Acetaminophen (APAP) +/- Oxycodone: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Acetaminophen (APAP) +/- Oxycodone (NCT04122443), a randomized phase 4 study. The primary outcome is Change in Pain Assessment.

2. Clinical Question

The question is about the difference between two treatment sequences in patients whose pain had not been adequately relieved by ibuprofen. Because both arms received ibuprofen before the Stage 2 medication, the contrast focuses on the additional medication strategy rather than on ibuprofen versus no treatment. The registry’s primary outcome is a continuous score, and the reported contrast is a difference in group means. Other outcomes listed in the registry include sustained pain relief, adequacy of analgesia, satisfaction with medication, and medication-related adverse events. Their presence as registered outcomes does not establish that results for each were posted. Further results for those outcomes are not reported in the registry record.

3. Trial Design

This is a randomized, parallel-group, Phase 4 study registered as completed. Montefiore Medical Center is listed as the sponsor. The registry gives an enrollment of 393 and describes a study based in emergency departments. The registered comparison is ibuprofen followed by acetaminophen alone versus ibuprofen followed by oxycodone/acetaminophen. The registry’s overall design fields identify randomized allocation, quadruple masking, and a parallel model.

The study description distinguishes two stages. Stage 1 is described as open label, and the primary outcome description states that no outcome measures were assessed during that stage. Stage 2 is described as double blinded; the primary pain assessment was conducted in this stage, two hours following treatment. The relationship between the overall quadruple-masking designation and the stage-specific descriptions is not explained in the registry record. The practical masking procedures and which roles were masked are also not reported in the registry record.

The posted primary outcome includes 77 participants in each of the two Stage 2 arms. These outcome denominators differ from the overall enrollment figure, but an explanation for the difference, including the numbers entering each stage or included in the analysis, is not reported in the registry record. The trial’s original sample-size justification, recruitment targets by stage, and any stopping or interim-analysis procedures are not reported in the registry record. The record lists four secondary outcomes and describes a total of five outcome measures, but the posted primary comparison is the change in pain assessment. These design details define the scope of the results; they do not by themselves establish how participants were handled in the analysis.

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.

Before assignment: During enrollment into Stage 1 (ibuprofen open label stage), 924 patients were screened for participation and 393 were enrolled. Of the 393, a total of 159 reported insufficient relief of pain from ibuprofen and requested more medication to treat the pain. Five patients who met criteria to progress to the randomized stage withdrew of their own volition. As such, 154 patients progressed to Stage 2. 77 were randomized to oxycodone/acetaminophen and 77 were randomized to acetaminophen alone.

Stage 1 - Open Label

Reasons for not completing this period:

Stage 2 - Double Blinded

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: 393 patients were enrolled into Stage 1 (Ibuprofen open label stage). 154 patients progressed to Stage 2 (two-arm, double blinded) of the study. An analysis of baseline characteristics inclusive of only the 239 Stage 1 participants was not conducted. As such, Age, Sex/Gender, and Pain Assessment baseline data representing only Stage 1 participants is not available.

6. Primary Endpoint

The registry lists the primary outcome as Change in Pain Assessment, measured over 2 hours following treatment.

The primary endpoint is change in pain assessment from baseline, measured with the Numeric Rating Scale. Participants verbally estimated current pain intensity on a scale from 0, indicating no pain at all, to 10, indicating the worst imaginable pain. The endpoint is a continuous measure, and the registry reports group means and standard deviations. Positive mean changes were associated in the registry description with increased pain relief.

The outcome was assessed two hours following treatment in Stage 2. A change score is used to describe how pain ratings shifted from baseline during that period, while comparing the mean changes between groups addresses whether the average recorded change differed by assigned medication strategy. Interpreting the scale requires attention to the stated direction: larger positive changes correspond to greater pain relief under the registry’s definition. The posted results do not provide individual participant scores or the full distribution of change scores, so the group mean does not describe every participant’s experience.

The registry’s outcome title refers to change in pain assessment, while the reported analysis is labelled as a mean difference in final values. The posted summary does not clarify that wording distinction. It reports values of 2.9 and 4.0 for the two arms and a mean difference of 1.1. The unit is recorded as a score on a scale. The meaning of the endpoint is therefore limited to the recorded pain-score outcome at the specified assessment, rather than a comprehensive measure of pain over time.

7. Results Posted in the Registry

• Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2): mean 4.00 versus 2.90 on control; difference 1.10 (95% CI 0.31 to 1.89), standardized effect d = 0.44; z-test p = 0.006.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous, so its arm-level summaries are means and standard deviations. A mean describes the average score change in a group. A standard deviation describes the spread of participant scores around that average. Neither statistic captures every feature of the distribution: for example, group means and standard deviations alone do not show whether scores were skewed or whether a small number of unusual values influenced the average.

What does the mean difference represent?

The reported mean difference compares the two group means. The acetaminophen arm’s mean is 2.9, and the oxycodone/acetaminophen arm’s mean is 4.0. The posted difference is 1.1 points, with the combination arm as the comparison group relative to the acetaminophen arm. Because the registry says that positive mean changes correspond to increased pain relief, the positive difference indicates that the combination arm had the higher average recorded change at the assessment time. This is a comparison of group averages, not a statement about each participant or a measure of how many participants experienced a particular outcome.

The registry’s reported analysis is labelled “Mean Difference (Final Values)” and gives a 95% confidence interval of 0.3 to 1.9. The primary outcome description, however, calls the endpoint change from baseline. The registry does not explain the difference in those labels, so the result is best described using the posted outcome and comparison wording without assuming details of the underlying model.

What does the unadjusted recalculation add?

An unadjusted recalculation uses the posted arm-level summary statistics to estimate a simple difference between group means and its uncertainty. It does not substitute for a trial’s complete analysis plan, and it does not account for adjustments or modeling choices that are not represented in those summaries. The recalculated mean difference is 1.1, with an unadjusted p-value of 0.006. The recalculation is useful as a check on the reported summary, but it cannot reconstruct unreported individual-level analyses. The registry’s reported result agrees with the recalculation to the displayed precision, and no discrepancy is flagged.

A p-value summarizes how unusual data at least as discrepant as those observed would be under a specified null model and the assumptions used for the test. It is not the chance that a treatment effect is real, and it does not measure the probability that the result will replicate. It also does not express the size of the group difference; the estimate and confidence interval address size and precision more directly.

Why can over-dispersion matter?

Over-dispersion is a general concern when observed variability is greater than a statistical model assumes. If a model understates variability, its uncertainty estimates may be too narrow and inferential results may appear more precise than warranted. For a continuous outcome, the standard deviations help describe observed spread, but a registry summary alone does not establish whether model assumptions were checked or whether an alternative variance model was needed. The methods used to assess distributional assumptions are not reported in the registry record. Thus, over-dispersion is a general statistical consideration, not a documented problem in this study.

What can be inferred about the analysis method?

The registry identifies the reported comparison as a superiority analysis and supplies a mean difference and confidence interval. It does not state the specific statistical test or model in the posted analysis details. Whether the estimate was adjusted for baseline pain, other covariates, or stratification factors is not reported in the registry record. The analysis population, treatment of protocol deviations, and approach to missing outcome values are also not reported. These omissions prevent a full reconstruction of the sponsor’s analysis and make the simple unadjusted recalculation only a limited companion to the posted result.

The parallel-group randomized design indicates that participants were assigned to distinct treatment arms, but the registry summaries do not establish the exact sequence of data exclusions or the completeness of follow-up. The arm-level outcome counts are 77 per arm; the registry gives overall enrollment of 393 and does not explain how participants flow from enrollment to the posted Stage 2 outcome sample. Without a participant flow description or a stated analysis population, it is not possible to determine from the record whether the reported comparison includes all randomized participants or only those with an available endpoint.

The registry lists secondary outcomes such as sustained pain relief, adequacy of analgesia, satisfaction with medication, and medication-related adverse events. Multiple outcome testing can increase the chance of finding at least one apparently notable result when many comparisons are assessed. That is a general statistical issue. Whether the study prespecified a hierarchy, controlled the family-wise error rate, or adjusted for multiple comparisons is not reported in the registry record. The primary comparison can be interpreted on its own terms, but the record does not establish how it fits into a broader multiplicity plan.

10. Confidence Intervals and Precision

The sponsor-reported 95% confidence interval for the mean difference runs from 0.3 to 1.9 points. A confidence interval describes a range of values reasonably compatible with the observed data and the analysis assumptions. In repeated use of the same procedure under its assumptions, intervals constructed in this way would cover the true parameter at the stated rate. For an individual study, the interval is not a guarantee that the true value lies inside it, nor is it a range containing a stated proportion of individual participant outcomes.

The interval is centered around the reported difference of 1.1 and spans values that are positive. Its width shows that the estimate is not exact: the data are compatible with a range of mean differences rather than only the point estimate. The lower and upper limits describe uncertainty in the group-level contrast, not uncertainty about an individual participant’s pain score. The standard deviations of 2.4 and 2.6 describe variability among participants and serve a different purpose from the confidence interval.

The unadjusted recalculation produces a confidence interval that agrees with the sponsor’s interval to the displayed precision. The sponsor’s values are reported to one decimal place, so the posted interval gives a rounded view of the limits. No discrepancy is flagged. The reported analysis method is not specified, which limits assessment of the assumptions behind the sponsor’s interval. Details of missing-data handling and any model adjustments are also not reported in the registry record.

Precision should be considered alongside the endpoint’s timing and study population. The interval pertains to the reported mean difference for the two-hour assessment in Stage 2. It does not quantify effects at other assessment times or establish how the result varies across participant subgroups. Subgroup-specific estimates and their precision are not reported in the registry record.

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 sample-size display is a planning illustration based on the observed mean difference, not a record of the trial’s original design calculation. The figures are participants per arm, rather than total events. The listed scenarios consider detecting 100%, 75%, and 50% of the observed effect. For each scenario, the display gives the number of participants per arm for 80% power and for 90% power.

In general, power is the probability that a study would detect an effect at a chosen significance level if that effect were the true one and the design assumptions held. The 80% power column describes the illustrated number of participants per arm for an analysis designed to have an 80% chance of detecting the specified effect under those assumptions. The 90% power column makes the corresponding illustration for a 90% chance. These are prospective planning quantities; they do not describe the probability that the completed study’s result is correct.

The planning assumptions listed with the display are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is defined as the stated fraction of the observed effect. Under these assumptions, the listed participants per arm are 82 and 109 for planning around 100% of the observed effect, 145 and 194 for 75%, and 325 and 435 for 50%, for 80% and 90% power respectively. Smaller effects require more participants to detect under the same assumptions, which is why the planning figures rise as the target effect becomes a smaller fraction of the observed effect.

These calculations are not observed power. They are illustrations based on the observed effect and the stated assumptions, not evidence about the trial’s original planned sample size or its actual probability of detecting an effect. The trial’s original sample-size justification and design assumptions are not reported in the registry record.

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 = 1.100; pooled standard deviation σ = 2.502.
2. n = 2 × (1.96 + 0.842)² × 2.502² / 1.100² = 81.2, rounded up to 82 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 <- 1.1                      # observed difference in means
sigma <- 2.50199920063936                     # 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(4122443)
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 = 82 (80% power), 109 (90% power)
 75% of observed effect: n per arm = 145 (80% power), 194 (90% power)
 50% of observed effect: n per arm = 325 (80% power), 435 (90% power)
power.t.test: 82.2 
Simulated power at n = 82 per arm: 0.798 (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 sponsor’s posted analysis reports a mean difference of 1.1, with a 95% confidence interval from 0.3 to 1.9, and labels the comparison as superiority. The unadjusted recalculation from the posted arm summaries also gives a mean difference of 1.1. Its confidence limits agree with the sponsor’s reported limits to the displayed precision. No discrepancy is flagged.

The recalculation also gives an unadjusted p-value of 0.006. The sponsor’s reported analysis entry does not include a p-value, and its specific statistical method is not stated in the registry record. It is therefore important not to treat the recalculated p-value as though it were necessarily the sponsor’s test result. The recalculation is a simple analysis of the posted summary statistics; the sponsor’s reported confidence interval and superiority label remain the registry’s own analysis information.

The posted comparison is based on 77 participants per arm. The registry does not describe the analysis population, adjustment variables, or missing-data method, so the relationship between the simple recalculation and any fuller sponsor analysis cannot be determined in detail. The close agreement of the displayed mean difference and interval supports consistency at the reported precision, but does not reveal unreported model choices.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists four secondary outcomes: sustained pain relief, adequacy of analgesia, satisfaction with medication, and medication-related adverse events. It also reports a total of five outcome measures, while the primary outcome is the change in pain assessment. The available primary comparison is the mean difference in the Stage 2 pain measure. Results for the listed secondary outcomes, apart from posted adverse-event information, are not reported in the registry record.

When a study evaluates several outcomes or makes multiple comparisons, the chance of observing at least one result that appears notable can increase. This is a general statistical consideration, not evidence that a particular error occurred in this trial. A protocol may address multiplicity by specifying a primary outcome, ordering tests, or adjusting significance thresholds. Whether the study used a multiplicity strategy, and how the primary analysis was protected from other comparisons, is not reported in the registry record. No adjustment should be assumed.

Missing-data handling is also not reported in the registry record. The record does not state how participants without an observed two-hour score were treated, whether imputation was used, or what assumptions were made about missingness. Nor does it report sensitivity analyses exploring alternative missing-data assumptions. These details matter because results based only on observed scores can differ from results under other assumptions when outcome data are missing.

The analysis population is not defined in the posted results. The registry reports 77 participants per arm for the primary outcome and overall enrollment of 393, but does not explain the movement from overall enrollment to the Stage 2 outcome groups. It is not stated whether the reported analysis follows intention-to-treat principles, includes only participants with complete measurements, or uses another population definition. Reasons for exclusions or departures from assigned treatment are not reported in the registry record.

The registered design fields identify randomized allocation, while the stage descriptions identify Stage 1 as open label and Stage 2 as double blinded. The registry does not explain how these stages relate to the analysis population or provide details about adherence, protocol deviations, or masking procedures. These omissions constrain assessment of bias and robustness. They do not change the numerical result, but they limit how completely the analysis can be evaluated.

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 zero serious adverse events in each of the two Stage 2 medication groups and zero deaths in those groups. The serious-event risk groups include 74 participants in the ibuprofen-then-acetaminophen arm and 76 in the ibuprofen-then-oxycodone/acetaminophen arm. The registry separately reports 6 participants affected by other adverse events in the acetaminophen arm and 18 in the oxycodone/acetaminophen arm, with 74 and 76 participants at risk respectively.

These safety figures should be read as posted counts, not as a complete characterization of safety. The serious-event denominators differ from the primary outcome sample sizes of 77 per arm. The registry does not explain the difference. No serious adverse-event terms are listed among the top serious terms, and the reported deaths are zero in both Stage 2 groups.

The record does not describe event severity beyond the serious-versus-other distinction, the timing of events, the method used to collect them, or whether participants could experience more than one event. The counts do not establish why an event occurred or whether it was caused by a medication. They also do not support broad conclusions from the absence of reported serious events; interpretation is limited to the counts and denominators posted in the registry.

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

The posted primary result is a positive mean difference in pain-score change at two hours following treatment: 1.1 points in favor of the ibuprofen-then-oxycodone/acetaminophen group relative to the ibuprofen-then-acetaminophen group, with a 95% confidence interval from 0.3 to 1.9. The registry defines positive changes as associated with increased pain relief. These are the recorded group summaries for the Stage 2 outcome sample, with 77 participants in each arm.

The result does not mean that every participant in one group experienced more pain relief than every participant in the other. Group means summarize averages and can conceal substantial variation. The standard deviations, 2.4 and 2.6, show that scores varied within both groups. The posted summary does not give individual score distributions, the number of participants meeting a threshold for meaningful relief, or the proportion whose pain improved.

The result applies to the endpoint and time specified in the registry. It does not establish how pain scores compared at other times, how long any change lasted, or whether there were differences in the other registered outcomes. Although the registry lists sustained pain relief, adequacy of analgesia, satisfaction, and medication-related adverse events, results for several of these outcomes are not reported in the registry record.

The confidence interval communicates uncertainty about the mean difference under the reported analysis. It does not express the likely range of individual responses, and the p-value from the unadjusted recalculation does not measure clinical importance. The registry does not define a threshold for interpreting the size of the score difference, so the practical importance of the estimate cannot be determined from the posted statistical result alone.

Finally, the record does not report the sponsor’s specific statistical method, analysis population, missing-data approach, or original sample-size justification. It also does not explain why the primary outcome sample sizes are smaller than total enrollment. These gaps do not erase the posted comparison, but they limit evaluation of how the analysis was conducted and how it relates to all enrolled participants. The appropriate interpretation is therefore bounded to the recorded Stage 2 group comparison and its stated uncertainty.

17. Why This Trial Matters Statistically

This trial offers a clear example of why an estimated difference and its uncertainty should be read together. The mean difference of 1.1 describes the direction and size of the average contrast on the recorded pain scale, while the 95% confidence interval from 0.3 to 1.9 shows that the estimate is not known with exact precision. The p-value from the unadjusted recalculation addresses compatibility with a null model, not the importance of the difference or the likely response of an individual participant.

The endpoint is a continuous change score. Mean-based methods provide a concise comparison, but they do not convey the full distribution of responses. The arm standard deviations of 2.4 and 2.6 remind readers that participant scores varied around the means. This distinction is central to interpreting clinical trial summaries: a difference in average outcomes is not the same as a uniform difference in individual outcomes.

The record also illustrates the importance of relating a result to its population, time point, and analysis sample. The primary outcome concerns Stage 2 and a two-hour assessment, with 77 participants per arm, while total enrollment is 393. Without a participant-flow explanation, analysis-population definition, and missing-data methods, the record does not fully show how the posted comparison relates to all enrolled participants.

Finally, the study has several registered secondary outcomes, but a primary result should not be taken as a substitute for those outcomes or for a multiplicity plan. The statistical interpretation is strongest when the estimate, interval, outcome definition, analysis details, and reporting limitations are considered together. This case highlights both the value of transparent effect estimates and the limits of registry summaries when analytic details are not posted.

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.

Several limitations specific to this registry record affect interpretation. The record describes a two-stage study, with Stage 1 open label and Stage 2 double blinded, but the primary outcome is assessed only in Stage 2. No outcome measures were assessed in Stage 1 according to the outcome description. The registry does not explain the practical relationship between the stage structure and the overall quadruple-masking designation, or how participants progressed between stages.

Overall enrollment is 393, while the primary outcome groups each contain 77 participants. The serious-adverse-event risk groups contain 74 and 76 participants. The registry does not explain these different denominators, provide a participant flow, or state why some participants are not included in the posted outcome summaries. The analysis population and treatment of missing observations are not reported in the registry record.

The sponsor’s statistical method is not identified in the posted analysis entry. It is not stated whether the comparison adjusted for baseline pain or other factors, or how model assumptions were evaluated. The recalculation is unadjusted and cannot recover details of any individual-level analysis. The original sample-size rationale and trial-specific design assumptions are also not reported in the registry record; the displayed planning illustrations are based on the observed effect and should not be read as the trial’s original calculation.

The primary endpoint is a self-reported pain rating at a single stated assessment time. The registry does not provide individual observations, distributional summaries beyond the standard deviations, or a threshold for interpreting the size of a difference. The sponsor’s result is labelled as a mean difference in final values, whereas the outcome description refers to change from baseline; the record does not clarify this terminology.

Finally, the registry lists secondary outcomes but does not post results for all of them, and it does not report a multiplicity strategy. The safety counts are limited to the posted categories and denominators. These reporting gaps constrain assessment of the breadth, robustness, and generalizability of the findings without changing what the posted primary summary states.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Acetaminophen (APAP) +/- Oxycodone — NCT04122443.
• Registry record last updated 2024-02-28; status last verified 2024-02.
• Results first posted 2024-02-28.
• 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

NCT04122443 is a completed, randomized, parallel-group Phase 4 study sponsored by Montefiore Medical Center. It enrolled 393 participants and examined emergency-department treatment strategies for acute musculoskeletal pain after insufficient relief with prescription-strength ibuprofen. The primary Stage 2 endpoint was change in pain assessment on the Numeric Rating Scale two hours following treatment.

The posted primary outcome includes 77 participants per arm. Mean changes were 2.9 with ibuprofen followed by acetaminophen and 4.0 with ibuprofen followed by oxycodone/acetaminophen. The sponsor reports a mean difference of 1.1, with a 95% confidence interval from 0.3 to 1.9, and labels the analysis as superiority. An unadjusted recalculation agrees with the reported result to displayed precision.

Serious adverse events and deaths are recorded as zero in both Stage 2 groups. The registry does not report several important analysis details, including the analysis population, missing-data handling, specific statistical method, and explanation for differences in denominators. The findings therefore describe the posted Stage 2 comparison, with those reporting limitations in view.