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 A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%) (NCT03587116), a na phase 3 study. The primary outcome is Annualized Bleeding Rate (ABR) for Treated Bleeds and All Bleeds During Prospective Data Collection Period in Hemophilia B Participants: Efficacy Analysis Set.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03587116 |
| Phase | Phase 3 |
| Condition | Hemophilia B, Hemophilia A |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 212 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderately severe to severe hemophilia B or hemophilia A, with factor activity thresholds stated in the study title. The official title further specifies participants negative for nAb to the relevant AAV vector or capsid. The primary outcome concerns the hemophilia B efficacy analysis set; the complete eligibility criteria for that set are not reported in the registry record.
Intervention
Usual-care prophylaxis replacement therapy: FIX for the hemophilia B cohort and FVIII for the hemophilia A cohort. These are the current replacement therapies participants were receiving, not gene therapy interventions.
Comparator
There is no randomized comparator. The study is listed as single-group, open-label and nonrandomized. Its two disease cohorts receive different standard-of-care factor replacement therapies, so they are not like-for-like control groups and should not be treated as a direct comparison.
Primary question
For participants in the hemophilia B efficacy analysis set, what is the mean annualized bleeding rate for treated and all bleeds during prospective data collection while receiving FIX prophylaxis? The registry describes the study as establishing baseline prospective efficacy and safety data in the usual-care setting before a respective Phase 3 gene therapy study. It does not report the primary outcome estimate, its standard deviation, or an inferential comparison.
3. Trial Design
This completed study is registered as Phase 3, open-label, non-investigational product, and single-group. Allocation is listed as not applicable, and masking is listed as none. Its purpose was to collect prospective efficacy and safety data during current replacement prophylaxis in the usual-care setting, before respective gene therapy studies. It is therefore a lead-in study of replacement therapy, not a randomized evaluation of gene therapy.
The study includes separate adult cohorts with hemophilia B and hemophilia A. Participants in the hemophilia B cohort received standard-of-care FIX replacement therapy; participants in the hemophilia A cohort received standard-of-care FVIII replacement therapy. These cohorts represent different conditions and replacement factors. The registry does not describe them as randomized arms, and comparison between them would not isolate a treatment effect.
Enrollment is listed as 212. The registry gives a start date of 2018-07-26, a primary completion date of 2024-12-13, and a completed status. The brief summary states that hemophilia A enrollment was completed and that, at the time described, enrollment was occurring only for the hemophilia B cohort. The record does not give further details about the timing of that enrollment update.
The primary outcome is annualized bleeding rate in hemophilia B participants during prospective data collection. Secondary outcomes include annualized infusion rate for both disease cohorts, with different analysis sets and, for hemophilia B, retrospective and combined retrospective-prospective periods also listed. The registry lists 36 outcome measures and 0 analyses. Detailed procedural information, including a complete account of follow-up and analysis conduct, is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Standard of Care FIX Replacement Therapy (Hemophilia B) | Standard of Care FVIII Replacement Therapy (Hemophilia A) |
|---|---|---|
| STARTED | 111 | 101 |
| Safety Analysis Set | 111 | 101 |
| Efficacy Analysis Set | 110 | 96 |
| Per-protocol Analysis Set | 107 | 81 |
| Protocol Amendment 5 Analysis Set | 39 | 24 |
| COMPLETED | 107 | 99 |
| NOT COMPLETED | 4 | 2 |
Reasons for not completing this period:
| Reason | Standard of Care FIX Replacement Therapy (Hemophilia B) | Standard of Care FVIII Replacement Therapy (Hemophilia A) |
|---|---|---|
| Lost to Follow-up | 0 | 1 |
| No Longer Met Eligibility Criteria | 0 | 1 |
| Withdrawal by Subject | 4 | 0 |
Analysis population for the primary outcome, as defined in the registry: Efficacy analysis set: participants who signed an informed consent form (ICF), had their blood sample collected and assayed for AAV-Spark100 or AAV6 immunity testing, who were subsequently identified as nAb negative (negative for nAb to AAV-Spark100 for the hemophilia B cohort), met the inclusion/ exclusion criteria and who participated in the prospective data collection phase as part of their usual healthcare setting.
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.
| Characteristic | Unit | Standard of Care FIX Replacement Therapy (Hemophilia B) | Standard of Care FVIII Replacement Therapy (Hemophilia A) | Total |
|---|---|---|---|---|
| Participants analysed | 111 | 101 | 212 | |
| Age, Customized: 18-44 Years | Participants | 93 | 84 | 177 |
| Age, Customized: 45-64 Years | Participants | 18 | 17 | 35 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 111 | 101 | 212 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 4 | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 91 | 76 | 167 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 16 | 21 | 37 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 18 | 17 | 35 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 6 | 8 |
| Race (NIH/OMB): White | Participants | 90 | 78 | 168 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Annualized Bleeding Rate (ABR) for Treated Bleeds and All Bleeds During Prospective Data Collection Period in Hemophilia B Participants: Efficacy Analysis Set, measured over During prospective data collection period (from baseline visit of the study [Day 1] up to end of study follow-up [maximum follow-up: 1269 days]).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Bleeds per year |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the annualized bleeding rate (ABR), measured as bleeds per year, for treated bleeds and all bleeds in hemophilia B participants in the efficacy analysis set. The registry defines all bleeds as treated plus untreated bleeds. A treated bleed is an event followed by coagulation factor administration within 72 hours of bleeding signs or symptoms; an untreated bleed is one not followed by factor administration within that period.
For each participant, the registry describes ABR as the number of bleeds divided by the number of days from the baseline visit, Day 1, to the end of study, then multiplied by 365.25 days. Annualizing allows the rate to be expressed on a per-year scale even when participants have different lengths of observation. This is a general feature of rate measures: the time under observation is incorporated so that counts from differing follow-up durations can be described on a common time scale.
Bleeding rate is used to characterize prospective bleeding experience while participants receive usual-care FIX prophylaxis. The measure is reported as a mean with standard deviation. A mean describes the average rate across the analysis population; a standard deviation describes how variable individual rates are around that average. The registry identifies the measurement and its period, which extends from baseline to the end of study follow-up, with maximum follow-up listed as 1269 days. It does not report the mean ABR or standard deviation in the record summarized for this analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a prospective baseline assessment of usual-care factor prophylaxis. Its primary outcome is defined for hemophilia B participants: mean ABR for treated and all bleeds during the prospective collection period. The posted registry information identifies how the rate was constructed and names the efficacy analysis set, but does not report the numerical outcome estimates. Consequently, the bleeding experience cannot be characterized from the registry record as a particular rate or level of precision.
The study is open-label and single-group, with allocation listed as not applicable. It does not provide a randomized control comparison. The hemophilia A cohort is not an appropriate control for the hemophilia B cohort: the cohorts have different conditions and receive different factor replacement therapies. Differences between them, if reported elsewhere, would not by themselves establish a treatment effect. No such comparative estimate is reported in the registry record.
The study's stated role is to establish baseline prospective efficacy and safety data before respective gene therapy studies. This describes the intended context of the data collection, not a test of gene therapy. The interventions listed are standard-of-care FIX and FVIII replacement therapies. The record does not report results from a gene therapy intervention or an estimate comparing gene therapy with replacement therapy.
The outcome definition distinguishes treated bleeds from all bleeds. Treated status depends on whether coagulation factor was administered within 72 hours of signs or symptoms. Thus, the two outcome descriptions do not represent interchangeable counts: the all-bleeds measure includes untreated events as well. The registry does not provide numerical results that would show how the two definitions affected the estimated rates.
The primary endpoint is reported as a mean with standard deviation, but neither value is included in the posted results summarized in the record. No confidence interval or hypothesis test result for this primary measure is reported in the registry record. Without an estimate and its uncertainty, the direction, magnitude, and precision of the observed mean cannot be assessed. Absence of a reported result is not evidence that the rate was zero or that no bleeds occurred.
The record lists 0 analyses. It therefore does not provide analysis-specific estimates or inferential results for the listed outcomes. The safety information includes counts for adverse-event categories and a list of serious adverse-event terms with percentages; those entries should be read as the registry's reported descriptive safety information, not as a randomized safety comparison. The study design and incomplete outcome reporting limit the conclusions that can be drawn from the record alone.
9. Statistical Methods Explained
The registry identifies the primary endpoint as a continuous measure reported using a mean and standard deviation. Its stated unit is bleeds per year. The following concepts explain how to interpret that type of outcome and the design described in the record; they do not supply missing study results or unreported analysis procedures.
What does annualized bleeding rate represent?
In general, a rate relates the number of events to the time during which those events could be observed. The registry's ABR definition uses each participant's bleed count over the days from baseline to the end of study, then scales that rate to a year using 365.25 days. This scaling makes rates easier to describe when observation time varies. It does not make the underlying observation periods identical, and interpretation still depends on the population and follow-up represented.
The outcome includes two related definitions. All bleeds includes treated and untreated events. Treated bleeds are defined by coagulation factor administration within 72 hours after signs or symptoms; untreated bleeds do not meet that treatment condition. The registry therefore uses a treatment-based distinction in addition to recording bleeding events. The record does not report how events were adjudicated or how uncertain event classifications were handled.
Why are the mean and standard deviation reported?
For a continuous outcome, the mean describes the average value in the analysis set. The standard deviation describes spread among participant-level values around that mean. A mean alone does not show whether individual observations are tightly clustered or widely dispersed. A standard deviation is not a confidence interval: it describes variability among observations, whereas a confidence interval, in general, describes uncertainty around an estimated quantity. No confidence interval for the primary outcome is reported in the registry record.
Bleeding counts can vary between participants. As a general statistical consideration, count data may show greater variability than a simple model assumes; this is often called over-dispersion. When over-dispersion is present, a model that assumes less variability can understate uncertainty. The registry record does not report whether a count model was used, whether over-dispersion was assessed, or whether model-based estimates were produced. The primary outcome is identified as a mean and standard deviation, so no particular modeling method should be inferred.
What does the design allow readers to assess?
The study is listed as open-label, single-group, and nonrandomized, with allocation not applicable. General statistical interpretation of such a design is descriptive: it can characterize outcomes observed in the enrolled population during the stated period, but it does not create a randomized counterfactual showing what would have happened to the same participants under another treatment. The registry's two cohorts also differ by disease and replacement factor. They should not be treated as equivalent groups for estimating a treatment contrast.
The registry describes prospective data collection from the baseline visit to end of study follow-up, with maximum follow-up listed as 1269 days. Prospective collection means that outcomes are gathered during the observation period rather than relying only on recall of earlier experience. It does not, by itself, remove selection effects, differences in exposure, or missing information. Details of how follow-up time and incomplete observation were handled are not reported in the registry record.
How should planning illustrations be understood?
Planning illustrations are not evidence that a study had a specified probability of detecting an effect. The listed assumptions describe a planning calculation using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. For time-to-event calculations, the stated planning quantity is total events; for other calculations, it is participants per arm. These are illustrations, not observed power, and they do not substitute for reported outcome estimates or an account of the trial's own design rationale. The registry does not report a sample-size justification or the assumptions used in the original study design.
In general, a confidence interval communicates the range of values compatible with an estimate under the method used, while a p-value summarizes how surprising the data would be under a specified null hypothesis and model. Neither is reported for the primary endpoint in the registry record. No particular hypothesis test, confidence-interval method, or adjustment procedure should be attributed to this study based on the available record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 36 outcome measures, spanning the primary bleeding-rate measure and secondary outcomes that include annualized infusion rate. Several outcomes are specified for different analysis sets or collection periods. Considering many outcomes can raise a multiplicity issue: in general, the more hypotheses examined, the greater the chance of at least one apparently notable result when all null hypotheses are true. Whether and how this concern was addressed depends on the prespecified analysis plan.
A multiplicity strategy, such as a hierarchy of outcomes or a statistical adjustment, is not reported in the registry record. The record lists 0 analyses, and no outcome-specific test results or adjusted estimates are reported. It is therefore not possible to determine which outcomes were tested, whether any testing sequence was used, or how any multiplicity was handled.
The primary outcome names the hemophilia B efficacy analysis set. Its description says participants signed an informed consent form, had a blood sample collected and assayed for AAV-Spark100 or AAV6 immunity testing, and were subsequently identified as nAb negative for the hemophilia B cohort. The available description is cut off while listing further eligibility requirements. The complete analysis-population criteria are not reported in the registry record. The exact analysis populations for the other outcomes are not fully described in the information.
Missing-data methods are also not reported in the registry record. The record does not specify how missing bleed reports, incomplete follow-up, withdrawals, or participants with limited observation were handled in the primary analysis. It does not state whether any imputation, sensitivity analysis, or other missing-data procedure was used. These details matter because the endpoint is calculated over observed time and an incomplete record may affect both event counts and time at risk.
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 |
|---|---|---|---|
| Standard of Care FIX Replacement Therapy (Hemophilia B) | 9 | 111 | 8.1% |
| Standard of Care FVIII Replacement Therapy (Hemophilia A) | 4 | 101 | 4.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard of Care FIX Replacement Therapy (Hemophilia B) | 0 of 111 |
| Standard of Care FVIII Replacement Therapy (Hemophilia A) | 0 of 101 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Standard of Care FIX Replacement Therapy (Hemophilia B) | 4 of 111 |
| Standard of Care FVIII Replacement Therapy (Hemophilia A) | 0 of 101 |
Most frequent serious adverse event terms
| Event term | Organ system | Standard of Care FIX Replacement Therapy (Hemophilia B) | Standard of Care FVIII Replacement Therapy (Hemophilia A) |
|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 2 of 111 | 0 of 101 |
| Enteritis | Gastrointestinal disorders | 1 of 111 | 0 of 101 |
| Appendicitis | Infections and infestations | 1 of 111 | 0 of 101 |
| Joint injury | Injury, poisoning and procedural complications | 1 of 111 | 0 of 101 |
| Ligament rupture | Injury, poisoning and procedural complications | 1 of 111 | 0 of 101 |
| Ligament sprain | Injury, poisoning and procedural complications | 1 of 111 | 0 of 101 |
| Tooth fracture | Injury, poisoning and procedural complications | 1 of 111 | 0 of 101 |
| Arthropathy | Musculoskeletal and connective tissue disorders | 1 of 111 | 0 of 101 |
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | 1 of 111 | 0 of 101 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 1 of 111 | 0 of 101 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Standard of Care FIX Replacement Therapy (Hemophilia B) | Standard of Care FVIII Replacement Therapy (Hemophilia A) |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 2 of 111 | 0 of 101 |
| Haematoma | Vascular disorders | 2 of 111 | 0 of 101 |
Serious events with the highest arm-level rate: gastrointestinal haemorrhage (1.8%), haemorrhoidal haemorrhage (1.0%), upper gastrointestinal haemorrhage (1.0%), wound infection (1.0%), b-cell lymphoma (1.0%).
The registry lists serious adverse-event information separately for the FIX replacement therapy hemophilia B group and the FVIII replacement therapy hemophilia A group. For the hemophilia B group, the serious-event fields show 111 at risk and 9 affected; the other-adverse-event fields show 111 at risk and 4 affected. For the hemophilia A group, the corresponding serious-event fields show 101 at risk and 4 affected, while the other-adverse-event fields show 101 at risk and 0 affected. Deaths are listed as 0 in both groups.
These are descriptive counts, not comparative estimates. Because the groups differ by disease and factor therapy and the study is not randomized, the counts should not be used as a direct safety comparison between treatments. The registry also lists serious adverse-event terms with percentages: gastrointestinal haemorrhage, 1.8%; haemorrhoidal haemorrhage, 1.0%; upper gastrointestinal haemorrhage, 1.0%; wound infection, 1.0%; B-cell lymphoma, 1.0%; and enteritis, 0.9%. The record does not provide further context for interpreting those percentages, such as a term-specific analysis method. These entries do not establish causation or comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study's setting and the outcomes it intended to characterize: prospective efficacy and safety data during usual-care factor replacement therapy in adult hemophilia B and hemophilia A cohorts. For the primary outcome, the record defines ABR for treated and all bleeds in the hemophilia B efficacy analysis set and describes the observation period and calculation. It also provides descriptive adverse-event counts.
The record does not report the primary ABR mean or standard deviation, confidence intervals, or hypothesis-test results. Accordingly, it cannot establish from these posted results what mean bleeding rate was observed or how precisely it was estimated. The lack of a reported estimate should not be interpreted as a finding of no bleeding or no difference. The absence of reported analyses also means that outcome-specific results cannot be evaluated from this record.
The study is not a randomized comparison of replacement therapy with another treatment. Its purpose was to establish baseline data before respective gene therapy studies, and the listed interventions are current FIX or FVIII replacement therapies. It does not estimate the effect of gene therapy, nor does it support a causal claim that one cohort's regimen is superior to the other's. The cohorts represent different hemophilia conditions and are not interchangeable controls.
As a general principle, statistical estimates describe the people and observation periods included in the analysis. Applying them to other populations or settings requires information about eligibility, follow-up, and analysis that is not fully available in the registry record. The conclusions supported by this record are therefore about study design, endpoint definitions, and the safety counts that are explicitly listed—not unreported efficacy estimates or treatment effects.
13. Why This Trial Matters Statistically
Prospective outcome collection can help characterize experience during usual-care prophylaxis, including bleeding over observed time rather than relying solely on retrospective recollection. This study's lead-in purpose also places the data in a baseline context before respective gene therapy studies. From a statistical perspective, a clearly defined baseline period and outcome can be useful for describing the population entering later research, provided the results and analysis methods are available for evaluation.
The endpoint definition is consequential. The primary measure distinguishes treated bleeds from all bleeds, and uses each participant's follow-up duration in annualizing the event rate. Those choices define what the mean represents. A reader needs both the numerical estimate and information about its variability to understand whether the average reflects a fairly consistent experience or substantial participant-to-participant differences. The registry identifies mean and standard deviation as the summary approach but does not report their values.
The record also illustrates why design labels matter. This is an open-label, single-group study, not a randomized treatment comparison. Its disease cohorts receive different factor therapies and cannot serve as like-for-like controls for one another. Recognizing that distinction prevents descriptive baseline information from being mistaken for evidence of a causal treatment contrast.
Finally, outcome and safety reporting need to be interpreted alongside the analysis populations and missing-data methods. The registry lists multiple outcomes and analysis sets but does not report analysis results or a multiplicity strategy. The study's stated baseline role may be relevant to the context of later research, but the record alone does not show the primary bleeding-rate result or its precision. These limits are central to a statistically sound reading.
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.
The main limitation of this record for assessing efficacy is that it does not report numerical results for the primary endpoint. Although the endpoint, unit, summary measure, and collection period are described, the mean ABR and standard deviation are not reported in the registry record. Nor does the record give a confidence interval or test result that would describe inferential uncertainty.
The study has no randomized comparator, and it is registered as single-group and open-label. The hemophilia B and hemophilia A cohorts differ in condition and in the factor replacement therapy received, so they do not form a direct control comparison. The design can describe outcomes in the enrolled setting but does not, by itself, establish a causal effect relative to an alternative treatment.
The analysis-population description for the primary endpoint is incomplete in the registry record. The displayed description ends while listing eligibility requirements. The record also does not report how missing data, incomplete observation, or varying follow-up were handled, despite the endpoint using time from baseline to end of study. These omissions make it difficult to assess how representative the analyzed population was or how sensitive the rate might be to incomplete data.
Although 36 outcome measures are listed, 0 analyses are recorded. The registry does not report whether multiplicity was addressed, the statistical methods used for the primary endpoint, or the study's sample-size justification. The available safety counts are descriptive, and further details about the listed serious adverse-event percentages are not reported in the registry record. These reporting gaps limit interpretation beyond the stated design and definitions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%) — NCT03587116.
- Registry record last updated 2025-11-06; status last verified 2025-10.
- Results first posted 2025-11-06.
- 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
This is a completed, open-label, nonrandomized lead-in study of standard-of-care FIX prophylaxis in adults with hemophilia B and FVIII prophylaxis in adults with hemophilia A. Enrollment is listed as 212; the study start date is 2018-07-26 and the primary completion date is 2024-12-13. The primary outcome is mean annualized bleeding rate for treated and all bleeds during prospective data collection in the hemophilia B efficacy analysis set, measured in bleeds per year.
The registry describes the outcome definition and follow-up period but does not report its numerical results. It lists 36 outcome measures and 0 analyses. Serious and other adverse-event counts and selected serious-event terms are reported descriptively. The record does not report a randomized treatment comparison, a multiplicity strategy, missing-data procedures, or the sample-size justification.