This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall (NCT00089544), a non-randomized phase 2 study. The primary outcome is Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00089544 |
| Phase | Phase 2 |
| Condition | Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma AJCC v7, Stage II Adult Soft Tissue Sarcoma AJCC v7 |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Patients with primary soft tissue sarcoma of the arm, leg, or body wall were the target population. The registry also lists recurrent adult soft tissue sarcoma and Stage I, Stage II, and Stage III adult soft tissue sarcoma among the conditions. The primary endpoint population was eligible patients who started study treatment.
Intervention
The study examined preoperative thalidomide with radiation therapy. The pathway for high-grade or intermediate-grade disease also included doxorubicin, ifosfamide, and dacarbazine. Surgery was part of both cohort descriptions.
Comparator
This was a non-randomized, parallel study, not a randomized comparison. Cohort A received chemotherapy, radiation, thalidomide, and surgery; Cohort B received thalidomide, radiation, and surgery. The cohorts should not be treated as like-for-like control groups.
Primary question
The primary endpoint concerned whether eligible patients who started treatment received the specified levels of preoperative radiation, chemotherapy when applicable, and thalidomide. The registry record says early study closure meant this endpoint could not be fully evaluated according to the protocol plan.
The clinical rationale described in the registry is that preoperative treatment might shrink a tumor before surgery. The study’s stated aims were to examine preoperative thalidomide with radiation for low-grade primary soft tissue sarcoma, and thalidomide with radiation and chemotherapy for high-grade or intermediate-grade primary soft tissue sarcoma. These aims describe the questions motivating the trial, not evidence that either treatment pathway produced tumor shrinkage or improved a clinical outcome.
Other listed outcomes were wound complications graded with CTCAE v3.0 and response to preoperative therapy assessed using RECIST criteria. The registry record does not include result estimates for those outcomes in the registry record for this analysis. Consequently, the primary question that can be discussed is treatment delivery, and even that endpoint was not fully evaluated under the planned approach.
3. Trial Design
This was a phase II, non-randomized, parallel study with no masking. The registry lists an enrollment of 23 and a status of terminated. The sponsor was the National Cancer Institute. The title and summary describe preoperative treatment for primary soft tissue sarcoma of an extremity or body wall, with treatment pathways distinguished by tumor grade.
Cohort A is described as receiving doxorubicin, ifosfamide, and dacarbazine, along with thalidomide and radiation, followed by surgery. Its chemotherapy schedule is stated as intravenous treatment on days 1-3, 22-24, and 43-45, with G-CSF beginning on days 4, 25, and 46 and continuing until blood counts recover. Cohort B is described as receiving daily oral thalidomide beginning on day 1 and continuing until 1 week before surgery, radiation on weekdays during weeks 1-5, and surgical resection between days 77 and 91. The registry descriptions are truncated, so they do not establish the full treatment schedules.
Because allocation was not randomized, differences between cohorts could reflect differences in disease grade, treatment selection, or other characteristics, rather than treatment effects alone. The cohort descriptions therefore do not create a controlled comparison. There is no basis in the registry record for interpreting one cohort as a control arm for the other.
The registry describes the study as a pilot phase II investigation. It records early closure and says the primary endpoint could not be fully evaluated according to the protocol plan. The reason for termination, the recruitment target, and the statistical rationale for the planned enrollment are not reported in the registry record. Nor is a detailed statistical analysis plan reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | Cohort B (Thalidomide, Radiation, Surgery) |
|---|---|---|
| STARTED | 16 | 7 |
| COMPLETED | 15 | 7 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | Cohort B (Thalidomide, Radiation, Surgery) |
|---|---|---|
| Ineligible | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Eligible patients who started study treatment.
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: All eligible patients who started treatment.
| Characteristic | Unit | Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | Cohort B (Thalidomide, Radiation, Surgery) | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 7 | 22 | |
| Age, Continuous | years | 49.0 (20.0 to 75.0) | 47.0 (39.0 to 81.0) | 48 (20 to 81) |
| Sex: Female, Male: Female | Participants | 7 | 2 | 9 |
| Sex: Female, Male: Male | Participants | 8 | 5 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation, measured over Duration of treatment (which can continue up to approximately 15 months)..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was treatment delivery, expressed as the number of participants meeting a compliance definition. Compliance required receiving at least 95% of the preoperative protocol dose of radiation therapy, all 3 cycles of MAID when applicable, and thalidomide on 75% of the days during radiation. The endpoint population was eligible patients who started study treatment. The registry gives a treatment duration that could continue up to approximately 15 months.
This type of endpoint addresses whether participants received the intended treatment, rather than whether tumors responded or whether a clinical outcome changed. Treatment delivery can be important when interpreting a trial: if the planned regimen is not completed, outcome findings may reflect both the regimen and the extent to which it was received. That general consideration does not establish why any individual participant did or did not meet the compliance definition.
The registry says the endpoint was to be estimated using a binomial distribution with an associated 95% confidence interval. It also states that early study closure prevented full evaluation under the protocol plan. A numerical estimate and confidence interval for compliance are not reported in the registry record. The endpoint therefore cannot be interpreted as a completed estimate of the proportion meeting the specified treatment-delivery criteria.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive constraint is that the primary endpoint was not fully evaluated according to the protocol plan. The registry describes how compliance was defined and how it was intended to be estimated, but it does not report a numerical compliance result or its 95% confidence interval. There is therefore no reported estimate of the proportion of eligible treatment starters who met the complete definition, and no precision interval to assess.
The enrollment of 23 describes the overall study enrollment; it is not itself an endpoint result. The safety groups list 15 participants at risk in Cohort A and 7 in Cohort B, but those are safety denominators and should not be substituted for the primary endpoint analysis population. The actual number included in a treatment-delivery analysis is not reported in the registry record.
The registry lists wound complications and response to preoperative therapy as secondary outcomes. Numerical results for those outcomes are not reported in the registry record. The treatment description and biological rationale do not supply evidence of response or benefit in the absence of outcome results. In particular, the stated aim of studying whether treatment might shrink tumors is not a reported finding that tumors did shrink.
The study was non-randomized and had no masking. Cohorts received different treatment combinations, and the trial is not described as a like-for-like comparison. Even if cohort outcome estimates were available, differences between groups could not be attributed to the treatment combinations alone on the basis of this design. The record also does not report adjusted comparative analyses.
The safety entries describe participants affected by serious and other adverse events. In Cohort A, 9 of 15 participants were affected by serious adverse events, and 15 of 15 by other adverse events. In Cohort B, 3 of 7 were affected by serious adverse events, and 7 of 7 by other adverse events. These counts describe the recorded safety groups; they are not efficacy estimates. The registry record does not give the event-level detail needed to interpret duration, recurrence, timing, or the relationship of each event to treatment.
Overall, the posted information supports a description of the intended treatment-delivery question, the non-randomized design, and the reported safety counts. It does not support a quantified conclusion about treatment compliance, tumor response, or comparative effects. Statistical precision for the primary endpoint cannot be judged from an estimate that is not reported in the registry record.
9. Statistical Methods Explained
The registry planned to treat the primary endpoint as a binary outcome: each eligible patient who started treatment would either meet the full compliance definition or not meet it. In general, a binary outcome records whether a specified condition occurred; it does not measure a continuous quantity such as tumor size. For this endpoint, the condition combined the radiation, applicable chemotherapy, and thalidomide requirements. Meeting only some components would not satisfy the complete definition as written.
What does a binomial estimate describe?
In general, a binomial model describes counts of participants who meet a binary condition among a defined set of participants. The corresponding proportion estimates how common that condition was in the analyzed group. Here, the intended population was eligible patients who started study treatment, not necessarily everyone enrolled. Eligibility, treatment initiation, and inclusion in an analysis are distinct concepts; the number analyzed for the primary endpoint is not reported in the registry record.
The registry states that the primary result was to be accompanied by a 95% confidence interval. In general, a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. It is not a guarantee that the interval contains the true value, and it does not correct bias from selection, missing outcomes, or study design. Since neither the primary estimate nor its interval is reported, the precision of the intended compliance estimate cannot be assessed.
Why does the non-randomized design matter?
Random allocation is one way to balance measured and unmeasured characteristics between treatment groups, on average. In a non-randomized study, treatment assignment may be related to patient or disease characteristics. This trial also used different treatment combinations in its two cohorts. Cohort A included chemotherapy, while Cohort B did not, and the title describes treatment pathways by tumor grade. Thus, a simple contrast between cohorts would mix treatment differences with potential differences in the populations selected for each pathway. The registry specifically identifies the arms as not being a like-for-like control comparison. No causal interpretation of a cohort difference is warranted from the information recorded.
The absence of masking is another design feature. In general, masking can reduce the influence of knowledge about treatment assignment on some assessments or decisions. The registry does not describe masked assessment. This does not establish that a particular assessment was biased, but it is relevant context when considering outcomes that may involve judgment or care decisions. The record does not report additional procedures to address this issue.
What can the safety counts tell readers?
Safety counts are descriptive summaries of affected participants in each recorded group. They can indicate how many participants experienced at least one event within the registry’s reporting categories, but they do not by themselves describe event timing, duration, recurrence, severity beyond the serious classification, or causality. The serious adverse-event terms listed include White blood cell decreased (33.3%), Thromboembolic event (33.3%), Wound dehiscence (28.6%), Neutrophil count decreased (26.7%), Platelet count decreased (20.0%), and Pain in extremity (20.0%). The registry information does not identify the denominator or cohort attribution for each term in the registry record, so those percentages should not be assigned to a particular cohort or interpreted as incidence estimates for all enrolled participants.
What do planning calculations mean?
In general, sample-size calculations describe the size of a future study under specified assumptions about the outcome, target effect, significance level, allocation, and statistical model. They are planning illustrations, not observed power and not a measure of whether this trial detected a treatment effect. The assumptions recorded for planning illustrations include a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These calculations do not establish that the trial itself was designed with those assumptions. The registry does not report a trial-specific sample-size justification, and the actual observed primary effect is not reported in the registry record.
For time-to-event outcomes, a general sample-size approach may focus on the number of events; for other outcomes, planning may be expressed as participants per arm. No time-to-event primary endpoint is listed for this trial. The primary endpoint is a binary treatment-delivery measure. Any planning illustration should therefore be understood as a hypothetical design calculation, not as a result from the trial or evidence of efficacy.
Multiplicity is the issue of interpreting several statistical tests or outcomes together. When many outcomes are examined, the chance of at least one apparently notable result can increase unless the analysis plan addresses that concern. The registry lists multiple outcomes but records no analyses. Whether a multiplicity adjustment was planned or used is not reported in the registry record. Without reported analysis results or a detailed analysis plan, the impact of multiplicity cannot be assessed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures, including the treatment-delivery primary endpoint and secondary outcomes concerning wound complications and response by RECIST criteria. It records 0 analyses. Numerical results and analysis details for the listed outcomes are not reported in the registry record. The registry also states that early closure prevented full evaluation of the primary endpoint according to the protocol plan.
When a study examines multiple outcomes or statistical tests, multiplicity can make isolated findings harder to interpret. General approaches include designating a primary outcome in advance, controlling the overall error rate, or treating secondary findings as exploratory. The registry identifies a primary endpoint, but whether multiplicity procedures were planned or applied is not reported in the registry record. Without reported analyses, there are no test results to evaluate for multiplicity.
The primary endpoint population is described as eligible patients who started study treatment. The enrollment count does not establish how many eligible participants started treatment or how many had complete endpoint information. The number analyzed, the handling of missing data, and reasons for missing endpoint information are not reported in the registry record. It is also not reported whether the planned estimate used all eligible treatment starters or another analysis population in practice.
These gaps matter because the interpretation of a proportion depends on who was included and how incomplete observations were handled. If participants with missing compliance information differ from those with complete information, an estimate based only on complete cases could be misleading. That is a general possibility, not a finding about this study. No imputation strategy, sensitivity analysis, or analysis-population definition beyond the planned population is reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | 9 | 15 | 60.0% |
| Cohort B (Thalidomide, Radiation, Surgery) | 3 | 7 | 42.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | 15 of 15 |
| Cohort B (Thalidomide, Radiation, Surgery) | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | Cohort B (Thalidomide, Radiation, Surgery) |
|---|---|---|---|
| White blood cell decreased | Investigations | 5 of 15 | 0 of 7 |
| Thromboembolic event | Vascular disorders | 5 of 15 | 0 of 7 |
| Neutrophil count decreased | Investigations | 4 of 15 | 0 of 7 |
| Platelet count decreased | Investigations | 3 of 15 | 0 of 7 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 3 of 15 | 0 of 7 |
| Anemia | Blood and lymphatic system disorders | 2 of 15 | 0 of 7 |
| Edema limbs | General disorders | 2 of 15 | 0 of 7 |
| Infections and infestations - Other | Infections and infestations | 1 of 15 | 1 of 7 |
| Skin infection | Infections and infestations | 1 of 15 | 1 of 7 |
| Wound dehiscence | Injury, poisoning and procedural complications | 0 of 15 | 2 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) | Cohort B (Thalidomide, Radiation, Surgery) |
|---|---|---|---|
| Fatigue | General disorders | 14 of 15 | 4 of 7 |
| Anemia | Blood and lymphatic system disorders | 13 of 15 | 2 of 7 |
| Constipation | Gastrointestinal disorders | 11 of 15 | 3 of 7 |
| Nausea | Gastrointestinal disorders | 13 of 15 | 1 of 7 |
| Vomiting | Gastrointestinal disorders | 10 of 15 | 0 of 7 |
| Anorexia | Metabolism and nutrition disorders | 8 of 15 | 1 of 7 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 8 of 15 | 1 of 7 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 9 of 15 | 0 of 7 |
| Peripheral sensory neuropathy | Nervous system disorders | 6 of 15 | 3 of 7 |
| Dermatitis radiation | Injury, poisoning and procedural complications | 5 of 15 | 3 of 7 |
Serious events with the highest arm-level rate: white blood cell decreased (33.3%), thromboembolic event (33.3%), wound dehiscence (28.6%), neutrophil count decreased (26.7%), platelet count decreased (20.0%).
The safety record gives group-level counts for participants at risk and participants affected. In Cohort A, 15 participants were at risk for serious adverse events and 9 were affected; 15 were at risk for other adverse events and 15 were affected. In Cohort B, 7 participants were at risk for serious adverse events and 3 were affected; 7 were at risk for other adverse events and 7 were affected. These are counts within the recorded safety groups, not results for the full enrollment unless the denominators happen to match, which the registry record does not establish.
The listed serious adverse-event terms are White blood cell decreased (33.3%), Thromboembolic event (33.3%), Wound dehiscence (28.6%), Neutrophil count decreased (26.7%), Platelet count decreased (20.0%), and Pain in extremity (20.0%). The registry information does not specify the denominator or cohort attribution for these percentages in the registry record for this analysis. They should therefore be read as recorded term percentages, not as comparisons between cohorts.
Death counts are not reported in the registry record. The group counts do not provide event onset, duration, recurrence, or a determination that an event was caused by treatment. Serious and other adverse-event counts are distinct safety summaries and should not be interpreted as treatment efficacy results.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II study examined preoperative treatment pathways involving thalidomide and radiation, with chemotherapy included in one pathway, before surgery for primary soft tissue sarcoma. It also establishes that treatment delivery was the primary endpoint and gives the criteria intended to define compliance. These registry entries describe the study question and its planned measurement; they do not show that the regimen was completed as intended or that it changed tumor outcomes.
The primary endpoint could not be fully evaluated according to the protocol plan because the study closed early. No numerical compliance estimate or associated confidence interval is reported in the registry record. The secondary outcomes are listed, but their numerical results are not reported in the registry record either. Consequently, the available information does not quantify treatment response, wound complication risk, or a treatment effect.
The safety record does report affected-participant counts in the two cohorts and percentages for selected serious adverse-event terms. These provide a descriptive account of recorded safety events, but they do not identify causality or support a controlled safety comparison. Cohort sizes, treatment composition, and possible patient differences must be kept in view, especially because allocation was non-randomized and the arms were not like-for-like control groups.
What the study does not mean is that the treatments were effective or ineffective. The absence of a reported result is not evidence of no effect, and the treatment rationale is not proof of benefit. Likewise, the safety counts alone do not establish that a treatment caused a particular event or that one pathway was safer than the other. The appropriate reading is limited to the recorded design, planned endpoint, early closure, and available descriptive safety data.
13. Why This Trial Matters Statistically
This trial illustrates why the endpoint and the analysis population need to be read together. The primary outcome was not tumor response but treatment delivery: participants had to meet a combined definition involving radiation, applicable chemotherapy, and thalidomide. A result for that endpoint would have described adherence to the specified regimen among eligible patients who started treatment. It would not, by itself, have established clinical benefit.
Early closure has a direct statistical consequence in this record: the endpoint could not be fully evaluated according to the protocol plan. Without the intended estimate and confidence interval, readers cannot assess the observed level of compliance or its precision. The enrollment count cannot fill that gap because it does not identify the number of eligible treatment starters with evaluable endpoint data.
The design also demonstrates why non-randomized cohorts should not automatically be compared as if one were a control for the other. The cohorts received different combinations, and the study’s treatment pathways were described according to tumor grade. Any apparent difference could reflect the populations or clinical pathways as well as the therapies. The registry explicitly cautions that the groups are not like-for-like control arms.
Finally, the registry distinguishes planned statistical work from completed analysis. It describes a binomial estimate with a 95% confidence interval, but gives no completed primary result, and records no analyses. This gap makes the study a useful example of how a clear endpoint definition does not guarantee an interpretable estimate. The design, conduct, and completeness of reporting all shape what can be concluded from clinical trial data.
14. 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.
Early study closure is a central limitation because the registry says the primary endpoint could not be fully evaluated according to the protocol plan. The reason for termination and the extent to which the planned endpoint data were collected are not reported in the registry record. No numerical primary estimate or confidence interval is reported, preventing assessment of both the observed compliance level and its precision.
The record lists an enrollment of 23, while the safety groups list 15 participants at risk in Cohort A and 7 in Cohort B. The registry information does not explain this difference or establish how many participants were eligible, started treatment, or contributed to each outcome analysis. The endpoint’s planned population is specified, but its realized analysis population is not reported in the registry record.
The non-randomized design and distinct treatment combinations limit cohort comparisons. The registry itself states that the arms are not a like-for-like control comparison. Masking was absent, and details of outcome assessment procedures are not reported in the registry record. The treatment descriptions are truncated, so the complete regimens cannot be reconstructed from the record information used for this analysis.
Results for the listed secondary outcomes are not reported in the registry record. Adverse-event term percentages do not have a stated denominator or cohort attribution in the registry entries, and death counts are not reported. Missing-data methods, multiplicity procedures, a detailed statistical analysis plan, and a trial-specific sample-size justification are also not reported in the registry record. These limitations constrain interpretation; they do not determine what unreported results would have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall — NCT00089544.
- Registry record last updated 2018-04-13; status last verified 2018-03.
- Results first posted 2013-07-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00089544 is a terminated, non-randomized, parallel phase II study sponsored by the National Cancer Institute. It examined preoperative thalidomide and radiation for primary soft tissue sarcoma, with chemotherapy included in the pathway described for high-grade or intermediate-grade disease. The registry records an enrollment of 23 and no masking.
The primary endpoint was treatment delivery among eligible patients who started treatment, using specified requirements for radiation, applicable MAID cycles, and thalidomide use. The registry planned a binomial estimate with a 95% confidence interval but states that early closure prevented full evaluation according to the protocol plan. A numerical primary result is not reported in the registry record. Secondary outcomes included wound complications and RECIST response, with no numerical results reported in the registry information available for this analysis.
Safety counts are recorded for Cohort A and Cohort B, alongside selected serious adverse-event term percentages. Because allocation was non-randomized and the treatment groups were not like-for-like controls, those counts do not establish comparative effects. The record supports description of the trial design and recorded safety data, but not a quantified conclusion about compliance, response, or treatment effect.