A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
Phase: PHASE1
Conditions: Migraine
Sponsor: Eli Lilly and Company

Protocol Addendum H8H-MC-LAHX(1.1)
A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients 
with Migraine
NCT03988088   
Approval Date: 11-Jun-2019 

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 1
LY573144
1. Protocol Addendum H8H-MC-LAHX(1.1)
An Open-Label Study of Lasmiditan in Pediatric Patients
with Migraine
Confidential Information
The information contained in this protocol addendum is confidential and is 
intended for the use of clinical investigators.  It is the property of Eli Lilly and Company or 
its subsidiaries and should not be copied by or distributed to persons not involved in the 
clinical investigation of lasmiditan (LY573144), unless such persons are bound by a 
confidentiality agreement with Eli Lilly and Company or its subsidiaries.  This document and 
its associated attachments are subject to United States Freedom of Information Act (FOIA) 
Exemption 4.
Lasmiditan (LY573144)
This addendum is to be performed in addition to all procedures required by protocol 
H8H-MC-LAHX or any subsequent amendments to that protocol.
Eli Lilly and Company
Indianapolis, Indiana USA 46285
Protocol Addendum (1) Electronically Signed and Approved by Lilly: 29 March 2019
Revised Protocol Addendum (1.1) Electronically Signed and Approved by Lilly on date 
provided below.
Approval Date: 11-Jun-2019 GMT

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 2
LY573144
2. Table of Contents
Protocol Addendum H8H-MC-LAHX(1)
An Open-Label Study of Lasmiditan in Pediatric Patients with 
Migraine
Section
Page
1.
Protocol Addendum H8H-MC-LAHX(1.1) An Open-Label Study of 
Lasmiditan in Pediatric Patients with Migraine....................................................................1
2.
Table of Contents................................................................................................................2
3.
Rationale for Addendum .....................................................................................................7
4.
Protocol Additions or Changes............................................................................................8
4.1.
Objectives and Endpoints...............................................................................................8
4.2.
Study Design..................................................................................................................9
4.3.
Justification for Dose ...................................................................................................10
4.4.
Inclusion and Exclusion Criteria...................................................................................10
4.5.
Lifestyle and Dietary Considerations............................................................................10
4.6.
Method of Treatment Assignment ................................................................................10
4.7.
Dose Modification........................................................................................................11
4.8.
Preparation/Handling/Storage/Accountability...............................................................12
4.9.
Study Treatment Compliance .......................................................................................12
4.10. Concomitant Therapy...................................................................................................12
4.10.1.
Rescue .................................................................................................................13
4.11. Discontinuation of Study Treatment .............................................................................13
4.12. Discontinuation from the Study Addendum..................................................................14
4.13. Study Assessments and Procedures ..............................................................................14
4.13.1.
Efficacy Assessment ............................................................................................14
4.13.2.
Safety...................................................................................................................14
4.13.2.1.
Safety Assessments ........................................................................................14
4.13.2.2.
Clinical Safety Laboratory Assessments .........................................................14
4.13.2.3.
Puberty and Menstrual Status..........................................................................14
4.13.3.
Adverse Events and Serious Adverse Events........................................................14
4.13.3.1.
Method of Detecting AEs and SAEs...............................................................15
4.14. Treatment of Overdose.................................................................................................15
4.15. Pharmacokinetics .........................................................................................................15
4.16. Statistical Considerations and Data Analysis ................................................................15
4.16.1.
Sample Size Determination ..................................................................................15
4.16.2.
Statistical Analyses ..............................................................................................15

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 3
LY573144
4.16.2.1.
Efficacy Analyses...........................................................................................16
4.16.2.2.
Clinical Evaluation of Safety..........................................................................16
4.16.2.3.
Statistical Evaluation of Safety.......................................................................16
4.16.3.
Pharmacokinetic Analyses....................................................................................16
4.16.4.
Data Review during the Study..............................................................................16
4.16.5.
Interim Analyses..................................................................................................16
5.
References ........................................................................................................................17

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 4
LY573144
List of Tables
Table
Page
Table LAHX(1).1.
Planned Treatment Regimen .....................................................................11

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 5
LY573144
List of Figures
Figure
Page
Figure LAHX(1)1.
Study design visit schedule. ..................................................................9

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 6
LY573144
List of Attachments
Attachment
Page
Attachment 1.
Schedule of Activities....................................................................................18
Attachment 2.
Clinical Laboratory Tests...............................................................................20
Attachment 3.
Abbreviations and Definitions........................................................................22
Attachment 4.
Protocol Addendum LAHX(1.1) Revisions....................................................25

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 7
LY573144
3. Rationale for Addendum
Country and Sites
This addendum applies only to participants in Study H8H-MC-LAHX (LAHX) at clinical sites in 
the United States (US).
Rationale
This addendum provides participants the opportunity to treat up to 4 migraine attacks per month 
with lasmiditan for a period of 3 months after completing pharmacokinetic (PK) assessments in 
the single-dose PK study LAHX.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 8
LY573144
4. Protocol Additions or Changes
This protocol addendum provides the requirements applicable to the open-label extension of 
Study LAHX.
4.1.
Objectives and Endpoints
Objectives and Endpoints
Objectives
Endpoints
Primary
To evaluate the safety and tolerability of 3-month 
intermittent use of lasmiditan in the acute treatment of 
migraine in pediatric patients

TEAEs

SAEs

AEs of interest

Change from baseline in laboratory, ECG, and 
vital sign parameters
Secondary
To characterize the reasons for discontinuation

Discontinuation rates
Exploratory
To describe patient-reported global impression of 
change after treatment with lasmiditan
The proportion of migraine attacks with PGI-C scores of 
better or a lot better
Abbreviations:  AE = adverse event; ECG = electrocardiogram; PGI-C = Patient Global Impression of Change; 
SAE = serious adverse event; TEAE = treatment-emergent adverse event.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 9
LY573144
4.2.
Study Design
This is an open-label, 3-month extension of Study LAHX in pediatric patients with migraine
(Figure LAHX(1)1).
Abbreviations:  PK = pharmacokinetic.
Figure LAHX(1)1.
Study design visit schedule.
Visit 4
All potential study participants will complete assessments noted in the Schedule of Activities in 
Attachment 1 to determine if they are eligible to participate in this addendum.
Enrolled study participants and their parent or guardian will receive instructions regarding study 
procedures.  The participant’s parent or guardian is responsible for assisting children, if 
necessary, with completion of the diary assessments and other study procedures.
Lasmiditan will be dispensed to enrolled participants.  The amount of lasmiditan dispensed will 
be determined by weight measured at Visit 4, and will be sufficient to treat up to 4 migraine 
attacks per month with 1 dose of lasmiditan per 24 hours.
Visits 5 and 6
Study participant assessments will be completed as noted in the Schedule of Activities.
Participant diaries will be reviewed and recorded in the appropriate electronic case report form 
(eCRF).
Lasmiditan will be dispensed at each visit.  The amount of lasmiditan dispensed will be sufficient 
to treat up to 4 migraine attacks per month with 1 dose of lasmiditan per 24 hours.
Visit 7
This is the end of study visit.  Study participant assessments will be completed as noted in the 
Schedule of Activities.
Visit 1
Screening
Visit 2
PK and Safety
Assessments
Visit 3
24 hour 
Assessments
Visit 801
Follow-up
Visit 4
Visit 5
Month 1
Visit 6
Month 2
Visit 7
Month 3
End of Study
Participants in 
Japan or those 
who will not 
proceed to 
addendum
Participants 
proceeding to 
addendum
Addendum visits

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 10
LY573144
4.3.
Justification for Dose
This addendum will include doses corresponding to the 100-mg adult equivalent exposure. 
Because the main PK study will still be ongoing at the start of this open-label addendum, a 
conservative approach was taken to target a lower exposure than that used in the main protocol.  
This will provide additional safety information for treatment of multiple migraine attacks in the 
pediatric population.
4.4.
Inclusion and Exclusion Criteria
The inclusion and exclusion criteria for Study LAHX apply to this addendum with the exception 
of the following changes.
Inclusion Criterion [3] and Exclusion Criterion [24] are not applicable for this addendum.
[3]
Are migraine free on day of lasmiditan administration at the time of predose 
assessments.
[24] Are on a central nervous system active drug, which is known to affect levels 
of attention or sedation, such as a benzodiazepine for sleep or anxiety, or 
stimulants for Attention Deficit Hyperactivity Disorder.
Exclusion criterion 23 is changed to
[23] Have a positive urine drug screen for any substances of abuse.
One retest is allowed if the urine drug screen is positive, at the investigators 
discretion.  Positive results are acceptable if due to regular and medically 
acceptable use of a prescribed medication, such as a benzodiazepine for sleep 
or anxiety, or stimulants for Attention Deficit Hyperactivity Disorder.
4.5.
Lifestyle and Dietary Considerations
Diary
Participants will record information about the migraine attacks, use of medication, global 
impression of change, and any adverse events (AEs) in a paper diary between study visits.
Both study participants and their parent or guardian will receive instructions for completion of 
the diary in case participants need help completing the assessments.
Activity Restrictions
During the treatment of a migraine attack, patients may have some transient restrictions on their 
usual activities due to the experience of pain and symptoms of a migraine attack, study 
procedures, and effects of study treatment.
4.6.
Method of Treatment Assignment
Patients who meet all criteria for enrollment will receive blisters that contain doses of lasmiditan 
50 mg or lasmiditan 100 mg, according to their body weight determined at Visit 4.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 11
LY573144
The lasmiditan dose will be determined by the participant’s weight, with the target to achieve an 
adult exposure equivalent of 100 mg (Table LAHX(1).1).
Participants can take a single dose of lasmiditan to treat up to 4 migraine attacks per month.
Only 1 lasmiditan dose is allowed per 24 hours.
Lasmiditan will be supplied to the clinical sites in blisters.
Table LAHX(1).1.
Planned Treatment Regimen
Participant Body Weight 
15 kg to ≤40 kg 
>40 kg to ≤55 kg
Treatment Name
Lasmiditan
Lasmiditan
Dosage Formulation
Tablet
Tablet
Unit Dose Strength(s)/Dosage 
Level(s)
50 mg x1 
100 mg x1
Route of Administration
Oral
Oral
Dosing Instructions
With approximately 240 mL of room temperature water in a sitting position
The investigator or his or her designee is responsible for

explaining the correct use of lasmiditan to the patient and parent or guardian and site 
personnel

ensuring that patients are able to swallow whole tablets

verifying that instructions are followed properly

maintaining accurate records of lasmiditan dispensing and collection at each visit, and

returning all unused medication to Eli Lilly and Company (Lilly), or its designee, unless 
the sponsor and sites have agreed that all unused medication is to be destroyed by the 
site, as allowed by local law.
The participant’s parent or guardian is responsible for

maintaining control and inventory of lasmiditan, and

ensuring that lasmiditan is taken properly.
4.7.
Dose Modification
No dose modification is allowed in this study.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 12
LY573144
4.8.
Preparation/Handling/Storage/Accountability
Lasmiditan will be labeled in accordance with regulatory requirements.
All study treatment must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access limited 
to the investigator and authorized site staff.
The investigator or his or her designee is responsible for

confirming that appropriate temperature conditions have been maintained during transit 
for all study treatment received and any discrepancies are reported and resolved before 
use of the study treatment

ensuring that only participants enrolled in the study receive study treatment and only 
authorized site staff supply study treatment, and

study treatment accountability, reconciliation, and record maintenance (that is, receipt, 
reconciliation, and final disposition records).
Further guidance and information for the final disposition of unused study treatments are 
provided in the Pharmacy manual.
4.9.
Study Treatment Compliance
Participant compliance with study treatment will be assessed at each visit by counting returned 
tablets. Deviation(s) from the prescribed dosage regimen will be recorded in the eCRF.
4.10. Concomitant Therapy
What Is Allowed
Patients may use their usual treatment for migraine attacks when they do not choose to treat with 
lasmiditan.
For patients taking medication for a chronic condition, including preventive medications for
migraine, treatment regimen must be stable for at least 3 months prior to Visit 4.
What Is Not Allowed
Any investigational treatment other than lasmiditan is prohibited for the duration of a patient’s 
participation in the study from Visit 4 through end of study.
If a patient requires the initiation of concomitant medication to reduce the frequency of migraine 
episodes, or a change in ongoing migraine medication after Visit 4, they should be withdrawn 
from the study.
Patient Diary
Patients will be asked to record all medication use, including changes in dosing of previous 
medications, in a paper diary.  Information needed includes

name of medication

reason for use

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 13
LY573144

start and end dates of medication, and

dosage strength and frequency.
Parents or guardians can assist the patient in completing the diary.  This information will be 
reviewed with the clinic site staff during each clinic visit.
4.10.1. Rescue
Rescue medication is permitted as needed 2 hours after taking lasmiditan.
The patient may use their usual headache therapy.
The date and time of rescue medication administration as well as the name and dosage regimen 
of the rescue medication must be recorded in the paper diary.
Exceptions
Ergots, opioids, and barbiturates may not be used until 24 hours after lasmiditan administration.
4.11. Discontinuation of Study Treatment
Possible reasons leading to discontinuation of lasmiditan:

Pregnancy

The participant or the participant’s parents or legal guardian requests to discontinue 
lasmiditan

A hepatic event or liver test abnormality
Discontinuation of the investigational product for abnormal liver tests should be 
considered by the investigator when a patient meets 1 of the following conditions after 
consultation with the Lilly-designated medical monitor:
o
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >8x upper 
limit of normal (ULN)
o
ALT or AST >5x ULN sustained for more than 2 weeks
o
ALT or AST >3x ULN and total bilirubin level (TBL) >2x ULN or international 
normalized ratio >1.5
o
ALT or AST >3x ULN with the appearance of fatigue, nausea, vomiting, right 
upper-quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%)
o
alkaline phosphatase (ALP) >3x ULN
o
ALP >2.5x ULN and TBL >2x ULN
o
ALP >2.5x ULN with the appearance of fatigue, nausea, vomiting, right quadrant 
pain or tenderness, fever, rash, and/or eosinophilia (>5%).
Participants who are discontinued from investigational product due to a hepatic event or 
liver test abnormality should have additional hepatic safety data collected via eCRF.

Participants experiencing signs of suicidal ideation or behavior
Discontinuation of investigational product should be considered, following a risk 
assessment, for participants who
o
answered “yes” to Question 4 or Question 5 on the “Suicidal Ideation” portion of 
the Columbia-Suicide Severity Rating Scale (C-SSRS), or

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 14
LY573144
o
answered “yes” to any of the suicide-related behaviors on the Suicidal Behavior 
portion of the C-SSRS.
A psychiatrist or appropriately trained professional may assist in the decision to 
discontinue the participant.
Participants discontinuing from the investigational product prematurely for any reason should 
complete AE and other follow-up procedures per Attachment 1 (Schedule of Activities) of the 
addendum, and Section 8.2 (Safety Assessments) and Section 8.3 (Adverse Events and Serious 
Adverse Events) of the protocol.
4.12. Discontinuation from the Study Addendum
The investigator will confirm eligibility of the patient for this addendum during Visit 4 as 
defined in the Schedule of Activities.  Patients who do not meet eligibility will be discontinued 
from the study addendum.
4.13. Study Assessments and Procedures
Attachment 1 lists the Schedule of Activities, detailing the study procedures and their timing.
Attachment 2 lists the Clinical Laboratory Tests.
4.13.1. Efficacy Assessment
A Patient Global Impression of Change (PGI-C) is a patient-rated global measure of change 
(Guy 1976) and represents a global assessment of effects of the study medication on multiple 
outcomes, including migraine pain, associated symptoms, side effects, and function (Geisser et 
al. 2010; Scott and McCracken 2015).
Patients will be asked to record their PGI-C at approximately 2 hours after dosing with 
lasmiditan in the patient diary. Results will be reviewed at each patient visit and entered in the 
eCRF.
4.13.2. Safety
4.13.2.1. Safety Assessments
Unscheduled or repeat safety assessments may be performed at the discretion of the investigator 
as needed.
4.13.2.2. Clinical Safety Laboratory Assessments
For each patient, laboratory tests detailed in Attachment 2 should be conducted according to the 
Schedule of Activities (Attachment 1).
4.13.2.3. Puberty and Menstrual Status
During the open-label extension addendum, only menstrual status will be collected at each visit.
4.13.3. Adverse Events and Serious Adverse Events
Lack of drug effect is not an AE in clinical studies, because the purpose of the clinical study is to 
establish treatment effect.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 15
LY573144
If a participant’s lasmiditan is discontinued as a result of an AE, study site personnel must report 
this to Lilly or its designee via eCRF, clarifying if possible the circumstances leading to 
discontinuations of treatment.
4.13.3.1. Method of Detecting AEs and SAEs
Patients will record AEs that occur during the treatment period in a paper diary.  Information will 
include start and end dates of AEs and severity.
At every postscreening visit, site personnel will review the patient paper diary with the 
patient/guardian and record any change in the preexisting condition(s) and any new conditions as 
AEs.
Investigators should record the following via eCRF for each AE:  date of onset, date of 
termination, severity, and their assessment of the potential relatedness of each AE to 
investigational product.
4.14. Treatment of Overdose
There is limited clinical trial experience with lasmiditan overdose.  There were no instances of 
overdose in the clinical pharmacology program.  In the Phase 2 and Phase 3 clinical studies, the 
maximum dose received by any adult patient in a 24-hour period was 600 mg.  No 
treatment-emergent AEs (TEAEs) were reported following any instance of dosing >400 mg (in a 
24-hour period).  Doses exceeding the maximum therapeutic dose may be associated with 
increased incidence and/or severity of AEs. Therefore, the patient should be monitored for signs 
and symptoms of adverse reactions. Patients who develop adverse reactions should receive 
appropriate treatment.
4.15. Pharmacokinetics
Pharmacokinetics is not applicable for this addendum.
4.16. Statistical Considerations and Data Analysis
4.16.1. Sample Size Determination
Only previously enrolled participants of Study LAHX at clinics in the US are eligible for this 
addendum.  Therefore, the sample size is determined by the number of these participants who 
decide to continue in this addendum.
4.16.2. Statistical Analyses
Statistical analysis of this addendum will be the responsibility of Lilly or its designee.
Efficacy and safety analyses will be conducted for all enrolled patients who receive a dose of 
lasmiditan in this addendum.
Data analyses will be presented by body weight category.
Additional exploratory analyses of the data will be conducted as deemed appropriate.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 16
LY573144
4.16.2.1. Efficacy Analyses
The proportion and exact 95% confidence interval of patients reporting a PGI-C score better or a 
lot better for each migraine attack after baseline will be reported.
Additional analyses of the PGI-C will be included in the statistical analysis plan.
4.16.2.2. Clinical Evaluation of Safety
All investigational product and protocol procedure-related AEs will be listed, and if the 
frequency of events allows, safety data will be summarized using descriptive methodology.
Adverse events will be classified by the most suitable term from the most current Medical 
Dictionary for Regulatory Activities (MedDRA) version.
The incidence of TEAEs will be presented by severity and by association with investigational 
product as perceived by the investigator.  Adverse events reported to occur prior to enrollment 
will be distinguished from those reported as new or increased in severity during the study.
All serious adverse events (SAEs) will be reported and classified by the most suitable term from 
the most current MedDRA version.
4.16.2.3. Statistical Evaluation of Safety
Safety parameters for analysis will be

AEs (including clinically significant ECGs [electrocardiograms])

clinical laboratory parameters

vital signs

C-SSRS assessments
The parameters will be listed, and summarized using standard descriptive statistics.
Additional analysis will be performed if warranted upon review of the data.
4.16.3. Pharmacokinetic Analyses
Pharmacokinetic analyses are not applicable for this addendum.
4.16.4. Data Review during the Study
Safety data will be reviewed on an ongoing basis.  Additional reviews may be performed, as 
deemed appropriate.
4.16.5. Interim Analyses
There will be no interim analyses in this addendum.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 17
LY573144
5. References
Geisser ME, Clauw DJ, Strand V, Gendreau RM, Palmer R, Williams DA. Contributions of 
change in clinical status parameters to Patient Global Impression of Change (PGIC) scores 
among persons with fibromyalgia treated with milnacipran. Pain. 2010;149(2):373-378.
Guy W. Clinical Global Impressions (028-CGI), ECDEU Assessment Manual for 
Psychopharmacology, US Department of Health, Education, and Welfare, ADAMHA, NIMH 
Psychopharmacology Research Branch. Rockville (MD); 1976; p 217-222.
Scott W, McCracken LM. Patients’ impression of change following treatment for chronic pain: 
global, specific, a single dimension, or many? J Pain. 2015;16(6):518-526.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 18
LY573144
Attachment 1.Schedule of Activities
Schedule of Activities for Patients Participating in H8H-MC-LAHX(1) Addendum
Visit
Month 
1
Month 
2
Month 
3
EOS
ED
Notes
4a
5
6
7
(Target) interval (days) 
since previous visit
30±3
30±3
30±3
Procedure/Assessments
Informed consent/assent
X
Consent and assent form signed by patient and parent 
or guardian.
Physical examination
X
X
X
X
X
Vital signs
X
X
X
X
X
Blood pressure, pulse, and temperature.
Triplicate measurements at all visits, in the sitting 
position.  Measure blood pressure by an automated 
calibrated machine, if calibration is required
Weight
X
Menstrual status
X
X
X
X
12-lead ECG (single)
X 
X
X
Patients must be supine for at least 5 minutes before 
collection and remain supine, but awake during the 
procedure
Concomitant medications
X
X
X
X
X
Adverse events
X
X
X
X
X
Study drug dispensed
X
X
X
Provide detailed instructions to participant for study 
drug
Review study diary
X
X
X
X
X
Study drug accountability
X
X
X
X
Collect empty dosing card(s) and unused study drug.  
Review dosing compliance
Clinical Laboratory 
Tests
Hematology
X
X
X
Clinical chemistry
X
X
X
Urinalysis
X
X
X
Urine drug screen 
X
X
X
X
X
For patients aged > 10 years
Pregnancy test 
for females of 
childbearing potential
X
X
X
X
X
A positive urine pregnancy test must be followed by a 
serum pregnancy test for confirmation
Scales and
Questionnaires
C-SSRS/SHSF/SHFU
X
X
X
X
X
Suicidal ideation and behavior subscales are adapted 
for the assessment of 11 preferred ideation and 
behavior categories.  The C-SSRS will be collected 
only in patients ≥7 years old.  The SHFU Form is 
required only if triggered by the SHSF
PGI-C
X
X
X
X
The PGI-C is contained within the patient diary

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 19
LY573144
Abbreviations:  C-SSRS = Columbia-Suicide Severity Rating Scale; ECG = electrocardiogram; ED = early 
discontinuation; EOS = end of study visit; PGI-C = Patient Global Impression of Change; SHFU = Self-Harm 
Follow-Up form; SHSF = Self-Harm Supplement Form.
a
The confirmation of eligibility visit for the addendum will occur at the same time as Study LAHX Day 14, 
Follow-up visit.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 20
LY573144
Attachment 2.Clinical Laboratory Tests
Hematologya
Clinical Chemistrya,
Hemoglobin  
Sodium
Hematocrit
Potassium
Erythrocyte count (RBC)
Bicarbonate
Mean cell volume 
Chloride
Mean cell hemoglobin 
Calcium
Mean cell hemoglobin concentration 
Phosphorus
Leukocytes (WBC) 
Platelets
Magnesium 
Absolute counts of:
Neutrophils
Total bilirubin
Lymphocytes
Direct bilirubin
Monocytes
Alkaline phosphatase (ALP)
Eosinophils
Aspartate aminotransferase (AST)
Basophils
Alanine aminotransferase (ALT)
     
Blood urea nitrogen (BUN)
Creatinine
Urinalysisa,
Uric acid
Specific gravity
pH
Glucose (random)
Protein
Albumin 
Glucose
Total protein
Ketones
Bilirubin
Urobilinogen
Other Tests
Leukocyte esteraseb
Serum pregnancy testa
Blood
Nitrite
Urine pregnancy test (local)
Urine cultureb
Urine drug screena
Microsopic analysisb
Abbreviations:  RBC = red blood cell; WBC = white blood cell.
a
Assayed by sponsor-designated laboratory.
b
A positive leukocyte esterase result will require a follow-up sample with microscopic analysis and possibly a 
urine culture.
Note:  Additional tests may be performed at the discretion of the investigator as needed.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 21
LY573144
Protocol H8H-MC-LAHX Addendum Sampling Summary
Purpose
Blood Volume per Sample 
(mL)
Maximum Number of 
Blood Samples
Total Volume (mL)
Hematologya
2
2
4
Chemistrya
2.5
2
5
Serum pregnancy testa,b
0
1
0
Total
9
Total for clinical purposes rounded up to the nearest 10 mL
10
Hepatic monitoringc
3-30
Abbreviations:  CRP = Clinical Research Physician; CRS = Clinical Research Scientist.
a
Additional samples may be drawn if needed for safety purposes.
b
Sample volume included with chemistry test volume.
c
Unscheduled hepatic monitoring testing may be performed as part of patient follow-up, based on laboratory 
safety values and in consultation with Lilly CRP/CRS.

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 22
LY573144
Attachment 3.Abbreviations and Definitions

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 23
LY573144
Term
Definition
AE
adverse event:  Any untoward medical occurrence in a patient or clinical investigation 
patient administered a pharmaceutical product that does not necessarily have a causal 
relationship with this treatment.  An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated 
with the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.
ALP
alkaline phosphatase
ALT
alanine aminotransferase
assent
Agreement from a child or other individual who is not legally capable of providing consent, 
but who can understand the circumstances and potential risks involved in participating in a 
study (required by some institutional review boards [IRBs]/ethical review boards [ERBs]).
AST
aspartate aminotransferase
C-SSRS
Columbia-Suicide Severity Rating Scale
eCRF
electronic case report form
enter
Patients entered into a study are those who sign the informed consent form directly or 
through their legally acceptable representatives.
informed consent
A process by which a patient voluntarily confirms his or her willingness to participate in a 
particular study, after having been informed of all aspects of the study that are relevant to 
the patient’s decision to participate.  Informed consent is documented by means of a 
written, signed, and dated informed consent form.
Investigational 
product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference 
in a clinical study, including products already on the market when used or assembled 
(formulated or packaged) in a way different from the authorized form, or marketed products 
used for an unauthorized indication, or marketed products used to gain further information 
about the authorized form.
Investigator
A person responsible for the conduct of the clinical study at a study site.  If a study is 
conducted by a team of individuals at a study site, the investigator is the responsible leader 
of the team and may be called the principal investigator.
Legal 
Representative
An individual or judicial or other body authorized under applicable law to consent, on 
behalf of a prospective patient, to the patient’s participation in the clinical study.
MedDRA
Medical Dictionary for Regulatory Activities
open label
A study in which there are no restrictions on knowledge of treatment allocation; therefore 
the investigator and the study participant are aware of the drug therapy received during the 
study.
PGI-C
Patient Global Impression of Change
PK
pharmacokinetic

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 24
LY573144
SAE
serious adverse event
screen
The act of determining if an individual meets minimum requirements to become part of a 
pool of potential candidates for participation in a clinical study.
TBL
total bilirubin
TEAE
treatment-emergent adverse event:  Any untoward medical occurrence that emerges during 
a defined treatment period, having been absent pretreatment, or worsens relative to the 
pretreatment state, and does not necessarily have to have a causal relationship with this 
treatment.
ULN
upper limit of normal
US
the United States

H8H-MC-LAHX(1.1) Clinical Protocol Addendum
Page 25
LY573144
Attachment 4.Protocol Addendum LAHX(1.1) Revisions
Overview
Protocol Addendum I6T-MC-LAHX(1) has been revised.  The revised protocol addendum is 
indicated by revision (1.1) and will be used to conduct the study in place of any preceding 
version of the protocol addendum.
This table describes the changes to this addendum. 
Section
Additions 
Deletions
Rationale
Attachment 2 
Clinical Laboratory Tests
Urinalysis:  

Blood

Nitrite
Clinical Chemistry: 

Bicarbonate

Chloride

Calcium

Phosphorus

Magnesium 
Alkaline phosphatase

Triglycerides

Total cholesterol

Bone specific 
alkaline 
phosphatase
Tests were added/deleted
to harmonize with what is 
collected in the main 
protocol.

Leo Document ID = 394f1c0b-90de-4857-a0c7-b9338974df19
Approver: 
Approval Date & Time: 11-Jun-2019 14:09:27 GMT
Signature meaning: Approved
Approver: 
Approval Date & Time: 11-Jun-2019 15:45:29 GMT
Signature meaning: Approved
PPD
PPD