Hempzorb81 – A1c, Weight, Girth

Technical Memo

TO: MATT SMITH-MED7, LLC

FROM: SHAUNNA K. BURBIDGE, PHD

PROJECT: STATISTICAL ANALYSIS OF HEMPZORB 81 (MED7) VERSUS PLACEBO

DATE: OCTOBER 20, 2020

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1.0 Summary Statistics

Before a full statistical panel could be run and evaluated, a baseline evaluation was established. Table 1, 2, and 3 below show the summary statistics for the Med? and placebo groups.

Table 1. Summary Statistics-Placebo Group

Table 2. Summary Statistics-Med 7 Group 1

Table 3. Summary Statistics-Med7 Group 2

Next, categorical variables were created for blood pressure and A1C based upon clinically accepted parameters defined in the tables below. Table 4 shows the sample percentage for each A1C category and Table 5 shows the sample percentage for each blood pressure category prior to the study, at 90 days and at 180 days.

Table 4. Blood A1C- Sample Percentages

Category Source: American Diabetes Association, 2020

Table 5. Blood Pressure - Sample Percentages

*Category Source: American Heart Association, 2020

2.0 Statistical Analysis

First, a set of paired samples t-tests were employed to identify if the Med? groups experienced a significant change in any of the health variables from baseline to 180 days. An examination of the placebo group found a no significant change in any of the measured variables during the study period (Table 6). The mean value in Tables 6 and 7 below shows the baseline mean measurement minus the 180-day mean measurement. Note: A prior analysis was conducted to identify changes from baseline to day 90. Those results are not presented in this memo.

Table 6. Paired Samples t-Test: Baseline to 180 Days (Placebo)

The analysis of Med 7 Group 1 identified significant decreases in systolic blood pressure, weight, abdominal girth, and blood A1C. As shown below in Table 7, systolic blood pressure went down by approximately 6.5 points. Subject weight was reduced by an average of 5.7 pounds (p=0.000), while abdominal girth was reduced by 3.6 inches (p=0.000). Blood A1C was reduced by 1.31 during the study period (p=0.000).

Table 7. Paired Samples t-Test: Baseline to 180 Days (Med7 3 ml)

The analysis of Med 7 Group 2 (4 ml) identified significant reductions in blood pressure, weight, abdominal girth, and blood A1C. As shown below in Table 8, blood pressure went down by 6.8 points (systolic) and 3.6 points (diastolic) (p= 0.000). Subject weight was reduced by an average of 6.7 pounds (p=0.000), while abdominal girth was reduced by an average or 3.8 inches (p=0.000). Blood A1C was reduced by 1.042 during the study period (p=0.000).

Table 8. Paired Samples t-Test: Baseline to 180 Days (Med7 4 ml)

Study participants in the Med? groups received an increase in their dose during this time period (from 1ml to 3ml and 2ml to 4ml respectively). Paired samples t-tests were also employed to evaluate health changes from 90-180 days. Tables 9, 10, and 11 below outline changes in health metrics during that time period.

Table 9. Paired Samples t-Test: 90 Days to 180 Days (Placebo)

An analysis of the placebo group identified a significant increase in average weight (1.8 pounds) between Day 90 and Day 180 of the study period. There was no significant change in the other measured health metrics.

Table 10. Paired Samples t-Test: 90 Days (Med7 1ml) to 180 Days (Med7 3 ml)

The analysis of Med 7 Group 1 identified significant decreases in systolic blood pressure, weight, abdominal girth, and blood A1C. As shown in Table 10, systolic blood pressure went down by approximately 4.4 points (p=0.001). Subject weight was reduced by an average of 5.8 pounds (p=0.000), while abdominal girth was reduced by 1.8 inches (p=0.000). Blood A1C was reduced by 0.80 during the study period (p=0.000).

Table 11. Paired Samples t-Test: 90 Days (Med7 2ml) to 180 Days (Med7 4 ml)

The analysis of Med 7 Group 2 (4 ml) identified significant reductions in blood pressure, weight, abdominal girth, and blood A1C. As shown in Table 11, blood pressure went down by 5.2 points (systolic) and 2.8 points (diastolic) (p= 0.000). Subject weight was reduced by an average of 6.7 pounds (p=0.000), while abdominal girth was reduced by an average or 2.1 inches (p=0.000). Blood A1C was reduced by 0.526 during the study period (p=0.000).

Lastly, independent samples t-tests were run to determine if there is a significant difference in the day 0-180 and the day 90-180 change between the two Med? groups and the placebo group.

The analysis determined that from day 0-180 subjects in the Med? (1ml and 3ml) group saw a significant reduction in systolic blood pressure (5.5 points), weight, abdominal girth and blood A1C. Participants in Med? Group 1 saw a significant reduction in weight compared  to  those in  the placebo  group(!:::.x̄=14.08 pounds, p=0.000). Participants in Med? Group 1 also saw a significant reduction in abdominal girth compared to the placebo group(!:::.x̄=4 inches, p=0.000).  Additionally, subjects in the Med? group saw a significant reduction in blood A1C level compared to those in the placebo group(!:::.x̄=1.343 percent, p=0.000).

Table 12. Independent Samples t-test: Change from Baseline to Day 180 (Med7 (3 ml) vs Placebo)

A second analysis determined that subjects in  the Med? (2ml and 4ml) group saw a very significant

improvement in all health metrics compared to participants in the placebo group from day Oto day 180 (Table 13). Med? Group 2 participants saw a significant reduction in blood pressure(!:::.x̄= systolic: 5.9 points, diastolic: 3.92  points),  weight  (!:::.x̄=13.604  pounds)  abdominal  girth  (!:::.x̄=4.228  inches)  and  blood  A1C  (!:::.x̄=1.075 percent) compared to those in the placebo group.

Table 13. Independent Samples t-test: Change from Baseline to Day 180 (Med7 (4 ml) vs Placebo)

Next, independent t-test analysis determined that subjects in Med? Group 1 (1 ml and 3ml) saw a significant improvement in weight, abdominal girth and blood A1C between day 90 and day 180 compared to participants in the placebo group (Table 14). Med? Group 1 participants saw a significant reduction in weight(!:::.x̄=5.74 pounds), abdominal girth(!:::.x̄=2.9 inches), and blood A1C (!:::.x̄=0.82 percent) compared to those in the placebo group.

Table 14. Independent Samples t-test: Change from Day 90 to Day 180 (Med7 (3 ml) vs Placebo)

An additional independent t-test analysis determined that subjects in Med? Group 2 (2 ml and 4ml) group saw a significant improvement in all metrics between day 90 and day 180 compared to participants in the placebo group (Table 15). Med? Group 1 participants saw a significant reduction in blood pressure (!:::.x̄= systolic: 3.85 points, diastolic: 2.96 points), weight (!:::.x̄=6.58 pounds), abdominal  girth (!:::.x̄=2.38 inches), and blood A1C(!:::.x̄=0.54 percent) compared to those in the placebo group.

Table 15. Independent Samples t-test: Change from Day 90 to Day 180 (Med7 (4 ml) vs Placebo)

Lastly, several independent sample t-tests were used to identify changes based on other characteristics of the sample. This included groups such as male vs female, participants with elevated A1C, participants with High Blood pressure, etc.

First an analysis ought to determine if men and women differed in their response to the Med? product over time. A preliminary analysis identified that men lost significantly more total weight than women over the 180 days of the study (p=0.05). However, men typically weight more than women. Therefore, the data was standardized to ensure equal comparisons. To more accurately represent change in weight, each individual's change in weight from Day 0 to Day 180 was divided by their baseline weight, so that weight change was represented as a percentage of total weight (e.g. Subject X lost 4% of their body weight over the course of the study). As shown in Tablel 6 below, after standardizing the data male participants saw a significantly larger reduction in systolic blood pressure (4.5 points) than women over the study period.

Table 16. Independent Samples t-test: Change from Baseline to Day 180 (Men vs Women)

*Percentage of body weight change from baseline to Day 180

Next, the analysis examined all participants who began the study with an elevated baseline A1C over 7% (American Diabetes Association, 2020). An independents samples t-test determined that participants receiving Med?  (all  doses)  saw  significant  reductions  in  systolic  blood  pressure  (11x̄=4.5  points),  weight  (11x̄=14.02 pounds), abdominal  girth (11x̄=4.5 inches), and blood  A1C (11x̄=1.36 percent)  over the placebo  group.  The confidence interval in table 17 shows that 95% of subjects in the Med? groups saw between a 1.13% and 1.6% reduction in their blood A1Cover the study period.

Table 17. Independent Samples t-test: Change from Baseline to Day 180 (Elevated A1C: Med7 vs Placebo)

Lastly, subjects in the two Med? dosage groups (1-3ml and 2-4ml) were compared using an independents samples t-test to identify if there was a significant difference in the health metric change of the two groups. Table 18 shows that there was no significant difference in health metrics between the lower dose Med? group and the higher dose Med? group over the 180-day study period. This implies that the higher dose did not result in an increased benefit in the health metrics measured.

Table 18. Independent Samples t-test: Change from Baseline to Day 180 (Med7 1-3ml vs Med7 2-4ml)

3.0 Conclusions

Subjects in both Med? dosing groups saw significant improvements to all health metrics when compared to subjects in the placebo group. Participants in the Med? groups also saw continued health improvement and reductions in health metric measurements between Day 90 and Day 180 as their dosage was increased (2ml per group). Male participants receiving Med? (both groups) saw a significantly larger reduction in systolic blood pressure than female participants over the 180-day study period. Study subjects who began the study with an elevated blood A1C level who received Med? (any dose) had a significantly larger drop in blood A1C levels over the study than subjects in the placebo group (1.1-1.6 percent). There was no significant difference in the total change in health metrics between Med? Group 1 (1-3ml) and Med? Group 2 (2-4ml).

4.0 Limitations

The analysis was limited by the data provided. A more advanced statistical evaluation would be possible if additional demographic and personal information was available for the subjects in the Med? and placebo groups. Additionally, a larger sample would provide additional statistical validity and allow for more in depth analysis.

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