A Randomized, Placebo-controlled, Double-blind, Parallel Study to Determine the Effect of Farlong® NotoGinseng™ (Farlong® Ginseng Plus®) on Cholesterol and Blood Pressure
Phase: PHASE2
Conditions: Hyperlipidemias, Hypertension
Sponsor: LongStar HealthPro, Inc. DBA Farlong Pharmaceutical

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
1 of 10 
 
 
 
 
Statistical Analysis Plan (SAP) 
 
16GCHY 
 
Protocol Title:  
A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on 
cholesterol and blood pressure 
 
Protocol Number: 
16GCHY 
 
SAP Date: 
 
May 27, 2019 
 
Version: 
 
1.0 
 
 
Study Phase: 
 
Phase II 
 
 
Study Design: 
Randomized, placebo-controlled, double-blind, parallel study 
 
Sponsor: 
 
Yunnan PanLongYunHai Pharmaceuticals, Ltd. & Longstar 
Healthpro, Inc. DBA Farlong Pharmaceutical 
 
Sponsor Contact: 
Mr. ShaoXing Liu 
Yunnan PanLongYunHai Pharmaceuticals, Ltd. 
Chuxiong Economic Technology Development District 
Yunnan, China 675000 
86-137-08789513 
 
Ms. Jing Struve 
Longstar Healthpro, Inc. DBA Farlong Pharmaceutical 
4010 Valley Blvd., #101 
Walnut, CA 91789 (909)468-9215 
 
CRO: 
 
 
KGK Science Inc. 
Suite 1440, One London Place 
255 Queens Ave 
London Ontario N6A 5R8 
Canada 
519-438-9374 
 
Qualified Investigator: David Crowley, MD 
KGK Science Inc. 
519-438-9374 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
2 of 10 
 
Signatures 
I have read and approved of this statistical analysis plan for use in the study. 
 
STATISTICIAN: 
 
__________________________ 
 
____________________ 
 
Hui Guo, MSc  
 
 
 
Date 
 
Biostatistician 
             KGK Science Inc. 
 
 
 
 
 
 
 
SCIENTIFIC DIRECTOR: 
 
__________________________ 
 
____________________ 
 
Malkanthi Evans, PhD  
 
 
Date 
 
Scientific Director 
 
KGK Science Inc. 
 
 
SPONSOR RESEARCH DIRECTOR/MANAGER: 
 
 
 
__________________________ 
 
____________________ 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
SPONSOR CLINICAL MANAGER/SENIOR SCIENTIST: 
 
 
 
__________________________ 
 
____________________ 
  
 
 
 
 
Date 
  
 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
3 of 10 
 
 
Table of Contents 
Signatures ............................................................................................................................. 2 
Table of Contents .................................................................................................................. 3 
1. 
Overview ....................................................................................................................... 4 
1.1 
Study Goal .........................................................................................................................4 
1.2 
Study Design ......................................................................................................................4 
1.3 
Study Timepoints ...............................................................................................................4 
1.4 
Study Populations ..............................................................................................................4 
1.5 
Primary Outcome ...............................................................................................................4 
1.6 
Secondary Outcomes ..........................................................................................................4 
1.7 
Safety Outcomes ................................................................................................................5 
2. 
Statistical Evaluation ..................................................................................................... 5 
2.1 
General Approach ..............................................................................................................5 
2.1.1 
Demographic Characteristics .................................................................................................. 6 
2.1.2 
Treatment Exposure and Compliance ..................................................................................... 6 
2.1.3 
Premature Discontinuation ..................................................................................................... 7 
2.1.4 
Protocol Deviations ................................................................................................................. 7 
2.2 
Efficacy analysis .................................................................................................................7 
2.2.1 
Primary Variable:..................................................................................................................... 7 
2.2.2 
Interim Analysis ....................................................................................................................... 8 
2.2.3 
Secondary Variable .................................................................................................................. 8 
2.2.4 
Exploratory and Subgroup Analyses ........................................................................................ 8 
2.3 
Safety Analysis ...................................................................................................................8 
2.3.1 
Safety Variable ........................................................................................................................ 8 
2.3.2 
Adverse Events ........................................................................................................................ 8 
2.4 
Statistical and Analytical Issues ..........................................................................................8 
2.4.1 
Handling of Dropouts and Missing Data ................................................................................. 8 
2.4.2 
Outliers .................................................................................................................................... 9 
2.4.3 
Site Effects ............................................................................................................................... 9 
2.4.4 
Assessment of Model Fit ......................................................................................................... 9 
3. 
Appendix ..................................................................................................................... 10 
Table 1. Schedule of Assessments ................................................................................................. 10 
 
 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
4 of 10 
 
1. Overview 
1.1 
Study Goal 
The objective of this study was to determine the effect of Farlong NotoGinseng™ (Farlong 
Ginseng Plus®) on cholesterol and blood pressure. 
 
1.2 
Study Design 
This was a randomized, placebo-controlled, double-blind, parallel study with a 4-week 
therapeutic lifestyle change diet (TLC) run-in period and a 12-week supplementation period.  
The study was conducted at a single site at KGK Synergize Inc. in London, Ontario, Canada. 
 
1.3 
Study Timepoints 
Subjects were expected to participate in the study for up to 84 days. Subjects attended the 
study at visit 1 (screening) for informed consent and at visit 2 (baseline) for confirmation of 
eligibility and randomization. 
 
Participants were scheduled to be assessed at visit 1 (screening, day -56 to day -28), visit 2 
(baseline, day 0), visit3 (day28), visit 4 (day 56), and visit 5 (end of study, day 84). The 
demographic information and medical history were recorded at visit 1. Details of the schedule 
of assessments are shown in Appendix table 1.  
 
 
1.4 
Study Populations 
A total of three populations are defined for all summaries and analyses. Subjects who have 
satisfied the population criteria will be classified in the designated population. 
 
• The Safety Population will consist of all participants who received any amount of either 
product, and on whom any post-randomization safety information is available. 
• The Intent-to-Treat (ITT) Population will consist of all participants who received either 
product, and on whom any post-randomization efficacy information is available. 
• The Per Protocol (PP) Population will consist of all participants who consumed at least 
80% of supplement or placebo doses, do not have any major protocol violations and 
complete all study visits and procedures connected with measurement of the primary 
variable. 
 
1.5 
Primary Outcome 
The difference in serum LDL-C from baseline to week 12 between Farlong NotoGinseng™ 
(Farlong Ginseng Plus®) and placebo after 12 weeks of supplementation 
 
1.6 
Secondary Outcomes 
1. The difference in serum LDL-C from baseline to week 8 between Farlong Notoginseng 
and placebo 
2. The difference in blood pressure from baseline to week 8 between Farlong Notoginseng 
and placebo 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
5 of 10 
 
3. The difference in blood pressure from baseline to week 12 between Farlong 
Notoginseng and placebo 
4. The difference in triglycerides from baseline to week 8 between Farlong Notoginseng 
and placebo 
5. The difference in triglycerides from baseline to week 12 between Farlong Notoginseng 
and placebo 
6. The difference in HDL-C from baseline to week 8 between Farlong Notoginseng and 
placebo 
7. The difference in HDL-C from baseline to week 12 between Farlong Notoginseng and 
placebo 
8. The difference in total cholesterol from baseline to week 8 between Farlong 
Notoginseng and placebo 
9. The difference in total cholesterol from baseline to week 12 between Farlong 
Notoginseng and placebo 
10. The difference in endothelial vasodilation, as measured by the EndoPAT, from baseline 
to week 8 between Farlong Notoginseng and placebo 
11. The difference in endothelial vasodilation, as measured by the EndoPAT, from baseline 
to week 12 between Farlong Notoginseng and placebo 
 
1.7 
Safety Outcomes 
1. Vital signs (heart rate) in the Farlong Notoginseng and placebo group 
2. Weight and BMI in the Farlong Notoginseng and placebo group 
3. Hematology (complete blood count (CBC)), Hb1Ac, electrolytes (Na, K, Cl, Ca), liver 
function (bilirubin, AST, ALT) and kidney function (creatinine) in the Farlong Notoginseng 
and placebo group 
4. Incidence of adverse events in the Farlong Notoginseng and placebo over the course of 
the study 
 
2. Statistical Evaluation  
2.1 
General Approach 
The primary and secondary endpoints will be analysed for both ITT and PP Population. Safety 
parameters will be analysed for Safety Population. All data will be summarised by study group 
and/or visit as specified in the study objectives.   
 
For continuous variables, the minimum and maximum, the arithmetic mean, median, and 
standard deviation will be presented to two decimal places. This will be accompanied by the 
number of subjects included in the analysis for that time point.  
 
For categorical variables, counts and percentages will be used. The denominator for each 
percentage will be the number of subjects within the population study group unless otherwise 
specified.  
 
Changes in continuous endpoints from screening/baseline will be calculated as:  

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
6 of 10 
 
 
Change to Vi = Value at Vi – Value at V screening/baseline 
 
All hypothesis tests will be carried out at the 5% (2-sided) significance level unless otherwise 
specified. P-values will be rounded to three decimal places. P-values less than 0.001 will be 
reported as <0.001 in tables. 
 
All analyses will be performed using R Statistical Package or SAS. 
 
2.1.1 Demographic Characteristics 
Demographic and biometric information and vital signs at screening will be presented for the 
ITT and PP populations. This will include the following: 
 
1. Age (years) 
2. Gender (male/female) 
3. Ethnicity (African/African American/Central American/East Asian/Eastern European 
White/Hispanic or Latino/Middle Eastern/Native American/South Asian/South 
American/South Asian/South American/South East Asian/Western European White) 
4. Weight (kg) 
5. Systolic blood pressure (mmHg) 
6. Diastolic blood pressure (mmHg) 
7. Heart rate (bpm) 
 
Age, weight, BMI, blood pressure, and heart rate will be described as continuous variables. 
Gender and ethnicity will be treated as categorical variables.  
 
Possible differences at screening for continuous variables between two groups will be assessed 
by independent two-sample t-test, and Satterthwaite's correction will be conducted when the 
variances of the two groups are significantly different. 
 
Possible differences for categorical variables between two groups will be assessed by the chi-
square test or Fisher’s exact (2-tail) test, as appropriate. 
 
2.1.2 Treatment Exposure and Compliance 
Compliance will be calculated with the number of dosage units taken divided by the number of 
dosage units expected to have been taken multiplied by 100.  
 
number of dosage units taken
number of dosage units expected to have been taken x 100% 
Compliance will be analysed as a continuous variable.  
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
7 of 10 
 
Possible differences for compliance between two groups at each visit and throughout the 
follow-up will be assessed by independent two-sample t-test, and Satterthwaite's correction 
will be conducted when the variances of the two groups are significantly different. 
 
2.1.3 Premature Discontinuation 
For each premature discontinuation, the following parameters will be listed: participant 
number and the reason for premature discontinuation.  
 
2.1.4 Protocol Deviations 
Protocol deviations will be listed with subject number, date and description of protocol 
deviation. 
 
2.2 
Efficacy analysis 
An effectiveness analysis based on the intent-to-treat population and the per protocol 
population will be performed with the same statistical method. LDL-C, Blood pressure, 
triglycerides, HDL-C, total cholesterol, EndoPAT score will be assessed as continuous variables. 
 
Possible differences at baseline between two groups will be assessed by independent two-
sample t-test, and Satterthwaite's correction will be conducted when the variances of the two 
groups are significantly different. 
 
2.2.1 Primary Variable: 
The primary outcome variable is serum LDL-C. 
 
The primary hypotheses of the change in serum LDL-C are as follows: 
 
H0: μa = μb  
  
H1: μa ≠ μb 
 
Where μa = mean change of LDL-C from baseline to week 12 in group A 
 
μb = mean change of LDL-C from baseline to week 12 in group B 
 
The null hypothesis will be assessed by Mixed Model for Repeated Measures. The model will 
include the change value of the outcome variable at each visit as a dependent variable, baseline 
value of the dependent variable as a covariate, and group, visit and group by visit as fix effects. 
Four covariance structures will be tested separately and the one that provided the smallest AIC 
will be selected. The tested covariance structures included Compound Symmetry (CS), 
Heterogeneous CS (CSH), first-order autoregressive [AR(1)], and heterogeneous autoregressive 
[ARH(1)]. P-values for between group comparisons and within-group changes from baseline will 
be obtained from the model. 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
8 of 10 
 
2.2.2 Interim Analysis 
There was no planned interim analysis in this study.  
 
2.2.3 Secondary Variable 
The following secondary variables will be assessed as the method of serum LDL-C described in 
section 2.2.1: 
 
1. LDL-C  
2. Blood pressure 
3. Triglycerides 
4. HDL-C  
5. Total cholesterol  
6. EndoPAT score 
 
2.2.4 Exploratory and Subgroup Analyses 
Exploratory and subgroup analyses may be performed using the same methodology as for 
primary and secondary outcomes.  
 
2.3 
Safety Analysis 
2.3.1 Safety Variable 
The available values at each visit will be described for the following safety variables: 
 
1. Heart rate 
2. Weight and BMI  
3. Hematology (complete blood count (CBC)), Hb1Ac, electrolytes (Na, K, Cl, Ca), liver 
function (bilirubin, AST, ALT) and kidney function (creatinine)  
 
Heart rate, weight, BMI, CBC, Hb1Ac, Na, K, Cl, Ca, bilirubin, AST, ALT, and creatinine will be 
treated as continuous variables. 
 
2.3.2 Adverse Events 
Adverse events (AEs) will be presented separately as the number and percentage of subjects for 
each system organ class, preferred term, and lower level term. Furthermore, the lower level 
term, intensity, relationship, action taken, and outcome will be reported for each adverse 
event. The difference of adverse event between two groups will be assessed with two-tailed 
Chi-square or Fisher’s exact test as appropriate. 
 
2.4 
Statistical and Analytical Issues 
2.4.1 Handling of Dropouts and Missing Data 
Missing values in the intention-to-treat analysis will be assessed for reasons and pattern for 
missingness and imputed with multiple imputation method as a sensitivity analysis. No 
imputation will be performed for missing values of the per protocol or the safety populations. 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
9 of 10 
 
2.4.2 Outliers 
Every outlier will be checked at data validation before unblinding the study. Continuous 
variables will be checked by visual inspection using histograms, box-plots or scatter plots, and 
verified by referral back to source documents. If the values are not erroneous, they will be 
included in the analysis. 
 
2.4.3 Site Effects 
This is a single-site study. Therefore, site effect is not relevant. 
 
2.4.4 Assessment of Model Fit 
Q-Q plot and histogram will be generated for the evaluation of normality of the residuals of the 
model. If the residuals are highly skewed, ranks, log or other transformation of the dependent 
variable will be performed.  
 
 

Statistical Analysis Plan – 16GCHY:   
 A randomized, placebo-controlled, double-blind, parallel study  
to determine the effect of Farlong NotoGinseng™ (Farlong Ginseng Plus®) on cholesterol and blood pressure 
10 of 10 
 
3. Appendix 
 
Table 1. Schedule of Assessments 
 
 
 
Visit 1 
Screening 
 
Phone 
Call 
Visit 2 
Baseline 
Day 0 
Visit 3 
Day 28 
Week 4 
Visit 4  
Day 56 
Week 8 
Visit 5 
Day 84 
Week 12 
Informed consent 
X 
 
 
 
 
 
Review inclusion/exclusion criteria 
X 
 
X 
 
 
 
Review medical history 
X 
 
 
 
 
 
Review concomitant therapies 
X 
 
X 
X 
X 
X 
Height*, weight, heart rate, blood 
pressure (diastolic and systolic) 
X 
 
X 
X 
X 
X 
Urine pregnancy test 
X 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
Physical examination 
 
 
X 
 
 
 
Framingham Risk Score Assessment 
X 
 
 
 
 
 
Laboratory test: 
CBC, electrolytes (Na, K, Cl, Ca), HbA1c, 
creatinine, AST, ALT, bilirubin, hs-CRP* 
 
X 
 
 
 
 
 
X 
Lipid Panel  
X 
 
X 
X 
X 
X 
EndoPAT measurement  
 
 
X 
X 
X 
X 
IP dispensed 
 
 
X 
X 
X 
 
IP returned 
 
 
 
X 
X 
X 
TLC Counseling 
X 
X 
 
 
 
 
3-day Food records dispensed  
X 
 
X 
X 
X 
 
3-day Food records returned 
 
 
X 
X 
X 
X 
Study diary dispensed 
 
 
X 
X 
X 
 
Study diary returned 
 
 
 
X 
X 
X 
Compliance calculated 
 
 
 
X 
X 
X 
Adverse events assessed  
 
 
 
X 
X 
X