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 Allogeneic SCT of NiCord®, UCB-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies (NCT01590628), a na phase 1, phase 2 study. The primary outcome is Safety and Tolerability Will be Measured by Acute NiCord® Infusional Toxicity..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01590628 |
| Phase | Phase 1, Phase 2 |
| Condition | Sickle Cell Disease & Thalassemia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Gamida Cell ltd |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hemoglobinopathies, with the listed conditions of sickle cell disease and thalassemia. The registry record gives an enrollment of 16. It does not report further eligibility details or describe the characteristics of the participants in the primary endpoint population.
Intervention
NiCord, described as a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. The registry record also includes a group described as receiving NiCord with unmanipulated cord blood units.
Comparator
The registry record lists NiCord and NiCord with unmanipulated cord blood as groups, but this is a single-group study and allocation is listed as not applicable. These groups are not a randomized, like-for-like control comparison.
Primary question
The primary endpoint is intended to assess safety and tolerability by measuring acute NiCord infusional toxicity within 24 hours post-infusion. The count of participants meeting this endpoint is not reported in the registry record.
The main question is therefore about acute safety following infusion, rather than a comparative estimate of benefit. The registry record also lists transplant-related mortality, event-free survival, and overall survival as secondary outcomes. It does not report results for those outcomes, their follow-up definitions, or the time points at which they were assessed.
The group-specific adverse-event figures describe observed safety information, but they do not resolve the primary question: the acute toxicity result within the specified 24-hour window is not reported in the registry record. Nor do the listed groups establish a causal comparison between treatment strategies. The record identifies the study as single group, with no masking and allocation listed as not applicable. Any interpretation should preserve that distinction between descriptive observations and a controlled estimate of treatment effect.
3. Trial Design
This is a completed Phase 1 and Phase 2 clinical study with a single-group model. The registry record lists an enrollment of 16 and the conditions sickle cell disease and thalassemia. The study start is recorded as 2012-09, and primary completion as 2018-09. The sponsor is Gamida Cell ltd.
The intervention is NiCord, a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. The listed groups are “NiCord + Unmanipulated CBU” and “NiCord.” The record does not describe these as randomized arms: allocation is listed as not applicable, and the study is not a randomized comparison. The groups should therefore be read as descriptive groups, not as equivalent treatment and control groups that support an unbiased head-to-head treatment estimate.
Masking is listed as none. The registry record does not report a separate control intervention, a randomization procedure, or a masking procedure. It also does not report the protocol rationale for the group structure, the treatment assignment process, or a sample-size justification for the trial itself. The sample-size planning illustration uses stated assumptions, but it is not a report of the study’s original design rationale.
The primary endpoint is a participant count for acute NiCord infusional toxicity assessed within 24 hours post-infusion. Secondary outcomes listed are transplant-related mortality, event-free survival, and overall survival. Although these outcomes are named, their results and analysis details are not reported in the registry record. The record lists five outcome measures and zero analysis records. That listing does not provide an estimate of the primary endpoint or show how each outcome was analyzed.
Although the status is completed, completion status alone does not establish that all planned measurements were collected, analyzed, or reported. The posted information supports a description of the design and listed safety counts, while leaving important details about conduct and outcome analysis unspecified.
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 | NiCord + Unmanipulated CBU | NiCord |
|---|---|---|
| STARTED | 13 | 3 |
| COMPLETED | 11 | 3 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | NiCord + Unmanipulated CBU | NiCord |
|---|---|---|
| Death | 2 | 0 |
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 | NiCord + Unmanipulated CBU | NiCord | Total |
|---|---|---|---|---|
| Participants analysed | 13 | 3 | 16 | |
| Age, Categorical: <=18 years | Participants | 13 | 3 | 16 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 9 | 1 | 10 |
| Sex: Female, Male: Male | Participants | 4 | 2 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 | 3 | 16 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 3 | 16 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 13 | 3 | 16 |
| Sickle Cell or Thalassemia Disease Type: Hb SS | Participants | 13 | 2 | 15 |
| Sickle Cell or Thalassemia Disease Type: Hb SC | Participants | 0 | 0 | 0 |
| Sickle Cell or Thalassemia Disease Type: Hb SBeta0 Thal | Participants | 0 | 1 | 1 |
| Sickle Cell or Thalassemia Disease Type: Hb SD | Participants | 0 | 0 | 0 |
| Sickle Cell or Thalassemia Disease Type: Hb SOarab | Participants | 0 | 0 | 0 |
| Sickle Cell or Thalassemia Disease Type: Other SCD Type | Participants | 0 | 0 | 0 |
| Sickle Cell or Thalassemia Disease Type: Beta Thal Major | Participants | 0 | 0 | 0 |
| Sickle Cell or Thalassemia Disease Type: Alpha Thal Major | Participants | 0 | 0 | 0 |
| CMV Screen (IgG or Total) (Segment S) positive | Participants | 7 | 2 | 9 |
| Performance Status: 100 | Participants | 6 | 2 | 8 |
| Performance Status: 90 | Participants | 3 | 0 | 3 |
| Performance Status: 80 | Participants | 4 | 0 | 4 |
| Performance Status: 70 | Participants | 0 | 1 | 1 |
| Disease characteristics: Three or More Recurrent Painful Events in the Past 2 Years | participants | 6 | 2 | 8 |
| Disease characteristics: Acute Chest Syndrome (Two or More Episodes in the Past 2 Years) | participants | 2 | 0 | 2 |
| Disease characteristics: SCD-related & clinically significant neurologic event | participants | 4 | 1 | 5 |
| Disease characteristics: Abnormal MRI/MRA | participants | 5 | 1 | 6 |
| Disease characteristics: chronic PRBC transfusion therapy | participants | 0 | 0 | 0 |
| Disease characteristics: Patient has undergone TCD velocity tests | participants | 1 | 0 | 1 |
| Hydroxyurea use prior to enrollment | Participants | 10 | 2 | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Safety and Tolerability Will be Measured by Acute NiCord® Infusional Toxicity., measured over 24 hours post-infusion.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is described as safety and tolerability measured by acute NiCord infusional toxicity. It is expressed as a number of participants, with assessment within 24 hours post-infusion. In practical terms, this endpoint is intended to count participants who experienced acute toxicity associated with the infusion during the stated window. The registry record does not provide the operational criteria for what qualified as toxicity, how events were assessed, or whether severity grades were used.
A short, prespecified assessment window can focus attention on immediate events temporally close to an infusion. Counting participants can also provide a straightforward descriptive measure: it indicates how many people met the endpoint, rather than the total number of episodes. General statistical context: a participant count is often useful for a safety endpoint because a person can experience more than one event, while a count of affected participants avoids treating repeated events in one person as separate people. The registry record does not specify whether that distinction was applied in its endpoint analysis.
The endpoint’s stated purpose is safety and tolerability, but its result is not reported in the registry record. The serious adverse-event figures listed elsewhere do not substitute for this primary result: they do not identify which events occurred within 24 hours or define them as acute infusion toxicity. Without the endpoint count and its assessment details, the registry entry does not permit an estimate of the frequency of acute infusional toxicity.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint is a participant count for acute NiCord infusional toxicity within 24 hours post-infusion. No count or estimate for that endpoint is reported in the registry record. Accordingly, the central safety outcome cannot be quantified from the posted results. The record’s completed status does not fill this reporting gap.
The adverse-event information does report group-specific counts. In the “NiCord + Unmanipulated CBU” group, 13 participants are listed as at risk for serious events and 13 as affected; the corresponding figures in the “NiCord” group are 3 and 3. Other adverse events are listed for 13 and 3 participants at risk, with 0 affected in each group. Deaths are listed as 2 in the first group and 0 in the second. These are descriptive counts as recorded; the registry entry does not provide the time period, event attribution, or analysis population for interpreting them further.
Several serious adverse-event terms are also listed with percentages: Transplant rejection, Renal Failure, Respiratory failure, and Hypotension each have 33.3%; Graft versus host disease and Bacteraemia each have 23.1%. The registry record does not report the denominator or event-count basis for these percentages, and it does not provide enough information to interpret them as comparative risks. The percentages should therefore be read as registry-listed figures, not as estimates that establish differences between the groups.
The groups are not a randomized comparison. Their observed counts cannot be treated as evidence that one group had more or fewer events because of its treatment. Differences in group composition, follow-up, or other factors could affect descriptive counts; the registry record does not report enough detail to assess those possibilities. The listed deaths also cannot be attributed to treatment from these figures alone.
Event-free survival, overall survival, and transplant-related mortality are listed as secondary outcomes, but their estimates are not reported in the registry record. No confidence intervals, hypothesis tests, or adjusted analyses are reported. The available information supports a limited description of recorded adverse-event counts, but not a precise estimate of the primary endpoint, a comparative treatment effect, or a conclusion about the listed survival outcomes.
9. Statistical Methods Explained
Statistical methods can help distinguish what a trial’s observations describe from what they can support as an inference. In this study, the record identifies a participant-count primary endpoint, lists group-level adverse-event counts, and names several secondary outcomes. It does not report analysis estimates or analysis records. The methods explanation below provides general context for interpreting such information; it does not imply that an unreported method was used in this trial.
What does a participant count represent?
For a binary safety outcome, each participant is classified according to whether the event occurred during the specified assessment period. A count reports the number meeting the event definition. A proportion or risk would relate that count to a defined population at risk. General statistical context: an uncertainty interval around a proportion expresses how precisely the observed proportion estimates an underlying event frequency, under the assumptions of the analysis. Neither an interval nor a primary endpoint estimate for acute infusional toxicity is reported in the registry record.
Counts also depend on clear definitions. The record names acute NiCord infusional toxicity and gives the 24 hours post-infusion timeframe, but does not report the event criteria, severity classification, or adjudication procedure. Without these details, readers cannot determine how consistently events were identified or whether multiple manifestations were counted as one participant meeting the endpoint.
Why does the study structure matter?
A randomized comparison aims to make treatment groups comparable, on average, with respect to factors that could influence outcomes. Here, allocation is listed as not applicable and the study model is single group. The listed groups are not a randomized control comparison. General statistical context: in a nonrandomized comparison, differences in observed outcomes may reflect differences in participant characteristics, care, follow-up, or other factors, as well as any treatment-related effects. Statistical adjustment can address measured factors under suitable assumptions, but cannot automatically remove bias from unmeasured or poorly measured factors. The registry record does not report an adjusted comparison.
Masking is listed as none. General statistical context: masking can reduce the influence of expectations on some assessments, particularly when outcomes involve judgment. The extent to which this matters depends on the outcome and how it is measured. The registry record does not describe endpoint assessment procedures, so the potential role of assessment judgment cannot be evaluated from the posted information.
How should event percentages be read?
Percentages are interpretable only with a clear numerator and denominator. The serious-event terms are listed with percentages, but their denominators and event-count basis are not reported in the registry record. It is therefore not possible to establish from those percentages how many participants experienced each term or whether the percentages refer to participants, events, or another basis. General statistical context: repeated events in one person can make an event count differ from a count of affected participants. Those measures answer different questions and should not be interchanged.
Uncertainty also matters. A percentage without an uncertainty interval can look more definitive than the underlying information warrants, especially when based on a small number of observations. General statistical context: a confidence interval gives a range of values compatible with the data under the method’s assumptions; it is not a guarantee that the true value lies within that particular interval. No confidence intervals for the listed safety figures are reported in the registry record.
What can the planning illustration tell readers?
The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It frames the effect to detect as a stated fraction of the observed effect. These are assumptions for an illustration, not a description of the trial’s own design or analysis plan. The record does not report the trial’s sample-size justification or explain whether these assumptions match its original planning.
General statistical context: a planning calculation asks what sample size might be needed under specified assumptions about the effect, variability, significance level, and desired power. Such calculations depend on those inputs. An illustration based on an observed effect is especially dependent on that estimate and should not be read as an independent demonstration of study adequacy. It is not observed power. No sample-size result is reported in the registry record, and an illustration cannot supply missing trial outcomes or establish that the study could detect a clinically relevant effect.
The record does not report an interim analysis plan, a statistical analysis plan, or the handling of missing outcomes. It also does not report estimates for the primary or secondary endpoints. As a result, readers cannot assess the planned inferential procedures, the precision of the outcome estimates, or whether the reported safety counts reflect a prespecified analysis population.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary endpoint and several secondary outcomes, but does not report a statistical analysis plan, analysis estimates, or hypothesis tests. It does not report whether the study planned multiple comparisons, or whether any adjustment for multiple testing was intended. These details are not reported in the registry record.
General statistical context: when many outcomes or comparisons are tested, the chance of finding at least one apparently notable result can increase if each test is treated as though it were the only one. A prespecified testing hierarchy or an adjustment can help manage that issue, depending on the aims of the study. The outcome list alone does not show which, if any, inferential claims were intended to be confirmatory. Because no tests or estimates are reported, there is no basis to assess multiplicity handling for this study.
Missing-data procedures and the extent of missing outcome information are not reported in the registry record. The analysis populations are also not defined. It is therefore unclear which participants would have been included in each outcome analysis, how incomplete follow-up was handled, or whether all enrolled participants contributed to every reported measure. General statistical context: missing observations can affect an estimate when the likelihood of being observed is related to the outcome or participant characteristics. The consequences depend on why data are missing and on the analysis assumptions; they cannot be determined from a count of enrolled participants alone.
The record lists five outcome measures and zero analysis records, but does not provide results for the primary endpoint or the listed secondary outcomes. Without outcome-level denominators, missingness information, and analysis populations, the precision and potential selection effects of any outcome estimate cannot be evaluated.
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 |
|---|---|---|---|
| NiCord + Unmanipulated CBU | 13 | 13 | 100.0% |
| NiCord | 3 | 3 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| NiCord + Unmanipulated CBU | 2 of 13 |
| NiCord | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| NiCord + Unmanipulated CBU | 0 of 13 |
| NiCord | 0 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | NiCord + Unmanipulated CBU | NiCord |
|---|---|---|---|
| Graft versus host disease | Immune system disorders | 3 of 13 | 0 of 3 |
| Bacteraemia | Infections and infestations | 3 of 13 | 0 of 3 |
| Hyperglycaemia | Metabolism and nutrition disorders | 3 of 13 | 0 of 3 |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | 3 of 13 | 0 of 3 |
| Pyrexia | General disorders | 2 of 13 | 0 of 3 |
| Transplant rejection | Immune system disorders | 1 of 13 | 1 of 3 |
| Anal fissure | Gastrointestinal disorders | 1 of 13 | 0 of 3 |
| Nausea | Gastrointestinal disorders | 1 of 13 | 0 of 3 |
| Acute graft versus host disease | Immune system disorders | 1 of 13 | 0 of 3 |
| Anaphylactic reaction | Immune system disorders | 1 of 13 | 0 of 3 |
Serious events with the highest arm-level rate: transplant rejection (33.3%), renal failure (33.3%), respiratory failure (33.3%), hypotension (33.3%), graft versus host disease (23.1%).
The registry record reports serious-event counts by listed group. For “NiCord + Unmanipulated CBU,” it lists 13 participants at risk and 13 affected; for “NiCord,” it lists 3 at risk and 3 affected. For other adverse events, the record lists 13 and 3 at risk, respectively, and 0 affected in each group. Deaths are listed as 2 and 0, respectively. These are descriptive registry figures, not a randomized treatment comparison.
Serious-event terms are listed with the following percentages: Transplant rejection, Renal Failure, Respiratory failure, and Hypotension at 33.3% each; Graft versus host disease and Bacteraemia at 23.1% each. The denominator and basis for these percentages are not reported in the registry record. The percentages should not be interpreted as rates for a defined follow-up period or as comparisons between groups without that information.
The record does not report event timing, severity detail, relatedness to treatment, follow-up duration, or the number of recurrent events. These figures also do not report the primary endpoint of acute infusional toxicity within 24 hours post-infusion. They should be read as the listed safety counts and terms, without inferring causation or comparing the groups as if treatment assignment had been randomized.
12. What the Result Does, and Does Not, Mean
The registry record identifies the study’s intended primary safety question: how many participants experienced acute NiCord infusional toxicity within 24 hours post-infusion. It does not report the result for that endpoint. Consequently, the main outcome cannot be quantified from the registry entry, and the record cannot establish how precisely acute toxicity was measured or estimated.
The posted adverse-event figures provide descriptive information, including group-specific serious-event counts, other-event counts, deaths, and percentages for several serious-event terms. They do not show that NiCord caused or prevented any particular event. They also do not support a treatment comparison: the study is listed as single group, allocation is not applicable, and the groups are not a randomized control comparison. The record does not provide the timing and denominators needed to interpret the listed term percentages as risks over a defined period.
Several secondary outcomes are named, including transplant-related mortality, event-free survival, and overall survival. Their results are not reported in the registry record. The available entry therefore does not allow readers to assess those outcomes, their precision, or any relationship between the groups.
General statistical context: a completed study can still have incomplete public outcome reporting. A study’s status does not replace the outcome estimates, analysis populations, and uncertainty measures needed to interpret its findings. Here, the enrollment and adverse-event counts describe what the record lists, but they cannot fill in missing primary and secondary outcome results.
The appropriate reading is limited: the registry record documents the study design and certain adverse-event figures, while leaving the primary endpoint result and important analysis details unreported. It does not provide a basis for concluding that the intervention is effective or ineffective, or for attributing the listed events or deaths to treatment.
13. Why This Trial Matters Statistically
This trial is statistically notable because its central endpoint is a short-window safety measure expressed as a count of participants, while the registry entry does not report that result. The contrast between a clearly stated endpoint and an absent endpoint estimate illustrates why registration details and outcome reporting are distinct: the outcome definition identifies what was intended to be measured, but readers need results and analysis details to interpret what was observed.
The study also lists two groups without random allocation. That distinction matters because descriptive group counts do not have the same interpretation as results from a randomized comparison. A reader may see differences in counts, but the record does not provide a design that supports attributing any difference to treatment. This is particularly important for adverse events and deaths, where timing, follow-up, event definitions, and participant characteristics all influence interpretation.
The serious-event percentages further illustrate the importance of denominators. A percentage can appear precise while remaining difficult to interpret if its population and event basis are unspecified. Without those details, it is not possible to know whether the figures refer to affected participants, total events, or another measure, or to compare them reliably with other outcomes.
Finally, the record names survival and mortality outcomes but does not report their results, analysis methods, or uncertainty. General statistical context: transparent reporting of estimates, denominators, analysis populations, and missing-data handling is needed for readers to judge both the size and the precision of a result. These gaps limit what can be learned statistically from the public record, even though the trial is marked completed.
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 principal limitation of the registry record is that it does not report the result for the primary endpoint, acute NiCord infusional toxicity within 24 hours post-infusion. The entry gives the endpoint’s purpose and timeframe but not the number of participants meeting it, an estimate of frequency, or an uncertainty measure.
The adverse-event figures lack important context. The registry record does not report the relevant follow-up period, the criteria used to classify events, the attribution of events to treatment, or the denominator and basis for the listed serious-event percentages. It also does not report whether the participant counts refer to unique individuals across categories or how recurrent events were handled. The listed deaths have no reported timing or cause in these data.
The study is single group and not randomized. The two listed groups should not be treated as a like-for-like control comparison, and the record does not report an adjusted analysis that could address measured differences. Participant characteristics and group assignment details are not reported in the registry record.
Although transplant-related mortality, event-free survival, and overall survival are listed, their results and definitions are not reported. The record also does not report analysis populations, missing-data handling, a statistical analysis plan, multiplicity procedures, or an interim analysis plan. It does not report the trial’s sample-size justification. These omissions restrict assessment of precision, potential bias, and whether analyses followed prespecified methods. The listed completion status and enrollment do not resolve these limitations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Allogeneic SCT of NiCord®, UCB-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies — NCT01590628.
- Registry record last updated 2022-05-20; status last verified 2022-04.
- Results first posted 2022-04-27.
- 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
The registry record describes NCT01590628, “Allogeneic SCT of NiCord®, UCB-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies.” It is listed as a completed Phase 1 and Phase 2, single-group study sponsored by Gamida Cell ltd, with enrollment of 16. The study start is recorded as 2012-09 and primary completion as 2018-09.
The intervention is NiCord, a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells. The primary endpoint is a participant count for acute NiCord infusional toxicity within 24 hours post-infusion. Its result is not reported in the registry record. Listed secondary outcomes are transplant-related mortality, event-free survival, and overall survival; their results are also not reported.
The registry record lists group-specific serious and other adverse-event counts, deaths, and percentages for several serious-event terms. Because allocation is not applicable and the study is not a randomized comparison, these figures are descriptive and do not establish comparative treatment effects.