.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: each participant’s AUC is a numerical score, and the registry reports group means and standard deviations. A mean describes the group’s average endpoint value. A standard deviation describes how dispersed participant values are around that mean. They answer different questions: the mean locates the center of the group’s observed values, while the standard deviation describes variability among those values.

What does the mean difference represent?

The reported comparison is the mean difference for BTX 300U relative to placebo. Its estimate is -3.428 score*week. A negative difference means the active-group mean AUC is numerically lower than the placebo-group mean AUC. The endpoint definition says negative changes indicate improvement and that the AUC has a negative sign. Thus, the direction of the numerical contrast is consistent with a more negative average AUC in the BTX 300U group. This interpretation describes the scale and contrast, not a guarantee of benefit for any individual.

The test named in the registry is a two-sided t-test. A t-test assesses whether the observed difference in means is compatible with a null model in which the population mean difference is zero, under the assumptions of the test. “Two-sided” means departures in either direction are considered, rather than testing only for a difference in one prespecified direction. The reported p-value is 0.006. It quantifies how unusual the observed test result, or a more extreme one, would be if the null model and test assumptions held. It does not provide the probability that the null model is true.

What does the confidence interval add?

The sponsor-reported 95% confidence interval for the mean difference extends from -5.841 to -1.016. A confidence interval expresses uncertainty about an estimated parameter using a method with a stated long-run coverage property: across repeated studies under the method’s assumptions, intervals constructed this way would contain the true parameter at the stated rate. For this single study, the interval gives a range of values compatible with the data and analysis method. It is not a range containing a stated proportion of individual participants, and it does not assign a probability to each possible value.

The unadjusted recalculation uses the posted group means, standard deviations, and group sizes to form a simple comparison. It yields the same mean difference, -3.428, but a 95% confidence interval from -5.816 to -1.04 and p = 0.005. Such a calculation is based on summary statistics and does not reproduce any unreported features of the sponsor’s analysis. The registry’s reported analysis remains the direct account of the trial analysis; recalculated values are useful as a transparent cross-check, not as evidence that the sponsor used a particular hidden method.

Why can a summary-statistic recalculation differ?

Small differences can arise when analyses use different details, such as the precise variance estimate, handling of missing observations, or model specification. The registry record does not describe enough analysis detail to identify a cause for the small numerical differences in the confidence limits and p-values. It would be speculative to attribute them to a particular procedure. The agreement in the reported point estimate does not make the uncertainty calculations identical.

General statistical context: an unadjusted comparison treats the stated endpoint contrast as the test being evaluated, without correcting its significance level for other outcomes or repeated analyses. When many questions are tested, the chance of at least one apparently unusual result can increase. A multiplicity procedure can address that issue, but the registry record does not report whether a correction was planned or applied. The reported p-value should therefore be understood as the result for the stated analysis, not assumed to be a family-wise adjusted result.

What is the role of dispersion?

The standard deviations are 6.69 in the BTX 300U group and 6.65 in the placebo group. They indicate considerable variation in endpoint values around the group averages, but do not by themselves reveal whether the values are symmetric, clustered, or influenced by unusual observations. General statistical context: if participant outcomes vary more than a model assumes, standard errors and confidence intervals can be unreliable. This is often described as over-dispersion in settings where a model expects less variability. The posted endpoint is continuous and the record does not report a specific over-dispersion assessment, distributional diagnostic, or robust variance analysis; none should be assumed.

The mean comparison also reduces the full outcome distribution to a small set of summaries. It cannot show how many participants improved, stayed unchanged, or had a higher score, because those counts are not reported for the primary endpoint. Nor does a group-level mean establish the likely result for a specific participant. The endpoint AUC itself summarizes repeated scores, so interpretation depends both on the MAS measurements and on how those measurements are combined over the double-blind period.

The analysis population is described as the Full Analysis Set, including all randomized participants except those who received no investigational product and those with no post-treatment MAS ankle assessment. This is not a complete description of missing-data handling: the registry does not state how any other missing measurements were treated, whether values were imputed, or whether sensitivity analyses were conducted. Because exclusions and missing outcomes can affect group comparisons, those details are relevant to judging how robust the estimate is.

Finally, statistical significance and clinical importance should not be conflated. The p-value and confidence interval address statistical compatibility and precision under an analysis model. The registry does not report a threshold for a clinically important difference in this AUC measure. The result therefore supports a numerical comparison of group means, but the clinical meaning of the estimated difference cannot be settled by the p-value alone.

10. Confidence Intervals and Precision

The sponsor-reported estimate is a mean difference of -3.428 score*week, with a 95% confidence interval from -5.841 to -1.016. The interval is entirely below zero, indicating that the reported analysis places the estimated difference on the negative side of the no-difference value. Under the endpoint’s stated direction, a negative AUC change indicates improvement. The interval’s endpoints also show that the estimated magnitude is uncertain: values across a range of negative differences are compatible with the reported data and method.

The interval is not a prediction range for individual participants. Individual AUC values may vary around the group mean, as reflected by standard deviations of 6.69 for BTX 300U and 6.65 for placebo. A confidence interval for a group contrast and the spread of participant values answer separate questions. The interval also does not establish whether the estimated difference crosses a clinically meaningful threshold; such a threshold is not reported in the registry record.

The simple unadjusted recalculation gives a 95% confidence interval from -5.816 to -1.04. Its endpoints are close to, but not identical to, the sponsor-reported limits. The reported estimate is the same, while the recalculated p-value is 0.005 compared with the sponsor-reported 0.006. These small differences are a reason to distinguish the registry’s reported analysis from a recalculation using summary data.

Precision depends on the amount of information, variability, and analysis assumptions. The record reports the primary outcome group counts and standard deviations, but does not provide participant-level values, detailed model diagnostics, or the handling of all missing data. Consequently, further checks of distributional assumptions or alternative analysis choices cannot be made from the registry record alone.

11. 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 entries are illustrations based on the observed mean difference, not the trial’s original design calculations. For this continuous outcome, the figures are participants per arm, not total event counts. The underlying illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers detecting the stated fraction of the observed effect.

The 80% power column gives the illustrative number of participants per arm under those assumptions for a design with an 80% chance of detecting the specified effect if that effect were the true one. The 90% power column uses a higher chance of detection under the same general assumptions and therefore requires a larger planning group for the same effect size. For example, planning for 100% of the observed effect lists 60 participants per arm for 80% power and 80 participants per arm for 90% power.

Planning for 75% of the observed effect lists 106 participants per arm for 80% power and 142 participants per arm for 90% power. Planning for 50% of the observed effect lists 238 participants per arm for 80% power and 319 participants per arm for 90% power. The pattern illustrates a general principle: smaller effects are harder to distinguish from random variation, so they require more participants under otherwise similar assumptions.

These are hypothetical planning illustrations computed from the observed effect, not the original trial’s documented design assumptions. The registry record does not report the trial’s own sample-size justification. This is not observed power: it does not describe the probability that the completed study detected an effect, nor does it measure the reliability of the observed estimate.

12. 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 = -3.428; pooled standard deviation σ = 6.669.
2. n = 2 × (1.96 + 0.842)² × 6.669² / -3.428² = 59.4, rounded up to 60 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 <- -3.428                      # observed difference in means
sigma <- 6.6693396382886                     # 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(460655)
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 = 60 (80% power), 80 (90% power)
 75% of observed effect: n per arm = 106 (80% power), 142 (90% power)
 50% of observed effect: n per arm = 238 (80% power), 319 (90% power)
power.t.test: 60.4 
Simulated power at n = 60 per arm: 0.794 (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.

13. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary comparison as a two-sided t-test, with a mean difference of -3.428, a 95% confidence interval from -5.841 to -1.016, and p = 0.006. The analysis compares BTX 300U with placebo. The registry record does not provide further details of the test’s variance specification or any additional model terms.

A simple unadjusted recalculation from the posted group summaries gives the same mean difference, -3.428, but a 95% confidence interval from -5.816 to -1.04 and p = 0.005. The point estimate agrees, while the uncertainty limits and p-value differ slightly. The recalculation is a summary-statistic check and does not reproduce any analysis steps that are not described in the registry record.

These recalculated figures should be kept distinct from the trial’s reported results. The sponsor’s analysis is the analysis reported in the registry, while the recalculation is a separate unadjusted calculation. The record does not identify why the small differences occur, so attributing them to a particular statistical choice would be speculative. There is no reported discrepancy flag for this comparison.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and 12 posted secondary outcomes, alongside one analysis for the primary outcome. Secondary measures include change in MAS ankle score, Physician’s Rating Score, time to walk 10 meters, and functional disability ratings assessed by several observers. Open-label phase measures are also listed. The existence of multiple outcomes means that the primary result should be distinguished from findings across the broader set of measured outcomes.

The registry record does not report a multiplicity-adjustment procedure, a hierarchy for testing outcomes, or whether any outcomes were designated as confirmatory versus exploratory beyond identifying the primary endpoint. It is therefore not possible to determine from the record whether the reported p-value was adjusted for the number of outcomes or analyses. The stated p = 0.006 should be read as the p-value for the reported primary comparison, not assumed to control the overall probability of a false positive across all study questions.

The analysis population is described as the Full Analysis Set. It includes all randomized participants except those who received no investigational product and those with no post-treatment MAS ankle assessment. The record does not report detailed counts for each exclusion or a full account of missing primary outcome observations. It also does not report the procedure for handling missing measurements, such as imputation, use of available observations, or sensitivity analyses.

Other analysis-plan information is also not reported in the registry record, including whether interim analyses were conducted, the original sample-size justification, the prespecified statistical analysis plan, or model diagnostics. Those omissions do not negate the posted result, but they limit assessment of how the reported analysis relates to all planned analyses and how sensitive it may be to missing data or analytic assumptions.

General statistical context: multiplicity matters because testing many hypotheses can increase the chance of at least one result appearing statistically unusual by chance. Missing data matter because exclusions or incomplete follow-up can change the analyzed population and potentially affect estimates. Without details on adjustment and missing-data procedures, these issues remain uncertainties rather than grounds for assuming either a particular bias or a particular correction.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: angina pectoris (3.4%), epilepsy (2.0%), depression (2.0%), gastroenteritis (2.0%), convulsion (1.8%).

The registry reports serious adverse events for the double-blind groups as 5 of 58 in BTX 300U and 1 of 62 in placebo. It also reports other adverse events as 16 of 58 and 16 of 62, respectively. These are counts of participants affected relative to the stated at-risk group sizes, as presented in the registry; the record does not provide event-level timing or duration for these summaries.

For the open-label sequences, the serious adverse event counts are 3 of 50 for DB BTX + OL BTX and 8 of 57 for DB Placebo + OL BTX. The corresponding other adverse event counts are 23 of 50 and 16 of 57. These groups reflect different treatment sequences and should not be treated as a randomized comparison equivalent to the double-blind BTX 300U-versus-placebo contrast.

The registry lists serious-event terms with percentages, including Angina pectoris (3.4%), Epilepsy (2.0%), Depression (2.0%), Gastroenteritis (2.0%), Convulsion (1.8%), and Facial bones fracture (1.8%). The record does not specify the treatment group for these term-level percentages in the posted list, so they should not be assigned to a particular arm. Death counts are not reported in the registry record. These summaries describe reported events; they do not by themselves establish that an event was caused by study treatment.

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

The posted primary results describe a difference between group averages in the AUC for MAS ankle-score change through Week 12 of the double-blind phase. The BTX 300U mean was -8.513 score*week, compared with -5.085 score*week for placebo. The sponsor-reported mean difference was -3.428, with a 95% confidence interval from -5.841 to -1.016 and p = 0.006. The endpoint definition identifies negative changes as improvement, so the active group’s mean AUC was more negative over this period.

This is evidence about a group-level endpoint under the reported analysis, not a description of every participant. It does not say how many individuals experienced a particular change, how outcomes were distributed, or whether a particular person would have the same outcome. The group standard deviations indicate variation around the means, but the registry does not provide participant-level results for evaluating the range or shape of that variation.

The result also does not alone establish clinical importance. The registry does not report a minimum clinically important difference for the AUC or another threshold by which to judge the size of the mean difference. A confidence interval describes statistical uncertainty, and a p-value describes compatibility with a null model under test assumptions; neither substitutes for a clinical importance threshold.

The primary result is limited to the double-blind comparison and the specified MAS ankle-score endpoint. The study had an open-label phase, but that phase is not the primary comparison. The registry’s record does not provide enough detail to assess every design and analysis decision, including the original sample-size rationale, detailed missing-data methods, and multiplicity handling.

Accordingly, the posted data support a numerical comparison of the observed group means and report statistical evidence against a zero mean difference for the primary analysis. They do not establish outcomes beyond the measured endpoint and period, prove a mechanism, or settle the meaning of the difference for individual patients.

17. Why This Trial Matters Statistically

This trial illustrates why the definition of an endpoint matters to interpretation. The primary outcome is not a single MAS assessment at Week 12; it is the AUC for change from baseline through Week 12. That summary incorporates the pattern of change over the double-blind period, and its units are score*week. The endpoint description also explicitly defines the direction: negative changes indicate improvement, and the AUC has a negative sign.

It also demonstrates the distinction between a point estimate, uncertainty, and participant variability. The mean difference is -3.428, while the sponsor-reported confidence interval runs from -5.841 to -1.016. The standard deviations describe spread in each group rather than uncertainty in the contrast. Keeping those quantities separate helps prevent a confidence interval from being mistaken for a range of individual outcomes.

The posted primary analysis and the simple unadjusted recalculation have the same mean difference but slightly different confidence limits and p-values. This provides a practical example of why a recalculation from summary data should be labeled as such and not presented as if it were the trial’s original analysis. The registry’s report is the direct record of the sponsor’s stated test, while the recalculation is a transparent check based on the group summaries.

Finally, the record contains an extensive set of secondary measures and an open-label phase, while the primary conclusion rests on a specified double-blind comparison. The absence of reported multiplicity and missing-data details places limits on broader interpretation. Statistically, the case underscores the value of reading the outcome definition, analysis population, reported interval, and trial record omissions together rather than relying on a p-value alone.

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.

The registry record leaves several details necessary for a full assessment unreported. It does not give the original sample-size justification or the trial’s prespecified statistical analysis plan. The planning illustrations based on the observed effect are not a substitute for those original design assumptions. Interim analyses are also not reported in the registry record.

The treatment naming is not fully reconciled: the intervention list identifies GSK1358820, while the posted active arm is called BTX 300U. The arm descriptions are blank. The record also does not identify which parties were included in the quadruple masking classification or provide detailed randomization and allocation-concealment procedures.

For the primary endpoint, the Full Analysis Set excludes randomized participants who received no investigational product and those with no post-treatment MAS ankle assessment. Detailed counts for exclusions are not reported, and the handling of other missing measurements is not described. No sensitivity analyses or diagnostic checks are reported in the registry record. These gaps limit assessment of how missingness or model assumptions could affect the estimated difference.

The registry lists multiple secondary outcomes but does not report how multiplicity was handled. The primary confidence interval and p-value are therefore interpreted as reported for the primary analysis, without assuming an adjustment across outcomes. The record also provides no clinical importance threshold for the AUC, which limits interpretation of the magnitude in practical terms.

Finally, adverse-event summaries provide counts and selected serious-event terms, but the term-level list does not specify treatment groups, and deaths are not reported in the registry record. The open-label safety groups represent treatment sequences and should not be treated as a randomized comparison equivalent to the double-blind groups. These limitations define what can be concluded from the registry record without implying that unreported procedures were or were not performed.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity — NCT00460655.
• Registry record last updated 2010-09-08; status last verified 2010-08.
• Results first posted 2010-01-26.
• 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

NCT00460655 is a completed Phase 3 randomized, quadruple-masked, parallel, placebo-controlled study sponsored by GlaxoSmithKline. The registry records a start of 2007-05, primary completion in 2008-12, and enrollment of 120. The official title describes a multicenter double-blind phase followed by open-label treatment.

The primary outcome was AUC for change from baseline in MAS ankle score through Week 12 of the double-blind phase. The posted mean difference for BTX 300U relative to placebo was -3.428 score*week. The sponsor-reported 95% confidence interval was -5.841 to -1.016, with p = 0.006 from a two-sided t-test. Negative changes are defined in the registry as improvement.

The record lists 12 posted secondary outcomes and safety summaries for the double-blind and open-label treatment sequences. Details on multiplicity adjustment, the original sample-size rationale, and the handling of missing data are not reported in the registry record.