A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 Trial
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Sponsor: Lumos Pharma

Protocol Title:  
An Open-Label, Multicenter, Phase 2 Study to Evaluate Growth and Safety of LUM-201 
Following 12 Months of Daily rhGH Treatment in Children with Idiopathic Growth Hormone 
Deﬁciency who have Previously Completed the LUM-201-01 Trial 
 
NCT #: 05250063 
 
Date: 19 January 2022 

LUM-201 (Ibutamoren mesylate) 
 
Protocol 201-04 
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INVESTIGATOR’S AGREEMENT
An Open-Label, Multicenter, Phase 2 Study to Evaluate Growth and Safety of LUM-201 
Following 12 Months of Daily rhGH Treatment in Children with Idiopathic Growth 
Hormone Deficiency who have Previously Completed the LUM-201-01 Trial 
Protocol Date: 19 January 2022 
The information contained in this protocol and all other information relevant to this study are the 
confidential and proprietary information of Lumos Pharma, Inc., and except as may be required 
by federal, state or local laws or regulation, may not be disclosed to others without prior written 
permission of Lumos Pharma, Inc. 
I have read the protocol for Study LUM-201-04, including all appendices, and I agree that it 
contains all of the necessary information for me and my staff to conduct this study as described.  
I will conduct this study as outlined herein, in accordance with the regulations stated in the 
Federal Code of Regulations for Good Clinical Practice (GCP) and International Council for 
Harmonisation (ICH) guidelines and will make a reasonable effort to complete the study within 
the time designated. 
I will provide all study personnel under my supervision copies of the protocol and any 
amendments, as well as access to all information provided by Lumos Pharma, Inc. I will discuss 
the material with them to ensure that they are fully informed about the study. 
Printed Name of Investigator 
Signature of Investigator 
Date
 

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Table 1 Schedule of Assessments
Visit
Screening/ 
Baseline 
+ 30 Days 
from end of 
prior study
Month 1 
(± 3 days)
Month 3 
(± 7 days)
Month 6  
(± 7 days)
Month 9 
(± 7 days)
Month 12/ 
Early 
Term 
(± 7 days) 
Follow-up 
Contact 
Scheduled Visit No. 
1 
2
3
4
5
6 
Informed 
consent/assent 
X 
Inclusion/exclusion 
criteria review 
X 
 
 
 
 
 
 
Medical history 
X 
 
 
 
Physical 
examinationb 
Xa 
 
X 
 
Tanner staging
Xa
X
X
X
X
Adverse events
X
X
X
X
X
X
X
Concomitant 
medications
X 
X 
X 
X 
X 
X 
X 
Vital signs
X 
X
X
X 
X 
X 
Stadiometer height 
and weight 
Xa 
Xc 
X 
X 
X 
X 
 
Bone age 
 
 
X 
 
ECGd
X 
 
X
X 
 
X 
Enrollment
X 
 
 
 
Laboratory 
assessments
 
 
 
 
 
 
Hematology, CBC
Xa 
X
X
X 
 
X 
Serum chemistry 
panel
Xa 
X 
X 
X 
 
X 
 
HbA1c
Xa 
 
 
X 
 
X 
Fasting glucose
Xa 
 
 
X 
 
X 
Thyroid panel 
(TSH, T4, T3)
Xa 
 
 
X 
 
X 
 
Lipids
Xa 
 
 
X 
 
X 
Urinalysis 
(Dipstick)
Xa 
X 
X 
IGF-1 sample
Xa
X
X
X
IGFBP-3 sample 
Xa 
 
X
X 
 
X 
GH samplee
X 
 
 
X 
 
X 
Drug accountability/
Compliance check 
X 
X 
X 
X 
X 
 
Study drug dispensed 
X 
X
X
X 
X 
Commence daily 
treatment with LUM-
201
X 
 
 
 
 
 
 
Dose adjustment, 
when applicable  
X 
X 
X 
X 
 
 
Abbreviations: CBC = complete blood count; ECG = electrocardiogram; GH = growth hormone; HbA1c = hemoglobin A1c; 
IGF-1 = insulin-like growth factor 1; IGFBP-3 = insulin-like growth binding protein 3; T3 = triiodothyronine; T4 = free 
thyroxine; TSH = thyroid stimulating hormone 
a Screening/Baseline visit of this study can coincide with the last visit of the LUM-201-01 study. Therefore, 
overlapping assessments, such as vital signs, safety labs, Tanner staging and stadiometer height and weight, may be 

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completed only once to satisfy both protocol requirements. If the Baseline/Screening visit occurs within 30 days of 
the LUM-201-01 Month 12 visit, repeat assessments are not necessary. If the Baseline/Screening visit is not scheduled 
within 30 days of the LUM-201-01 Month 12 visit, a discussion needs to take place with the Medical Monitors.  
b Complete physical examination will be performed at Baseline and Month 12 visits. For any patients complaining of 
headache, fundoscopy examination should be performed per investigator’s judgment. 
c At Month 1 visit, only weight will be collected. Height will not be collected. 
d ECGs will be performed pre-dose for all subjects at Screening/Baseline Day1 (Visit 1), and 1 hour ± 10 min at 
Screening/Baseline Day 1, Month 3 (Visit 3), Month 6 (Visit 4), and Month 12 (Visit 6). ECGs will be interpreted by 
a central reader using age-related normative data. 
e GH sample should be collected at 0 (pre-dose) and 60 ± 10 minutes after LUM-201 administration.

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TABLE OF CONTENTS 
1.0
TITLE PAGE .....................................................................................................................1
2.0
PROTOCOL SYNOPSIS..................................................................................................4
3.0
ABBREVIATIONS AND DEFINITIONS .....................................................................14
4.0
WHO  WORLD HEALTH ORGANIZATION INTRODUCTION AND 
BACKGROUND ..............................................................................................................16
4.1
Background of the Disease ....................................................................................16
4.2
Background of Treatment Options.........................................................................17
4.3
Summary of Nonclinical and Clinical Data for LUM-201 ....................................17
4.4
Potential Risks and Benefits to Human Subjects ...................................................17
5.0
STUDY OBJECTIVES ....................................................................................................17
5.1
Primary Objective ..................................................................................................17
5.2
Secondary Objective ..............................................................................................18
6.0
INVESTIGATIONAL PLAN .........................................................................................18
6.1
Overall Study Design .............................................................................................18
6.2
Rationale for the Study ..........................................................................................18
6.3
Rationale for Selection of the Treatment Population .............................................18
6.4
Rationale for Selection of LUM-201 Dose ............................................................18
6.5
Rationale for Study Design ....................................................................................20
6.6
Study Duration and Dates ......................................................................................20
6.7
Safety Reviews and Stopping Rules ......................................................................20
6.8
Stopping Rules .......................................................................................................20
6.8.1
Individual Subjects ................................................................................20
6.8.2
LUM-201 Treatment Arms ...................................................................21
6.9
Discussion of Study Design ...................................................................................21
6.10
Study Endpoints .....................................................................................................21
6.10.1
Growth Endpoints .................................................................................21
6.10.2
PD Endpoints ........................................................................................22
6.10.3
Safety Endpoints ...................................................................................22
7.0
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................22
7.1
Inclusion Criteria ...................................................................................................22
7.2
Exclusion Criteria ..................................................................................................22
7.3
Subject Withdrawals and Replacements ................................................................23
8.0
ENROLLMENT AND BLINDING PROCEDURES ...................................................23
8.1
Methods of Subject Assignment ............................................................................23
8.2
Blinding..................................................................................................................23
9.0
STUDY TREATMENTS .................................................................................................23

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9.1
Description of Treatments......................................................................................23
9.1.1
LUM-201 ..............................................................................................23
9.2
Administration of Treatment..................................................................................24
9.2.1
Treatment Interruption ..........................................................................24
9.2.2
Dose Reduction .....................................................................................24
9.3
Concomitant Medications ......................................................................................24
9.4
Restrictions ............................................................................................................24
9.5
Treatment Adherence .............................................................................................25
9.6
Packaging and Labeling .........................................................................................25
9.7
Storage, Transport, and Accountability: ................................................................25
9.8
Investigational Product Retention at Study Site ....................................................25
9.8.1
Prohibited Medications .........................................................................25
9.9
Overdose Instructions ............................................................................................25
10.0
RISKS/PRECAUTIONS .................................................................................................25
11.0
STUDY ASSESSMENTS AND PROCEDURES ..........................................................26
11.1
Assessments of Efficacy ........................................................................................26
11.1.1
Height and Weight ................................................................................26
11.1.2
Bone Age ...............................................................................................26
11.2
Assessments of Pharmacodynamic (PD) Markers .................................................26
11.3
Assessments of Safety............................................................................................26
11.3.1
Physical Examination ............................................................................26
11.3.2
Vital Signs .............................................................................................27
11.3.1
Electrocardiograms (ECG) ....................................................................27
11.3.2
Clinical Laboratory Tests ......................................................................27
11.4
Study Procedures ...................................................................................................28
11.4.1
Informed Consent ..................................................................................28
11.4.2
Medical History and Genetic Testing ...................................................28
11.4.3
Other Study Procedures.........................................................................28
11.4.4
Sample Collection, Storage and Shipping .............................................28
11.4.5
Dispensing Study Drug .........................................................................28
11.5
Study Activities ......................................................................................................28
11.5.1
Screening/Baseline (visit 1) +30 day window from LUM-201-01 
Month 12 visit (visit 11) ........................................................................28
12.0
ADVERSE EVENT ASSESSMENT AND REPORTING ...........................................33
12.1
Definitions..............................................................................................................33
12.1.1
Adverse Event (AE) ..............................................................................33

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12.1.2
Serious Adverse Events (SAEs) ............................................................33
12.2
Adverse Event Reporting and Descriptions ...........................................................34
12.2.1
Severity .................................................................................................34
12.2.2
Relationship to Study Treatment (Suspected Adverse Reactions) ........35
12.2.3
Expected Adverse Events ......................................................................36
12.2.4
Pregnancy and Abortion ........................................................................36
12.3
Reporting Requirements for Serious Adverse Events ...........................................36
12.4
Follow-up for Adverse Events ...............................................................................37
13.0
STATISTICS ....................................................................................................................37
13.1
General Considerations ..........................................................................................37
13.2
Determination of Sample Size ...............................................................................38
13.3
Analysis Populations ..............................................................................................38
13.3.1
Intent-to-treat (Full Analysis Set) .........................................................38
13.3.2
Per Protocol ...........................................................................................38
13.3.1
Safety Population ..................................................................................39
13.4
Demographics and Baseline Characteristics ..........................................................39
13.5
Efficacy Analyses ..................................................................................................39
13.5.1
Effects of LUM-201 on Growth ............................................................39
13.6
Safety Analyses ......................................................................................................39
13.7
Missing and Spurious Data ....................................................................................40
13.8
Retention of Data ...................................................................................................40
13.9
Interim Analysis .....................................................................................................40
14.0
STUDY DURATION AND TERMINATION ...............................................................41
15.0
STUDY COMPLIANCE AND ETHICAL CONSIDERATIONS ...............................41
15.1
Compliance Statement ...........................................................................................41
15.2
Informed Consent...................................................................................................41
15.3
Institutional Review Board or Independent Ethics Committee .............................41
16.0
ADMINISTRATIVE PROCEDURES ...........................................................................41
16.1
Sponsor Responsibilities ........................................................................................41
16.1.1
Study Supplies .......................................................................................42
16.1.2
Investigator Training .............................................................................42
16.1.3
Ongoing Communication of Safety Information During the Study ......42
16.1.4
Study Monitoring ..................................................................................42
16.1.5
Study Auditing and Inspecting ..............................................................43
16.2
Investigator Responsibilities ..................................................................................43
16.2.1
Subject Screening Log ..........................................................................43

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16.2.2
LUM-201 Accountability ......................................................................43
16.2.3
Reporting and Recording of Study Data ...............................................44
16.2.4
Source Documentation ..........................................................................44
16.2.5
Tissue and Blood Sample Collection/Storage .......................................45
16.3
Clinical Trial Insurance..........................................................................................45
16.4
Study Administrative Letters and Protocol Amendments .....................................45
17.0
POLICY FOR PUBLICATION AND PRESENTATION OF DATA ........................46
18.0
REFERENCES .................................................................................................................47
19.0
APPENDICES ..................................................................................................................51
19.1
Appendix 1: Concomitant Medications .................................................................51
19.2
Appendix 2: Laboratory Testing ............................................................................52
19.3
Appendix 3: Clinical Laboratory Analytes ............................................................53
 
LIST OF TABLES 
Table 1 Schedule of Assessments....................................................................................................7
Table 2 PEM Positive Subject Height Velocity at 6 Months in Merck Study 020 ........................19
Table 3 Specialty Laboratory Tests ...............................................................................................52
 

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3.0
ABBREVIATIONS AND DEFINITIONS
ADHD 
attention deficit hyperactivity disorder 
ADL
activities of daily living 
AE 
adverse event 
AHV 
annualized height velocity 
ALT 
alanine transaminase (serum glutamic pyruvic transaminase [SGPT]) 
ANCOVA 
analysis of covariance 
AST 
aspartate transaminase (serum glutamic oxaloacetic transaminase [SGOT]) 
AUC 
area under the curve 
BMI 
body mass index 
CBC 
complete blood count 
CI 
confidence interval 
CFR 
Code of Federal Regulations 
CRF/eCRF
case report form/electronic case report form 
CRO
contract research organization
CRT 
controlled room temperature 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTS 
Clinical Trial Supplies
L-DOPA 
levodopa 
ECG 
electrocardiogram 
EOS 
End of Study 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice
GGT 
gamma glutamyl transferase
GH 
growth hormone 
GHD 
growth hormone deficiency 
GHRH 
growth hormone releasing hormone 
GHRP-6 
GH-releasing hexapeptide 
GHSR1a 
GH secretagogue receptor 
HbA1c 
hemoglobin A1c 
HDL 
high-density lipoprotein 
HT-SDS 
height standard deviation score 
HV 
height velocity 

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IB 
Investigator Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IGFBP-3 
insulin-like growth factor binding protein 3 
IGF-1 
insulin-like growth factor 1 
IMP 
investigational medicinal product  
IND 
investigational new drug 
IEC 
Independent Ethics Committee  
IH 
intracranial hypertension  
IRB 
Institutional Review Board
LDL 
low-density lipoprotein 
LTSE 
Long-Term Safety Extension  
MedDRA 
Medical Dictionary for Regulatory Activities 
MM 
medical monitor 
MRI 
magnetic resonance imaging 
PD 
pharmacodynamic(s) 
PGHD 
pediatric growth hormone deficiency 
PI 
Principal Investigator 
rhGH 
recombinant human growth hormone 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SD 
standard deviation 
SDS 
standard deviation score 
SST 
somatostatin 
SUSAR 
serious unexpected suspected adverse reaction 
T3 
triiodothyronine 
T4 
free thyroxine 
TEAE 
treatment-emergent adverse events 
TSH 
thyroid-stimulating hormone 
US 
United States 
WBC 
white blood cell 

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4.0
WHO WORLD HEALTH ORGANIZATION INTRODUCTION AND 
BACKGROUND 
Patients with untreated growth hormone deficiency (GHD) frequently attain adult heights less 
than 5 feet and have abnormal body composition (1). Treatment with recombinant human growth 
hormone (rhGH) initiates a period of accelerated or “catch-up” growth (2). Normal adult heights 
and body compositions have been attained when rhGH was begun at an early age and continued 
throughout the growing years (3,4,5,6,7). However, adherence with daily injections represents a 
treatment burden difficult to overcome in a substantial number of patients. Lack of adherence 
can lead to substantial losses of treatment effect (8,9,10). Long-acting formulations of rhGH, 
taken weekly, are now in clinical trials or have recently been approved in some regions, and may 
offer one alternative to decrease the treatment burden of daily injections (11,12,13). An 
additional alternative would be administration of an orally active compound to restore secretion 
of adequate levels of endogenous GH. 
LUM-201 (ibutamoren mesylate, L-163,191; formerly MK 0677) is a potent, orally active, non-
peptidyl GH secretagogue and a mimetic of GH-releasing hexapeptide (GHRP-6), an effective 
GH secretagogue in man (14,15). LUM-201 and other GH secretagogues, along with the 
endogenous peptide hormone ghrelin, act on the GH secretagogue receptor (GHSR1a) in the 
anterior pituitary and hypothalamus to stimulate the release of GH. This pathway represents an 
additional regulation of GH release from pituitary somatotrophs to that mediated by growth 
hormone releasing hormone (GHRH; stimulating) and somatostatin (SST; inhibitory), the latter 
acting through SST receptor subtypes 2 and 5 to block GHRH-mediated effects. Both stimulatory 
pathways lead to a pulsatile release of GH. LUM-201, binding to its receptors in the 
hypothalamus, not only stimulates the secretion of GHRH, but also suppresses the secretion of 
SST. 
Lumos Pharma, Inc. (Sponsor) initiated a Phase 2 trial of LUM-201 in December 2020 in 80 
children diagnosed with GHD (NCT04614337). In that ongoing clinical trial, approximately 20 
patients are being randomized to 12-month treatment with rhGH.  The current protocol aims to 
provide a 12-month LUM-201 treatment option for those 20 patients. If the Long-Term Safety 
Extension (LTSE) Study is open to enrollment at study sites, subjects may be allowed to enroll 
into the LTSE Study.    
4.1 
Background of the Disease 
GHD in childhood is an uncommon disorder, occurring in about 1 in 4000 children (16,17). 
Children with untreated GHD will have significant short stature. In most cases, adult height is 
less than 5 feet (1.52 m) (18). GHD is the consequence of low or absent secretion of GH from 
the pituitary gland. The numerous causes include neoplasia, trauma, inflammation, surgery, 
and/or irradiation of the central nervous system and genetic causes. In children, GHD results in 
inadequate circulating insulin-like growth factor 1 (IGF-1) levels. Low circulating IGF-1 
concentrations are also used as a diagnostic criterion (16). PGHD is usually subcategorized as 
either organic (including both congenital and acquired), which is usually associated with an 

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inability to make GH and is a more severe form of GHD, or idiopathic GHD. Of the 
approximately 60-70% of the PGHD population identified as having idiopathic GHD, most are 
felt to have hypothalamic dysregulation as the cause of their GHD, as most of this population 
tests as GH-sufficient after completion of puberty. 
Along with significant growth failure, children with untreated GHD will have abnormal body 
composition with decreased bone mineralization, decreased lean body mass, and increased fat 
mass. Adults with GHD have decreased lean body mass, increased fat mass, weakness, 
reductions in exercise capacity, muscle mass/strength, cardiac performance, bone density, and 
neuropsychological disturbances. 
4.2
Background of Treatment Options
Current treatment of GHD children is limited to subcutaneous (SC) injections of rhGH. 
Treatment is required for an average of approximately 7 years, but in cases of organic GHD 
treatment may persist throughout adult life.
4.3 
Summary of Nonclinical and Clinical Data for LUM-201  
Comprehensive safety pharmacology and toxicology studies for LUM-201 have been completed 
(including chronic and juvenile toxicology, genotoxicity, 2-year carcinogenicity, and 
developmental and reproductive toxicology) and support chronic use of LUM-201 in the 
pediatric population.  
To date, LUM-201 has been studied in more than 1200 people (~200 children and ~1000 adult 
and elderly subjects). LUM-201 has been generally well-tolerated in healthy volunteer, pediatric, 
young adult, and elderly subjects enrolled in clinical studies. 
4.4 
Potential Risks and Benefits to Human Subjects
The main risk of LUM-201 in children is increased appetite.  
Detailed information on these and other risks of LUM-201 in humans is provided in the 
Investigator Brochure (IB) for LUM-201.  
The potential benefit of LUM-201 is acceleration of linear growth. 
5.0 
STUDY OBJECTIVES 
5.1 
Primary Objective 
 Assess the growth response to LUM-201 administration in children with idiopathic growth 
hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the LUM-
201-01 trial. 

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5.2
Secondary Objective 
 To assess safety of LUM-201 administration in children with PGHD previously treated with 
daily rhGH for 12 months. 
6.0
INVESTIGATIONAL PLAN 
6.1
Overall Study Design 
This is a multiple center, 12-month, open-label in children with GHD who completed 12 months 
of rhGH treatment in the LUM-201-01 Trial. Up to 20 subjects will be enrolled.  
Following successful screening, subjects will be assigned to the 3.2 mg/kg daily oral dose of 
LUM-201. IGF-1 samples will be collected throughout the study. If an IGF-1 SDS value > +2.0 
is confirmed by a follow-up (unscheduled) lab, the LUM-201 dose may be reduced to 1.6 
mg/kg/day.  
The follow-up safety history of subjects will be collected by telephone visit 30 days after their 
final visit.  
6.2 
Rationale for the Study 
This study investigates how children respond to daily LUM-201 after 12 months of treatment 
with daily injectable rhGH. In healthy children, GH is secreted in an ultradian pattern of discrete 
pulses (25). Secreted GH stimulates synthesis and release of IGF-1. Together, GH and IGF-1 
signal the numerous intracellular mechanisms that culminate in physical growth during 
childhood (26). Children with GHD have diminished endogenous GH pulses, diminished IGF-1 
and in consequence have inadequate growth. Growth can be restored with injections of rhGH but 
rhGH injections are associated with sustained and pharmacologically elevated levels of GH and, 
occasionally, of IGF-1. This study will evaluate growth and IGF-1 concentrations while on 
LUM-201 treatment in children previously treated with rhGH, who have previously 
demonstrated that they are able to secrete endogenous GH upon treatment with LUM-201 
through the results of their PEM (Predictive Enhancement Marker) results in the LUM-201-01 
Trial.  
6.3 
Rationale for Selection of the Treatment Population 
The study population is limited to children who were assigned to rhGH comparator arm in the 
LUM-201-01 Trial and have completed that clinical trial, and thus have previously demonstrated 
that they are capable of responding to LUM-201 with an increase in GH as part of the PEM 
assessment. 
6.4 
Rationale for Selection of LUM-201 Dose 
A dose-finding study of LUM-201 was conducted in naïve-to-treatment, pre-pubertal children 
with GHD randomized to receive either placebo, 0.4 mg/kg/day or 0.8 mg/kg/day LUM-

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6.5
Rationale for Study Design 
This study is designed as a switch study for patients treated with rhGH in the LUM-201-01 Trial 
to generate initial data on the second year height velocity and safety of LUM-201 in children 
previously treated with rhGH for one year. Periodic safety laboratories will be drawn and height 
measurements will be obtained to gather information on how LUM-201 administration supports 
continued growth after the first year of catch-up growth attained under rhGH treatment in the 
LUM-201-01 Trial. 
6.6
Study Duration and Dates 
The total duration of treatment for each subject is 12 months.  
The on-study time for each subject will be approximately 13-14 months, including Screening (up 
to 30 days), active treatment (12 months), and Follow up (30 days). If the LTSE Study is opened 
at a study site, subjects may be allowed to enroll into the LTSE Study. If a subject enrolls in the 
LTSE Study, the subject will not be required to have a post-treatment contact after Month 12 
(visit 6).  
6.7 
Safety Reviews and Stopping Rules 
The Medical Monitors (MMs) will monitor safety and clinical laboratory safety events on an 
ongoing basis. The MM will review data for any potential risks to subjects and determine if 
criteria for any Stopping Rules have been met. 
6.8 
Stopping Rules  
6.8.1 Individual Subjects 
Any subject who meets any of the following criteria should immediately have further study 
related therapy withheld until the subject can be thoroughly evaluated and the data discussed by 
the treating physician, MM, and Sponsor. 
1. The MM and/or the Principal Investigator (PI) concludes it is unsafe for the subject to 
continue. 
2. A new diagnosis emerges that could influence the response to treatment. 
3. Occurrence of serious adverse events related to study drug. 
4. A new medication is commenced that could influence the response to treatment. 
5. Occurrence of new intracranial tumor. 
6. Development of new malignancy. 
7. Glucose at any time > 200 mg/dL. 

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8. QTcb >500 msec or uncorrected QT >600 msec, or QTc change from baseline of >60 
msec, and > upper limit of normal (ULN).   
9. Clinically relevant laboratory abnormalities, including serum ALT and/or AST > 3x ULN. 
Subjects meeting an individual stopping criterion may be withdrawn from the trial. 
Subjects meeting an individual stopping criterion may, after thorough evaluation, return to study 
treatment if there is agreement between the PI, MMs, and Sponsor provided that it can be clearly 
determined factors that resulted in a stopping criterion met were not related to study therapy or 
have been appropriately managed, and resumption of study therapy is not believed to provide 
increased or unwarranted risk to the subject. 
6.8.2 LUM-201 Treatment Arms
Although at start of treatment this is a single arm study, as subjects may have a single dose 
reduction to a 1.6 mg/kg/day LUM-201 dose during the course of the study, there may be more 
than one treatment arm at the end of the trial. Given this, a LUM-201 arm may be discontinued if 
the determination is made that it is unsafe to continue because of an unexpected frequency, 
severity or type of adverse event (AE).  
6.9
Discussion of Study Design 
This study was designed for 12 months of treatment to allow the necessary minimum amount of 
time to assess change in height in this population.  
The individual assessments employed are standard pediatric practice for the evaluation of growth 
and growth-promoting treatments in children. The frequency of blood tests, electrocardiograms 
(ECGs), PD markers, and bone ages are appropriate to the evaluation of a new investigational 
product (LUM-201). 
6.10
Study Endpoints 
6.10.1 Growth Endpoints 
Growth parameters of efficacy (at Month 3 [visit 3], Month 6 [visit 4] and Month 12 [visit 6]) 
will be assessed based on: 
 Annualized height velocity.  
 Change in HT-SDS. (33)  
 Change in Weight and Weight SDS. (33) 
 Change in BMI and BMI SDS. (33) 
 Change in Bone Age (Only Month 6 [visit 4]). 

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6.10.2 PD Endpoints  
PD will be assessed by:  
 GH, IGF-1 and IGFBP-3.  
6.10.3 Safety Endpoints 
Safety of LUM-201 will be assessed by AEs and SAEs, routine laboratory tests (hematology, 
chemistry panel including liver enzymes and urinalysis), HbA1c, blood glucose, free thyroxine 
(T4), triiodothyronine (T3), thyroid-stimulating hormone (TSH), lipids, physical examinations, 
ECGs and vital signs. 
7.0 
SELECTION AND WITHDRAWAL OF SUBJECTS 
The Screening population will consist of children with PGHD who successfully completed 12 
months of treatment with rhGH in LUM-201-01 study. 
Approximately 20 subjects will be screened to allow enrollment of up to 20 subjects.  
Following successful screening, subjects will be enrolled and commence their assigned 
3.2 mg/kg daily oral LUM-201 treatment. Subjects may withdraw from the study at any time.  
7.1 
Inclusion Criteria 
Potential study subjects must meet all the inclusion criteria listed below to be eligible for study 
participation: 
1. Parent/caregiver must sign the informed consent, and the subject must sign the assent, as 
applicable. 
2. Must have previously completed 12 months of daily rhGH treatment as part of the LUM-
201-01 PGHD trial. 
3. Is eligible for study participation as confirmed by the principal investigator (PI). 
7.2 
Exclusion Criteria  
Potential study subjects meeting any of the exclusion criteria listed below will not be eligible for 
participation in the study.  
1. Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk 
to use of LUM-201. 
2. Uses any medication that, in the opinion of the PI and/or MM, can independently cause 
short stature or limit the response to exogenous growth factors. 

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3. Has planned or is receiving current long-term treatment with medications known to act as 
substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes 
LUM-201 (see Appendix 1 for list of example medications). Subjects receiving shorter-
term (two weeks or less) treatment with these medications should be evaluated on case-
by-case basis by the PI in consultation with the MM. 
4. Has been randomized to LUM-201 in the LUM-201-01 trial.
7.3
Subject Withdrawals and Replacements
Consent may be withdrawn at any time for any reason by the subject or subject caregiver without 
prejudice to further treatment. In addition, the MM or PI may withdraw a subject if medically 
necessary. If possible, subjects who withdraw early should complete the Month 12 visit (visit 6) 
activities and return at the scheduled Month 12 visit (visit 6) for a final evaluation of the growth 
endpoints.  
8.0 
ENROLLMENT AND BLINDING PROCEDURES 
8.1 
Methods of Subject Assignment 
Each screened subject will enter the Subject Number previously assigned in the LUM-201-01 
trial, at the Screening/Baseline visit (visit 1). Subject Numbers will not be reassigned.  
8.2 
Blinding 
This study is an open-label study; no blinding is required. 
9.0 
STUDY TREATMENTS 
9.1 
Description of Treatments 
All subjects will receive a single oral 3.2 mg/kg dose of LUM-201 at the Screening/Baseline visit 
(visit 1) which will include measurement of GH concentrations at baseline and 60 ± 10 minutes
after dosing. 
All subjects will commence their dosing at the Screening/Baseline visit (visit 1) and continue 
treatment until the Month 12 visit (visit 6). 
9.1.1 LUM-201 
Subjects will receive 3.2 mg/kg/day as an oral dose taken in the morning without regard to 
meals. If subject is not tolerating the 3.2 mg/kg/day dose, the PI and MM will determine if dose 
reduction would be appropriate on an individual basis. 

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9.2
Administration of Treatment
All subjects and their caregivers will receive instruction on the storage, handling, and 
administration of their assigned study drug at the Screening/Baseline (visit 1). At all subsequent 
study visits, LUM-201 will be administered at the Health Care Facility by trained study staff. On 
non-visit days medications will be administered at home.  
The dose of study drug will only be adjusted based on body weight at Month 1 (visit 2), Month 3 
(visit 3), Month 6 (visit 4) and Month 9 (visit 5). All changes in LUM-201 dosage will include 
instructions by the study staff to the subject caregiver.  
LUM-201 tablets are not to be divided, chewed or crushed. The number of tablets prescribed at 
each visit will be weight-specific. Doses of LUM-201 (number of tablets) are found in the 
Pharmacy Manual. Subject’s weight should be rounded to the nearest kg.  
9.2.1 Treatment Interruption
Study drug may be stopped temporarily for new medical events at the discretion of the PI and/or 
MM. Removal of subjects from the study or from a treatment arm are described in the Stopping 
Rules (Section 6.8). 
9.2.2 Dose Reduction 
Study drug dose may be reduced if the IGF-1 SDS is confirmed by a follow-up (unscheduled) 
laboratory testing to be > +2.0 at any visit after the Screening/Baseline visit (visit 1) or if the 
subject has demonstrated safety and tolerability issues to the 3.2 mg/kg/day dose administration. 
One dose reduction to 1.6 mg/kg is allowed. All dose reductions should be discussed with the 
Medical Monitors before implemented. 
9.3
Concomitant Medications 
Restrictions on concomitant medications are noted in the Inclusion and Exclusion Criteria 
(Sections 7.1 and 7.2) and in Appendix 1. Commencement of new medications that can influence 
the subject’s safety or response to study drug are prohibited. Use of medications required for 
treatment of intercurrent illness will be reviewed by the MM. Generally, use of medications for 
treatment of intercurrent illness will be allowed for up to 2 weeks, with LUM-201 administration 
paused, as needed. If illness persists past 2 weeks, the MM should be consulted, and the subject 
may need to terminate LUM-201 treatment. 
9.4 
Restrictions
All subjects must complete an overnight (after 10 p.m.) fast prior to Screening/Baseline (visit 1), 
Month 6 (visit 4) and Month 12 (visit 6). There are no other restrictions regarding diet or 
exercise, except for prohibited consumption of grapefruit or grapefruit juice. Subjects planning 
foreign travel should consult with their Study Coordinator. 

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9.5
Treatment Adherence 
Administration of all LUM-201 will be performed by health care professionals or the caregiver. 
A subject who misses more than 10% of the intended doses without good reason such as meeting 
a stopping rule or the treatment of an intercurrent illness will be considered non-compliant.  
Efforts should be made to complete all protocol-specified activities within the allotted time 
frame. 
9.6
Packaging and Labeling 
LUM-201 will be supplied in high-density polyethylene (HDPE) bottles with an induction seal 
and a polypropylene child-resistant closure. Each bottle is packaged with a 1-gram desiccant and 
may include polyester coil. All clinical supplies will be provided as 100-count bottles.  
9.7 
Storage, Transport, and Accountability: 
LUM-201 shall be stored, transported, and used at controlled room temperature (CRT), defined 
as 15°C-25°C (59°F-77°F). 
All unused LUM-201 shall be returned by the subject to the Study Site. The number of 
remaining tablets will be recorded.  
9.8 
Investigational Product Retention at Study Site 
Unused LUM-201 no longer needed for the trial will be held by the Study Site at the storage 
conditions in Section 9.7. Product returned by subjects will be held by the Study Site at ambient 
temperature. Such supplies should be segregated from other Product and clearly marked as not to 
be used on the Study. At the end of the Study, these materials will be destroyed or returned to the 
sponsor. 
9.8.1 Prohibited Medications 
If a subject needs to start medications capable of altering the safety or efficacy of study drug 
(e.g., guanfacine hydrocholoride to treat ADHD) while on trial, they may be excluded from 
continued trial participation. See Appendix 1 for complete details regarding prohibited 
medications and foods. 
9.9 
Overdose Instructions 
For cases of suspected overdose, the PI should contact the MM. 
10.0 
RISKS/PRECAUTIONS 
Increases in intracranial hypertension (IH), retinal damage due to increased intracranial pressure, 
and blood glucose abnormalities have been noted in patients treated with rhGH (1,3). It is not 

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known if this will be associated with LUM-201 treatment. The PI should contact the MM if signs 
or symptoms of IH occur, primarily headache or visual changes. 
11.0
STUDY ASSESSMENTS AND PROCEDURES
11.1
Assessments of Efficacy 
11.1.1 Height and Weight 
Height will be measured without shoes or socks, in triplicate, by a calibrated stadiometer. Height 
 Height 
should be measured during study visits at approximately the same time of day as the baseline 
height assessment (e.g., if the baseline is an AM height assessment, the clinic visits should be 
scheduled prior to noon, so that follow-up height assessments are also collected in the AM).
If not previously recorded in the LUM-201-01 trial, the heights of both parents should be 
measured. Reported heights should be recorded for parents unavailable for measurement. 
11.1.2 Bone Age 
Digitized radiographs of the left hand and wrist will be recorded at Month 6 visit (visit 4) and
will be interpreted by the central reader to determine bone age. 
11.2 
Assessments of Pharmacodynamic (PD) Markers 
Serum IGF-1, IGFBP-3 and GH are PD markers that will be evaluated in all subjects, as 
indicated in the Schedule of Assessments (Table 1).  
PD markers concentration measurements will be performed by central laboratories. 
11.3 
Assessments of Safety 
Safety assessments will be based on reports of AEs and SAEs (see Section 12.0 for full details), 
routine laboratory tests (hematology, chemistry panel including liver enzymes, and urinalysis), 
HbA1c, blood glucose, Free T4, T3, TSH, lipids, physical examinations, ECGs and vital signs.  
11.3.1 Physical Examination 
A complete physical examination will be performed at Screening/Baseline (visit 1) and at the 
Month 12 visit (visit 6) or Early Termination Visit for early study terminations. Fundoscopy may 
be performed at visits where headache is recorded as an AE, per PI’s discretion. Signs of 
increased intracranial pressure should be confirmed by an ophthalmologist and lead to 
appropriate medical evaluation. Tanner staging of pubertal development will be performed at 
Screening/Baseline (visit 1), Month 3 (visit 3), Month 6 (visit 4), Month 9 (visit 5) and Month 12 
(visit 6). Tanner staging to include breast development, pubic and axillary hair and, in males, 
testicular volumes.  

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11.3.2 Vital Signs 
Vital signs should be recorded in the sitting position after approximately 5 minutes of rest. Vital 
signs include pulse, blood pressure, respiratory rate, and oral temperature. 
11.3.1 Electrocardiograms (ECG) 
A 12-lead ECG (rhythm, atrial rate, ventricular rate, PR interval, QRS duration, QT/QTc, 
morphology, and overall interpretation) will be recorded as described in Table 1, and as 
described in the Medpace Core Laboratories Site Acquisition Manual. Results will be interpreted 
by a central reader. ECGs collected prior to study drug administration at Screening/Baseline Day 
1 (Visit 1) will be used as baseline. 
11.3.2 Clinical Laboratory Tests 
Clinical laboratory tests will be performed at the following time points. For more information, 
refer to the LUM-201-04 Laboratory Manual, and (Appendix 2) in this protocol. 
 Complete blood count (CBC, including hemoglobin, hematocrit, red blood cell indices, white 
blood cell count [WBC], and platelet count), serum chemistry panel (including glucose, 
sodium, potassium chloride, bicarbonate, blood urea nitrogen [BUN], creatinine, alanine 
aminotransferase [AST], aspartate aminotransferase [ALT], and total bilirubin) will be 
performed at:  
o Screening/Baseline (visit 1) (results from the Month 12 visit [visit 11] on the LUM-201-
01 Trial can be used) 
o Month 1 (visit 2)
o Month 3 (visit 3) 
o Month 6 (visit 4)
o Month 12 (visit 6)
 Lipid studies (low- and high-density lipoproteins [LDL and HDL, respectively], cholesterol, 
and triglycerides), thyroid function (T3, T4, and TSH), Urinalysis (specific gravity, pH, and 
Multi-stix readings), HbA1c, and Fasting glucose will be assessed at: 
o Screening/Baseline (visit 1) (results from the Month 12 visit [visit 11] on the LUM-201-
01 Trial can be used) 
o Month 6 (visit 4) 
o Month 12 (visit 6) 
 

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11.4
Study Procedures 
11.4.1 Informed Consent
Informed consent must be provided for each subject by a legally authorized representative prior 
to any study activity. Where applicable, subjects will also complete an Assent Form. 
11.4.2 Medical History and Genetic Testing
A complete medical history will be obtained at the Screening. No genetic testing will be required 
for this study.  
11.4.3 Other Study Procedures 
Medical assessments and treatments required by intercurrent illness or trauma may be employed 
at the discretion of the PI. 
11.4.4 Sample Collection, Storage and Shipping
Biological samples collection, processing, storage, and shipping instructions will be provided in 
a study-specific laboratory manual. 
11.4.5 Dispensing Study Drug 
Site staff will dispense study drug per Pharmacy Manual instructions. 
11.5
Study Activities
11.5.1 Screening/Baseline (visit 1) +30 day window from LUM-201-01 Month 12 visit 
(visit 11)   
Screening/Baseline (visit 1) will typically be conducted as specified in the protocol for the LUM-
201-01 Trial. Assessments completed for the LUM-201-01 Month 12 (visit 11) will not need to 
be repeated for the Screening/Baseline (visit 1).  
The following procedures will also be conducted specifically for the LUM-201-04 trial: 
 Obtain informed consent (and assent where applicable). 
 Verify inclusion and exclusion criteria. 
 Record medical history.  
 Record any adverse events. 
 Record prior and concomitant medications.  
 Record vital signs (prior to LUM-201 administration and approximately 1 hour after the 
LUM-201 administration). 

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 Record ECG (1 hour ± 10 minutes after LUM-201 administration) 
 Collect GH serum samples 0 (pre-dose) and 60 ± 10 minutes post-dose. 
 Dispense study drug adequate to permit dosing through Month 1 (visit 2). 
 Instruct caregivers on storage and administration of study drug. 
 Remind caregiver to begin at-home administration of study drug on the following day. 
 Schedule Month 1 (visit 2) for 30 ± 3 days from Screening/Baseline (visit 1). 
 Remind subjects not to take their study drug prior to Month 1 (visit 2) clinic visit. 
The following assessments completed for the LUM-201-01 Month 12 visit (visit 11) will not 
need to be repeated: 
 Collect safety labs, IGF-1 and IGFBP-3 samples.  
 Conduct physical examination (including Tanner pubertal staging). 
 Record height and weight.  
 Record ECG (prior to LUM-201 administration) 
11.5.1.1 
Month 1 ± 3 days (Visit 2) 
Month 1 (visit 2) will be conducted 30 ± 3 days from the Screening/Baseline (visit 1). The 
following procedures will be conducted: 
 Record AEs. 
 Record concomitant medications. 
 Record vital signs. 
 Record weight. 
 Collect samples for: 
o hematology/CBC. 
o serum chemistries. 
 Study drug: 
o Complete drug accountability/compliance check. 
o Adjust drug dose to current body weight (if applicable). 
o Dispense study drug adequate to permit dosing through Month 3 (visit 3). 
 Administer LUM-201. 
 Answer any questions and encourage compliance with daily dosing. 

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 Schedule Month 3 (visit 3) for 3 months ± 7 days from Baseline (visit 1). 
 Remind subjects not to take their study drug prior to Month 3 (visit 3) clinic visit. 
11.5.1.2 
Month 3 ± 7 days (visit 3) 
Month 3 (visit 3) will be conducted 3 Months ± 7 days from Baseline (visit 1). The following 
procedures will be conducted. 
 Record AEs.
 Record concomitant medications.
 Record vital signs. 
 Record ECG 1 hour ± 10 minutes after LUM-201 administration  
 Record height and weight. 
 Conduct Tanner pubertal staging.  
 Collect samples for: 
o hematology/CBC. 
o serum chemistries. 
 Collect IGF-1 and IGFBP-3 serum samples (pre-dose). 
 Study drug: 
o Complete drug accountability/compliance check. 
o Adjust drug dose to current body weight (if applicable). 
o Dispense study drug adequate to permit dosing through Month 6 visit (visit 4). 
o Administer LUM-201. 
 Schedule Month 6 (visit 4) for 6 months ± 7 days from Baseline visit (visit 1). 
 Remind subjects not to take their study drug prior to Month 6 (visit 4) clinic visit. 
11.5.1.3 
Month 6 ± 7 days (Visit 4) 
Month 6 (visit 4) will be conducted after an overnight fast (beginning at 10 p.m.) 6 Months ± 7 
days from Baseline (visit 1). The following procedures will be conducted. 
 Conduct Tanner pubertal staging.  
 Record AEs. 
 Record concomitant medications. 
 Record height and weight. 
 Record vital signs. 
 Record ECG 1 hour ± 10 minutes after LUM-201 administration  

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 Conduct X-ray to assess bone age (may be done within 7 days prior to or after the visit). 
 Collect fasting samples for:  
o hematology/CBC. 
o serum chemistries. 
o HbA1c. 
o fasting glucose. 
o thyroid panel (TSH, T4, T3). 
o lipids. 
o urinalysis (dipstick).  
 Collect IGF-1 and IGFBP-3 samples (pre-dose). 
 Collect GH serum samples 0 (pre-dose) and 60 ± 10 minutes post-dose. 
 Provide a snack after collection of fasting labs. 
 Study drug: 
o Complete drug accountability/compliance check. 
o Adjust drug dose to current body weight (if applicable). 
o Dispense study drug. 
o Administer LUM-201. 
 Schedule Month 9 (visit 5) for 9 Months ± 7 days after Baseline (visit 1). 
11.5.1.4 
Month 9 ± 7 days (Visit 5) 
Month 9 (visit 5) will be conducted 9 Months ± 7 days from Baseline (visit 1). The following 
procedures will be conducted. 
 Conduct Tanner pubertal staging.  
 Record AEs. 
 Record concomitant medications. 
 Record height and weight. 
 Record vital signs. 
 Study drug: 
o Complete drug accountability/compliance check. 
o Adjust drug dose to current body weight (if applicable). 
o Dispense study drug. 
o Administer LUM-201. 

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 Schedule Month 12 (visit 6) for 12 Months ± 7 days after Baseline (visit 1). 
 Remind subjects not to take their study drug prior to Month 12 (visit 6) clinic visit. 
11.5.1.5 
Month 12 ± 7 days (Visit 6) (Performed after an overnight [10 p.m.] fast) or 
Early Termination (ET) Visit 
Month 12 (visit 6) will be conducted after an overnight fast (beginning at 10 p.m.). The 
following procedures will be conducted. 
 Conduct physical exam with Tanner pubertal staging. 
 Record AEs. 
 Record concomitant medications. 
 Record vital signs. 
 Record ECG 1 hour ± 10 minutes after LUM-201 administration  
 Record height and weight.
 Collect fasting samples for:  
o hematology/CBC. 
o serum chemistries. 
o HbA1c. 
o fasting glucose. 
o thyroid panel (TSH, T4, T3). 
o lipids. 
o urinalysis (dipstick).  
Collect IGF-1 and IGFBP-3 samples (pre-dose). 
Collect GH serum samples 0 (pre-dose) and 60 ± 10 minutes post-dose. 
 Provide a snack after collection of fasting labs. 
 Study drug: 
o Complete drug accountability/compliance check. 
11.5.1.6 
Post-treatment Follow-up Contact (approximately 30 ± 5 days after Month 12  
[visit 6], by telephone) for subjects who don’t transition to the LTSE Trial
The following procedures will be conducted. 
 Record concomitant medications. 
 Record AEs. 

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 Complete End of Study (EOS) Form. 
11.5.1.7 
Study Auditing and Inspecting  
The Sponsor may audit the study conduct, compliance with the protocol and accuracy of the 
data. 
The PI/institution will permit study-related monitoring, audits, and inspections by the Sponsor, 
Institutional Review Board/Independent Ethics Committee (IRB/IEC), government regulatory 
bodies and Lumos Pharma, Inc. personnel or its designees by providing direct access to source 
data/documents after appropriate notification from Sponsor. 
12.0
ADVERSE EVENT ASSESSMENT AND REPORTING  
12.1
Definitions
12.1.1 Adverse Event (AE)
Adverse Event (AE): Any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. An AE can therefore be any unfavorable and 
unintended sign (including a clinically significant abnormal finding in laboratory tests or other 
diagnostic procedures), symptom, or disease temporally associated with the use of a drug, 
without any judgment about causality. An AE can arise from any use of the drug and from any 
route of administration, formulation, or dose, including an overdose.  
Disease progression is not considered to be an AE or serious adverse event (SAE). If there are 
specific AEs that are always part of disease progression, these do not need to be reported as AEs 
or SAEs. Pre-existing medical conditions (other than natural progression of the disease being 
studied) judged by the PI or subject to have worsened in severity or frequency or changed in 
character during the protocol-specified AE reporting period will be reported as AEs or SAEs as 
appropriate. 
An AE or SAE can also be a complication that occurs as a result of protocol mandated 
procedures. 
12.1.2 Serious Adverse Events (SAEs)
An AE is considered serious, if in the view of either the PI or Sponsor, it results in any of the 
following outcomes: 
 Death. 
 A life-threatening AE.  
An AE is considered "life-threatening" if in the view of either the PI, or Sponsor, its 
occurrence places the subject at immediate risk of death. It does not include an AE that, had 
it occurred in a more severe form, might have caused death.

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 Inpatient hospitalization or prolongation of an existing hospitalization.  
 A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions. 
 A congenital anomaly or birth defect. 
Important medical events that may not result in death, be life-threatening or require 
hospitalization may be considered serious when, based on the appropriate medical judgment, 
they may jeopardize the subject and may require medical or surgical intervention to prevent one 
of the outcomes listed in the definition of SAE. Examples of such medical events are intensive 
treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in 
inpatient hospitalization; or development of drug dependency or drug abuse. 
12.2
Adverse Event Reporting and Descriptions
Record new AEs from the start of study treatment until 30 days after the last dose of study 
treatment or until the subject starts new GHD treatment, including new investigational treatment, 
whichever occurs earlier. Also record Screening/Baseline (visit 1) procedure-related AEs that 
occur before the start of study treatment. Other than study procedure-related AE, any other event 
that precedes the first exposure to study drug should be collected as a baseline condition on the 
Medical History form. 
Record all AEs either observed by the PI or one of his or her medical collaborators, or reported 
by the subject spontaneously, or in response to the direct question below, in the AEs section of 
the subject's CRF/eCRF, in the source document, and if applicable, record on the SAE form. 
Whenever possible, the PI should group signs and symptoms (including laboratory tests or other 
results of diagnostic procedures) into a single diagnosis under a single term. For example, cough, 
rhinitis, and sneezing might be reported as "upper respiratory infection" or a pulmonary infiltrate, 
positive sputum culture, and fever might be reported as “pneumonia.” 
To optimize consistency of AE reporting across centers, ask the subject a standard, general, non-
leading question to elicit any AEs (such as “Have you had any new symptoms, injuries, illnesses 
since your last visit?”).  
Death is an outcome of an SAE and usually not itself an SAE, unless it is death with no 
identifiable cause or event. In all other cases, record the cause of death as the SAE. The PI will 
assess the status of previously reported, and occurrence of new AEs and SAEs at all subject 
evaluation time points during the study. 
12.2.1 Severity 
Use the definitions found in the Common Terminology Criteria for Adverse Events (CTCAE) 
v5.0 (November 2017) for grading the severity (intensity) of AEs. The CTCAE v5.0 displays 
Grades 1 through 5 with unique clinical descriptions of severity for each referenced AE and 

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provides additional guidance. Should a subject experience any AE not listed in the CTCAE v5.0, 
use the following grading system to assess severity: 
 Grade 1 – Mild; asymptomatic or mild symptoms with no impact on activities of daily living 
(ADL); clinical or diagnostic observations only; intervention not indicated. 
 Grade 2 – Moderate; minimal, local or noninvasive intervention indicated; limiting some 
age-appropriate instrumental ADL, such as attending school, activities, etc.
 Grade 3 – Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL, such as bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
 Grade 4 – Life-threatening consequences; urgent intervention indicated. 
 Grade 5 – Death related to AE. 
12.2.2 Relationship to Study Treatment (Suspected Adverse Reactions) 
Assess all AEs/SAEs for relationship to study treatment or if applicable, to study procedure. 
If an AE/SAE occurs before the first dose of study drug, report it only if it is considered related 
to a study-specific procedure (e.g., bleeding or injection site reaction). Those events will be 
recorded in the study database but will not be part of the treatment-emergent AE analysis.  
To ensure consistency of AE and SAE causality assessments, the PI should apply the general 
guideline shown below. Multi-drug regimens should have a causality assessment of each 
component to aid in analysis. 
Related  
(Suspected Adverse 
Reaction) 
A suspected adverse reaction means any AE for which there is a 
reasonable possibility that the drug caused the AE. Reasonable 
possibility means there is evidence to suggest a causal relationship 
between the drug and the AE such as a plausible temporal 
relationship between the onset of the AE and administration of the 
drug; and/or the AE follows a known pattern of response to the 
drug; and/or the AE abates or resolves upon discontinuation of the 
drug or dose reduction and, if applicable, reappears upon 
re-challenge. Further examples of the type of evidence that would 
suggest a causal relationship between the drug and the AE: 
A single occurrence of an event that is uncommon and known to be 
strongly associated with drug exposure.  
One or more occurrences of an event that is not commonly 
associated with drug exposure, but is otherwise uncommon in the 

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population exposed to the drug (e.g., acute myocardial infarction in 
a child). 
An aggregate analysis of specific events observed in a clinical 
study (such as known consequences of the underlying disease or 
condition under investigation or other events that commonly occur 
in the study population independent of drug therapy) that indicates 
those events occur more frequently in the drug treatment group 
than in a concurrent or historical control group. 
Not Related  
(Not Suspected) 
AEs that do not meet the definition above. (e.g., are not reasonably 
related to the drug, or are judged to likely related to some cause 
other than study drug. 
12.2.3 Expected Adverse Events 
Expected AEs include increased appetite. 
Deviations from expected results for subject age that are deemed as clinically significant by the 
PI should be recorded as AEs.  
12.2.4 Pregnancy and Abortion 
Although it is unlikely, in the event of pregnancy, subjects will be discontinued from treatment 
but followed through to completion/termination of the pregnancy. 
12.3 
Reporting Requirements for Serious Adverse Events  
All SAEs regardless of causality will be reported by the PI to the MM within 24 hours through 
the 30-day period after the last dose of study treatment. The minimum data required for the 
initial SAE report includes the subject ID, the SAE term, the start date of the SAE, and the initial 
relatedness (either Drug-related or Drug-unrelated).  Deaths and SAEs occurring after the 30-day 
safety follow-up period AND considered related to study treatment or study procedures must 
also be reported. 
Report all SAEs (initial and follow-up information) on an SAE form and send the form to the 
Sponsor or designee, within 24 hours of the discovery of the event or information (see below). 
The Sponsor or designee may request follow-up and other additional information from the PI 
(e.g., hospital admission or discharge notes, laboratory results). SAEs will be followed up 
through completion or treatment termination. 

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The AHV at the time point t2 is defined as follows:
where h2 and h1 are the heights (cm) measured at t2 and t1 (in days), respectively. Of note, h1 is 
the height measured at Baseline visit (visit 1). 
Standard Deviation Scores for height, weight, and BMI will be computed using the WHO Child 
Growth Standards available from the World Health Organization (WHO) website (33).
Standard Deviation Scores for IGF-1 will be computed using reference standards for healthy 
children available from the central reference laboratory.
Mean values and change from Baseline (visit 1) values will be compiled for all clinical 
laboratory tests. Shift tables may be employed to document treatment related changes.  
All bone age results will be determined by a central reader using the Greulich and Pyle method 
(35). Change in Bone Age will be calculated. The ratios of bone age to chronological age 
(BA/CA) from LUM-201-01 Month 6 visit and this trial’s Month 6 (visit 4), and the change in 
the ratio between the LUM-201-01 Month 6 visit and this trial’s Month 6 (visit 4) will be 
described.  
Target HT-SDS will be computed from the observed maternal and paternal heights, their height 
SDS as determined from the WHO Child Growth Standards, and the calculation method of 
Hermanussen and Cole (36).
A summary table of subjects with AHV at Month 12 (visit 6) < 70% of their AHV at the Month 
12 visit in LUM-201-01 will be determined.
13.2
Determination of Sample Size
No formal calculation of power and sample size will be performed.
13.3
Analysis Populations 
13.3.1 Intent-to-treat (Full Analysis Set)
The Full Analysis Set includes all enrolled subjects who have received at least one dose of study 
treatment. This set will be used for the safety analysis.   
13.3.2 Per Protocol 
The Per Protocol Population includes all enrolled subjects who complete Month 12 (visit 6) and 
have not missed more than 10% of scheduled doses and who do not have any significant protocol 

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deviations. The Per Protocol Population will be used for the primary evaluation, the growth 
response to treatment. 
13.3.1 Safety Population 
The Safety Population is defined as all subjects having at least one dose of study drug. 
13.4
Demographics and Baseline Characteristics
Demographic and Baseline Characteristics include:
 Age. 
 Gender. 
 Race/Ethnicity. 
 Birth weight and gestational age. 
 Birth weight percentile for gestational age. 
 Maternal and paternal heights for calculation of MPH. 
 Bone age (as measured at Month 6  in LUM-201-01 Trial). 
 Target HT-SDS (computed from maternal and paternal heights). 
 Height and HT-SDS. 
 Weight and weight SDS. 
 BMI and BMI SDS. 
 Tanner Stage. 
 Baseline IGF-1, IGF-1 SDS. 
 
13.5 
Efficacy Analyses 
13.5.1 Effects of LUM-201 on Growth
Descriptive statistics will be compiled for 6-month and 12-month AHV, change in HT-SDS, 
change in weight, weight SDS, BMI, and BMI SDS. These measures will be calculated from 
least square means from an analysis of covariance (ANCOVA) with age, Baseline HT-SDS, and 
bone age delay as covariates.  
13.6 
Safety Analyses 
AEs and SAEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA 
Version 23.1). Summary tables of treatment-emergent AEs (TEAEs) will be provided. 
Laboratory and vital sign parameters will be summarized by treatment group using descriptive 

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statistics at baseline and at each on-study evaluation, also including the change from baseline. 
Shift tables for laboratory parameters will be produced showing the number and percentage of 
subjects with changes to or from the normal range (e.g., normal to low, normal to high, low to 
normal, etc.) from baseline to each subsequent visit 
13.7
Missing and Spurious Data 
Laboratory assays values below the lower limit of quantification will be treated as 0 for 
statistical summaries.  
For height related endpoints, missing results will be imputed by carrying the last non-missing 
height value forward and using this value to derive HV and HT-SDS at the analysis time points. 
This is a conservative estimate of HV and change in HT-SDS, as it assumes no further change in 
height after the last measurement.  
13.8
Retention of Data 
The PI must ensure that clinical study records are retained according to national regulations, as 
documented in the clinical trial agreement entered into with the Sponsor in connection with this 
study. The PI will maintain all records and documents pertaining to the study for a period of: at 
least 2 years after Food and Drug Administration (FDA) approval of the drug or at least 2 years 
after withdrawal of the Investigational New Drug (IND) under which this study was conducted, 
whichever is longer. In countries outside the US, records must be kept for the period of time 
required by the US FDA as a minimum, and record retention should also comply with the local 
country regulatory requirements, if longer retention times are required than in the US. Mandatory 
documentation includes copies of study protocols and amendments, financial disclosures, each 
FDA Form 1572, IRB/IEC approval letters, signed informed consent form (ICFs), drug 
accountability records, SAE forms transmitted to the Sponsor, subject files (source 
documentation) that substantiate entries in case report form/electronic case report form 
(CRF/eCRFs), all relevant correspondence, and other documents pertaining to the conduct of the 
study. These records must remain in each subject's study file and be available for verification by 
study monitors at any time. 
The PI must inform the Sponsor immediately if any documents are to be destroyed, transferred to 
a different facility, or transferred to a different owner. The Sponsor should be given the option of 
collecting the documents before destruction. 
13.9 
Interim Analysis 
No interim analysis is planned, but interim analyses may be performed at Sponsor discretion as 
described in the Statistical Analysis Plan (SAP).  

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14.0
STUDY DURATION AND TERMINATION 
The expected study duration is through completion of Month 12 (visit 6) or withdrawal of 
consent. The study is expected to start in 2022. 
15.0
STUDY COMPLIANCE AND ETHICAL CONSIDERATIONS
15.1
Compliance Statement 
The study will be conducted in accordance with the International Council for Harmonisation 
Good Clinical Practice (ICH GCP) guidelines, principles enunciated in the Declaration of 
Helsinki, and all human clinical research regulations in countries where the study is conducted. 
15.2
Informed Consent
The ICFs used for the study must comply with the Declaration of Helsinki, federal regulations 
US 21 CFR Part 50, and ICH GCP guidelines, and any other local regulations. The PI, or a 
person delegated by the PI, must explain the medical aspects of the study, including the nature of 
the study and the treatment, orally and in writing, in such a manner that the subject is aware of 
potential benefits and risks. Subjects must be informed that participation is voluntary and that 
they may withdraw from the study at any time, without prejudice. Subjects, or a legal guardian if 
the subject is unable to, must give informed consent in writing. 
The informed consent process must be conducted, documented in the source document 
(including the date), and the form must be signed, before the subject undergoes any study-
specific procedures.
15.3
Institutional Review Board or Independent Ethics Committee  
The PI must submit the protocol, protocol amendments, and the ICF for the proposed study, 
along with any other documents required by the center's IRB/IEC to the center's duly constituted 
IRB/IEC for review and approval. The PI must also ensure that the IRB/IEC reviews the progress 
of the study on a regular basis and, if necessary, renews its approval of the study on an annual 
basis. A copy of each IRB/IEC approval letter must be forwarded to the Sponsor before the study 
is implemented. Documentation of subsequent reviews of the study must also be forwarded to 
the Sponsor. 
16.0 
ADMINISTRATIVE PROCEDURES 
16.1 
Sponsor Responsibilities 
Lumos Pharma, Inc. reserves the right to terminate the study and remove all study materials from 
the study center at any time. Lumos Pharma, Inc. and the PI will assure that adequate 
consideration is given to the protection of the subjects' interests. Specific circumstances that may 
precipitate such termination are: 
 Request by Health Authority to terminate the study. 

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 Unsatisfactory subject enrollment with regard to quality or quantity. 
 Significant or numerous deviations from study protocol requirements, such as failures to 
perform required evaluations on subjects, maintain adequate study records or inaccurate, 
incomplete or late data recording on a recurrent basis. 
 The incidence or severity of AEs in this or other studies indicating a potential health hazard 
caused by the study treatment. 
16.1.1 Study Supplies
The Sponsor will supply sufficient quantities of the following materials to the clinical center:
 LUM-201 as described in Section 9.0.
 IB for LUM-201. 
 CRFs or data collection tools (e.g., laboratory kits, ECG machines). 
Refer to the Study Manual for a list of additional Sponsor-provided supplies for this study.  
16.1.2 Investigator Training 
The study site will have a study initiation meeting to ensure the center staff understand the 
protocol, study requirements, and data capture processes. This training will take place before the 
first subject is enrolled. Study center staff will be provided with information regarding GCP and 
regulations specific to the conduct of clinical studies. The study center is responsible for 
ensuring that new team members are adequately trained and the training is documented. 
16.1.3 Ongoing Communication of Safety Information During the Study
The Sponsor will provide the PI with documentation of SAEs, from this study and other studies, 
especially those that are related to LUM-201 and unexpected (Section 12.3), as appropriate. The 
PI must forward documentation on SUSARS to the IRB/IEC, as described in Section 12.3. 
The Sponsor will also notify the PI about any other significant safety findings that could alter the 
safety profile of the Investigational Medicinal Product (IMP) from what is described in the 
protocol and significantly affect the safety of subjects, affect the conduct of the study, or alter the 
IRB/IEC's opinion about continuation of the study. 
16.1.4 Study Monitoring 
Representatives of the Sponsor will monitor the study. Routine monitoring visits will be 
conducted to: 
 Assure compliance with the study protocol and appropriate regulations. 

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 Verify that (1) the informed consent process was conducted before initiation of any 
study-specific procedures (i.e., performed solely for the purpose of determining eligibility for 
the study) and before provision of study treatment, and (2) this process is adequately 
documented. 
 Verify that the protocol, protocol amendments, and safety information are submitted to the 
IRB/IEC and approved by the IRB/IEC in a timely manner. 
 Review the CRF/eCRFs and source documents to ensure that reported study data are 
accurate, complete, and verifiable from source documents. 
 Verify that study treatments are stored properly and under the proper conditions, that they are 
in sufficient supply, and that receipt, use, and return of LUM-201 at the study center are 
controlled and documented adequately. 
 Verify that the PI and study center personnel remain adequately qualified throughout the 
study. 
 Verify that the research facilities, including laboratories and equipment, are maintained 
adequately to conduct the study safely and properly. 
16.1.5 Study Auditing and Inspecting
The Sponsor may audit the study conduct, compliance with the protocol and accuracy of the data 
in one or more centers.  
The PI/institution will permit study-related monitoring, audits, and inspections by the Sponsor, 
IRB/IEC, government regulatory bodies, and Lumos Pharma, Inc. Quality Assurance personnel 
or its designees by providing direct access to source data/documents after appropriate 
notification from Sponsor. 
16.2 
Investigator Responsibilities 
16.2.1 Subject Screening Log 
The PI must keep a record that lists all subjects who signed an informed consent and the reason 
for non-inclusion if they were not ultimately enrolled or treated. 
16.2.2 LUM-201 Accountability 
An initial supply of LUM-201 will be shipped to the study center's pharmacy when all the 
initiation documents, including IRB/IEC approval, IRB/IEC approved ICF, and business 
agreements, have been received and reviewed by the Sponsor and upon activation of the study 
center by the Sponsor or its authorized representative. Thereafter, the study pharmacist or 
authorized site personnel is responsible for ordering a resupply. 

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Keep the IMP in a locked, limited-access room. The study treatment must not be used outside the 
context of the protocol. Under no circumstances should the PI or other study center personnel 
supply IMP to other subjects or clinics or allow supplies to be used other than as directed by this 
protocol without prior authorization from the Sponsor.  
The monitor will regularly review and verify all IMP supplies and associated documentation. 
Maintain an accurate accounting of the study treatments. These records must show dates, lot 
numbers, quantities received, dispensed and returned, and must be available for monitoring by 
the Sponsor. The PI will ensure that any used and unused IMP and other study material is 
destroyed or returned to the Sponsor on completion of the study. If the IMP is destroyed at the 
study center, there should be documentation of destruction at the study center. The Sponsor 
and/or their representatives will verify final drug accountability. IMP accountability records must 
be maintained and readily available for inspection by representatives of the Sponsor and are open 
to inspections by regulatory authorities at any time. 
16.2.3 Reporting and Recording of Study Data 
Data will be captured and compiled using procedures developed by the Sponsor or their 
representatives. Clearly record all requested study data on the CRF/eCRF and other study forms 
as required. Whenever possible, record the reason for missing data in the source document. Only 
individuals who are identified on the study personnel responsibility/signature log may enter or 
correct data in the CRF/eCRF. Incomplete or inconsistent data on the CRF/eCRFs will result in 
data queries that require resolution by the PI or designee. 
The PI must assure subject anonymity and protection of identities from unauthorized parties. On 
CRF/eCRFs or other documents or subject records provided to the Sponsor, identify subjects by 
code (subject number, initials, date of birth) and not by names. The PI should maintain 
documents not for submission to the Sponsor (e.g., subjects' signed informed consent) in strict 
confidence. 
16.2.4 Source Documentation 
The PI must maintain adequate and accurate source documents upon which CRF/eCRFs for each 
subject are based. They are to be separate and distinct from CRF/eCRFs, except for cases in 
which the Sponsor has predetermined that direct data entry into specified pages of the subject's 
CRF/eCRF is appropriate. These records should include detailed notes on: 
 The oral and written communication with the subject regarding the study treatment 
(including the risks and benefits of the study). Record the date of informed consent in the 
source documentation. 
 The subject's medical history before participation in the study. 
 The subject's basic identifying information, such as demographics, that links the subject's 
source documents with the CRF/eCRFs. 

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 The results of all diagnostic tests performed, diagnoses made, therapy provided, and any 
other data on the condition of the subject. 
 The subject's exposure to study treatment. 
 All AEs.
 The subject's exposure to any concomitant therapy (including start and stop dates, route of 
administration, and dosage). 
 All relevant observations and data on the condition of the subject throughout the study. 
16.2.5 Tissue and Blood Sample Collection/Storage 
Tissue and blood components samples that are collected as part of routine medical care or as part 
of protocol procedures may be stored and analyzed for additional PD analyses.
After the study, samples may be used for additional investigation to help identify factors that 
may influence response to therapy. Such samples will be used in compliance with guidelines 
defined by FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using 
Leftover Human Specimens that are Not Individually Identifiable (issued 25 April 2006) and 
European Agency for the Evaluation of Medicinal Products (EMEA)'s Reflection Paper on 
Pharmacogenomic Samples, Testing and Data Handling (EMEA 2007).  No DNA will be 
collected. 
16.3
Clinical Trial Insurance 
Clinical trial insurance has been undertaken according to the laws of the countries where the 
study will be conducted. An insurance certificate will be made available to the participating 
study centers upon request. 
16.4
Study Administrative Letters and Protocol Amendments 
The Sponsor may issue Study Administrative Letters (1) to clarify certain statements or correct
obvious errors/typos/inconsistencies in the study protocol, (2) to change the logistical or 
administrative aspects of the study, such as study personnel or contact information, or (3) to 
instruct PI of MM’s safety decisions for immediate implementation for safety reasons.  
For all other changes, the Sponsor will initiate any change to the protocol in a protocol 
amendment document. The study center will submit the amendment to the IRB/IEC together 
with, if applicable, a revised model ICF. If the change in any way increases the risk to the 
subject, information on the increased risk must be provided to subjects already actively 
participating in the study, and they must read, understand, and sign any revised ICF confirming 
willingness to remain in the study. 

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The PI must obtain IRB/IEC approval before any protocol amendment can be implemented, 
except for administrative changes or changes necessary to eliminate an immediate risk to study 
subjects, as outlined above. 
17.0
POLICY FOR PUBLICATION AND PRESENTATION OF DATA 
The Sponsor encourages the scientific publication of data from clinical research studies. 
However, the PI may not present or publish partial or complete study results individually without 
review by the Sponsor. The PI and the Sponsor may propose appropriate scientific manuscripts 
or abstracts from the study data. The Sponsor must review and comment on all proposed 
publications before submission for publication. The detailed procedures for the review of 
publications are set out in the clinical trial agreement entered into with the Sponsor in connection 
with this study. These procedures are in place to ensure coordination of study data publication 
and adequate review of data for publication against the validated study database for accuracy. 
Names of the PI and Sponsor representatives responsible for designing the study and analyzing 
the results will be included in the publication(s). 
Qualification of authorship will follow the requirements of the International Committee of 
Medical Journal Editors (www.icmje.org). The site PI shall be listed as lead author on 
manuscripts and reports of study results. In addition, other than clinical pharmacology studies in 
healthy volunteers or Phase 1 studies, all clinical studies must be registered with 
ClinicalTrials.gov.
 

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18.0
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19.0
APPENDICES 
19.1 
Appendix 1: Concomitant Medications 
LUM-201 is primarily metabolized by CYP3A/4 and has been shown in vitro to induce 
CYP3A4, CYP2C8, CYP2C9 and CYP2C19, under conditions that may be clinically relevant. 
Thus, potential study subjects receiving medications that are primarily metabolized by either 
CYP3A/4, CYP2C8, CYP2C9 or CYP2C19 (< 5% contribution by other isoforms) or are strong 
inducers or moderate or strong inhibitors of CYP3A/4 should not be screened. Subjects 
commencing these medications during the study may be withdrawn at the discretion of the PI 
and the MM. 
Select examples of drugs and other items interacting with CYP3A/4 include:
Midazolam
Triazolam
Clarithromycin
Itraconazole
Ketoconazole 
Phenytoin 
Rifampin
Carbamazepine
Protease inhibitors used as anti-viral agents
Grapefruit and grapefruit juice should also be avoided 
In vitro experiments also indicate LUM-201 is substrate of P-gp and inhibits P-gp and MATE1, 
under conditions that may be clinically relevant. Thus, potential study subjects receiving 
medications that are strong inhibitors of P-gp or are potent substrates of P-gp or MATE1 should 
not be screened. Subjects commencing these medications during the study may be withdrawn at 
the discretion of the PI and the MM. Select examples of these items include: 
P-gp substrate prescribed in children: fexofenadine (Allegra®). 
P-gp inhibitor: clarithromycin. 
MATE1 substrate: metformin. 
The PI should consult with the MM regarding concomitant medication use while on study. Study 
participants will be given a letter they should share with their primary physician to inform them 
of study participation and concomitant medication restrictions. 
 

LUM-201 (Ibutamoren mesylate) 
 
Protocol 201-04 
Lumos Pharma, Inc. 
 
Protocol Version 2.0 19 January 2022 
CONFIDENTIAL 
 
Page 52 of 53 
19.2
Appendix 2: Laboratory Testing
Table 3 Specialty Laboratory Tests
Matrix/ 
Analyte 
Screening/Baseline 
(Visit 1)
Month 3 (Visit 3)
Month 6 (Visit 4) 
Month 12 (Visit 6) 
No. of 
Samples
Collection 
Times
No. of 
Samples
Collection 
Times
No. of 
Samples 
Collection 
Times 
No. of 
Samples
Collection 
Times 
IGF-1 
0* 
–
1 
0 min
1 
0 min
1 
 
0 min
IGFBP-3
0*
–
1 
0 min 
1
0 min 
1
0 min 
GH
2 
0, 60 min
0 
– 
2
0, 60 min
2
0, 60 min
Note: Time “0” is pre-dose 
*: These samples are collected at the Month 12 visit on the LUM-201-01 study.  
 

LUM-201 (Ibutamoren mesylate) 
 
Protocol 201-04 
Lumos Pharma, Inc. 
 
Protocol Version 2.0 19 January 2022 
CONFIDENTIAL 
 
Page 53 of 53 
19.3
Appendix 3: Clinical Laboratory Analytes 
Hematology
Serum Chemistry
Urinalysis
Other Tests
- Complete blood count 
(CBC)
 - Hemoglobin 
 - Hematocrit 
 - RBC counts 
 - RBC indices 
 - WBC counts 
   - WBC differential 
 - Platelets 
 
- Alkaline phosphatase
- ALT
- AST 
- Bilirubin 
- GGT 
- Glucose  
- LDL 
- HDL 
- Cholesterol 
- Triglycerides 
- Sodium 
- Potassium 
- Chloride 
- Calcium 
- Phosphate 
- CO2 
- BUN 
- Creatinine 
- Total Protein 
-  Albumin 
- Globulin 
- Dipstick
 -Specific gravity
 -pH 
 -Protein 
 -Glucose 
 -Ketones 
 -Leukocyte 
 -Blood 
 
- Pregnancy test  
(if applicable) 
Thyroid function 
tests
   -T3 
   -T4 
   -TSH 
- HbA1c 
 
 
ALT = alanine aminotransferase; AST = aspartate aminotransferase; GGT = gamma glutamyl transferase; 
HbA1c = hemoglobin A1c; CO2 = bicarbonate; HDL = high density lipoprotein; LDL = low density lipoprotein; 
RBC = red blood cell; T3 = triiodothyronine; T4 = free thyroxine; TSH = thyroid-stimulating hormone; 
WBC = white blood cell