Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nipro Medical Corporation | INDUSTRY |
| Dialysis Clinic, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.
10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.
Current patients receiving dialysis treatment for end stage renal disease and who meet the inclusion/exclusion criteria will be entered into the study. These patients will continue on their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each patient will be studied for three weeks with each week starting with a dialyzer of a different manufacture but of comparable characteristics. Solute clearances and removal will be determined at each of the three dialysis sessions during the week. During session 2 of each week additional specimens will be taken to analyze for hemocompatibility. At the end of the study all clearances and the hemocompatibility markers for each dialyzer will be compared to one another as well as to the manufactures stated characteristics. Blood for the clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also be recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solute Clearance | Active Comparator | Solute clearance at 60 minutes for urea, creatinine, phosphate, beta 2 microglobulin, and myoglobin will be determined three times for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers at the 60 minute time point. |
|
| Hemocompatibility | Active Comparator | Hemocompatibility will be determined using the markers C3a, C5a, thrombin/anti-thrombin complex and complete blood count with platelets will be determined one time for each dialyzer at session 2 and at time points 0, 15, 30, 60, and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers .. |
|
| Solute removal rate | Active Comparator | Solute (urea, creatinine, phosphate, beta 2 macroglobulin, and myoglobin) removal rate will be determined time points 0 and 240 minutes for ELISIO-15H, Revaclear and Optiflux 160NR dialyzers . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISIO-15H | Device | Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance and Solute Removal Characteristics of Dialyzers | Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:((([S]60'Art - [S]60'Ven) / [S]60'Art) * Qb) where [S] = solute concentration; Qb = blood flow rate. S | During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers. |
| Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets. | Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period. |
| Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers. | Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.. |
| Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers. | Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Madhukar Misra, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Clinic Incorporated | Columbia | Missouri | 65201 | United States |
There were no significant events. We didn't lose any consented patients prior to starting the study. There was no special preparation prior to start of study other than inclusion/exclusion criteria which took place prior to consent.
Patients were pre-screened to determine if met inclusion/exclusion criteria by the study coordinator. If they met the criteria the primary investigator met with them explained the project and if interested he then consented them. Once consented the patient started the study on the following Monday.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: ELISIO, Then Revaclear, Then Optiflux | This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| FG001 | Experimental: Revaclear, Then Optiflux, Then ELISIO | This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| FG002 | Experimental: Optiflux, Then ELISIO, Then Revaclear | This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant was removed by the PI when it was determined that he had had a procedure to the fistula during the study period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: ELISIO, Then Revaclear, Then Optiflux | This group will start week one with the ELISIO dialyzer, followed by the Revaclear dialyzer in week two and in the third finish with the Optiflux dialyzer. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clearance and Solute Removal Characteristics of Dialyzers | Clearances of small, middle and large molecular weight solutes will be measured at 60 minute time point utilizing urea, creatinine, beta 2 microglobulin, phosphate and myoglobin. Dialyzer clearance is calculated as follows: 60 minute clearance:((([S]60'Art - [S]60'Ven) / [S]60'Art) * Qb) where [S] = solute concentration; Qb = blood flow rate. S | Posted | Mean | Standard Deviation | milliliters per minute (ml/min) | During each of the three weekly dialysis sessions measurements of urea were made at the 60 minute time point for each patient in the study. At the end of the study all measurements were summed for each of the three dialyzers. |
|
Participant was monitored continuously each of the three dialysis sessions per week over the three week study period.
Adverse events would be comprised of any clinically relevant event during the time the patient was on the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: ELISIO | This group were dialyzed three times in during one week with the ELISO Dialyzer. There were no adverse events during any of the study periods. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Madhukar Misra, MD | University of Missouri, Department of Medicine, Division of Nephrology | 573 882-7993 | misram@health.missouri.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2015 | Jul 3, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2019 | Jan 14, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007688 | Kidneys, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Open Label
Not provided
|
| Revaclear | Device | Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
|
|
| Optiflux | Device | Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
|
|
| Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers. | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis. |
| Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers. | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point. |
| Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers. | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point. |
| Experimental: Revaclear, Then Optiflux, Then ELISIO |
This group will start week one with the Revaclear dialyzer, followed by the Optiflux dialyzer in week two and finish with the ELISIO dialyzer in week three. . Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| BG002 | Experimental: Optiflux, Then ELISIO, Then Revaclear | This group will start with the Optiflux dialyzer in week one, followed by the ELISIO dialyzer in week two and finish with the Revaclear dialyzer in week three. Each patient will undergo three successive hemodialysis sessions during each week following their established regimen. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age was recorded at the time the patient started the study. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | BUN Clearance Revaclear | Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
| OG002 | BUN Clearance Elisio | Solute clearance at 60 minutes for urea. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
| OG003 | Creatinine Clearance Optiflux | Solute clearance at 60 minutes for creatinine. |
| OG004 | Creatinine Clearance Revaclear | Solute clearance at 60 minutes for creatinine. ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
| OG005 | Creatinine Clearance ELISIO | Solute clearance at 60 minutes for creatinine, ELISIO-15H: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Revaclear: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. Optiflux: Each patient to undergo 3 successive hemodialysis/week with this dialyzer. |
| OG006 | Phosphate Clearance Optiflux | Phosphate clearance at 60 minutes |
| OG007 | Phosphate Clearance Revaclear | Phosphate Clearance at 60 minutes. |
| OG008 | Phosphate Clearance Elisio | Phosphate Clearance at 60 minutes. |
| OG009 | Beta 2 Microglobulin Revaclear | Beta 2 microglobulin clearance at 60 minutes |
| OG010 | Beta 2 Microglobulin Optiflux | Beta 2 microglobulin clearance at 60 minutes. |
| OG011 | Beta 2 Microglobulin ELISIO | Beta 2 Microglobulin clearance at 60 minutes. |
| OG012 | Myoglobin Clearance Optiflux | Myoglobin clearance at 60 minutes. |
| OG013 | Myoglobin Clearance Revaclear | Myoglobin clearance at 60 minutes. |
| OG014 | Myoglobin Clearance ELISIO | Myoglobin clearance at 60 minutes. |
|
|
|
| Primary | Hemocompatibility as Shown by C5a for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers of Dialyzers | The molecules monitored will be C5a, thrombin/anti-thrombin complex and a complete blood count with platelets. | Posted | Mean | Standard Deviation | Percent change from baseline | Once a week during the second of the three weekly sessions specimens will be taken at time points 0, 15, 30, 60 and 240 minutes. Measurements, all patients, were summed for each dialyzer type by time period. |
|
|
|
|
| Primary | Hemocompatibility as Shown by Thrombin/Antithrombin Complex for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers. | Measure of the % change from Baseline for the hemocompatibility marker Thrombin/Antithrombin complex for the Optiflux, Revaclear, and ELISIO dialyzers. | Posted | Mean | Standard Deviation | % Change from Baseline | Once a week during the second of the three weekly sessions specimens will be taken at the 60 and 240 minutes timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis.. |
|
|
|
|
| Primary | Hemocompatibility as Shown by Hematocrit for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Hematocrit for the Optiflux, Revaclear, and ELISIO dialyzers. | Posted | Mean | Standard Deviation | Percent change from baseline. | Once a week during the second of three weekly sessions samples will be taken at the 0, 15, 30, 60, and 240 minute timepoints. Measurements for all patients were summed for each dialyzer type by time period for analysis. |
|
|
|
|
| Primary | Hemocompatibility as Shown by Hemoglobin for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Hemoglobin for the Optiflux, Revaclear, and ELISIO dialyzers. | Posted | Mean | Standard Deviation | Percent Change from Baseline | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time points. Measurements for all patients were summed for each dialyzer type and time point for analysis. |
|
|
|
|
| Primary | Hemocompatibility as Shown by White Cell Count for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker White Cell Count for the Optiflux, Revaclear, and ELISIO dialyzers. | Posted | Mean | Standard Deviation | Percent Change from Baseline | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point. |
|
|
|
|
| Primary | Hemocompatibility as Shown by Platelets for Optiflux, Revaclear, and ELISIO Hemodialysis Dialyzers | Measure of the % change from Baseline for the hemocompatibility marker Platelets for the Optiflux, Revaclear, and ELISIO dialyzers. | Posted | Mean | Standard Deviation | Percent Change from Baseline | Once a week during the second of the three weekly sessions samples will be taken at the 0, 15, 30, 60 and 240 minutes time periods. All measurements for all patients were summed for each dialyzer type and time point. |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Experimental: Revaclear | This group were dialyzed three times in during one weekwith the Revaclear dialyzer. There were no adverse events during any of the study periods | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Experimental: Optiflux | This group was dialyzed three times in during one weekwith the Optiflux dialyzer. There were no adverse events during any of the study periods | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| t-test, 2 sided |
Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. |
| =0.216 |
The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. |
| Superiority |
No significant difference |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.952 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority | No significant difference |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.714 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority | No Significant difference |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.156 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.427 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| No significant difference | t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.487 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| No significant difference | Wilcoxon (Mann-Whitney) | The difference in the median values between the two groups is not > enough to exclude that the difference is due to random sampling variability | =0.111 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority | Failed normality test |
| No significant difference | Wilcoxon (Mann-Whitney) | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.198 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority | Failed normality test |
| Showed a significant difference | t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.007 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| No significant difference | t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.202 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| No significant difference | t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.540 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used. | =0.015 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the <0.050 level. | Superiority |
| Wilcoxon (Mann-Whitney) | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.413 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.314 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.769 | The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. | Superiority |
Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. |
| 1.000 |
The p value was not adjusted for multiple comparisons and the difference was considered significant at the p<0.05 level. |
| Superiority |
| Wilcoxon (Mann-Whitney) | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | 0.713 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.424 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.230 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.678 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.643 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.430 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.295 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.723 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.749 | Superiority |
| Wilcoxon (Mann-Whitney) | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.967 | Superiority |
Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.
| =0.993 |
| Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.650 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.299 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.659 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.176 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.853 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.494 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.631 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.370 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.950 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.377 | Superiority |
Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.
| =0.578 |
| Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.225 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.125 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.466 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.534 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.584 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.981 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.568 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.240 | Superiority |
| Wilcoxon (Mann-Whitney) | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.724 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.445 | Superiority |
Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.
| =0.292 |
| Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.714 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.176 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.190 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | -0.009 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.911 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.388 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.337 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.575 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.880 | Superiority |
| t-test, 2 sided | Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used. | =0.731 | Superiority |