A Proof-of-concept Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
Phase: PHASE1
Conditions: Healthy
Sponsor: Hofseth Biocare ASA

CLINICAL PROTOCOL COVER PAGE 
 
Protocol Title: 
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
 
Protocol Number:  
18PEHH 
 
Protocol Date: 
 
May 3, 2018 
 
Version: 
 
 
2 
 
Study Phase: 
 
Phase I 
 
Study Design: 
 Open-Label 
 
Sponsor: 
 
 
Hofseth Biocare ASA 
Havnegata 11 
6005 Aalesund 
Norway 
 
                                           
 
Sponsor Contact: 
 
Dr. Bomi Framroze 
Hofseth Biocare ASA  
Email: bf@hofsethbiocare.no  
Telephone: 650-283-2335 
 
CRO:  
 
 
KGK Science Inc. 
 
 
 
 
Suite 1440, One London Place 
 
 
 
 
255 Queens Ave 
 
 
 
 
London Ontario N6A 5R8 
 
 
 
 
Canada 
 
 
 
 
Telephone: 519-438-9374 
 
 
Qualified Investigator: 
David Crowley, MD 
 
 
 
 
KGK Science Inc.  
 
 
 
 
Telephone: 519-438-9374 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 2 of 41 
 
PROTOCOL SIGNATURE SHEET 
The sponsor and the investigator agree to conduct the study in compliance with the clinical study protocol 
(and amendments), International Conference on Harmonization (ICH) guidelines for current Good Clinical 
Practice (cGCP) and applicable regulatory requirements. 
Name 
Signature 
Date 
Sponsor:  
Dr. Bomi Framroze 
Hofseth Biocare ASA 
Havnegata 11 
6005 Aalesund 
Norway 
 
 
Scientific Director:  
Malkanthi Evans, PhD 
Scientific Director 
KGK Science Inc. 
255 Queens Ave., 
Suite 1440 
London, ON N6A 5R8 
Canada 
 
 
 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 3 of 41 
 
1 
LIST OF ABBREVIATIONS  
AE 
Adverse Event 
BMI 
Body Mass Index 
BP 
Blood Pressure 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
EDTA 
Ethylene Diamine Tetra Acetic Acid 
etc. 
“and so forth” 
e.g. 
“for example” 
et al 
“and others” 
g 
Gram 
g 
gravity  
GCP 
Good Clinical Practice 
Hb 
Hemoglobin 
HbA1c 
Glycated hemoglobin 
HR 
Heart Rate 
lbs. 
Pounds 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonization 
IRB 
Institutional Review Board 
kg 
Kilogram 
LOCF 
Last Observation Carried Forward 
MCH 
Mean Corpuscular Hemoglobin 
MCHC 
Mean Corpuscular Hemoglobin Concentration 
MCV 
Mean Corpuscular Volume 
QI 
Qualified Investigator 
RBC 
Red Blood Cells 
RDW 
Red Cell Distribution Width 
ROS 
Reactive Oxygen Species 
RNS 
Reactive Nitrogen Species  
SAE 
Serious Adverse Event 
SPH 
Salmon Protein Hydrolysate 
SST 
Serum Separating Tube 
WBC 
White Blood Cell 
WHO 
World Health Organization 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 4 of 41 
 
TABLE OF CONTENTS 
1 
LIST OF ABBREVIATIONS ............................................................................................................................ 3 
2 
INTRODUCTION .............................................................................................................................................. 7 
3 
STUDY OBJECTIVES ...................................................................................................................................... 8 
4 
STUDY DESIGN ................................................................................................................................................ 9 
5 
SELECTION OF STUDY POPULATION .................................................................................................... 10 
5.1 
INCLUSION CRITERIA ................................................................................................................................... 10 
5.2 
EXCLUSION CRITERIA .................................................................................................................................. 10 
5.3 
CONCOMITANT MEDICATIONS AND WASHOUT PERIODS ........................................................................... 11 
5.3.1 
Prescribed Medications ....................................................................................................................... 11 
5.3.2 
Over-the-counter Medications, Supplements, and Foods/Drinks ........................................................ 11 
5.3.3 
Rescue Medications ............................................................................................................................. 12 
5.4 
PREMATURE/DISCONTINUATION CRITERIA ................................................................................................ 12 
6 
INVESTIGATIONAL PRODUCT ................................................................................................................. 13 
6.1 
MANUFACTURING AND STORAGE ................................................................................................................ 13 
6.2 
LABELING AND CODING ............................................................................................................................... 13 
6.3 
INVESTIGATIONAL PRODUCT ....................................................................................................................... 13 
6.4 
DIRECTIONS .................................................................................................................................................. 13 
7 
STUDY ASSESSMENTS................................................................................................................................. 14 
7.1 
VISIT 1; SCREENING (DAY -45 TO DAY -1) * ................................................................................................ 14 
7.2 
VISIT 2; BASELINE (DAY 0) .......................................................................................................................... 14 
7.3 
COMPLIANCE PHONE CALLS........................................................................................................................ 15 
7.4 
VISIT 3; END-OF-STUDY; WEEK 18 (DAY 128 ± 3) ...................................................................................... 15 
7.5 
CLINICAL ASSESSMENTS AND PROCEDURES ............................................................................................... 16 
7.5.1 
Questionnaires ..................................................................................................................................... 16 
7.5.2 
Height, Weight ..................................................................................................................................... 16 
7.5.3 
Waist Circumference............................................................................................................................ 16 
7.5.4 
Hip Circumference ............................................................................................................................... 17 
7.5.5 
Blood Pressure ..................................................................................................................................... 17 
7.5.6 
Buccal Cell Swab Collection ............................................................................................................... 17 
7.5.7 
Sample Preparation for RNA ............................................................................................................... 17 
7.5.8 
Future Analyses ................................................................................................................................... 18 
7.5.8.1 
Oxidative Stress-Related Gene Expression ..................................................................................................... 18 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 5 of 41 
 
7.5.8.2 
Total ROS/RNS free radical activity ............................................................................................................... 18 
7.5.8.3 
Human Inflammatory Cytokine Levels ........................................................................................................... 18 
7.5.9 
Compliance .......................................................................................................................................... 18 
7.6 
LABORATORY ANALYSES ............................................................................................................................. 19 
7.7 
TERMINATION OF THE TRIAL ....................................................................................................................... 20 
7.8 
PROTOCOL AMENDMENTS ........................................................................................................................... 20 
8 
SAFETY INSTRUCTIONS AND GUIDANCE ............................................................................................ 21 
8.1 
ADVERSE EVENTS AND LABORATORY ABNORMALITIES ............................................................................ 21 
8.1.1 
Adverse Events ..................................................................................................................................... 21 
8.1.2 
Serious Adverse Event ......................................................................................................................... 21 
8.1.3 
Unexpected Adverse Reaction.............................................................................................................. 22 
8.1.4 
Laboratory Test Abnormalities ............................................................................................................ 22 
8.2 
TREATMENT AND FOLLOW-UP OF AES AND LABORATORY ABNORMALITIES ........................................... 22 
8.2.1 
Treatment and Follow-up of AEs ......................................................................................................... 22 
8.2.2 
Treatment and Follow-up of Laboratory Abnormalities ...................................................................... 23 
8.3 
REPORTING OF SAES AND UNEXPECTED ADVERSE REACTIONS ................................................................ 23 
9 
STATISTICAL EVALUATION ..................................................................................................................... 24 
9.1 
DETERMINATION OF SAMPLE SIZE ............................................................................................................... 24 
9.2 
ANALYSIS PLAN ............................................................................................................................................ 24 
9.3 
STATISTICAL ANALYSIS PLAN...................................................................................................................... 24 
9.3.1 
Premature Discontinuation Description .............................................................................................. 24 
9.3.2 
Safety ................................................................................................................................................... 24 
9.4 
PROTOCOL DEVIATION DESCRIPTION ......................................................................................................... 25 
9.5 
PROTOCOL AMENDMENTS ........................................................................................................................... 25 
10 
DATA COLLECTION AND STORAGE ...................................................................................................... 25 
11 
ETHICAL ASPECTS OF THE STUDY ........................................................................................................ 26 
11.1 IRB APPROVAL ............................................................................................................................................. 26 
11.2 VOLUNTEER INFORMATION AND INFORMED CONSENT .............................................................................. 26 
11.3 POTENTIAL RISKS AND PROCEDURES TO MINIMIZE RISK ......................................................................... 26 
12 
QUALITY ASSURANCE AND QUALITY CONTROL.............................................................................. 27 
12.1 AUDITING ...................................................................................................................................................... 27 
12.2 MONITORING ................................................................................................................................................ 27 
12.3 DATA MANAGEMENT .................................................................................................................................... 27 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 6 of 41 
 
13 
REFERENCE LIST ......................................................................................................................................... 29 
14 
APPENDICES .................................................................................................................................................. 30 
14.1 APPENDIX I - SCHEDULE OF ASSESSMENTS ................................................................................................. 30 
14.2 APPENDIX II – PRODUCT TOLERANCE QUESTIONNAIRE ............................................................................ 31 
14.3 APPENDIX III – VITALITY AND QUALITY OF LIFE QUESTIONNAIRE .......................................................... 32 
14.4 APPENDIX IV – HAIR, NAILS, AND SKIN SELF-ASSESSMENT QUESTIONNAIRE .......................................... 39 
14.5 APPENDIX V – GENE TABLE - RT² PROFILER PCR ARRAY ........................................................................ 40 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 7 of 41 
 
2 
INTRODUCTION 
In the United States. 38% of Americans report waking up and feeling tired for more than four days a week 
(Moore, 2015). During 2010-2011, 15.3% of women and 10.1% of men reported feelings of fatigue and 
exhaustion on most days or every day for 3 months (Blackwell, 2013). Increased lethargy and fatigue and 
decreased time and energy for nonwork-related activities may be contributed by a decreased amount of 
physiological energy to complete work-related tasks (Haas and Brownlie, 2001). This may ultimately lead 
to lower perceived overall quality of life. 
Red blood cells are essential in oxygen transport thus making them an important part of health. Hemoglobin, 
the protein in red blood cells, is responsible for oxygen transport and plays an important role in oxygen 
transport and energy production. Iron is the essential element found in hemoglobin (Haas and Brownlie, 
2001). Poor levels of red blood red cells, hemoglobin, and iron in the bloodstream has been implicated in 
sub-optimal oxygen transport and increased lethargy (Billett, 1990). In a placebo-controlled clinical trial, 
eight weeks of Salmon Protein Hydrolysate supplementation was shown to significantly increase red blood 
cells and hemoglobin enhance  alertness, and energy in anemic individuals (Bomi et al., 2015). 
Fatigue refers to a reduction of effort that may be caused by an imbalance in energy costs and expected 
reward of actions. It is one of the most common symptoms associated with immune system activation. Pro- 
and anti-inflammatory cytokines are released during an immune response. Cytokines induce behavioral 
alterations in the central nervous system through inducing modifications of neurotransmitters and brain 
functions. (Karshikoff et al., 2017). Salmon hydrolysate has been shown to augment cytotoxic activity of 
natural killer cells through enhancing T-helper cells and increasing the number of cytokines, implicating its 
immunomodulating effect (Kim, 2013).  
The investigative product, Salmon Protein Hydrolysate (SPH), is produced by the solubilization of salmon 
flesh and enzymatic hydrolyzation of the protein. This process is done at very low temperatures to fully 
separate fat from protein and to prevent oxidation. SPH contains 620 bioactive peptides and 21 amino acids. 
The oil ingredient is readily absorbed without the action of pancreatic proteases due to its high concentration 
of short peptides and free amino acids (Nørgaard et al., 2012). The low molecular weight of short peptides 
also allows for greater solubility in water and fast uptake of nitrogen with over 98% digestibility. 
The following open-label, proof-of-concept study will evaluate the effect of a 128-day salmon protein 
hydrolysate (ProGo®) supplementation on energy and anti-inflammatory modulation in healthy adults.  
 
 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 8 of 41 
 
3 
STUDY OBJECTIVES 
The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (ProGo®) on 
energy increase and anti-inflammatory modulation in healthy males and females 
 
Primary outcome: 
The change from baseline (Day 0) to end-of-study (Day 128) in energy level as assessed by a Vitality and 
Quality of Life Questionnaire after a 128-day supplementation with Salmon Protein Hydrolysate Powder 
(ProGo®) 
 
Secondary outcomes: 
1. Change from baseline to Day 128 in Red Blood Cell (RBC) count, RBC indices (MCV, MCH, 
MCHC), hematocrit, and Red Cell Distribution Width (RDW) after supplementation with Salmon 
Protein Hydrolysate Powder (ProGo®) 
2. Change from baseline to Day 128 in Hemoglobin (Hb) after supplementation with Salmon 
Protein Hydrolysate Powder (ProGo®) 
3. Change from baseline to Day 128 in relative expression of 84 stress genes (Section 14.5) as 
evaluated by oxidative stress-related gene RT Profiler PCR array after supplementation with 
Salmon Protein Hydrolysate Powder (ProGo®) 
4. Change from baseline to Day 128 in total Reactive Oxygen Species/Reactive Nitrogen Species 
free radical activity assessed by ROS/RNS assay after supplementation with Salmon Protein 
Hydrolysate Powder (ProGo®) 
5. Change from baseline to Day 128 in levels of human inflammatory cytokines (IL-1RA, IL-4, IL-
6, IL-10, IL-11, IL-13 and TGF-β) as measured by the Multi-Analyte ELISArray after 
supplementation with Salmon Protein Hydrolysate Powder (ProGo®) 
6. Change from baseline to Day 128 in glycated hemoglobin (HbA1c) and fasting glucose after 
supplementation with Salmon Protein Hydrolysate Powder (ProGo®) 
7. Change in score of the Hair, Nails, and Skin Self-Assessment Questionnaire after 128-day 
supplementation with Salmon Protein Hydrolysate Powder (ProGo®) 
 
Safety outcomes: 
1. The incidence of pre-emergent and post-emergent adverse events following a 128-day 
supplementation 
2. The effect of a 128-day supplementation on complete blood count which includes: hematology 
(WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) and 
platelet count 
3. The effect of a 128-day supplementation on vital signs: weight, blood pressure (BP) and heart rate 
(HR), and waist and hip circumference 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 9 of 41 
 
4 
STUDY DESIGN 
 
 
Screening 
-45 days  
Supplementation Period 
18 Weeks or 128 days 
 
 
 
 
 
 
 
              V1 
 
               V2 
                                                                                                       V3 
 
 
= Screening Period 
 
= Intervention Period 
 
This will be an open label study conducted at the KGK clinic in London, ON. 
 
The planned sample size for this study is 20 participants (includes 20% attrition). 
Study Arm 
Number of Participants  
Salmon Protein Hydrolysate (ProGo®) 
N = 20 
 
In order to evaluate primary, secondary, and safety outcomes, study assessments will be conducted at 
baseline and at Day 128.  
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 10 of 41 
 
5 
SELECTION OF STUDY POPULATION 
This study will enroll 20 healthy males and females. Each participant must fulfill the inclusion criteria and 
not meet any of the exclusion criteria as described in sections 5.1 and 5.2, respectively. 
 
5.1 
Inclusion Criteria 
1. 
Healthy male or female, 30-60 years of age 
2. 
Female participant is not of child bearing potential, defined as females who have had a 
hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or 
surgically with > 1 year since last menstruation) 
or, 
Females of childbearing potential must agree to use a medically approved method of birth control 
and have a negative urine pregnancy test result. All hormonal birth control must have been in use 
for a minimum of three months. Acceptable methods of birth control include: 
▪ 
Hormonal contraceptives including oral contraceptives, hormone birth control patch 
(Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-
Provera, Lunelle), or hormone implant (Norplant System) 
▪ 
Double-barrier method  
▪ 
Intrauterine devices 
▪ 
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to 
heterosexual partner(s) 
▪ 
Vasectomy of partner (shown successful as per appropriate follow-up) 
3. 
BMI of 18.5 kg/m²-32.5 kg/m² 
4. 
Agrees to comply with study procedures 
5. 
Willing to commit to taking product for 128 days (See questionnaire in 14.2) 
6. 
Agrees to provide voluntary, written, informed consent to participate in the study 
7. 
Agrees to maintain normal diet and exercise routine throughout the study 
8. 
Healthy as determined by medical history, medical physical test for good health, and laboratory 
results 
 
5.2 
Exclusion Criteria 
1. 
Women who are pregnant, breastfeeding, or planning to become pregnant during the trial  
2. 
Blood donation during or within 30 days of the last study visit 
3. 
Taking any specific energy supplements or vitamins at least 1 month prior to and during the trial 
as assessed by the QI 
4. 
Unstable weight for the last 2 months prior to the study assessed case by case by QI 
5. 
Individuals on a low protein diet 
6. 
Excessive consumption of alcohol equivalent to >2 alcoholic drinks/day  
7. 
Use of marijuana assessed case by case by QI 
8. 
Known allergy to the test material’s active or inactive ingredients 
9. 
Clinically significant abnormal Physical Examination results at screening 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 11 of 41 
 
10. Participation in clinical trials in the past 30 days  
11. Cognitively impaired and/or unable to give informed consent 
12. current cardiovascular disorders or uncontrolled blood pressure will be assessed by QI) 
13. Verbal confirmation of history of or current diagnosis of bleeding/blood disorder 
14. Verbal confirmation of Type I or Type II diabetes 
15. Verbal confirmation of kidney disease  
16. Verbal confirmation of history of liver disease 
17. Anemia based on hemoglobin and hematocrit at screening 
18. Thyroid disease assessed case by case by QI (5.3.1) 
19. Iron Supplementation (5.3.1) 
20. Mood stabilizers assessed case by case by QI (5.3.1) 
21. Energy boosting supplements (5.3.2) 
22. Individuals on workout supplements (5.3.2) 
23. Habitual users of energy drinks 
24. Melatonin supplementation assessed case by case by QI (5.3.2) 
25. Autoimmune disease or if immune-compromised (i.e. HIV positive, use of anti-rejection 
medication, rheumatoid arthritis, Hepatitis B/C positive) 
26. Surgical procedures which may impact the study outcomes within the past 3 months to be 
assessed by the QI  
27. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a 
follow up that is negative. Volunteers with cancer in full remission will be assessed by the QI 
for inclusion.  
28. Presence or history of neurological disorders or significant psychiatric illness as assessed by QI 
29. Any other condition, in the QI's opinion, which may adversely affect the participant's ability to 
complete the study or its measures or which may pose significant risk to the participant 
 
5.3 
Concomitant Medications and Washout Periods 
Participants who are currently taking any prescribed medications must agree to maintain their current 
method and dosing regimen during the course of the study unless recommended by their physician.   
5.3.1 
Prescribed Medications 
Participants on the following concurrent prescribed medications/treatments will be assessed by the QI:  
1. Thyroid medications to be evaluated case by case by QI 
2. Mood stabilizes to be evaluated case by case by QI 
3. Iron supplementation 
5.3.2 
Over-the-counter Medications, Supplements, and Foods/Drinks 
Volunteers who are currently consuming the following supplements will not be allowed to participate unless 
willing to undergo a 2-week washout: 
1. Energy boosting supplements  
2. Workout supplements 
3. Melatonin supplements to be evaluated case by case by QI 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 12 of 41 
 
5.3.3 
Rescue Medications 
Not applicable. 
5.4 
Premature/Discontinuation Criteria 
Personal reasons 
As stated in the Informed Consent Form, a participant may withdraw from the study for any reason at any 
time. 
Removal by Qualified Investigator 
Participant discontinuation should be considered at the discretion of the qualified investigator. The 
circumstances of any discontinuation have to be documented in detail in the participant file and final report. 
If possible, the evaluations planned for the end of treatment will be carried out at the time when the 
participant is withdrawn from the study. A participant leaving the study prematurely will NOT be replaced 
by another. It is understood by all concerned that an excessive rate of withdrawals can render the study un-
interpretable; therefore, unnecessary withdrawal of participants should be avoided. 
Criteria for removal of participants from the study will include: 
Clinical reasons 
A participant may be withdrawn from the study if, in the opinion of the qualified investigator, it is not in 
the participant's best interest to continue. Any participant who experiences a serious adverse event (SAE) 
may be withdrawn from the trial at the discretion of the qualified investigator. A participant will also be 
withdrawn due to adverse events causing clinically significant illness or the need for prohibited 
medication(s) during the trial. 
Protocol violation 
Any participant found to have entered this study in violation of the protocol will be discontinued from the 
study at the discretion of the qualified investigator. This will include any participant found to have been 
inappropriately enrolled (did not meet eligibility criteria). Participant non-compliance includes not showing 
up for study visits, not taking the investigational product as directed, or refusing to undergo study visit 
procedures. Participants who are found to be taking prohibited medications or supplements without the 
knowledge of the qualified investigator will also be withdrawn. Any major protocol deviations (i.e., those 
that increase the risk to participants and/or compromise the integrity of the study or its results) will result 
in participant discontinuation. 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 13 of 41 
 
6 
INVESTIGATIONAL PRODUCT 
6.1 
Manufacturing and Storage 
The investigational product will be provided to KGK by the Sponsor. The investigational product will be 
carefully stored at the study site in a lockable, limited access area, accessible only to study team personnel 
in compliance with pertinent regulations. Only authorized persons will have access to the investigational 
product. The products will be stored at room temperature and will not be exposed to direct sunlight or heat. 
The investigational products will be kept in a locked investigational product storage room at KGK Science 
Inc. on receipt. An accountability log will be kept for the investigational products.  
All unused investigational product will be returned to the study sponsor by KGK (at the sponsor’s expense) 
or destroyed on receipt of written confirmation from the sponsor at study closeout (within one month of 
last participant visit). 
Manufactured by: 
Hofseth Biocare ASA 
Havnegata 11 
6005 Aalesund 
Norway 
6.2 
Labeling and Coding 
The investigational product will be labeled according to the requirements of ICH-GCP guidelines and 
applicable local regulatory guidelines.  
6.3 
Investigational Product  
Dietary Ingredient 
Quantity (Qty) 
Salmon protein hydrolysate (ProGo®) 
4000 mg 
Non-medical ingredients: 750 mg Forest Fruit Flavoring (made up of Malic acid, Sucralose, Forest Fruit 
SY653533, Beetroot Powder, and Lecithin) 
6.4 
Directions 
Participants will be instructed to take 4.75 g powder in individual sachets (4 g Salmon Protein Hydrolysate 
(ProGo®) + 750 mg Forest Fruit Flavoring) mixed in 100-300 mL of water daily at breakfast for 128 days. 
Participants will be instructed to consume the product within 5-10 minutes of mixing with water. Clinic 
staff will instruct participants to save all unused and open packages and return them to KGK for a 
determination of compliance. If a morning dose is missed participants are instructed to take the dose as 
soon as possible after breakfast at any time during the same day. Participants will be advised not to exceed 
2 sachets daily. 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 14 of 41 
 
7 
STUDY ASSESSMENTS 
See 14.1 for the schedule of assessments. 
7.1 
Visit 1; Screening (Day -45 to Day -1) * 
* At the discretion of the Qualified Investigator, any participants falling outside of the screening window 
(Day -45 to Day -1) due to scheduling issues may be asked to repeat eligibility/screening procedures prior 
to enrolment.  
At screening, an informed consent form will be given to the potential volunteer. They will be required to 
read the information and will be given the opportunity to seek more information if needed, or provided with 
the option of taking the consent form home to review prior to making their decision. If agreeable, the 
volunteer will sign the consent form and receive a duplicate of the signed copy. Once consent has been 
obtained, the screening visit will proceed. Each volunteer will be sequentially assigned a screening number 
to be entered in the screening and enrollment log. No fasting is required for this visit. 
Screening assessments include: 
1. 
Obtain informed consent 
2. 
Review inclusion and exclusion criteria  
3. 
Review medical history and capture recurring conditions 
4. 
Review concomitant therapies and current health status  
5. 
Weight and height measurements for BMI calculation (Section 7.5.2)  
6. 
Waist and hip circumference measurements (Sections 7.5.3 and 7.5.4) 
7. 
Seated resting blood pressure and heart rate measurements (Section 7.5.5) 
8. 
Urine pregnancy test for female participants of child bearing potential  
9. 
Physical Examination (excludes genital and rectal examination)  
10. Collect blood sample for CBC  
11. Administer Product Tolerance Questionnaire to assess participants’ response to product (see 
14.2) 
The next visit will be scheduled for potentially eligible participants in ≤45 days. 
Reminders for participants prior to their next in-clinic visit: 
1. Refrain from consumption of supplements as per Section 5.3.2. 
2. Maintain current dietary and exercise habits 
3. 8-hour fast prior to next visit 
 
7.2 
Visit 2; Baseline (Day 0)  
Eligible participants will return to the clinic for baseline assessments. An 8-hour fasting period is required 
for this visit.  
Baseline (Day 0) assessments include: 
1. 
Review inclusion and exclusion criteria 
2. 
Review concomitant therapies and current health status and identify pre-emergent adverse 
events 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 15 of 41 
 
3. 
Weight measurement (BMI calculation) 
4. 
Waist and hip circumference measurements  
5. 
Seated resting blood pressure and heart rate measurements 
6. 
Urine pregnancy test for female participants of child bearing potential 
7. 
Two buccal cell swabs will be collected for DNA analysis (Section 7.5.6) 
8. 
Collect blood samples for future analysis (Section 7.5.8):  
o Oxidative stress-related gene expression (Sections 7.5.8.1 and 14.5) 
o Total ROS/RNS free radical activity (Section 7.5.8.2) 
o Human inflammatory cytokine levels (Section 7.5.8.3) 
9. 
Collect blood samples for HbA1c and fasting glucose  
10. Complete Vitality and Quality of Life Questionnaire (Section 14.2) 
11. Complete Hair, Nails, and Skin Self-Assessment Questionnaire (Section 14.4) 
12. Dispense investigational product and instruct participants on use 
13. Dispense study diary instructions for participants (record daily product use, changes in 
concomitant therapies, and any adverse events throughout the study).  
The next visit will be scheduled for Week 18 (Day 128 ± 3).  
Reminders for participants prior to their next in-clinic visit: 
1. Follow instructions on consumption of the investigational product and log any irregularities or 
missed doses in the subject diary 
2. Refrain from consumption of supplements as per Section 5.3.2.  
3. Complete and bring subject diaries on the next visit if diary is not completed using the app 
4. Maintain current dietary and exercise habits.  
5. Bring unused investigational product in the original packaging to next visit.  
6. 8-hour fast prior to next visit 
 
7.3 
Compliance Phone Calls 
Participants will be contacted via telephone at Week 6 and Week 12 to ensure compliance to study product 
and study processes.  
 
7.4 
Visit 3; End-of-Study; Week 18 (Day 128 ± 3) 
Participants will return to the clinic for Visit 3 assessments with any unused investigational product and 
completed study diaries if any. An 8-hour fasting period is required for this visit.    
Visit 3 assessments include: 
1. 
Return unused investigational product in the original packaging and remnants and calculation of 
compliance by counting the returned unused investigational product 
2. 
Ensure that study apps have been reviewed 
3. 
Collect and review study diaries if applicable 
4. 
Weight measurement (BMI calculation) 
5. 
Waist and hip circumference measurements 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 16 of 41 
 
6. 
Seated resting blood pressure and heart rate measurements 
7. 
Collect blood sample for CBC 
8. 
Collect blood samples for future analysis (Section 7.5.8):  
o Oxidative stress-related gene expression (Sections 7.5.8.1 and 14.5) 
o Total ROS/RNS free radical activity (Section 7.5.8.2) 
o Human inflammatory cytokine levels (Section 7.5.8.3) 
9. 
Collect blood samples for HbA1c and fasting glucose 
10. Complete Vitality and Quality of Life Questionnaire (Section 14.2)  
11. Complete Hair, Nails, and Skin Self-Assessment Questionnaire (Section 14.4) 
12. Physical Examination (excludes genital and rectal examination) 
13. Review concomitant therapies and adverse events 
 
7.5 
Clinical Assessments and Procedures 
Calculations or measurements of specific parameters are required as indicated in the schedule of 
assessments. Instructions for determining these parameters are provided in the following sections. 
7.5.1 
Questionnaires 
Product Tolerance Questionnaire will be completed at Visit 1 for screening (see Section 14.2). 
Vitality and Quality of Life Questionnaire for energy levels will be completed at Visit 2 and Visit 3 (see 
Section 14.3) 
Hair, Nails, and Skin Self-Assessment Questionnaire will be completed at Visit 2 and Visit 3 (see Section 
14.4) 
7.5.2 
Height, Weight 
Weight measurements will be performed with shoes removed, and bladder empty. Participants will be 
weighed on the same scale at all visits. 
At least two separate measurements will be taken at each visit. If the two measurements are more than 0.5 
kg (1.1 lbs.) apart, a third measurement will be taken. Then the two closest values will be selected and 
entered in the database.   
Measurement of height will be performed with the participant’s shoes removed. The participant’s knees 
will be straightened, and head held upright. 
7.5.3 
Waist Circumference 
The waist circumference is measured at the part of the trunk located midway between the lower costal 
margin (bottom of lower rib) and the iliac crest (top of pelvic bone) while the participant is standing. The 
measurer should stand beside the participant and fit the tape tightly against the skin but without compressing 
any underlying soft tissues. The circumference should be measured at the end of a normal expiration. At 
least two separate measurements should be taken at each visit. If the two measurements differ by more than 
10%, a third measurement should be taken. Then the two closest values will be selected and entered into 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 17 of 41 
 
the database. The method of measurement for waist circumference is from the Waist Circumference and 
Waist-Hip Ratio report of a WHO Expert Consultation, Geneva 8-11 December 2008. 
7.5.4 
Hip Circumference 
While participant is standing upright, place a measuring tape around the greater trochanteric prominence 
(the widest part of the hips).  Hold tape firmly but do not press the tape into the skin. Make sure the tape is 
parallel to the floor.  Record the reading. At least two separate measurements should be taken at each visit.  
If the two measurements differ by more than 10% a third measurement should be taken. Then the two 
closest values will be selected and entered into the database. The method of measurement for hip 
circumference is from the Waist Circumference and Waist-Hip Ratio report of a WHO Expert Consultation, 
Geneva 8-11 December 2008. 
7.5.5 
Blood Pressure 
In office, seated resting blood pressure and heart rate will be determined from 3 measurements obtained at 
least 1 minute apart. One arm will be chosen and used consistently throughout the study. Blood pressure 
will be checked in both arms at the first examination. If a consistent inter-arm difference exists, the arm 
with the higher pressure will be used throughout the study. The arm selected for use at the initial visit will 
be documented in the study file. 
The participant should be seated comfortably with the back supported and the upper arm bared without 
restrictive clothing. Feet should be flat on the floor, legs will not be crossed. The participant will rest in this 
position for at least 5 minutes prior to the first reading. 
As per the QI a high office blood pressure should be rechecked after participant is given a glass of water 
and is seated for 15 min. Also, participant should be queried about their usual blood pressure. 
The same recording method and the same equipment will be used for each participant throughout the study. 
7.5.6 
Buccal Cell Swab Collection 
Buccal cell swabs will be collected at baseline (visit 2) at the KGK Science clinic site to analyze single-
nucleotide polymorphisms (SNPs) to identify responders vs. non-responders. The clinic coordinator will 
verify that the participant’s mouth is empty and that the participant is still fasting. The clinic coordinator 
will sanitize their hands and don a mask and gloves. A sterile brush will be carefully removed from the 
collection package. Caution is exercised not to touch the swab tip with gloves or against any surface. The 
participant will be asked to open his or her mouth and the inside of the mouth will be scraped 10 times 
using the Buccal Collection brush against the inside of the cheek. The brush will be removed immediately 
without touching the brush against teeth, lips or other surfaces. The collection brush will then be removed 
from its handle using sterile scissors or a razor blade and placed into a microcentrifuge tube containing 300 
µL of cell lysis solution. This process will then be repeated using a fresh brush to generate a second buccal 
swab sample. The samples will be sent to Stanford for DNA analysis.  
7.5.7 
Sample Preparation for RNA 
One EDTA blood tube will be used for stabilization of whole blood RNA. The whole blood will be aliquoted 
into 6 cryovials- each containing 500 µL of whole blood. 1.3 mL of RNAlater will then be added to each 
cryovial to stabilize the whole blood RNA. The tubes will then be gently mixed 5 times and the samples 
will be stored at -40°C for future analysis (see Section 7.5.8.1).   

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 18 of 41 
 
7.5.8 
Future Analyses 
7.5.8.1 
Oxidative Stress-Related Gene Expression 
Previous in vitro experiments using PCR gene-array to evaluate the efficacy of SPH on oxidative stress, 
showed up- and down-regulation of multiple human oxidative stress-related genes. The present study will 
evaluate the same effects of the investigational product in vivo (Section 14.5). 
The PCR array is a highly sensitive and reliable method for the analysis of multiple genes. It will be used 
to analyze expression levels of 84 genes related to oxidative stress by determining which, if any, oxidative 
stress genes will be impacted by supplementation with the investigational product.  
RNA samples will be prepared for this analysis (Section 7.5.7) and stored at -80 C.  
7.5.8.2 
Total ROS/RNS free radical activity 
Measuring the effect of antioxidant interventions and ROS/RNS activity is crucial to suppressing or 
managing oxidative stress reducers. Previous studies have shown that fish protein hydrolysate has 
antioxidant properties (Girgih et al., 2013).  
An ROS/RNS Assay kit will be used for measuring total ROS/RNS free radical activity to evaluate the 
efficacy of the investigational product on the presence of free radicals. The kit will measure the total free 
radical presence of a sample using green fluorescence techniques. Fluorescence intensity is proportional to 
the total ROS/RNS levels within the sample. Free radical molecules are representative of both ROS, and 
RNS, which allows for the measurement of total free radical population within a sample.  
Serum samples will be centrifuged at 10,000 x g for 5 minutes and stored at -80°C.  
7.5.8.3 
Human Inflammatory Cytokine Levels 
In a previous study, supplementation with the investigational product showed significantly lower IL-6 
levels in comparison to a control (Framroze et al., 2016). The current study will evaluate the efficacy of the 
investigational product on levels of inflammatory cytokines, which includes IL-1RA, IL-4, IL-6, IL-10, IL-
11, IL-13 and TGF-β. 
Inflammatory cytokine levels will be measured using a multi-analyte ELISArray kit. This kit enables the 
analysis of protein expression for multiple protein targets.  
Serum samples will be centrifuged for 15 minutes at 1000 x g within 30 minutes of collection and then 
stored at ≤-20°C.  
7.5.9 
Compliance 
Compliance will be assessed by counting the returned unused study product at each visit. Compliance is 
calculated by determining 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 × 100% 
In the event of a discrepancy between the information in the treatment diary and the amount of study product 
returned, use will be based on the product returned unless an explanation for loss of product has been 
provided. Participants found to have a compliance of <80% or >120% will be counseled.   

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 19 of 41 
 
7.6 
Laboratory Analyses 
Blood samples will be drawn from the participants at screening (Visit 1), baseline (visit 2), and the end of 
Study (Visit 3) as indicated in the schedule of assessments. Blood draws will be performed from a 
participant’s arm via venipuncture. See Section 11.3 for potential risks associated with venipuncture. 
Protection of participant confidentiality will extend to all data generated from the assaying of these samples.  
These samples will be alphanumerically coded and the persons performing the analysis will not be aware 
of the subject’s identity. 
At screening (Visit 1), 4 mL of whole blood will be collected in: 
1. 1 x 4 mL EDTA vacutainer tube to generate plasma for: 
a. CBC (1 tube) 
At baseline (Visit 2), 23 mL of 8 hour fasting whole blood will be collected in: 
1. 1 x 4 mL EDTA vacutainer tube to generate plasma for: 
a. HbA1c (1 tube) 
2. 1 x 4 mL EDTA vacutainer tube for whole blood for: 
a. Future analysis - Gene expression analysis (1 tube) 
3. 3 x 5 mL SST vacutainer tube to generate serum for: 
a. Future Analysis - ROS/RNS and Inflammatory Cytokines (2 tubes) 
b. Fasting Glucose (1 tube) 
At the end of the study (Visit 3), 27 mL of 8 hour fasting whole blood will be collected in: 
1. 2 x 4 mL EDTA vacutainer tube to generate plasma for: 
a. CBC (1 tube) 
b. HbA1c (1 tube) 
2. 1 x 4 mL EDTA vacutainer tube for whole blood for: 
a. Future analysis - Gene expression analysis (1 tube) 
3. 3 x 5 mL SST vacutainer tube to generate serum for: 
a. Future Analysis - ROS/RNS and Inflammatory Cytokines (2 tubes) 
b. Fasting Glucose (1 tube) 
The total blood volume collection for the laboratory assessments listed above will be approximately 54 mL, 
over the period from screening to end of study (approximately 128 days). At any study visit, blood loss per 
volunteer is not expected to exceed 27 mL. Additional blood samples may be collected during the course 
of the study in order to perform or repeat laboratory tests outlined in the Schedule of Assessments if needed.  
The central laboratory, Life Labs, London Ontario, will be used in this study to measure CBC, HbA1c, and 
fasting glucose. 
Blood collected for future analysis will be shipped to the sponsor. 
Urine pregnancy test will be performed at the KGK Science clinic site.  

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 20 of 41 
 
7.7 
Termination of the Trial 
In the case of premature termination of the trial, participating investigators/participants, and the Institutional 
Review Board must be promptly informed of the termination. 
7.8 
Protocol Amendments 
If amendments to the study protocol are required after approval such changes will be captured in writing 
the reasons for the change documented and signed and dated by the sponsor. Any such amendments may 
be subject to IRB and Health Canada review/approval prior to implementation. Exception: if it becomes 
necessary to alter the protocol to eliminate an immediate hazard to participants, an amendment may be 
implemented prior to IRB approval. In this circumstance, the Investigator must notify IRB and Health 
Canada in writing within five (5) working days of the implementation. 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 21 of 41 
 
8 
SAFETY INSTRUCTIONS AND GUIDANCE 
8.1 
Adverse Events and Laboratory Abnormalities 
8.1.1 
Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has 
been administered an investigational product and which does not necessarily have a causal relationship with 
this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a product, whether or not it is 
considered related to that product. Pre-existing conditions which worsen during a study are to be reported 
as AEs. 
During the study, participants should record any adverse effects in their diary. At each visit the participant 
will be asked "Have you experienced any difficulties or problems since I saw you last"?  Any adverse events 
(AEs) will be documented and in the study record and will be classified according to the description, 
duration, intensity, frequency, and outcome. The qualified investigator will assess any AEs and decide 
causality. 
Intensity of AEs will be graded on a three-point scale (mild, moderate, severe) and reported in detail in the 
study record. 
Mild: 
Awareness of event but easily tolerated 
Moderate: 
Discomfort enough to cause some interference with usual activity 
Severe: 
Inability to carry out usual activity 
The causality relationship of investigational product to the adverse event will be assessed by the qualified 
investigator as either: 
Most probable: There is a reasonable relationship between the investigational product and AEs. 
The event responds to withdrawal of investigational product (dechallenge) and 
recurs with rechallenge when clinically feasible. 
Probable: 
There is a reasonable relationship between the investigational product and AEs. 
The event responds to dechallenge. 
Possible: 
There is a reasonable relationship between the investigational product and AEs. 
Dechallenge information is lacking or unclear. 
Unlikely: 
There is a temporal relationship to the investigational product administration but 
there is no reasonable causal relationship between the investigational product and 
the AEs. 
Not related: 
No temporal relationship to the investigational product administration or there is 
a reasonable causal relationship between non-investigational product, concurrent 
disease or circumstance and the AEs. 
8.1.2 
Serious Adverse Event 
A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side 
effect or precaution. It is any AE that results in any of the following outcomes: 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 22 of 41 
 
1. 
Death 
2. 
A life-threatening adverse event 
3. 
Inpatient hospitalization or prolongation of existing hospitalization 
4. 
A persistent or significant disability or incapacity 
5. 
A congenital anomaly/birth defect in the offspring of a participant who received the study 
treatment 
Important medical events that may not be immediately life-threatening or result in death or hospitalization 
but may jeopardize the participant or may require intervention to prevent one of the outcomes listed above. 
Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or the development of 
drug dependency or drug abuse. 
8.1.3 
Unexpected Adverse Reaction 
An unexpected adverse reaction is an adverse reaction, the nature and severity of which is not consistent 
with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational 
product or package insert/summary of product characteristics for an approved product). 
8.1.4 
Laboratory Test Abnormalities 
The investigator must assess the clinical significance of all abnormal laboratory values as defined by the 
compendium of normal values for the reference laboratory.  
Any treatment emergent abnormal laboratory result which is clinically significant, i.e., meeting one or more 
of the following conditions, should be recorded as a single diagnosis on the AEs form in the study record: 
1. 
Accompanied by clinical symptoms 
2. 
Leading to interruption or discontinuation of the investigational product 
3. 
Requiring a change in concomitant therapy 
This applies to any protocol and non-protocol specified laboratory result from tests performed after the first 
dose of the investigational product, which falls outside the laboratory reference range and meets the clinical 
significance criteria for liver and kidney tests as well as for hematology and clinical chemistry. 
This does not apply to any abnormal laboratory result which falls outside the laboratory reference range but 
which does not meet the clinical significance criteria or those which are a result of an AE which has already 
been reported. 
Any laboratory result abnormality fulfilling the criteria for a serious adverse event (SAE) should be reported 
as such, in addition to being reported as an AE in the study record. 
8.2 
Treatment and Follow-up of AEs and Laboratory Abnormalities 
8.2.1 
Treatment and Follow-up of AEs 
AEs, especially those for which the relationship to the investigational product is suspected, should be 
followed up until they have returned to baseline status or stabilized. 
If after follow-up, return to baseline status or stabilization cannot be established, an explanation should be 
recorded in the study record. 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 23 of 41 
 
8.2.2 
Treatment and Follow-up of Laboratory Abnormalities 
In the event of participant-initiated withdrawal or clinically significant unexplained abnormal laboratory 
test values, the participant will be withdrawn from the treatment and will remain in the study and be required 
to attend all remaining study visits as part of a safety arm.  
8.3 
Reporting of SAEs and Unexpected Adverse Reactions 
The qualified investigator will be responsible for classification of an AE as an SAE within 24 hours of 
notification. Causality should be signed off by the qualified investigator prior to reporting to ethics and 
regulatory bodies. Notification of any serious adverse events must be made in writing to the study sponsor. 
The IRB will be notified of all product related SAEs and unexpected adverse reactions.  
KGK Science must notify the TPD of all serious adverse events and reactions as follows: 
If it is neither fatal or life threatening, within 15 calendar days after the day on which the sponsor 
becomes aware of the information; and 
If it is fatal or life threatening, must be reported as soon as possible, but not later than seven (7) 
days after the day on which the sponsor becomes aware of the information. 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 24 of 41 
 
9 
STATISTICAL EVALUATION 
9.1 
Determination of sample size 
A Sample size of 16 completers are required for this study. A total of 20 participants will be enrolled in the 
study accounting for a 20% attrition rate. A formal sample size calculation was not conducted for this study 
as it is an open-label study. 
9.2 
Analysis Plan 
1. 
The Safety Population will consist of all participants who received any amount of product, and 
whom any safety information is available. 
2. 
The Intent-to-Treat (ITT) Population consists of all participants who received product and 
whom any efficacy information is available. 
3. 
The Per Protocol (PP) Population consists of all participants who consumed at least 80% of 
treatment doses, do not have any major protocol violations, and complete all study visits and 
procedures connected with measurement of the primary variable. 
9.3 
Statistical Analysis Plan 
An efficacy analysis based on the intent-to-treat population will be performed and an efficacy analysis 
based on the per-protocol population will be performed. Variables will be tested for normality and log-
normality. Log-normally distributed variables will be analyzed in the logarithmic domain. Non-normal 
variables will be analyzed by appropriate non-parametric tests. 
Appropriate missing values will be imputed with the most recent previously-available value (LOCF, or 
“last-observation-carried-forward” imputation). No imputation will be performed for missing values of 
safety variables.  
Data will be summarized in tabular form by visit. Numerical variables will be summarized as mean, 
standard deviation, standard error of the mean, median, and range (minimum and maximum). Changes from 
baseline to each subsequent visit will be summarized in the same way, along with a p value indicating 
whether the mean change is significantly different from zero (based on the paired Student t-test, or the non-
parametric Wilcoxon Signed-Ranks test). Sensitivity analysis may be conducted as judged by statisticians. 
9.3.1 
Premature Discontinuation Description 
For each premature discontinuation, the following parameters will be listed: participant number, dates of 
start and end of treatment, and the reason of premature discontinuation. 
9.3.2 
Safety 
For adverse events, a descriptive analysis will be given. Adverse events will be presented in a frequency 
table by category and treatment. Furthermore, description, frequency, severity and causality will be reported 
for each adverse event. 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 25 of 41 
 
Continuous safety parameters (e.g. weight, heart rate and blood pressure) will be summarized using a table 
including mean, standard deviation, median, minimum value, and maximum value for each measurement 
point. The changes from baseline will also be summarized similarly. 
9.4 
Protocol Deviation Description 
Protocol deviations will be listed in the final study report. 
9.5 
Protocol Amendments 
Once the protocol has been approved by the IRB and Health Canada, any changes to the protocol must be 
documented in the form of an amendment. All amendments will be documented in the final study report. 
 
10 DATA COLLECTION AND STORAGE 
All data collection and record storage will be done in compliance with ICH GCP Guidelines and applicable 
local regulatory guidelines. 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 26 of 41 
 
11 ETHICAL ASPECTS OF THE STUDY 
This study will be conducted with the highest respect for the individual participants (i.e., participants) 
according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the 
ICH Harmonised Tripartite Guideline for GCP.  
11.1 IRB Approval 
KGK Science Inc. will supply relevant documents for submission to an IRB for the protocol’s review and 
approval. The following must be submitted to the IRB: This protocol, a copy of the informed consent form, 
and, if applicable, volunteer recruitment materials and/or advertisements and other documents required by 
all applicable laws and regulations. The IRB’s written approval of the protocol and volunteer informed 
consent must be obtained before commencement of the study. The IRB approval must refer to the study by 
exact protocol title, number, and version date; identify versions of other documents (e.g., informed consent 
form) reviewed; and state the approval date. 
KGK must adhere to all requirements stipulated by the IRB. This may include notification to the IRB 
regarding protocol amendments, updates to the informed consent form, recruitment materials intended for 
viewing by volunteers, local safety reporting requirements and submission of the investigator’s annual/final 
status report to the IRB. 
11.2 Volunteer Information and Informed Consent 
Written consent documents will embody the elements of informed consent as described in the declaration 
of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and 
regulations. The informed consent form describes the planned and permitted uses, transfers, and disclosures 
of the volunteer’s personal and personal health information for purposes of conducting the study. The 
informed consent form further explains the nature of the study, its objectives, and potential risks and 
benefits, as well as the date informed consent is obtained. The informed consent form will detail the 
requirements of the volunteer and the fact that he or she is free to withdraw at any time without giving a 
reason and without prejudice to his or her further medical care.  
11.3 Potential Risks and Procedures to Minimize Risk 
All potential risks are disclosed to study participants prior to their participation. The potential risks 
associated with this study include venipuncture. Risks associated with venipuncture include pain, bruising, 
and infection at the site. Alcohol swabs and proper venipuncture procedure will be followed to minimize 
the risk of infection. 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 27 of 41 
 
12 QUALITY ASSURANCE AND QUALITY CONTROL 
12.1 Auditing 
All material used in clinical studies are subjected to quality control. Quality assurance audits may be 
performed by the sponsor or any health authority during the course of the study or after its completion.  
The Investigator agrees to comply with the sponsor and regulatory requirements in terms of auditing of the 
study. This includes access to the source documents for source data verification. 
12.2 Monitoring 
An initiation meeting will be conducted by the sponsor or an approved representative (CRO). At this 
meeting, the protocol and logistical aspects of the study will be reviewed with the Investigator and all study 
staff. 
Source documents will be reviewed to ensure that all items have been completed and that the data provided 
are accurate and obtained in the manner specified in the protocol. The participant files will be reviewed to 
confirm that: 
1. 
Informed consent was obtained and documented 
2. 
Enrolled participants fulfilled all inclusion criteria and did not meet any exclusion criteria; 
3. 
AE/SAE reporting has been performed as applicable 
4. 
Study visits have been conducted as per protocol and information has been recorded in the 
appropriate place in the source document 
5. 
The study product is being stored correctly and an accurate record of its dispensation to the 
study participants is being maintained (accountability) 
Incorrect, inappropriate, or illegible entries in the participant files will be returned to the Investigator or 
designee for correction. No data disclosing the identity of participants will leave the study center. The 
Investigator and any designees will maintain confidentiality of all participant records. 
The Investigator will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections 
and will allow direct access to source data and documents for these purposes. 
12.3 Data Management 
Data required for the analysis will be acquired from source documentation (including laboratory reports) 
and entered into OpenClinica Enterprise Version study instance designed specifically for this study. The 
two instances for the database would be created, test instance and production instance. The database would 
be test verified in the test instance and then moved to the production instance. A password protected user 
id’s will be created which would give access to the limited authorized personnel.  
 The standard data validation and validation checks would be performed on the production instance of the 
study by designing study specific rules. Data tables will be created, queried and exported during and at the 
end of study using PostgreSQL tool (pgadminIII 9.5) and MS Access.  
For Statistical analysis, the validated soft lock copy of the database will be sent to the Statistician to perform 
the analysis. The study database would be a read only file to ascertain changes in the data are not made 
during or after the analysis.  

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 28 of 41 
 
High safety standards for the transfer and storage of study data are guaranteed by the use of technologies 
such as password protection, firewalls and periodic backup to protect stored data.  
All study data is archived for a period not less than 25 years from the date of completion of the study in 
accordance with Health Canada regulatory requirements. 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 29 of 41 
 
13 REFERENCE LIST 
Billett, H.H. (1990). Hemoglobin and Hematocrit. In Clinical Methods: The History, Physical, and 
Laboratory Examinations, H.K. Walker, W.D. Hall, and J.W. Hurst, eds. (Boston: Butterworths), p. 
Blackwell, D. (2013). QuickStats: Percentage of Adults Who Often Felt Very Tired or Exhausted in the 
Past 3 Months,* by Sex and Age Group - National Health Interview Survey, United States, 2010-2011. 
Morb. Mortal. Wkly. Rep. 62, 275–276. 
Bomi, F., Vekariya, S., and Dhruv, S. (2015). A Placebo-Controlled Study of the Impact of Dietary Salmon 
Protein Hydrolysate Supplementation in Increasing Ferritin and Hemoglobin Levels in Iron-Deficient 
Anemic Subjects. J. Nutr. Food Sci. 05. 
Framroze, B., Vekariya, S., and Swaroop, D. (2016). A Placebo-Controlled, Randomized Study on the 
Impact of Dietary Salmon Protein Hydrolysate Supplementation on Body Mass Index in Overweight 
Human Subjects. J. Obes. Weight Loss Ther. 6, 1–5. 
Girgih, A.T., Udenigwe, C.C., Hasan, F.M., Gill, T.A., and Aluko, R.E. (2013). Antioxidant properties of 
Salmon (Salmo salar) protein hydrolysate and peptide fractions isolated by reverse-phase HPLC. Food Res. 
Int. 52, 315–322. 
Glynis, A. (2012). A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral 
Supplement in Women with Self-perceived Thinning Hair. J. Clin. Aesthetic Dermatol. 5, 28–34. 
Haas, J.D., and Brownlie, T. (2001). Iron deficiency and reduced work capacity: a critical review of the 
research to determine a causal relationship. J. Nutr. 131, 676S-688S; discussion 688S-690S. 
Karshikoff, B., Sundelin, T., and Lasselin, J. (2017). Role of Inflammation in Human Fatigue: Relevance 
of Multidimensional Assessments and Potential Neuronal Mechanisms. Front. Immunol. 8. 
Kim, S.-K. (2013). Marine Proteins and Peptides: Biological Activities and Applications (John Wiley & 
Sons). 
Moore, P. (2015). Two-fifths of Americans are tired most of the week (USA: YouGov). 
Nørgaard, J.V., Blaabjerg, K., and Poulsen, H.D. (2012). Salmon protein hydrolysate as a protein source in 
feed for young pigs. Anim. Feed Sci. Technol. 177, 124–129. 
  
 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 30 of 41 
 
14 APPENDICES 
14.1 Appendix I - Schedule of Assessments 
Schedule of Assessments (N=20) 
 
 
Visit 1 
Screening 
Visit 2 
Baseline 
Day 0 
Visit 3 
Week 18 
Day 128 
Informed consent 
X 
 
 
Review inclusion/exclusion criteria 
X 
X 
 
Review medical history 
X 
 
 
Review concomitant therapies 
X 
X 
X 
Height*, weight, heart rate, blood 
pressure, waist & hip circumference 
X 
X 
X 
Urine pregnancy test 
X 
X 
 
Physical examination 
X 
 
X 
Complete Blood Count  
X 
 
X 
Product Tolerance Questionnaire 
X 
 
 
DNA – buccal cells** 
 
X 
 
Future analysis blood draws** 
(oxidative stress-related gene 
expression, total ROS/RNS free radical 
activity, human inflammatory cytokine 
levels) 
 
X 
X 
HbA1c and Fasting plasma glucose 
 
X 
X 
Quality of Life Questionnaire  
 
X 
X 
Hair, Nails, and Skin Self-Assessment 
Questionnaire 
 
X 
X 
IP dispensed 
 
X 
 
IP returned 
 
 
X 
Study diary dispensed 
 
X 
 
Study diary returned 
 
 
X 
Compliance calculated 
 
 
X 
Adverse events pre-and post-emergent  
 
X 
X 
* only measured at Visit 1 
**KGK to draw, process and store blood for shipment to lab. Lab costs and shipment costs to be covered 
by Sponsor.  
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 31 of 41 
 
14.2 Appendix II – Product Tolerance Questionnaire 
 
 
      
      Product Tolerance Questionnaire 
 
YES 
 
NO 
 
1. Do you like the smell and taste of this product? 
 
 
 
 
 
2. If not, will you still take this product for 128 days? 
 
 
 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 32 of 41 
 
14.3 Appendix III – Vitality and Quality of Life Questionnaire 
This self-assessment questionnaire has been developed to be administered to a healthy population. 
 
Subject Initials: __________ 
Subject Number: __________ 
Visit Date: ____________ 
 
Vitality and Quality of Life Questionnaire 
Please respond to each of the following statements by indicating the degree to which the 
statement is true for you in general in your life.   
 
1. I feel alive and vital 
 
 
2. I don’t feel very energetic 
 
3. Sometimes I feel so alive I just want to burst 
 
4. I have energy and spirit 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 33 of 41 
 
5. I look forward to each new day 
 
6. I always feel alert and awake 
 
7. I feel energized when I wake up 
 
8. I feel energy and vitality throughout the day 
 
9. I have a midday slump in energy  
 
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 34 of 41 
 
10. I feel engaged and enthusiastic in my personal relationships (friends and family) 
 
11. I have good mental clarity and focus 
 
12. I feel I have a good sense of purpose and meaning in my life 
 
13. It takes a great effort to start things. This applies to everyday activates such as getting out of 
bed, washing myself, and eating  
 
14. I forget things slightly more often than I should, but I am able to manage by making notes  
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 35 of 41 
 
15. My thoughts are neither slow nor sluggish when it comes to work involving mental effort 
 
16. My thoughts often feel slow and sluggish, even when carrying out every day activities, for 
example, a conversation with a person or when reading the newspaper 
 
17. I become stressed easily 
 
18. I am often short-tempered or irritable  
 
19. I become irritated very quickly about small things or things that do not bother other people 
 
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 36 of 41 
 
20. I do not get enough sleep 
 
21. I have slight problems falling asleep or my sleep is shorter, lighter, or more restless  
 
22. My energy level fluctuates throughout the day. I can predict that I will feel better at certain 
times and worse at other times  
 
What time of day do you feel at your best? 
 
23. I feel unwell at all times of the day and night  
 
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
Not at all true  
 
 
Somewhat true  
 
 
 
Very true 
1  
 
 
   2 
 
 
 
 3 
 
 
 
4 
Morning 
 
         Afternoon   
 
           Evening   
 
            Night 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 37 of 41 
 
24. I wake up feeling tired  
 
25. I have a hard time participating in vigorous activity 
 
26. I don’t do much during the day 
 
27. I have enough energy for everyday life  
 
28. I have problems starting things 
 
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 38 of 41 
 
29. I feel no desire to do anything 
 
30. When I am doing something, I can concentrate quite well  
 
 
 
 
 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 
1  
      2 
 
   3 
 
4 
 
5 
            6 
              7 
  Never 
             Sometimes 
                                    Always 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 39 of 41 
 
14.4 Appendix IV – Hair, Nails, and Skin Self-Assessment Questionnaire 
This Self-Assessment Questionnaire was modified from (Glynis, 2012), and will be administered at 
baseline and end-of-study. 
 
Please review each of the parameters below and select the most appropriate answer. 
  
GREATLY 
SATISFIED 
MODERATELY 
SATISFIED 
SLIGHTLY 
SATISFIED 
SLIGHTLY 
DISSATISFIED 
MODERATELY 
DISSATISFIED 
GREATLY 
DISSATISFIED 
1. Hair 
Volume  
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
2. Softness of 
Hair  
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
3. Hair Shine 
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
4. Hair 
Strength  
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
5. Nail 
Strength 
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
6. Skin 
Hydration 
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
7. Overall 
Skin Health 
1 □ 
2 □ 
3 □ 
4 □ 
5 □ 
6 □ 
 
 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 40 of 41 
 
14.5 Appendix V – Gene table - RT² Profiler PCR Array 
 

Protocol 18PEHH:   
A proof-of-concept study to evaluate the efficacy of Salmon Protein 
Hydrolysate Powder on energy increase and anti-inflammatory modulation 
in healthy males and females. 
May 3, 2018 
 
-Confidential- 
Page 41 of 41