A Double-Blind, Placebo-Controlled Randomized Trial to Study the Viaskin Milk Efficacy and Safety for Treating IgE-Mediated Cow's Milk Allergy in Children
Phase: PHASE1
Conditions: Food Allergy
Sponsor: DBV Technologies

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Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 2 of 170 
This page intentionally left blank 
 
 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 4 of 170 
PROTOCOL SYNOPSIS 
 
Protocol 
Number: 
MILES (V135-201) 
Title: 
A Double-Blind, Placebo-Controlled Randomized Trial to Study the 
Viaskin MILk Efficacy and Safety for Treating IgE-Mediated Cow’s 
Milk Allergy in Children (MILES Study) 
Investigational 
Product: 
Viaskin Milk (DBV135) 
Indication: 
Immunoglobulin E (IgE)-mediated cow’s milk allergy 
Number of 
Study Centres: 
Seventeen sites in North America (United States and Canada) 
Phase: 
Phase 1/2 
Objectives: 
The objectives of this study are: 
• 
To evaluate the safety and efficacy of Viaskin Milk after 
12 months of epicutaneous immunotherapy (EPIT) 
treatment, for desensitizing IgE-mediated cow’s milk-allergic 
children. 
• 
To assess the long-term safety and efficacy of up to 48 
months of treatment with Viaskin Milk. 
• 
To assess the safety and the therapeutic benefit of the most 
effective tested dose of Viaskin Milk over 24 months of 
treatment. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 5 of 170 
Study Design: This is a multi-center, double-blind, placebo-controlled, randomized 
trial to study the safety and efficacy of Viaskin Milk applied 
epicutaneously every day to subjects from 2 to 17 years of age with 
IgE-mediated cow’s milk allergy (CMA). Viaskin Milk is a patch 
containing an extract of cow’s milk proteins. Subjects will receive 
blinded treatment for 1 year at one of the 3 doses of Viaskin Milk: 
150 µg, 300 µg, or 500 µg, or placebo. After the first year, all 
subjects were to switch to the highest dose of Viaskin Milk, 500 µg, 
and continue treatment in an open-label manner for up to a 
maximum of 3 additional years.  
Following results of the 12-month blinded period, all eligible 
subjects who wish to continue participation in the study will switch 
from Viaskin Milk 500 µg to Viaskin Milk 300 µg for 24 months of 
treatment.  
The study will be conducted at 17 sites in the United States and 
Canada, with selected Investigators and staff experienced in the 
diagnosis and management of CMA and anaphylaxis, and who are 
capable of performing a double-blind placebo-controlled food 
challenge (DBPCFC) in children (2 to 11 years old) and adolescents 
(12 to 17 years old). 
Eligible subjects with confirmed IgE-mediated CMA will perform a 
first DBPCFC at screening with escalating doses of cow’s milk 
proteins. Subjects showing a positive DBPCFC at screening, 
defined as the appearance of objective signs or symptoms to an 
eliciting dose of cow’s milk proteins ≤300 mg (approximately 9.4 mL 
of cow’s milk) will be randomized in the study. 
The study will be divided into 2 consecutive parts (Part A and 
Part B) for randomization of the subjects to treatment. 
Part A will evaluate the safety of 3 escalating doses of Viaskin Milk 
(150 µg, 300 µg, and 500 µg of cow’s milk proteins) versus placebo 
in successive cohorts of subjects before proceeding to Part B. In 
each cohort, evaluation of safety will be based on safety data 
collected and analyzed from subjects treated for 3 weeks. It is to be 
noted that after these first 3 weeks of treatment, Part A subjects will 
not discontinue treatment but instead will continue treatment up to 
Month 12, at which time subjects will undergo a second DBPCFC. 
Part B is designed to evaluate the efficacy and safety of the 3 doses 
of Viaskin Milk (150 µg, 300 µg, and 500 µg of cow’s milk protein, 
assessed to be safe from Part A) versus placebo. Subjects will be 
randomized to receive a 12 month treatment (blinded treatment 
period), at which time a second DBPCFC will be performed. The 
efficacy of Viaskin Milk will be assessed based on data pooled from 
subjects in both Part A and Part B, treated up to Month 12. 
After the Month 12 DBPCFC, all subjects from Part A and Part B 
were to continue treatment for another 12 months in an open-label 
manner with Viaskin Milk at 500 µg, the highest dose assessed to 
be safe from the safety data in Part A subjects. Then, a third 
DBPCFC was to be performed at Month 24. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 6 of 170 
 
After Month 24, eligible subjects from Part A or Part B were to be 
proposed to enter the study extension to receive 2 additional years 
of EPIT with open-label Viaskin Milk at 500 µg. For subjects 
entering the study extension, a fourth and fifth DBPCFC were to be 
performed at Month 36 and Month 48, respectively. Following 
results of the 12-month blinded period, DBPCFC procedures were 
stopped while the subjects were still receiving Viaskin Milk 500 µg. 
After implementation of Protocol Amendment 5, all subjects will 
receive Viaskin Milk 300 µg for 24 months, independently of the 
duration of previous treatment with Viaskin Milk 500 µg. For 
subjects switching to Viaskin Milk 300 µg, an optional DBPCFC may 
be performed after 12 and/or 24 months of treatment, at the 
decision of the Investigator and the subject. 
A final End-of-Study (EOS) visit will be performed for all subjects 
when they complete the study. The EOS visit was to take place 
2 weeks after the last DBPCFC at Month 24 for the subjects 
completing the study at Month 24, or 2 weeks after the last 
DBPCFC at Month 48, for subjects completing the study extension 
at Month 48. For subjects switching to Viaskin Milk 300 µg, the EOS 
visit will take place 2 weeks after the end of the 24-month treatment 
period at this dose. 
During their participation in the study, all subjects will be instructed 
to remain on a strict cow’s milk-free diet with no consumption of 
dairy products or baked milk products until their EOS visit (except 
during the DBPCFCs). 
Number of 
Subjects:  
Approximately 194 subjects (18 subjects in Part A and 176 subjects 
in Part B) will be randomized to treatment in this study. 
The number of subjects continuing beyond the Month 24 visit and/or 
in the treatment period with Viaskin Milk 300 µg will depend on the 
study extension eligibility criteria and the willingness of subjects to 
continue in the study. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 8 of 170 
Study 
Population: 
The inclusion and exclusion criteria for study entry are listed below. 
Inclusion Criteria: 
1. Signed Informed Consent Form (ICF) by 
parent(s)/guardian(s) of subjects and informed assent form 
(IAF) for subjects ≥7 years, or as per local or country 
specific guidelines or regulations. 
2. Male or female subjects 2 to 17 years old at Visit 1. 
3. Documented medical history or physician-confirmed 
diagnosis of IgE-mediated CMA with systemic symptoms 
related to ingestion of milk or dairy products. 
4. Subjects currently following a strict cow’s milk-free diet, with 
no consumption of dairy or baked milk products.  
5. Cow’s milk sIgE level at screening ≥10 kU/L  
6. Positive Skin Prick Test (SPT) to cow’s milk with a largest 
wheal diameter ≥6 mm. 
7. Positive DBPCFC at screening with an eliciting dose 
≤300 mg cow’s milk proteins (approximately ≤9.4 mL of 
cow’s milk). 
8. Negative urine pregnancy test for female subjects of 
childbearing potential. Female subjects of childbearing 
potential must agree and commit to use effective medical 
methods of contraception for the entire duration of their 
participation in the study. Sexual abstinence will be 
accepted as an effective method of contraception for girls 
below 15 years of age. 
9. Ability to perform spirometry procedures in accordance with 
the American Thoracic Society guidelines (2005) for 
subjects ≥6 years old. Ability to perform peak expiratory flow 
(PEF) measurements for subjects ≥5 years old. Subjects 
<8 years of age who have documented inability to 
adequately perform spirometry can perform only the PEF 
evaluation. Subjects <5 years of age may be enrolled if they 
had no clinical features of moderate or severe persistent 
asthma severity (as defined by the 2007 National Heart, 
Lung, and Blood Institute [NHLBI] Guidelines) within 1 year 
before Visit 1. 
10. Subjects and/or parents/guardians willing to comply with all 
study requirements during participation in the study. 

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Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 10 of 170 
Study 
Population 
(continued): 
12. Subjects with asthma conditions meeting 1 or several criteria 
below: 
• 
Uncontrolled persistent asthma (as defined by the 
2007 NHLBI guidelines) or subject is being treated 
with a combination therapy of medium or high daily 
dose of inhaled corticosteroid with a long acting 
inhaled β2-agonist. Intermittent asthmatic subjects 
who require intermittent use of inhaled 
corticosteroids for rescue are permitted.  
• 
At least 2 systemic corticosteroid courses for asthma 
within 1 year before Visit 1 or 1 oral corticosteroid 
course for asthma within 3 months before Visit 1, or 
during screening (unless used to treat symptoms 
triggered by the DBPCFC). 
• 
Prior intubation/mechanical ventilation due to asthma 
within 2 years before Visit 1, or during screening. 
13. Upper respiratory infection or gastroenteritis within 7 days of 
DBPCFC (DBPCFC must then be rescheduled at least 7 days 
after resolution of these conditions). 
14. Any history of milk immunotherapy (eg, oral immunotherapy, 
sublingual immunotherapy or specific oral tolerance induction). 
15. Prior history of any other food allergen immunotherapy (eg, oral 
immunotherapy, sublingual immunotherapy or specific oral 
tolerance induction) within 5 years before Visit 1.  
16. Subjects currently under aeroallergen immunotherapy and 
unwilling or unable to discontinue at the time of Visit 1. 
Aeroallergen Immunotherapy must be discontinued at the time 
of Visit 1. 
17. Use of any anti-IgE drug (eg, omalizumab), any 
immunomodulatory therapy, or any biological agent therapy 
(eg, anti-tumor necrosis factor drugs) within 1 year before 
Visit 1, or during screening. 
18. Generalized dermatologic diseases (eg, severe atopic 
dermatitis, uncontrolled generalized eczema, icthyosis vulgaris) 
with no intact zones to apply the Viaskin patch, or urticarial and 
mast cell disorders such as chronic idiopathic urticaria. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 11 of 170 
Study 
Population 
(continued): 
19. Subject and/or subject’s parents/guardians with obvious 
excessive anxiety and unlikely to cope with the conditions of a 
food challenge. 
20. Past or current disease, including but not limited to active 
eosinophilic gastrointestinal disorders, autoimmune disorders, 
immunodeficiency, malignancy, uncontrolled disease 
(hypertension, diabetes, psychiatric disorder, cardiac disease), 
or other disorders (eg, liver, gastrointestinal, kidney, 
cardiovascular, pulmonary disease or blood disorder) which in 
the opinion of the Investigator or the sponsor may affect the 
subject’s participation in the study or place the subject at 
increased risk. 
21. Subjects and/or parents/guardians unable to use the 
epinephrine auto-injector properly in spite of being adequately 
trained. 
22. Contraindicated condition for the use of epinephrine. 
23. Use of any investigational drug or device, or participation in 
another interventional clinical study within 3 months before 
Visit 1. 
24. Subjects receiving beta-blockers or angiotensin converting-
enzyme inhibitors.  
25. Subjects unable to follow the protocol requirements. 
 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 12 of 170 
Eligibility  
Criteria for  
Study 
Extension with 
Viaskin Milk 
500 µg (Months 
24 to 48):  
 
The inclusion and exclusion criteria for entry in the study extension 
up to Month 48 are listed below. 
Inclusion Criteria: 
1. Signed study extension ICF by parent(s)/guardian(s) of 
subjects and informed assent form for subjects ≥7 years, or as 
per local or country specific guidelines or regulations. 
2. Subjects who completed the first 2 years in MILES, including a 
complete documented DBPCFC at Month 24. 
Note: following results of the 12-month blinded period, Month 
24 DBPCFC should not be performed anymore. Inclusion 
criterion #2 becomes “Subjects who completed the first 2 years 
in MILES” 
3. Negative urine pregnancy test at Month 24 for female subjects 
of childbearing potential. Female subjects of childbearing 
potential must continue to agree and commit to using effective 
medical methods of contraception for the entire duration of their 
participation in the study. Sexual abstinence will be accepted 
as an effective method of contraception for females below 15 
years of age. 
4. Subjects must agree to continue following a strict cow’s milk-
free diet, with no consumption of dairy or baked milk products 
during participation in the study (except during the DBPCFCs). 
5. Subjects and/or parents/guardians willing to comply with all 
study requirements during participation in the study extension. 
 
Exclusion Criteria: 
1. Any new disorder or disease that may affect the subject’s 
participation in the study, or place the subject at increased risk, 
or for which epinephrine use is contraindicated. 
2. Poor compliance in patch application (below 80%), defined as 
patch not applied at all for >73 days (either consecutive or not) 
during the second year of participation in MILES. 
 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 13 of 170 
Eligibility  
Criteria for the 
switch to 
Viaskin Milk 
300 µg: 
Inclusion Criteria: 
1. Signed ICF by parent(s)/guardian(s) of subjects and informed 
assent form for subjects ≥7 years, or as per local or country 
specific guidelines or regulations. 
2. Negative urine pregnancy test at Visit Switch 1 for female 
subjects of childbearing potential. Female subjects of 
childbearing potential must continue to agree and commit to 
using effective medical methods of contraception for the entire 
duration of their participation in the study. Sexual abstinence 
will be accepted as an effective method of contraception for 
females below 15 years of age. 
3. Subjects must agree to continue following a strict cow’s milk-
free diet, with no consumption of dairy or baked milk products 
during participation in the study (except during the DBPCFCs). 
4. Subjects and/or parents/guardians willing to comply with all 
study requirements during participation. 
 
Exclusion Criteria: 
1. Any new disorder or disease that may affect the subject’s 
participation in the study, or place the subject at increased risk, 
or for which epinephrine use is contraindicated. 
2. Poor compliance in patch application (below 80%) during the 
previous year of participation in MILES. 
 
Primary 
Endpoint: 
The primary efficacy endpoint will be the percentage (%) of subjects 
who are treatment responders after the first 12 months of EPIT. 
A treatment responder is defined as a subject who meets at least 
one of the following criteria: 
• 
A ≥10-fold increase in the Cumulative Reactive Dose (CRD) 
of cow’s milk proteins at the Month 12 DBPCFC as 
compared to baseline value and reaching at least 144 mg of 
cow’s milk proteins (approximately 4.5 mL of milk) 
• 
A CRD of cow’s milk proteins ≥1444 mg (approximately 
45 mL of milk) at the Month 12 DBPCFC. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 14 of 170 
Secondary 
Endpoints: 
Secondary Efficacy Endpoints up to Month 12 (double-blind, 
placebo-controlled treatment period): 
• 
The mean and median CRD of cow’s milk proteins at 
Month 12 and change from baseline. 
• 
The change from baseline value in levels of sIgE and 
allergen-specific immunoglobulin G4 (sIgG4) to cow’s milk at 
all timepoints evaluated up to Month 12. 
• 
The change from baseline value in levels of sIgE and sIgG4 
to caseins, α-lactalbumin, and β-lactoglobulin at all 
timepoints evaluated up to Month 12.  
• 
The change from baseline in SPT wheal at all timepoints 
evaluated up to Month 12. 
• 
The change in the severity of symptoms elicited during the 
milk DBPCFC from baseline to Month 12.  
• 
The change from baseline in Quality of Life (QoL) 
assessments at Month 12. 
Endpoints after Month 12 (open-label treatment periods with 
Viaskin Milk 500 µg up to 48 months and Viaskin Milk 300 µg 
for 24 months): 
• 
The percentage (%) of subjects who are treatment 
responders over the course of open-label treatment with 
Viaskin Milk 500 µg and 300 µg.  
• 
The CRD of cow’s milk proteins over the course of open-
label treatment with Viaskin Milk 500 µg and 300 µg. 
• 
The levels of sIgE to cow’s milk over the course of open-
label treatment with Viaskin Milk 500 µg and 300 µg. 
• 
The levels of sIgG4 to cow’s milk proteins over the course of 
open-label treatment with Viaskin Milk 500 µg. 
• 
The levels of sIgE and sIgG4 to caseins, α-lactalbumin, and 
β-lactoglobulin over the course of open-label treatment with 
Viaskin Milk 500 µg and 300 µg.  
• 
The SPT wheal over the course of open-label treatment with 
Viaskin Milk 500 µg and 300 µg. 
• 
The severity of symptoms elicited during the milk DBPCFC 
over the course of open-label treatment with Viaskin Milk 
500 µg and 300 µg 
• 
The QoL assessments over the course of open-label 
treatment with Viaskin Milk 500 µg and 300 µg. 

Sponsor: DBV Technologies 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential 
Page 15 of 170 
Safety Endpoints: 
•
Adverse Events (AEs) and Treatment-Emergent Adverse
Events (TEAEs) by system organ class, preferred term,
maximum severity, and relatedness to the investigational
product.
•
Serious Adverse Events (SAEs) and Treatment-Emergent
Serious Adverse Events (TESAEs) by system organ class,
preferred term, severity, and relatedness to the
investigational product.
•
TEAEs leading to study discontinuation, and relatedness to
the investigational product.
•
Incidence, duration, and maximum severity of local
cutaneous reactions, as assessed by the subject.
•
Severity of local cutaneous reactions, as assessed by the
Investigator.
•
Adverse Events of Special Interest (AESI) including
systemic allergic symptoms and local AESI
•
Frequency and severity of symptoms elicited during the
DBPCFC.
•
Vital signs, physical examinations, and laboratory data.
•
Spirometry and PEF data.
Exploratory Endpoints: 
•
The change from baseline in epigenetic modifications at
Month 12, if evaluated
•
Epigenetic modifications over the course of open-label
treatment with Viaskin Milk 500 µg and 300 µg, if evaluated.
•
The relationship between the presence of filaggrin
mutations, safety, and response to treatment.
•
The change from baseline value in levels of sIgE to peanut,
egg, house dust mite, and grass pollen.
•
Enumeration and characterization of reactions triggered by
accidental consumption of cow’s milk (in any form) during
the study.
•
Analysis of “risk-taking behavior” of subjects (voluntary milk
consumption) during the study.
•
Planned management of the subject after termination of the
study.

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 16 of 170 
TABLE OF CONTENTS 
1 Introduction .......................................................................................................... 21 
1.1 Background .................................................................................................. 21 
1.2 Nonclinical Studies ...................................................................................... 22 
1.3 Clinical Studies ............................................................................................. 22 
1.4 Study Rationale ............................................................................................ 23 
2 Study Objectives .................................................................................................. 23 
3 Investigational Plan .............................................................................................. 23 
3.1 Overall Study Design and Plan .................................................................... 23 
3.1.1 
Data and Safety Monitoring Board ................................................ 25 
3.1.2 
Part A ........................................................................................... 26 
3.1.3 
Part B ........................................................................................... 26 
3.1.4 
Open-label treatment periods with Viaskin Milk 500 µg and 
Viaskin Milk 300 µg ....................................................................... 27 
3.1.5 
Summary Study Design Flow Charts ............................................ 28 
3.2 Discussion of Study Design ........................................................................ 33 
4 Selection of Subjects and Criteria for Withdrawal ............................................. 33 
4.1 Number of Planned Subjects ....................................................................... 33 
4.2 Eligibility Criteria for Study Enrollment ...................................................... 33 
4.2.1 
Inclusion Criteria ........................................................................... 33 
4.2.2 
Exclusion Criteria .......................................................................... 34 
4.3 Eligibility Criteria for Study Extension (Months 24 to 48) .......................... 36 
4.3.1 
Inclusion Criteria ........................................................................... 36 
4.3.2 
Exclusion Criteria .......................................................................... 36 
4.4 Eligibility criteria for the switch to Viaskin Milk 300 µg ............................. 37 
4.4.1 
Inclusion Criteria ........................................................................... 37 
4.4.2 
Exclusion Criteria .......................................................................... 37 
4.5 Removal of Subjects from Therapy or Assessments ................................ 37 
5 Investigational Products ...................................................................................... 38 
5.1 Drug Substance ............................................................................................ 38 
5.2 Investigational Products Administered ...................................................... 38 
5.3 Investigational Products Storage ................................................................ 39 
5.4 Packaging and Labelling ............................................................................. 39 
6 Administration of Study Treatments ................................................................... 39 
6.1 Method of Assigning Subjects to Treatment Groups ................................ 39 
6.2 Selection of Doses in the Study .................................................................. 39 
6.3 Administration of Study Treatments to Subjects ....................................... 40 
6.3.1 
Blinded Treatment Period ............................................................. 41 
6.3.2 
Open-label Treatment Period ........................................................ 42 
6.4 Blinding 44 

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6.5 Prior and Concomitant Therapy .................................................................. 44 
6.5.1 
Prior and Concomitant Therapy Records and 
Recommendations ........................................................................ 44 
6.5.2 
Prohibited Concomitant Treatments and Procedures: ................... 45 
6.5.3 
Permitted Concomitant Treatments and Procedures: .................... 45 
6.6 Treatment Compliance ................................................................................. 46 
6.7 Study Stopping Rules .................................................................................. 46 
7 Study Procedures ................................................................................................. 47 
7.1 Duration of Treatment .................................................................................. 47 
7.2 Study Visits and Assessments .................................................................... 47 
7.2.1 
Pre-Treatment Screening Period ................................................... 47 
7.2.2 
Part A, Part B, 12-month open-label treatment with Viaskin 
Milk 500 µg and study extension ................................................... 50 
7.2.3 
Open-label treatment with Viaskin Milk 300 µg ............................. 69 
7.2.4 
End-of-Study Follow Up Visit ........................................................ 76 
7.2.5 
Early Termination Visit .................................................................. 76 
7.3 Efficacy and Safety Variables ...................................................................... 77 
7.3.1 
Efficacy Assessments ................................................................... 77 
7.3.2 
Safety Assessments ..................................................................... 85 
7.3.3 
Exploratory Assessments.............................................................. 95 
7.4 Schedule of Assessments ........................................................................... 97 
8 Statistical Methods ............................................................................................. 108 
8.1 Statistical and Analytical Plans ................................................................. 108 
8.1.1 
Datasets or Populations Analyzed .............................................. 108 
8.1.2 
General Considerations .............................................................. 108 
8.1.3 
Subject Disposition ..................................................................... 109 
8.1.4 
Demographic and Other Baseline Characteristics ....................... 109 
8.1.5 
Concomitant Medications ............................................................ 109 
8.1.6 
Efficacy ....................................................................................... 109 
8.1.7 
Safety Variables .......................................................................... 113 
8.1.8 
Exploratory Variables .................................................................. 116 
8.2 Interim Analyses ......................................................................................... 117 
8.3 Determination of Sample Size ................................................................... 117 
8.4 Randomization Procedures ....................................................................... 118 
Random Sequencing of the Challenge Formulas During the DBPCFC ........ 118 
9 Quality Assurance and Quality Control ............................................................ 119 
9.1 Audit and Inspection .................................................................................. 119 
9.2 Monitoring ................................................................................................... 119 
9.3 Data Management and Coding .................................................................. 119 
10 Records and Supplies ........................................................................................ 120 
10.1 Drug Accountability ................................................................................... 120 
10.2 Financing and Insurance ........................................................................... 121 
11 Ethics .................................................................................................................. 122 

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11.1 Institutional Review Board......................................................................... 122 
11.2 Ethical Conduct of the Study ..................................................................... 122 
11.3 Subject Information and Consent ............................................................. 122 
11.4 Subject Confidentiality ............................................................................... 123 
12 Study Administration, Reporting and Publication, Including Archiving ........ 124 
12.1 Study Administration ................................................................................. 124 
12.2 Reporting and Publication, Including Archiving ...................................... 125 
13 References .......................................................................................................... 126 
14 Appendices ......................................................................................................... 128 
14.1 Investigator Signature Page ...................................................................... 129 
14.2 Oral Food Challenge Symptom Score Sheets .......................................... 130 
14.3 Quality of Life Questionnaire Forms ......................................................... 134 
14.3.1 
Food Allergy Quality of Life Questionnaire-Child Form 
(FAQLQ-CF) ............................................................................... 134 
14.3.2 
Food Allergy Quality of Life Questionnaire-Teenager Form 
(FAQLQ-TF)................................................................................ 139 
14.3.3 
Food Allergy Quality of Life Questionnaire – Parent Form 
for Children (FAQLQ-PF) ............................................................ 144 
14.3.4 
Food Allergy Quality of Life Questionnaire – Parent Form 
for Teenagers (FAQLQ-PFT) ...................................................... 150 
14.4 Anaphylaxis Staging System ..................................................................... 156 
14.5 Anaphylaxis Emergency Action Plan ........................................................ 157 
14.6 Inhalation Corticosteroid Dose Conversion Table by Age Category ...... 158 
14.7 Wash-Out Periods for Short-Acting and Long-Acting Antihistamines 
Based on Terminal Elimination Half-Life .................................................. 160 
14.8 Declaration of Helsinki ............................................................................... 161 
14.9 Reference Safety Information for the Cow’s Milk Food Challenge in 
the MILES study ......................................................................................... 170 
 
 
 

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LIST OF ABBREVIATIONS 
ACE 
= 
Angiotensin-Converting Enzyme 
AE 
= 
Adverse Event 
AESI 
= 
Adverse Event of Special Interest 
ALT 
= 
Alanine Aminotransferase 
ANCOVA = 
Analysis of Covariance 
AST 
= 
Aspartate Aminotransferase 
BDRM 
= 
Blinded Data Review Meeting 
BMI 
= 
Body Mass Index 
BUN 
= 
Blood Urea Nitrogen 
°C 
= 
Degrees Celsius 
CFR 
= 
Code of Federal Regulations 
cGCP 
= 
Current Good Clinical Practice 
CMA 
= 
Cow’s Milk Allergy 
CSR 
= 
Clinical Study Report 
CRD 
= 
Cumulative Reactive Dose 
CRO 
= 
Contract Research Organization 
CTD  
= 
Cumulative Tolerated Dose 
DBPCFC = 
Double-Blind Placebo-Controlled Food Challenge 
DBV 
= 
DBV Technologies 
DSMB 
= 
Data and Safety Monitoring Board 
eCRF 
= 
Electronic Case Report Form 
EDC 
= 
Electronic Data Capture 
EDS 
= 
Epicutaneous Drug Delivery System 
EOS 
= 
End-of-Study 
EPIT 
= 
Epicutaneous Immunotherapy 
ET 
= 
Early Termination 
FAS 
= 
Full Analysis Set 
FDA 
= 
Food and Drug Administration 
FEV1 
= 
Forced Expiratory Volume in 1 Second 
FAIM 
= 
Food Allergy Independent Measure 
FAQLQ-CF = 
Food Allergy Quality of Life Questionnaire – Child Form 
FAQLQ-PF= 
Food Allergy Quality of Life Questionnaire – Parent Form 
FAQLQ-PFT= 
Food Allergy Quality of Life Questionnaire – Parent Form 
Teenagers 
FAQLQ-TF = 
Food Allergy Quality of Life Questionnaire – Teenager Form 
FU 
= 
Follow-up 
GMP 
= 
Good Manufacturing Practice 
GSP 
= 
Global Safety and Pharmacovigilance 
h 
= 
Hour(S) 
IAF 
= 
Informed Assent Form 
ICF 
= 
Informed Consent Form 
ICH 
= 
International Conference on Harmonisation 
IgE 
= 
Immunoglobulin E 
IgG4 
= 
Immunoglobulin G4 
IP 
= 
Investigational Product 
IRB 
= 
Institutional Review Board 
ITT 
= 
Intent-to-Treat Set 
i.v. 
= 
Intravenous 
IWRS 
= 
Interactive Web Response System 
LOCF 
= 
Last Observation Carried Forward 
MedDRA    = 
Medical Dictionary for Regulatory Activities 
MMRM       =                 Mixed Model Repeated Measures 
n 
= 
Number of subjects with an observation 

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N 
= 
Number of subjects in the dataset or population 
NHLBI 
= 
National Heart, Lung, and Blood Institute 
OFC 
= 
Oral Food Challenge 
OLS 
= 
Open-label Set 
PC 
= 
Placebo Controlled 
PEF 
= 
Peak Expiratory Flow 
PPS 
= 
Per Protocol Set 
QA 
= 
Quality Assurance 
QoL 
= 
Quality of Life 
RBC 
= 
Red Blood Cell 
SAE 
= 
Serious Adverse Event 
SAP 
= 
Statistical Analysis Plan 
SD 
= 
Standard Deviation 
sIgE 
= 
Allergen-Specific Immunoglobulin E  
sIgG4 
= 
Allergen-Specific Immunoglobulin G4  
SOC 
= 
System Organ Class 
SOP 
= 
Standard Operating Procedure 
SPT 
= 
Skin Prick Test 
SS 
= 
Safety Set 
SUSAR 
= 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
= 
Treatment-Emergent Adverse Event 
TESAE 
= 
Treatment-Emergent Serious Adverse Event 
WBC 
= 
White Blood Cell 
WHODrug = 
World Health Organisation Drug Dictionary 
WMA 
= 
World Medical Association 

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1 
Introduction 
1.1 
Background 
Food allergies represent a major health problem that can affect up to 6% of young 
children and 3 to 4% of adults, and appears to have an increasing prevalence.1,2 
Allergic reactions to food can result from different immunologic mechanisms including 
immunoglobulin E (IgE)-mediated reactions (acute onset), non-IgE cell-mediated 
reactions (delayed or chronic onset) or a combination of both. Food allergies lead to a 
large variety of clinical symptoms involving the skin, and/or the gastrointestinal and 
respiratory tracts, and the cardiovascular system. Of these food allergy symptoms, 
those described as anaphylactic shock can be life-threatening and require a rapid 
admission to an emergency room. 
Cow’s milk allergy (CMA) is the most common food allergy in infants and young 
children, with an incidence of approximately 2 to 3% in developed countries.3,4 Several 
studies have shown that the prognosis for developing tolerance to cow’s milk is good, 
with a majority of patients outgrowing their CMA by the age of 2 to 3 years.5,6 However, 
other studies have shown that tolerance might also occur much later, with an 
increasing number of children whose CMA persists into school age and even into 
adolescence.7 Recent studies suggest that the resolution rate of CMA is approximately 
50% by 5 years of age.8,9 The low levels of allergen-specific IgE (sIgE) to cow’s milk 
and milk skin prick test (SPT) wheal size have been shown to be good predictors of 
resolution, while high levels of cow’s milk sIgE have been shown to be predictors of 
persistence of CMA.,,10 The concomitant presence of both asthma and allergic rhinitis, 
and the severity of atopic dermatitis have also been shown to be associated with a 
lower likelihood for developing tolerance., 
To date, the standard of care for management of food allergy is strict avoidance of the 
responsible allergen(s). This is especially challenging for cow’s milk, which is widely 
included in many dairy products, and also in smaller amounts in other manufactured 
food products. Consequently, the risk of accidental allergic reactions in children allergic 
to cow’s milk represents a major health concern, and the frequency of accidental 
exposure, some leading to severe reactions, could reach 40% in children over a 
12-month period.11 
There are no specific approved treatments for IgE-mediated CMA. Several studies 
have been carried out to investigate the effect of oral immunotherapy or sublingual 
immunotherapy for the treatment of CMA; these studies have shown some efficacy in 
increasing the quantity of cow’s milk consumed.12,13 However, occurrences of local 
adverse events (AEs), as well as systemic, potentially serious reactions during the 
course of oral immunotherapy are common.,14 In addition to the systemic side effects 
observed, the clinical desensitization can be lost in some cases within 1 week off 
therapy. Thus, developing alternative therapies for treating CMA or for improving the 
natural history of the disease represents a clear unmet medical need. 
DBV Technologies (DBV) is developing a novel product for the treatment of CMA. The 
investigational product, Viaskin Milk (DBV 135) consists of an epicutaneous drug 
delivery system like a patch (Viaskin delivery system), containing a solid deposit of 
formulated milk protein extract. Epicutaneous immunotherapy (EPIT), consisting of 
repeated applications of the patch containing the allergen to intact skin, is a novel 
method under investigation for the treatment of food allergies. 
The rationale for testing EPIT in humans for the treatment of CMA is based on the 
following: 

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1. EPIT has shown evidence of clinical benefit in animal and early human studies, 
especially in the pediatric population with CMA. 
2. EPIT provides a ready-to-use and easy-to-administer form of allergen 
immunotherapy, particularly well-adapted to the pediatric population. 
3. EPIT can directly target the immunocompetent cells (such as the Langerhans 
and Dendritic cells) in a nonvascularized environment (ie, the epidermis). 
EPIT is expected to have a better safety profile than the other forms of immunotherapy 
due to the slow delivery of large allergenic macromolecules in the epidermis that do not 
appear to pass through the basement membrane and enter the systemic circulation, 
hence reducing notably the risk of systemic distribution of the allergen. EPIT has been 
shown to be well tolerated and could represent a very promising approach for the 
treatment of CMA. 
1.2 
Nonclinical Studies 
Several nonclinical studies support the clinical development of Viaskin Milk. These 
include an efficacy study in milk-sensitized mice, toxicology studies (including 
repeat-dose, genotoxicity and tolerance studies), as well as biocompatibility studies 
performed with the Viaskin alone.  
The overall results of the studies support the conclusion that no toxic effects are 
expected with Viaskin Milk. Details regarding nonclinical studies with Viaskin Milk are 
available in the Investigator’s Brochure.15  
1.3 
Clinical Studies 
A brief summary of clinical study information for Viaskin Milk is included below. Refer to 
the Viaskin Milk (DBV 135) Investigator’s Brochure for additional details regarding 
clinical studies with Viaskin Milk. 
A pilot 3-month clinical study entitled “Efficacy of a new epicutaneous desensitization 
method to induce cow’s milk tolerance in children with cow’s milk protein allergy: a pilot 
study” has been completed (study #SV 782). The clinical study report (CSR) of this 
pilot trial was completed and its results have also been published.16 This double-blind, 
placebo-controlled, randomized pilot study evaluated the safety and efficacy of EPIT for 
the treatment of CMA in highly sensitive IgE-mediated CMA children. This study was 
performed utilizing an atopy patch test such as the commercially available Diallertest® 
diagnostic product. Diallertest is a ready-to-use cow’s milk allergen atopy patch test 
that has been made available by DBV Technologies on the French market in June 
2004 for the diagnosis of CMA. The Diallertest kit includes one control patch and one 
allergen patch containing 500 µg of skimmed cow’s milk powder (approximately 150 µg 
cow’s milk protein).  
Children aged between 3 months to 15 years and with cow’s milk protein sIgE 
>0.35 kU/L and/or a positive SPT to cow’s milk protein plus an oral milk challenge were 
eligible for participation in the study. If the oral cow’s milk challenge was positive at a 
dose <10 mL, the subjects were randomized (1:1) to receive active treatment patch 
(containing 1 mg of cow’s milk powder) or placebo. Each patch was applied on the 
posterior trunk in the inter-scapular space of the children for 48 hours, 3 times a week. 
The total duration of the blinded therapy was 3 months, followed by an open-label 
dosing up to an additional 6 months. The primary efficacy criterion was the maximal 
cumulative tolerated dose (CTD) of cow’s milk (in mL) after 3 months of the blinded 
treatment. 

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The mean age  standard deviation (SD) of the subjects enrolled in this study was 
3.82  2 years (range: from 10 months to 7 years and 8 months). A total of 9 children 
treated with the active patch and 7 children treated with placebo were incorporated in 
the per protocol analysis. An oral food challenge with cow’s milk was performed at 
baseline (Day 0) and after 3 months (Day 90) of blinded treatment. The maximal CTD 
of milk increased from a mean  SD of 1.77  2.98 mL at Day 0 to 23.61  28.61 mL at 
Day 90 in the active treatment group; in the active group, CTD slightly decreased in 
1 patient and increased by >10-fold in 2 patients and >100-fold in 3 patients after the 
EPIT treatment. The mean CTD did not change in the placebo group (4.36  5.87 mL 
at Day 0 to 5.44  5.88 mL at Day 90). Although this preliminary study failed to 
demonstrate a statistically significant improvement of the CTD (likely due to the limited 
number of subjects and short duration of the treatment period), subjects treated with 
the active patch demonstrated increased tolerance to milk exposure. 
No child required interruption of treatment because of an AE and none received 
epinephrine. No serious adverse events (SAEs) were reported during the trial. Overall, 
repeated application of the active patch was safe and well tolerated in this study.  
In summary, the results of the pilot study with cow’s milk EPIT demonstrated a 
favorable safety profile, a clear trend toward clinical efficacy, and suggested that longer 
treatment periods might be appropriate.  
1.4 
Study Rationale 
This study is designed to evaluate the safety and efficacy of repeated doses of Viaskin 
Milk delivered epicutaneously in pediatric subjects with IgE-mediated CMA. The goals 
of developing this new treatment are as follows: 
• 
To protect subjects with IgE-mediated CMA from the risk of severe reactions, in 
particular severe anaphylactic reactions, in case of accidental exposure to cow’s 
milk. 
• 
To permit or accelerate the re-introduction of cow’s milk and other dairy 
products into the diet of cow’s milk-allergic subjects. 
2 
Study Objectives 
The objectives of this study are: 
1. To evaluate the safety and efficacy of Viaskin Milk to induce desensitization to 
cow’s milk in IgE-mediated cow’s milk-allergic children after 12 months of EPIT 
treatment. 
2. 
To assess the long-term safety and efficacy of up to 48 months of treatment 
with Viaskin Milk. 
3. 
To assess the safety and the therapeutic benefit of the most effective tested 
dose of Viaskin Milk over 24 months of treatment. 
3 
Investigational Plan 
3.1 
Overall Study Design and Plan 
This is a multi-center, double-blind, placebo-controlled, randomized trial to study the 
safety and efficacy of Viaskin Milk applied epicutaneously every day to subjects from 

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Page 24 of 170 
2 to 17 years of age with IgE-mediated CMA. Viaskin Milk is a patch containing an 
extract of cow’s milk proteins. The placebo treatment will consist of a Viaskin patch 
containing a similar formulation without cow’s milk proteins. The study will be 
conducted at 17 sites in the United States and Canada, with selected Investigators and 
staff experienced in the diagnosis and management of CMA and anaphylaxis, and who 
are capable of performing a double-blind placebo-controlled food challenge (DBPCFC) 
in children (2 to 11 years old), adolescents (12 to 17 years old). 
Eligible subjects with confirmed IgE-mediated CMA will perform a first DBPCFC at 
screening with escalating doses of cow’s milk proteins. Subjects showing a positive 
DBPCFC at screening, defined as the appearance of objective signs or symptoms to 
an eliciting dose of cow’s milk proteins ≤300 mg (approximately 9.4 mL of cow’s milk) 
will be randomized in the study. 
Double-blind, placebo-controlled treatment period up to Month 12 
The study was divided into 2 consecutive parts for randomization of the subjects to 
treatment: Part A and Part B. Part A initially permitted an evaluation of the safety of 
3 escalating doses of Viaskin Milk (150 µg, 300 µg, and 500 µg cow’s milk proteins) 
versus placebo in successive cohorts of subjects before proceeding to Part B. Part B 
permitted an evaluation of the efficacy and safety of the 3 safe doses of Viaskin Milk 
(150 µg, 300 µg and 500 µg of cow’s milk protein, as assessed from the safety data in 
Part A subjects) versus placebo. The efficacy of Viaskin Milk was assessed based on 
data pooled from subjects in both Part A and Part B. Details of subject enrollment and 
the treatments administered for each part of the study are provided in Section 3.1.2 for 
Part A and in Section 3.1.3 for Part B.  
In both Part A and Part B of the study, subjects were randomized to receive treatment 
with Viaskin Milk versus placebo for 12 months (blinded treatment period), at which 
time a second DBPCFC was performed. The primary analysis of this study was 
conducted after data have been collected up to Month 12 visits including both days of 
the DBPCFC at Month 12. Consequently, results from the safety and efficacy data 
collected in all Part A and Part B subjects up to and including the Month 12 visits will be 
reported in the 12-Month CSR.  
Open-label periods with Viaskin Milk 500 µg up to 48 months and Viaskin Milk 
300 µg for 24 months 
After the Month 12 DBPCFC, all subjects from Part A and Part B were to continue 
treatment for another 12 months in an open-label manner with active Viaskin Milk at the 
highest dose selected (500 µg of cow’s milk protein), based on safety data in Part A 
subjects. A third DBPCFC was to be performed at Month 24. 
After Month 24, all eligible subjects from Part A and Part B were to be proposed to 
enter the study extension to receive 2 additional years of EPIT with open-label Viaskin 
Milk at 500 µg (see eligibility criteria in Section 4.3). For subjects entering the study 
extension, the fourth and fifth DBPCFCs were to be performed at Month 36 and 
Month 48, respectively.  
Results of the 12-month blinded period showed that the most effective tested dose was 
the Viaskin Milk 300 µg, and that this dose was safe1. Given that all subjects were 
currently receiving the 500-µg dose, all subjects will switch from Viaskin Milk 500 µg to 
                                               
1 Refer to the Investigator’s Brochure of Viaskin Milk for details about results of the 12-month 
blinded period. 

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Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 26 of 170 
3.1.2 Part A   
In Part A of the study, the safety of 3 escalating doses of Viaskin Milk, 150 µg, 300 µg, 
and 500 µg cow’s milk proteins, will initially be assessed over a 3-week treatment 
period. Subjects will be randomized into 3 successive cohorts of 6 subjects each to 
receive either Viaskin Milk or placebo in a 2:1 ratio. 
Cohort 1 (150 µg dose group): a total of 6 subjects will be randomized (2:1 ratio) to 
receive either Viaskin Milk at 150 µg (n=4) or placebo (n=2). Safety data will be 
collected and analyzed after 3 weeks of treatment. The 3-week safety data will be 
reviewed by the independent DSMB. If the DSMB considers that the 150 µg dose is 
safe, then Cohort 2 will open for randomization at the next highest dose of Viaskin 
Milk. 
Cohort 2 (300 µg dose group): the screening of subjects in Cohort 2 may start once 
the enrollment in Cohort 1 is complete, but no subject will be randomized and treated 
in this cohort before the review of the DSMB from the previous cohort has been 
completed and the DSMB recommendation made. The same process as described 
above for Cohort 1 will be repeated: a total of 6 additional subjects will be randomized 
(2:1 ratio) to receive Viaskin Milk at 300 µg (n=4) or placebo (n=2). Safety data after 
3 weeks of treatment will be collected and analyzed. In parallel, cumulative safety 
data from the previous Cohort 1 subjects will also be collected and made available for 
review by the DSMB. If the DSMB considers that the 300 µg dose is safe, then 
Cohort 3 will open for randomization at the next highest dose of Viaskin Milk. 
Cohort 3 (500 µg dose group): the screening of subjects in Cohort 3 may start once 
the enrollment in Cohort 2 is complete, but no subject will be randomized and treated 
in this cohort before the review of the DSMB from the previous cohort has been 
completed and the DSMB recommendation made. The same process as described 
above for Cohorts 1 and 2 will be repeated: a total of 6 additional subjects will be 
randomized (2:1 ratio) to receive Viaskin Milk at 500 µg (n=4) or placebo (n=2). 
Safety data after 3 weeks of treatment will be collected and analyzed. In parallel, 
cumulative safety data from subjects in the previous Cohorts 1 and 2 will also be 
collected and made available for review by the DSMB. The DSMB will assess 
whether this dose of 500 µg is also safe. 
All subjects in Part A will continue their blinded treatment at their assigned initial dose 
of treatment (150 µg, 300 µg, or 500 µg Viaskin Milk or placebo) up to Month 12. 
3.1.3 Part B  
After the analysis of the cumulative safety data of Part A subjects, the 3 doses of 
Viaskin Milk (150 µg, 300 µg, and 500 µg of cow’s milk protein) were kept to study the 
efficacy of Viaskin Milk in a placebo-controlled dose-finding Part B of the study.  
The screening of subjects in Part B may start after enrollment in Part A is complete; 
however, none of the subjects screened in Part B can be randomized and treated 
before the review of the safety data from Part A subjects has been completed by the 
DSMB and by the US Food and Drug Administration (FDA).  
A pause in the randomization will allow for this safety review to occur and 
recommendations to be released. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 27 of 170 
In Part B, approximately 176 additional subjects will be randomized (1:1:1:1 ratio) to 
receive Viaskin Milk 150 µg (n=44), Viaskin Milk 300 µg (n=44), Viaskin Milk 500 µg 
(n=44), or placebo (n=44) up to Month 12. 
3.1.4 Open-label treatment periods with Viaskin Milk 500 µg and Viaskin Milk 
300 µg 
Treatment period with Viaskin Milk 500 µg 
After the Month 12 DBPCFC, all subjects in Part A and in Part B were to continue 
treatment in an open-label manner for another 12 months up to Month 24 with Viaskin 
Milk at the highest dose selected (500 µg of cow’s milk protein), based on the safety 
data of Part A subjects. 
Subjects who terminated the study at Month 24 were to attend an EOS visit 2 weeks 
after the Month 24 DBPCFC. 
After the first 2 years in the MILES study, depending on the threshold of desensitization 
achieved at Month 24, a longer treatment period with EPIT may be valuable for some 
subjects. In contrast, the re-introduction of milk into the diet as early as possible (eg, 
baked milk products or dairy products) or the initiation of different therapies may be a 
preferred option for other subjects. For this purpose, all eligible subjects from Part A 
and Part B (see eligibility criteria in Section 4.3) were proposed to enter into the 
open-label study extension, to receive 2 additional years of EPIT with Viaskin Milk 
500 µg, if deemed appropriate by the Investigator, and depending on the willingness of 
each individual subject. 
Subjects who entered the study extension were to continue their treatment up to 
Month 48 and to perform additional DBPCFCs at Month 36 and at Month 48.  
Following results of the 12-month blinded period, the DBPCFCs that were to be 
performed at Month 24, Month 36 and Month 48 should not be conducted while 
the subjects are still receiving Viaskin Milk 500 µg.  
Switch to Viaskin Milk 300 µg 
Following results of the 12-month blinded period, all eligible subjects will switch from 
Viaskin Milk 500 µg to Viaskin Milk 300 µg for 24 additional months, independently of 
the duration of previous treatment with Viaskin Milk 500 µg: 
• 
Subjects who will decline to switch to Viaskin Milk 300 µg will be discontinued 
from the study and an ET visit or an EOS visit will be performed (see Section 
7.2.3); 
• 
Subjects who will switch to Viaskin Milk 300 µg will be treated for 24 additional 
months: 
o Until Visit S1 is performed and the subjects start with Viaskin Milk 
300 µg, they will continue to receive Viaskin Milk 500 µg. No DBPCFC 
should be performed while the subjects are still receiving Viaskin Milk 
500 µg. 
o Subjects will then follow a dedicated study flowchart (see Table 6 and 
Table 7), 
o Optional DBPCFCs can be performed after 12 and/or 24 months of 
treatment, 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 28 of 170 
If the decision is made by the Investigator and the subject to perform a 
DBPCFC, its performance must comply with the standardized 
methodology defined in Section 7.3.1.1. Standardized milk and placebo 
food challenge formula and material as well as the Manual of 
Procedures will be provided to all sites and must be used for conducting 
the food challenge. 
When performed, the results of these food challenge(s) will be 
documented and reported in the e-CRF. 
o The EOS visit will take place 2 weeks after the end of the treatment 
period. 
During their participation in the study all subjects will be instructed to remain on a strict 
cow’s milk-free diet with no consumption of dairy products or baked milk products until 
their final study visit (except during DBPCFC). At the end of participation in the study, 
the re-introduction of milk products (eg, dairy products or baked milk products) into the 
subject’s diet, or the decision to keep the subject under a strict cow’s milk-free diet will 
be left to the Investigator’s discretion. 
3.1.5 Summary Study Design Flow Charts 
3.1.5.1 
Process Summary of Enrollment 
Figure 1 presents a summary of the enrollment process into Part A and Part B of the 
study. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 30 of 170 
Figure 3 presents a summary of the study design for the open-label treatment period 
with Viaskin Milk 300 µg.

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 31 of 170 
Figure 2: Overview of the Study Design for Part A, Part B and the open-label treatment period with Viaskin Milk 500 µg as was planned before Protocol 
Amendment 5 
 
 
 
Abbreviations: D=day; FU=follow-up; M=month; DBPCFC=Double-Blind Placebo Controlled Food Challenge; 
 
Following results of the 12-month blinded period, Month 24, Month 36 and Month 48 DBPCFCs should not be performed while the subjects are 
still receiving Viaskin Milk 500 µg. 
 
 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 32 of 170 
Figure 3. Overview of study design for the open-label treatment period with Viaskin Milk 300 µg 
 
 
Abbreviations: FU=follow-up; M=month; DBPCFC=Double-Blind Placebo Controlled Food Challenge. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 33 of 170 
3.2 
Discussion of Study Design 
A randomized, double-blind study is considered the most suitable design, and placebo 
is considered the appropriate control, to evaluate the Viaskin Milk EPIT product in 
children and adolescent subjects with IgE-mediated CMA. Randomization and double-
blinding are used to minimize bias in treatment allocation and in the assessment of 
both safety and efficacy during the double-blind treatment period. Randomization and 
double-blinding also minimizes bias arising from the expectations of subjects and/or 
their parent(s)/guardian(s), the Investigators, and from individuals who collect the study 
data. 
An open-label extension at the highest safe dose based on the safety data collected 
during the Part A and B was initiated. The selected dose before the availability of 
efficacy data was the Viaskin Milk 500 µg.  
After the efficacy data became available at the end of the 12-month blinded period2, the 
most efficacious dose was determined to be the Viaskin Milk 300 µg. This dose was 
shown to be safe. Consequently, all subjects will switch over to this dose for an 
additional treatment period of 24 months. 
4 
Selection of Subjects and Criteria for Withdrawal 
4.1 
Number of Planned Subjects  
Approximately 194 children and adolescent subjects will be randomized in this study, 
18 subjects in Part A and 176 subjects in Part B. The screen failure rate is anticipated 
to be around 35%, therefore approximately 300 subjects may be screened in the study. 
4.2 
Eligibility Criteria for Study Enrollment 
4.2.1 Inclusion Criteria 
1. Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and 
informed assent form (IAF) for subjects ≥7 years, or as per local or country 
specific guidelines or regulations. 
2. Male or female subjects 2 to 17 years old at Visit 1. 
3. Documented medical history or physician-confirmed diagnosis of IgE-mediated 
CMA with systemic symptoms related to ingestion of milk or dairy products. 
4. Subjects currently following a strict cow’s milk-free diet, with no consumption of 
dairy or baked milk products.  
5. Cow’s milk sIgE level at screening ≥10 kU/L. 
6. Positive SPT to cow’s milk with a largest wheal diameter ≥6 mm. 
7. Positive DBPCFC at screening with an eliciting dose ≤300 mg cow’s milk 
proteins (approximately ≤9.4 mL of cow’s milk). 
8. Negative urine pregnancy test for female subjects of childbearing potential. 
Female subjects of childbearing potential must agree and commit to use 
                                               
2 Refer to the Investigator’s Brochure of Viaskin Milk for details about results of the 12-month 
blinded period. 

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C

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 35 of 170 
11. Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 
and/or use of systemic short-acting corticosteroids within 4 weeks before Visit 1 
or use of systemic long-acting or short-acting corticosteroids during screening 
(unless used to treat symptoms triggered by the DBPCFC or triggered by 
accidental allergen consumption; in the latter case DBPCFC must then be 
scheduled after a minimum of 7 wash-out days). 
12. Subjects with asthma conditions meeting 1 or several criteria below: 
• 
Uncontrolled persistent asthma (as defined by the 2007 NHLBI 
guidelines) or subject is being treated with a combination therapy of 
medium or high daily dose of inhaled corticosteroid with a long acting 
inhaled β2-agonist. Intermittent asthmatic subjects who require 
intermittent use of inhaled corticosteroids for rescue are permitted.  
• 
At least 2 systemic corticosteroid courses for asthma within 1 year 
before Visit 1 or 1 oral corticosteroid course for asthma within 3 months 
before Visit 1, or during screening (unless used to treat symptoms 
triggered by the DBPCFC). 
• 
Prior intubation/mechanical ventilation due to asthma within 2 years 
before Visit 1, or during screening. 
13. Upper respiratory infection or gastroenteritis within 7 days of DBPCFC 
(DBPCFC must then be rescheduled at least 7 days after resolution of these 
conditions). 
14. Any history of milk immunotherapy (eg, oral immunotherapy, sublingual 
immunotherapy or specific oral tolerance induction). 
15. Prior history of any other food allergen immunotherapy (eg, oral 
immunotherapy, sublingual immunotherapy or specific oral tolerance induction) 
within 5 years before Visit 1. 
16. Subjects currently under aeroallergen immunotherapy and unwilling or unable 
to discontinue at the time of Visit 1. Aeroallergen Immunotherapy must be 
discontinued at the time of Visit 1.  
17. Use of any anti-IgE drug (eg, omalizumab), any immunomodulatory therapy, or 
any biological agent therapy (eg, anti-tumor necrosis factor drugs) within 1 year 
before Visit 1, or during screening. 
18. Generalized dermatologic diseases (eg, severe atopic dermatitis, uncontrolled 
generalized eczema, icthyosis vulgaris) with no intact zones to apply the 
Viaskin patch, or urticarial and mast cell disorders such as chronic idiopathic 
urticaria. 
19. Subject and/or subject’s parents/guardians with obvious excessive anxiety and 
unlikely to cope with the conditions of a food challenge. 
20. Past or current disease, including but not limited to active eosinophilic 
gastrointestinal disorders, autoimmune disorders, immunodeficiency, 
malignancy, uncontrolled disease (hypertension, diabetes, psychiatric disorder, 
cardiac disease), or other disorders (eg, liver, gastrointestinal, kidney, 
cardiovascular, pulmonary disease or blood disorder) which in the opinion of the 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 36 of 170 
Investigator or the sponsor may affect the subject’s participation in the study or 
place the subject at increased risk. 
21. Subjects and/or parents/guardians unable to use the epinephrine auto-injector 
properly in spite of being adequately trained. 
22. Contraindicated condition for the use of epinephrine. 
23. Use of any investigational drug or device, or participation in another 
interventional clinical study within 3 months before Visit 1. 
24. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) 
inhibitors. 
25. Subjects unable to follow the protocol requirements. 
4.3 
Eligibility Criteria for Study Extension (Months 24 to 48) 
 Not applicable after subjects have switched to Viaskin Milk 300 µg. 
4.3.1 Inclusion Criteria 
1. Signed study extension ICF by parent(s)/guardian(s) of subjects and informed 
assent form for subjects ≥7 years, or as per local or country specific guidelines 
or regulations. 
2. Subjects who completed the first 2 years in MILES, including a complete 
documented DBPCFC at Month 24. 
Note: following results of the 12-month blinded period, Month 24 DBPCFC 
should not be performed anymore. Inclusion criterion #2 becomes 
“Subjects who completed the first 2 years in MILES”. 
3. Negative urine pregnancy test at Month 24 for female subjects of childbearing 
potential. Female subjects of childbearing potential must continue to agree and 
commit to using effective medical methods of contraception for the entire 
duration of their participation in the study. Sexual abstinence will be accepted 
as an effective method of contraception for females below 15 years of age. 
4. Subjects must agree to continue following a strict cow’s milk-free diet, with no 
consumption of dairy or baked milk products during participation in the study 
(except during the DBPCFCs). 
5. Subjects and/or parents/guardians willing to comply with all study requirements 
during participation in the study extension. 
4.3.2 Exclusion Criteria 
1. Any new disorder or disease that may affect the subject’s participation in the 
study, or place the subject at increased risk, or for which epinephrine use is 
contraindicated. 
2. Poor compliance in patch application (below 80%), defined as patch not applied 
at all for >73 days (either consecutive or not) during the second year of 
participation in MILES. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 37 of 170 
4.4 
Eligibility criteria for the switch to Viaskin Milk 300 µg 
The following eligibility criteria apply to the subjects who agree to switch to Viaskin Milk 
300 µg. 
4.4.1 Inclusion Criteria 
1. Signed ICF by parent(s)/guardian(s) of subjects and informed assent form for 
subjects ≥7 years, or as per local or country specific guidelines or regulations. 
2. Negative urine pregnancy test at Visit Switch 1 for female subjects of childbearing 
potential. Female subjects of childbearing potential must continue to agree and 
commit to using effective medical methods of contraception for the entire duration 
of their participation in the study. Sexual abstinence will be accepted as an 
effective method of contraception for females below 15 years of age. 
3. Subjects must agree to continue following a strict cow’s milk-free diet, with no 
consumption of dairy or baked milk products during participation in the study 
(except during the DBPCFCs). 
4. Subjects and/or parents/guardians willing to comply with all study requirements 
during participation. 
4.4.2 Exclusion Criteria 
1. Any new disorder or disease that may affect the subject’s participation in the study, 
or place the subject at increased risk, or for which epinephrine use is 
contraindicated. 
2. Poor compliance in patch application (below 80%) during the previous year of 
participation in MILES. 
 
4.5 
Removal of Subjects from Therapy or Assessments 
Subjects who are withdrawn from the study will not be replaced. Participation of a 
subject in this clinical study may be discontinued for any of the following reasons: 
• 
Adverse Event: any SAE, clinically significant AE, or severe laboratory 
abnormality. 
• 
Subject or parent(s)/guardian(s) decision (consent withdrawal). 
• 
Investigator decision: occurrences of any medical condition or 
circumstances that expose the subject to substantial risk and/or do not allow 
the subject to adhere to the requirements of the protocol. 
• 
Pregnancy. 
• 
Noncompliance: subject’s failure to comply with protocol requirements or 
study-related procedures. 
• 
Lost to follow-up: subject’s failure to return for scheduled visits despite 
telephone or written attempts of contact. 
• 
Sponsor or regulatory authority decision: termination of the study by the 
sponsor, FDA, or other regulatory authorities. 
• 
Death. 

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CCI

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 41 of 170 
Open-label treatment periods with Viaskin Milk 500 µg and Viaskin Milk 300 µg 
after Month 12 
After the Month 12 DBPCFC, all subjects were to receive Viaskin Milk 500 µg up to 
Month 24. After the Month 24 DBPCFC, all subjects who entered the study extension 
were to continue to receive Viaskin Milk 500 µg up to Month 48. 
Following results of the 12-month double-blind treatment period, all eligible subjects will 
switch to Viaskin Milk 300 µg for 24 months. 
6.3.1 Blinded Treatment Period 
To increase the safety of the patch at the beginning of the treatment, the daily duration 
of application will be gradually increased for the first weeks of treatment as follows: 
• 
6 hours of daily application during the first week (from Day 1 to Day 7); 
• 
12 hours of daily application during the second week (from Day 8 to Day 14); 
• 
24 hours of daily application from the third week (from Day 15) onwards. 
In case of severe local reactions, or if the subject presents an AE considered as a 
systemic “allergic reaction type” of any severity and related to the study drug, the daily 
duration of patch application can be adapted/reduced if the Investigator considers this 
could allow for an optimal management of the safety of the subjects. The daily duration 
of patch application could then be progressively extended day by day to reach the 
24-hours/day application after the AE resolves or stabilizes. In the rare event that 
Grade 4 local skin reactions occur, subjects should transiently discontinue patch 
application. Subjects should then visit the site for the next patch application and for 
adequate examination and treatment of the wounded zone (refer to Section 7.3.2.5, 
Adverse Events of Special Interest to the Sponsor). 
The patches will be applied on the inter-scapular area on the back of the children (2 to 
11 years old) and on the inner side of the arms for the adolescents (12 to 17 years old) 
and former adolescents who become adults (≥18 years old). Children who reach the 
age of 12 years during their participation in the study may continue to apply the 
patches on their back, or switch to the arms. For each site of application (arms or 
back), the specific place where the patch is applied will represent a zone: 6 zones in 
total will be used and rotated for application of the patches. The application of the patch 
should start with Zone 1 on Day 1, then Zone 2 on Day 2, then Zone 3 on Day 3…up to 
Zone 6 on Day 6. Then the patch will be applied back to Zone 1 on Day 7, Zone 2 on 
Day 8, etc. 
• 
For children (2 to 11 years old), the Zones 1, 2, and 3 will be located on 1 side 
of the spine and Zones 4, 5 and 6 will be located on the other side of the spine. 
• 
For adolescents (12 to 17 years old) and former adolescents who become 
adults (≥18 years old), the Zones 1, 2 and 3 will be located on 1 arm and 
Zones 4, 5, and 6 will be located on the other arm. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 43 of 170 
dose of Viaskin Milk selected for Part B (500 µg of cow’s milk protein), based on safety 
data of Part A subjects. The Viaskin Milk open-label treatment period was to continue 
until Month 24 for all subjects and until Month 48 for the subjects who entered the study 
extension. If a subject experienced reactions after the DBPCFC at Visit 13 that 
warranted postponing the application of the first patch of the open-label treatment 
period, it was permitted, at the discretion of the Investigator, to delay the application of 
the first patch of the open-label treatment up to a maximum of 7 days after Visit 13. 
To increase the safety of subjects at the beginning of the open-label treatment period, 
in particular for subjects crossing over from placebo to the active Viaskin Milk 
treatment, the daily duration of application was again to be adapted from Visit 13 for 
the first weeks of treatment as follows: 
• 
6 hours of daily application during the first week 
• 
12 hours of daily application during the second week 
• 
24 hours of daily application from the third week onwards  
At the time of Protocol Amendment 5, all subjects were currently receiving active 
treatment with Viaskin Milk 500 µg. The switch to Viaskin Milk 300 µg will not 
require a progressive increase of application duration, and all subjects will be 
able to start with 24 hours of daily application of Viaskin Milk 300 µg. 
During the open-label treatment periods with Viaskin Milk 500 µg and Viaskin Milk 
300 µg, the daily duration of patch application could also be reduced/adapted and 
progressively extended up over a few days to reach the 24-hours/day application in 
some specific cases, as described in the previous section, if the Investigator considers 
this could allow for an optimal management of the safety of the subjects. In the rare 
event that Grade 4 local skin reactions or other local AESI occur, subjects should 
transiently discontinue patch application. Subjects should then visit the site for the next 
patch application and for adequate examination and treatment of the wounded zone. 
Subjects should remain at the site for 1 hour before being discharged. The site staff 
should contact the subject via telephone the next day after removal of the patch to 
ensure that there are no additional local vesicles, blisters or other lesions evocative of 
skin disruption noted and the treatment with the patch can proceed as planned. The 
zone with vesicles or lesions should not be used for patch application until the zone 
has completely healed. 
The application of the patch with regard to the location (back or arm) and zones 
together with the recommendations for applying and removing the patch should 
continue as described above in the blinded treatment period section (refer to 
Section 6.3.1).  
If the patch was removed or has fallen off prematurely, the daily duration of application 
of the patch and the reason for early removal will be recorded in the subject diary 
cards. During the open-label treatment periods with Viaskin Milk 500 µg and Viaskin 
Milk 300 µg, the subjects will only record the days and time periods when the duration 
of application did not follow the durations recommended in the protocol. During the 
period of 24 hours of daily application, flexibility between 20 to 28 hours of daily 
application is permitted. 
For subjects who terminated the study at Month 24, the last patch application was to be 
the day before the second Month 24 DBPCFC (day before Visit 17). For subjects who 
entered the study extension after Month 24, the open-label treatment period was to 
continue with Viaskin Milk 500 µg until Month 48. For those subjects, the last patch 
application was to be on the day before the second Month 48 DBPCFC (day before 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 44 of 170 
Visit 23). The last application of Viaskin Milk 300 µg will depend upon the participation 
of the subject in the DBPCFC performed after 24 months of treatment: 
• 
If the subjects perform the DBPCFC, the last patch application will be the day 
before the second day of the DBPCFC/Visit S7; 
• 
If the subjects do not perform the DBPCFC, the last patch application will be 
the day before Month 24/Visit S6. 
6.4 
Blinding 
Double-blind, placebo-controlled treatment period up to Month 12 
This is a randomized, double-blind study. The subject, Investigator, medical monitor, 
sponsor, and the entire study processing team will remain blinded to treatment 
assigned (refer to Section 6.1, Method of Assigning Subjects to Treatment Groups) to 
the subjects during the 12-month double-blind treatment period and the blinding will 
remain until all 12-month data are collected.  
The appearance of Viaskin Milk and placebo patches will be identical. During the 
blinded treatment period, an Emergency Code Break procedure will be available to 
Investigators via IWRS, to allow for unblinding a subject or treatment kit, (ie, informing 
the Investigator of the treatment group to which the subject has been assigned). The 
blind for a specific subject can be broken by the Investigator only if the Investigator 
considers the information indispensable to the safety of the subject. If possible, the 
medical monitor at the CRO and the sponsor should be consulted before breaking the 
blind and the Investigator should always assess the relationship of the AE to the 
investigational product before breaking the blind. 
Open-label treatment period with Viaskin Milk 500 µg and Viaskin Milk 300 µg 
After the Month 12 DBPCFC and study procedures have been completed (Visit 13), all 
subjects were to continue treatment until Month 24 with Viaskin Milk in an open-label 
manner, at the highest dose of Viaskin Milk selected for Part B (500 µg of cow’s milk 
protein), based on safety data of Part A subjects. Treatment with open-label Viaskin 
Milk 500 µg was to continue until Month 48 for subjects who enter the study extension. 
After the switch to Viaskin Milk 300 µg, subjects will receive this treatment in an open-
label manner for 24 months.  
6.5 
Prior and Concomitant Therapy 
6.5.1 Prior and Concomitant Therapy Records and Recommendations 
All prior medications used within 6 months prior to Visit 1 will be recorded on the 
electronic case report form (eCRF). All medications taken any time from the study start 
until the end of the study will be recorded on the eCRF. 
Application of a topical corticosteroid to treat any local AE (eczematous lesions, 
pruritus, edema, etc) is allowed and will be recorded as concomitant medication. A 
topical medication with 1% hydrocortisone or equivalent will be distributed to each 
randomized subject at discharge on Day 1 (Visit 4). In case the 1% hydrocortisone 
topical medication is not sufficient to treat the local reaction, a topical medication 
containing a more potent corticosteroid can be prescribed and locally applied. 

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CCI

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 46 of 170 
• 
Treatments (other than those described above) prescribed in case of any AE. 
• 
After Protocol Amendment 5: Any food challenge to any other food than milk 
required for the subject’s medical management will be permitted. Whether the 
subject’s medical condition is still compatible with their participation in the study 
should be assessed by the Investigator and the Sponsor’s medical monitor 
before the food challenge is performed. Note that the initiation of any other 
immunotherapy treatment remains prohibited during the participation of the 
subject in the MILES study (refer to Section 6.5.2).    
6.6 
Treatment Compliance 
Subjects and/or parent(s)/guardian(s) will receive diary cards to record the daily 
application of Viaskin patches (see Section 7.3.2.12 for further details about diary 
cards). The duration of the patch application will be recorded every day from Day 1 
(Visit 4) up to Month 3 (Visit 9) on the subject diary cards. After Month 3, the subjects 
will only record the days and time periods when the duration of the patch application 
did not follow the durations recommended in the protocol. During the period of 24 hours 
of daily application, flexibility between 20 to 28 hours of daily application is permitted. If 
a Viaskin patch is removed prematurely or falls off, the daily duration of application of 
the patch and the reason for early removal will be recorded in the subject diary cards. 
The data recorded in the diary card by the subject and/or parent(s)/guardian(s) will be 
collected periodically during the subject’s visit at sites and entered into the eCRF or the 
clinical database. 
It is the Investigator’s responsibility to correctly instruct subjects and/or 
parent(s)/guardian(s) on how to store and administer the investigational product. At 
each visit, prior to dispensing a new investigational treatment box, the compliance of 
the subject will be assessed by evaluating the number of days the patches were 
applied (even for a duration that is less than the recommended duration), versus the 
number of days in that time interval. An overall compliance of ≥80% over the treatment 
period is sought. Subjects exhibiting a poor compliance (<80%) should be counseled 
on the importance of a good compliance.  
The Investigator or designated study personnel will maintain a log of all investigational 
product dispensed (see Section 10.1, Drug Accountability for details). 
6.7 
Study Stopping Rules 
Study enrollment will be suspended pending an expedited safety review by an 
independent DSMB, if any of the following occur: 
• 
Any death related to Viaskin dosing;  
• 
More than one Stage 3 anaphylaxis (see Appendix 14.4, Anaphylaxis Staging 
System) related to Viaskin application (and not occurring during the DBPCFCs); 
• 
More than 3 subjects requiring >1 injection of epinephrine related to Viaskin 
application (and not occurring during the DBPCFCs). 
Upon safety review, 1 of the following outcomes will be determined: 
• 
Accrual into the study may continue without modification; 
• 
Accrual into the study may continue with modifications as recommended by the 
DSMB; 
• 
Accrual into the study should stop. 

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7 
Study Procedures 
7.1 
Duration of Treatment 
The duration of treatment with the investigational product (Viaskin Milk or placebo) will 
be 12 months for all subjects in Part A and Part B during the double-blind treatment 
period, followed by an additional 12 months of active Viaskin Milk treatment during the 
open-label treatment period. For subjects entering the study extension, open-label 
treatment with Viaskin Milk 500 µg was to continue for two additional years but will be 
interrupted consecutive to the switch to Viaskin Milk 300 µg. Switching will allow 
subjects to receive 2 years of treatment with Viaskin Milk 300 µg. 
Consequently, the duration of active Viaskin Milk treatment will differ for each individual 
subject and could be up to approximately 6 years. 
7.2 
Study Visits and Assessments 
Double-blind treatment period up to Month 12 and open-label treatment period 
with Viaskin Milk 500 µg 
The planned study assessments are summarized in Table 2, Table 3, Table 4, and 
Table 5 for the first, second, third, and fourth year of treatment, respectively, as 
described in Section 7.4. A maximum of 24 site visits were planned for subjects in 
Part A and 23 site visits for subjects in Part B up to Month 48. In addition, a maximum 
of 15 phone contacts were to be held between scheduled site visits. 
Open-label treatment period with Viaskin Milk 300 µg 
The planned study assessments are summarized in Table 6 and Table 7 for the first 
and second years after the switch to Viaskin Milk 300 µg, respectively, as described in 
Section 7.4. A maximum of 7 site visits are planned, and a maximum of 5 phone calls 
will be held between scheduled site visits. 
The subjects and/or parent(s)/guardian(s) must be instructed that subjects 
should follow a strict cow’s milk-free diet with no consumption of cow’s milk, 
dairy products, or any baked milk products during their entire participation in the 
study. 
7.2.1 Pre-Treatment Screening Period 
The screening period will include 3 pre-treatment visits (Visits 1 to 3) for all subjects. 
The duration of the screening period up to the first day of treatment with the study drug 
at Visit 4 must be ≤60 days. This gives enough time for the subjects to perform their 
3 pre-treatment visits and plan for the Visit 4 based on their schedule and site’s 
availability. The screening period could however be shorter than 60 days. If applicable, 
subjects with abnormal laboratory assessments due to concomitant transient disease 
(flu, viral illness, etc) can repeat their laboratory assessments or be rescheduled for 
laboratory assessment at the discretion of the Investigator. 
7.2.1.1 
Visit 1 (Screening Visit) 
The site staff must go into IWRS to register the subject for Screening. 
Subjects will undergo the following procedures at this visit: 
Written and signed ICF/IAF will be obtained before any assessments are made. 

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Written and signed genetic ICF/IAF for optional genetic analysis (epigenetic and 
filaggrin analysis) may be obtained only if subjects or their parent(s)/guardian(s) agree 
to participate in these analyses. 
All subjects will be assessed for eligibility against the inclusion and exclusion criteria 
and assigned a subject identification number. 
Quality of Life (QoL) Food Allergy QoL Questionnaire (FAQLQ)/Food Allergy 
Independent Measure (FAIM) forms20 (Appendix 14.3) will be completed by the subject 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend on the age of 
the subject at the time of Visit 1. 
The subject’s full medical history, including history of CMA and any other type of 
allergy, if applicable. 
Prior medications (received within 6 months prior to Visit 1) and ongoing medications 
will be documented. 
Demographic data, including date of birth, sex, ethnic origin, weight (kg), and height 
(cm) will be collected. 
A physical examination, including a complete skin examination, will be performed and 
the results documented. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, immunological 
markers (IgE, immunoglobulin G4 [IgG4]) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for filaggrin 
mutations may be collected; only 1 sample for filaggrin mutations is to be collected 
during the study, either at this visit or at other visits listed in Table 2, Table 3, Table 4, 
and Table 5. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
AEs will be recorded from the day of signing the ICF/IAF. 
7.2.1.2 
Visit 2 (First day of the Screening DBPCFC) 
Visit 2 can be scheduled and conducted as soon as the laboratory results from Visit 1 
are available and confirm the eligibility criterion related to the cow’s milk sIgE (ie, the 
sIgE must be ≥10 kU/L). This visit 2 corresponds to the first day of the screening 
DBPCFC. 
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 

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Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the Oral Food Challenge (OFC) symptom score sheets 
(see Appendix 14.2). 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
7.2.1.3 
Visit 3 (Second day of the Screening DBPCFC) 
Visit 3 corresponds to the second day of the screening DBPCFC. Visit 3 will be 
scheduled within 7 days after Visit 2. However, Visit 3 may be scheduled up to a 
maximum of 14 days after Visit 2 and documented in the eCRF, if either of the following 
occur: (1) the subject experiences reactions after the DBPCFC at Visit 2 that require 
more than 7 days to elapse before the next food challenge, or (2) any intercurrent 
disease preventing the second day of the challenge to be conducted safely as planned; 
in this specific condition, the timeframe between the 2 days of challenges might exceed 
14 days and must be appropriately documented, or (3) the subject’s schedule or site 
logistics prevent the second day of food challenge to be performed within 7 days of the 
first day.  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge, ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 

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objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.1 and recorded in the eCRF. 
This will be the last criterion to determine whether the subject is eligible to be 
randomized to treatment or not. If the subject is not eligible for participation in the 
study, the site staff must go into IWRS to register the subject as Screen Failure. If the 
subject is eligible for participation in the study, the site staff must go into IWRS to 
register the subject for randomization once the Cohort or Part is open for 
randomization. Randomization by IWRS can be performed as soon as the eligibility of 
the subject is confirmed at the end of Visit 3, and up to the day of Visit 4. 
7.2.2 Part A, Part B, 12-month open-label treatment with Viaskin Milk 500 µg and 
study extension  
The following visit schedule applies until Protocol Amendment 5 is approved and 
the subjects switch to Viaskin Milk 300 µg. However, no further DBPCFC should 
be conducted while the subjects are still receiving Viaskin Milk 500 µg.  
Refer to Section 7.2.3 as soon as the Viaskin Milk 300 µg is available at the study site. 
7.2.2.1 
Visit 4 (Day 1) 
Visit 4 (Day 1) should take place within a maximum of 60 days after Visit 1 (screening 
visit). This visit corresponds to the first day of treatment.  
Subjects will undergo the following procedures at this visit: 
Subjects will be reassessed for eligibility against the inclusion and exclusion criteria 
before proceeding to allocation of a treatment kit. The site staff must login into IWRS to 
be allocated a randomization treatment kit for the subject. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
One patch will be taken from the Visit 4 treatment box and applied to the subject’s skin 
as described in Section 6.3.  
For only Part B subjects, the Visit 4 treatment box will be dispensed to the subject for 
daily application until the next visit. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be dispensed to the subject and instructions will be given for completion. 
Epinephrine auto-injector and the Anaphylaxis Emergency Action Plan (Appendix 14.5) 
will be dispensed and/or their utilization reviewed, as necessary.  

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Part A subjects will be observed at the site for a minimum duration of 6 hours 
after application of the patch at this visit.  
Part B subjects will be observed at the site for a minimum duration of 3 hours 
after application of the patch at this visit. 
Subjects can then be discharged from the site only after this observation period. 
This period can be extended beyond 3 or 6 hours if deemed necessary by the 
Investigator. 
Vital signs, PEF measurements, and the examination, grading, and photography of the 
area of the skin where the Viaskin patch is applied will be performed at the following 
timepoints: before application of the first patch, then at 30 minutes, 1 hour, 2 hours, 
3 hours and 6 hours (when applicable) after application of the patch. Note: for subjects 
in Part B, the 6-hour timepoint is not required. 
Subjects and/or their parent(s)/guardian(s) will be instructed to use the diary card and 
to bring the card to the site at each subsequent visit. Subjects and/or 
parent(s)/guardian(s) will be instructed to record any AEs and associated medications 
on the diary cards and will also be reminded to record the duration of application and 
reason(s) for early removal of the Viaskin patch, if the patch is removed before the 
recommended duration of application. Any accidental cow’s milk consumption (in any 
form) must also be documented on the diary cards. At subsequent visits, the diary card 
will be reviewed and the data will be collected by site personnel. 
7.2.2.2 
Visit 5 (Day 2) (for Part A Subjects Only) 
This visit is required only for subjects enrolled in Part A and will take place the day after 
Visit 4.  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
A new patch will be taken from the Visit 5 treatment box and applied to the subject’s 
skin as described in Section 6.3. 
The Visit 5 treatment box will be dispensed to the subject for daily application until the 
next visit. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded if required. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), if required. 

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Subjects will be observed at site for a minimum duration of 2 hours after 
application of the patch. The observation period can be extended beyond these 
2 hours if deemed necessary by the Investigator. 
7.2.2.3 
Visit 6 (Day 8/Week 1 ±2 days) 
Visit 6 (Day 8/Week 1) will take place 7 days ±2 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The treatment box from the previous visit will be collected from the subject and drug 
accountability/compliance will be assessed. 
The Visit 6 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary.  
7.2.2.4 
Visit 7 (Day 22/Week 3 ±3 days) 
Visit 7 (Day 22/Week 3) will take place 21 days ±3 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
Blood samples for hematology and biochemistry laboratory tests, as well as for 
immunological markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at Visit 1. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 

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The Visit 6 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated an initial re-supply kit for the subject. The 
Visit 7 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.5 
Visit 8 (Week 6 ±3 days) 
Visit 8 (Week 6) will take place 6 weeks ±3 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 7 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
The Visit 8 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.6 
Visit 9 (Month 3 ±7 days) 
Visit 9 (Month 3) will take place 3 months ±7 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 

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Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 8 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated an additional re-supply kit for the subject. 
The Visit 9 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.7 
Visit 10 (Month 6 ±7 days)  
Visit 10 (Month 6) will take place 6 months ±7 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 9 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated an additional re-supply kit for the subject. 
The Visit 10 treatment box will be dispensed to the subject.  
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the 

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auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 
7.2.2.8 
Visit 11 (Month 9 ±7 days) 
Visit 11 (Month 9) will take place 9 months ±7 days after Visit 4 (Day 1).  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 10 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed.  
Site staff will login into IWRS to be allocated an additional re-supply kit for the subject. 
The Visit 11 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.9 
Visit 12 (Month 12 ±7 days; First Day of the Month 12 
DBPCFC) 
Visit 12 (Month 12) will take place 12 months ±7 days after Visit 4 (Day 1). Visit 12 
corresponds to the first day of the Month 12 DBPCFC. 
Subjects will undergo the following procedures at this visit: 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by the 
subject (when applicable) and parent(s)/guardian(s) before any procedures at this visit 
are performed. The appropriate QoL questionnaire forms to complete depend on the 
age of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 

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Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 11 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the 
auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
There will be no dispensation of the Investigational product at this visit since it will be 
the last day of the double-blind treatment period. It is recommended that a patch not be 
applied on the day of the DBPCFC procedures at Visit 12 and subjects should be 
instructed to not apply any patch between Visit 12 and Visit 13. 
7.2.2.10 
Visit 13 (Second day of the Month 12 DBPCFC) 
Visit 13 corresponds to the second day of the Month 12 DBPCFC. Visit 13 will take 
place within 7 days after Visit 12. However, Visit 13 may be scheduled up to a 
maximum of 14 days after Visit 12 and documented in the eCRF, if either of the 
following occur: (1) the subject experiences reactions after the DBPCFC at Visit 12 that 
require more than 7 days to elapse before the next food challenge, or (2) any 
intercurrent disease preventing the second day of the challenge to be conducted safely 
as planned; in this specific condition, the timeframe between the 2 days of challenges 
might exceed 14 days and must be appropriately documented, or (3) the subject’s 
schedule or site logistics prevent the second day of  food challenge to be performed 
within 7 days of the first day.  

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Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
Site staff will login into IWRS. The treatment kit to be allocated at this Visit 13 should 
be the first open-label treatment kit for the subject. The Visit 13 treatment box will be 
dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because (a) clear objective 
reaction(s) has (have) occurred, the order of the challenge formulas can be unblinded 
and the results of the challenge will be established as described in Section 7.3.1.1.2 
and recorded in the eCRF. 
Visit 13 corresponds to the start date of the open-label treatment period. If the subject 
experiences reactions after the DBPCFC at Visit 13 that warrant postponing the 
application of the first patch of the open-label treatment, it is permitted, at the discretion 
of the Investigator, to delay the application of the first patch of the open-label treatment 
up to a maximum of 7 days after Visit 13.  
7.2.2.11 
Visit 14 (21 days ±3 days after Visit 13) 
Visit 14 will take place 21 days ±3 days after Visit 13. 
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed. 

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Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 13 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed.  
The Visit 14 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.12 
Visit 15 (Month 18 ±14 days)  
Visit 15 (Month 18) will take place 6 months ±14 days after Visit 13.  
Subjects will undergo the following procedures at this visit: 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, as well as 
immunological markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 14 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a re-supply open-label kit for the subject. 
The Visit 15 treatment box will be dispensed to the subject. 

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Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
7.2.2.13 
Visit 16 (Month 24 ±14 days; First Day of the Month 24 
DBPCFC)  
Before implementation of Protocol Amendment 5 
Visit 16 (Month 24) will take place 12 months ±14 days after Visit 13. Visit 16 
corresponds to the first day of the Month 24 DBPCFC. It is recommended that a patch 
not be applied on that day until all DBPCFC procedures have been completed. 
Subjects will undergo the following procedures at this visit: 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend upon the age 
of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 15 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 

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Site staff will login into IWRS to be allocated a small re-supply open-label kit to cover 
the period between both days of the DBPCFC. The Visit 16 treatment box will be 
dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After implementation of Protocol Amendment 5 
Until the subjects can switch to Viaskin Milk 300 µg, the following will apply: 
• 
The Visit 16 will proceed without the procedures related to the DBPCFC; 
• 
Site staff will login into IWRS to be allocated treatment kits for both Visit 16 and 
Visit 17; 
• 
Visit 17 will not be conducted. 
7.2.2.14 
Visit 17 (Second day of the Month 24 DBPCFC) - Not to be 
conducted after implementation of Protocol Amendment 5 
Visit 17 corresponds to the second day of the Month 24 DBPCFC. It is recommended 
that a patch not be applied on that day until all DBPCFC procedures have been 
completed. 
Visit 17 will take place within 7 days after Visit 16. However, Visit 17 may be scheduled 
up to a maximum of 14 days after Visit 16 and documented in the eCRF, if either of the 
following occur: (1) the subject experiences reactions after the DBPCFC at Visit 16 that 
require more than 7 days to elapse before the next food challenge, or (2) any 
intercurrent disease preventing the second day of the challenge to be conducted safely 
as planned; in this specific condition, the timeframe between the 2 days of challenges 
might exceed 14 days and must be appropriately documented, or (3) the subject’s 
schedule or site logistics prevent the second day of food challenge to be performed 
within 7 days of the first day.  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 

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Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 16 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed.  
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 
objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.2 and recorded in the eCRF. 
After the second day of the Month 24 DBPCFC, eligible subjects will be proposed 
to enter the study extension to receive 2 additional years of EPIT with open-label 
Viaskin Milk 500 µg.  Subjects who enter the study extension will undergo the 
following additional procedures: 
Written and signed ICF/IAF to enter study extension will be collected at Visit 17, if not 
collected previously. 
Eligibility criteria to enter study extension will be assessed. 
Site staff will login into IWRS to be allocated a re-supply open-label kit for the subject. 
The Visit 17 treatment box will be dispensed to the subject. 
For the subjects who do not enter the study extension, there will be no 
dispensation of the Investigational Product at this visit. It will be the end of the 
open-label treatment period. A final EOS follow-up visit will take place 14 days after 
Visit 17. 
7.2.2.15 
Visit 18 (Month 30 ±14 days)  
For the subjects who enter the study extension, a Visit 18 (Month 30) will take place 
18 months ±14 days after Visit 13.  
Subjects will undergo the following procedures at this visit: 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 

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SPT to cow’s milk will be performed.  
Blood samples for hematology and biochemistry laboratory tests, as well as 
immunological markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 17 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a re-supply open-label kit for the subject. 
The Visit 18 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) will be provided, as necessary. The expiry 
date of the auto-injector will be checked and a new auto-injector should be dispensed 
to the subject, as necessary. 
7.2.2.16 
Visit 19 (Month 36 ±14 days; First day of the Month 36 
DBPCFC)  
Before implementation of Protocol Amendment 5 
For subjects who entered the study extension, Visit 19 (Month 36) will take place 24 
months ±14 days after Visit 13. Visit 19 corresponds to the first day of the Month 36 
DBPCFC. It is recommended that a patch not be applied on that day until all DBPCFC 
procedures have been completed. 
Subjects will undergo the following procedures at this visit: 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend on the age of 
the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 

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Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 18 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a small re-supply open-label kit to cover 
the period between both days of the DBPCFC. The Visit 19 treatment box will be 
dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period may be extended beyond 
3 hours if deemed necessary by the Investigator. 
After implementation of Protocol Amendment 5 
Until the subjects can switch to Viaskin Milk 300 µg, the following will apply: 
• 
The Visit 19 will proceed without the procedures related to the DBPCFC; 
• 
Site staff will login into IWRS to be allocated treatment kits for both Visit 19 and 
Visit 20; 
• 
Visit 20 will not be conducted. 
 
7.2.2.17 
Visit 20 (Second day of the Month 36 DBPCFC) - Not to be 
conducted after implementation of Protocol Amendment 5 
Visit 20 corresponds to the second day of the Month 36 DBPCFC. It is recommended 
that a patch not be applied on that day until all DBPCFC procedures have been 
completed. 
For subjects who entered the study extension, Visit 20 will take place within 7 days 
after Visit 19. However, Visit 20 may be scheduled up to a maximum of 14 days after 
Visit 19 and documented in the eCRF, if either of the following occurs: (1) the subject 
experiences reactions after the DBPCFC at Visit 19 that require more than 7 days to 

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elapse before the next food challenge, or (2) any intercurrent disease preventing the 
second day of the challenge to be conducted safely as planned; in this specific 
condition, the timeframe between the 2 days of challenges might exceed 14 days and 
must be appropriately documented, or (3) the subject’s schedule or site logistics 
prevent the second day of food challenge to be performed within 7 days of the first day.  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 19 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a re-supply open-label kit for the subject. 
The Visit 20 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period may be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 
objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.2 and recorded in the eCRF. 
7.2.2.18 
Visit 21 (Month 42 ±14 days) 
For subjects who entered the study extension, Visit 21 (Month 42) will take place 30 
months ±14 days after Visit 13.  
Subjects will undergo the following procedures at this visit: 
Weight (kg) and height (cm) will be measured. 

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A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, as well as 
immunological markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 20 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a re-supply open-label kit for the subject. 
The Visit 21 treatment box will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the 
auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 
7.2.2.19 
Visit 22 (Month 48 ±14 days; First day of the Month 48 
DBPCFC)  
Before implementation of Protocol Amendment 5 
For subjects who entered the study extension, Visit 22 (Month 48) will take place 36 
months ±14 days after Visit 13. Visit 22 corresponds to the first day of the Month 48 
DBPCFC. It is recommended not to apply a patch on that day until all DBPCFC 
procedures have been completed. 
Subjects will undergo the following procedures at this visit: 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend upon the age 
of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 

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Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for the analysis of 
filaggrin mutations may be collected at this visit if not collected at a previous visit. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 21 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated a small re-supply open-label kit to cover 
the period between both days of the DBPCFC. The Visit 22 treatment box will be 
dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period may be extended beyond 
3 hours if deemed necessary by the Investigator. 
After implementation of Protocol Amendment 5 
Until the subjects can switch to Viaskin Milk 300 µg, the following will apply: 
• 
The Visit 22 will proceed without the procedures related to the DBPCFC; 
• 
Visit 23 will not be conducted. 
 
7.2.2.20 
Visit 23 (Second day of the Month 48 DBPCFC) - Not to be 
conducted after implementation of Protocol Amendment 5 
Visit 23 corresponds to the second day of the Month 48 DBPCFC. It is recommended 
that a patch not be applied on that day as it will be the end of the open-label treatment 
period.  

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For subjects who entered the study extension, Visit 23 will take place within 7 days 
after Visit 22. However, Visit 23 may be scheduled up to a maximum of 14 days after 
Visit 22 and documented in the eCRF, if either of the following occur: (1) the subject 
experiences reactions after the DBPCFC at Visit 22 that require more than 7 days to 
elapse before the next food challenge, or (2) any intercurrent disease preventing the 
second day of the challenge to be conducted safely as planned; in this specific 
condition, the timeframe between the 2 days of challenges might exceed 14 days and 
must be appropriately documented, or (3) the subject’s schedule or site logistics 
prevent the second day of food challenge to be performed within 7 days of the first day.  
Subjects will undergo the following procedures at this visit: 
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit 22 treatment box will be collected from the subject and drug 
accountability/compliance will be assessed. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period may be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 
objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.2 and recorded in the eCRF. 
All ongoing subjects will terminate the study at Month 48. There will be no 
dispensation of the Investigational product at this visit since it will be the end of the 
open-label treatment period for subjects who entered the study extension. A final EOS 
follow-up visit will take place 14 days after Visit 23. 

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7.2.2.21 
Additional Phone Contacts 
In addition to the regular study visits at site, the study personnel will contact the 
subjects/subjects’ guardians or parents by telephone to inquire about AEs, especially 
skin-related symptoms, and concomitant treatments if any. 
• Individual phone contacts (PCs) are designated “PC” followed by the number of 
the most recent clinic visit (e.g., “9”), followed by the letter “a” for the first phone 
call after that clinic visit, “b” for the next phone call after that same clinic visit, 
and so forth). During the first year of treatment, 7 PCs are scheduled at: Month 
2 (PC8a) 
• Month 4 (PC9a) 
• Month 5 (PC9b) 
• Month 7 (PC10a) 
• Month 8 (PC10b) 
• Month 10 (PC11a) 
• Month 11 (PC11b). 
The dates of these PCs during the first year of treatment will be calculated from the 
date of Visit 4 (Day 1), with a permitted window of  7 days. 
During the second year of treatment, 4 additional phone contacts (PCs) are scheduled 
at: 
• Month 14 (PC14a) 
• Month 16 (PC14b) 
• Month 20 (PC15a) 
• Month 22 (PC15b). 
The dates of these PCs during the second year of treatment will be calculated from the 
date of Visit 13 (start date of the open-label treatment period), with a permitted window 
of  7 days. 
For the subjects who enter in the study extension, 4 additional phone contacts (PCs) 
are scheduled at: 
• Month 27 (PC17a) 
• Month 33 (PC18a) 
• Month 39 (PC20a) 
• Month 45 (PC21a) 
The dates of these PCs during the third and fourth year of treatment will be calculated 
from the date of Visit 13 (start date of the open-label treatment period), with a permitted 
window of 14 days. 

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7.2.3 Open-label treatment with Viaskin Milk 300 µg 
The following study flowchart will apply after the implementation of Protocol Amendment 
5 and the subjects can switch to Viaskin Milk 300 µg.  
For the subjects not consenting to switch to Viaskin Milk 300 µg, the following procedures 
should be performed: 
• EOS visit procedures (Table 3) if the subject has reached Month 24 of open-label 
treatment with Viaskin Milk 500 µg, 
• ET visit procedures (Table 4 or Table 5) in all other cases. 
 
For the eligible subjects consenting to switch to Viaskin Milk 300 µg, the visit schedule 
and procedures are described in the sections below. Visit timepoints are in reference to 
the switch to Viaskin Milk 300 µg (e.g. “Month 6” should be understood as “Month 6 
following the switch to Viaskin Milk 300 µg”). 
7.2.3.1 
Visit S1 (Day 1) 
The subject should be contacted to schedule Visit S1 (Day 1).  
Signed written ICF/IAF for the switch to Viaskin Milk 300 µg will be obtained before any 
assessments are made. 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend upon the age 
of the subject at the time of Visit 1. 
Site staff will login into IWRS to be allocated open-label 300 µg kits for the subject. Visit 
S1 treatment boxes will be dispensed to the subject. The treatment box of the previous 
visit will be collected from the subject and drug accountability/compliance will be 
assessed.  
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected, unless already done within 1 month. In this case, 
the results of the previous visit may be used for Day 1. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be dispensed to the subject and instructions will be given for completion. 
Epinephrine auto-injector and the Anaphylaxis Emergency Action Plan (Appendix 14.5) 
will be dispensed and/or their utilization reviewed, as necessary. The expiry date of the 
auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 

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Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
7.2.3.2 
Visit S2 (Month 6 ±14 days) 
Visit S2 (Month 6) will take place 6 months ±14 days after Visit S1 (Day 1).  
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend upon the age 
of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit S1 treatment boxes will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated to be allocated open-label 300 µg kits for 
the subject. The Visit S2 treatment boxes will be dispensed to the subject.  
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the 
auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
7.2.3.3 
Visit S3 (Month 12 ±14 days; First Day of the optional Month 
12 DBPCFC) 
Visit S3 (Month 12) will take place 12 months ±14 days after Visit S1 (Day 1), for all 
subjects. Visit S3 corresponds to the first day of the optional Month 12 DBPCFC. 
Performing Month 12 DBPCFC is optional. If a subject experienced a severe 
anaphylaxis to cow’s milk during the MILES study, whether or not occurring during the 
DBPCFC, no further DBPCFC should be conducted for this subject. 
If the subject decides to perform the DBPCFC, no patch should be applied on that day 
until all DBPCFC procedures have been completed. 

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QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by the 
subject (when applicable) and parent(s)/guardian(s) before any procedures at this visit 
are performed. The appropriate QoL questionnaire forms to complete depend on the 
age of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination including a complete skin examination will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology, biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit S2 treatment boxes will be collected from the subject and drug 
accountability/compliance will be assessed. Site staff will login into IWRS to be 
allocated open-label 300 µg kits for the subject. The Visit S3 treatment boxes will be 
dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the 
auto-injector will be checked and a new auto-injector should be dispensed to the 
subject, as necessary. 
Only for subjects performing the DBPCFC: the grading of each symptom will be 
made using the grading definitions in the OFC symptom score sheets 
(see Appendix 14.2). Physical examination and vital signs measurements can be 
repeated anytime during the DBPCFC, as judged necessary by the Investigator. 
AEs occurring during the DBPCFC should be collected. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator.  
7.2.3.4 
Visit S4 (Second day of the optional Month 12 DBPCFC; only 
for subjects who performed the first day of the DBPCFC) 
Visit S4 will be performed only for subjects who performed the first day of the Month 12 
DBPCFC. This visit corresponds to the second day of the Month 12 DBPCFC. No 

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patch should be applied on that day until all DBPCFC procedures have been 
completed. 
Visit S4 will take place within 7 days after Visit S3. However, Visit S4 may be 
scheduled up to a maximum of 14 days after Visit S3 and documented in the eCRF, if 
either of the following occur: (1) the subject experiences reactions after the DBPCFC at 
Visit S3 that require more than 7 days to elapse before the next food challenge, or (2) 
any intercurrent disease preventing the second day of the challenge to be conducted 
safely as planned; in this specific condition, the timeframe between the 2 days of 
challenges might exceed 14 days and must be appropriately documented, or (3) the 
subject’s schedule or site logistics prevent the second day of food challenge to be 
performed within 7 days of the first day.  
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 
objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.2 and recorded in the eCRF. 

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7.2.3.5 
Visit S5 (Month 18 ±14 days) 
Visit S5 (Month 18) will take place 18 months ±14 days after Visit S1.  
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by the 
subject (when applicable) and parent(s)/guardian(s) before any procedures at this visit 
are performed. The appropriate QoL questionnaire forms to complete depend on the 
age of the subject at the time of Visit 1. 
Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, as well as 
immunological markers (IgE, IgG4) will be collected. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit S3 treatment boxes will be collected from the subject and drug 
accountability/compliance will be assessed. 
Site staff will login into IWRS to be allocated open-label 300 µg kits for the subject. The 
Visit S5 treatment boxes will be dispensed to the subject. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5) as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
7.2.3.6 
Visit S6 (Month 24 ±14 days; First Day of the optional Month 
24 DBPCFC) 
Visit S6 (Month 24) will take place 24 months ±14 days after Visit S1. Visit S6 
corresponds to the first day of the optional Month 24 DBPCFC. It is optional to perform 
Month 24 DBPCFC. If a subject experienced a severe anaphylaxis to cow’s milk during 
the MILES study, whether or not occurring during the DBPCFC, no further DBPCFC 
should be conducted for this subject. 
 If the subject decides to perform the DBPCFC, no patch should be applied on that day 
until all DBPCFC procedures have been completed. 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by subjects 
(when applicable) and parent(s)/guardian(s) before any procedures at this visit are 
performed. The appropriate QoL questionnaire forms to complete depend upon the age 
of the subject at the time of Visit 1. 

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Weight (kg) and height (cm) will be measured. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, and immunological 
markers (IgE, IgG4) will be collected. 
Only for subjects who signed the genetic ICF/IAF: a blood sample for epigenetic 
analysis will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
There will be no dispensation of the Investigational product at this visit. 
Only for subjects performing the DBPCFC: the grading of each symptom will be 
made using the grading definitions in the OFC symptom score sheets 
(see Appendix 14.2). Physical examination and vital signs measurements can be 
repeated anytime during the DBPCFC, as judged necessary by the Investigator. 
AEs occurring during the DBPCFC should be collected. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator.  
Only for subjects not performing the DBPCFC: The Visit S5 treatment boxes will be 
collected from the subject and drug accountability/compliance will be assessed. 
7.2.3.7 
Visit S7 (Second day of the optional Month 24 DBPCFC; only 
for subjects who performed the first day of the DBPCFC) 
Visit S7 corresponds to the second day of the Month 24 DBPCFC. This visit will be 
performed only for subjects performed the first day of the DBPCFC. No patch should 
be applied on that day until all DBPCFC procedures have been completed. 
Visit S7 will take place within 7 days after Visit S6. However, Visit S7 may be 
scheduled up to a maximum of 14 days after Visit S6 and documented in the eCRF, if 
either of the following occur: (1) the subject experiences reactions after the DBPCFC at 
Visit S6 that require more than 7 days to elapse before the next food challenge, or (2) 
any intercurrent disease preventing the second day of the challenge to be conducted 

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safely as planned; in this specific condition, the timeframe between the 2 days of 
challenges might exceed 14 days and must be appropriately documented, or (3) the 
subject’s schedule or site logistics prevent the second day of food challenge to be 
performed within 7 days of the first day.  
A physical examination, including a complete skin examination, will be performed 
before the DBPCFC and can be repeated anytime during the DBPCFC, as judged 
necessary by the Investigator. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured before the DBPCFC and can be repeated 
anytime during the DBPCFC, as judged necessary by the Investigator. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
DBPCFC will be performed and the grading of each symptom will be made using the 
grading definitions in the OFC symptom score sheets (see Appendix 14.2). 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be checked and given back to the subject and instructions 
repeated/reminded, if required. 
The Visit S5 treatment boxes will be collected from the subject and drug 
accountability/compliance will be assessed. 
Review/reminder of the utilization of the epinephrine auto-injector and the Anaphylaxis 
Emergency Action Plan (Appendix 14.5), as necessary. The expiry date of the auto-
injector will be checked and a new auto-injector should be dispensed to the subject, as 
necessary. 
A minimum duration of 3 hours observation after the last dose of the food 
challenge formula has been ingested is required at this visit, before the subject 
is discharged from the site. The observation period can be extended beyond 
3 hours if deemed necessary by the Investigator. 
After completion of the second day of the food challenge ie, after the last dose of the 
challenge has been administered or the challenge stopped because of (a) clear 
objective reaction(s) has (have) occurred, the order of the challenge formulas can be 
unblinded and the results of the challenge will be established as described in 
Section 7.3.1.1.2 and recorded in the eCRF. 
There will be no dispensation of the Investigational product at this visit since it will be 
the end of the treatment period. A final EOS follow-up visit will take place 14 days after 
Visit S7. 
7.2.3.8 
Additional Phone Contacts 
In addition to the regular study visits at site, the study personnel will contact the 
subjects/subjects’ guardians or parents by telephone to inquire about AEs, especially 
skin-related symptoms, and concomitant treatments if any. 
During the first year of treatment with Viaskin Milk 300 µg, 3 PCs are scheduled at 
Month 1, Month 4 and Month 9, with a permitted window of  14 days. 

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During the second year of treatment with Viaskin Milk 300 µg, 2 PCs are scheduled at 
Month 15 and Month 21, with a permitted window of  14 days. 
7.2.4 End-of-Study Follow Up Visit 
All subjects will have an EOS follow-up visit when they terminate their participation in 
the study. 
For subjects who complete the study at Month 24 of the open-label treatment period 
with Viaskin Milk 500 µg, the EOS visit will take place 14 days ±3 days after Visit 17 or 
after Visit 16 if the DBPCFC is not performed according to Protocol Amendment 5. 
For subjects who will switch to Viaskin Milk 300 µg, this EOS follow-up visit will take 
place: 
• 
If the subject did not perform the DBPCFC at Visit S6: 14 days ±3 days after 
Visit S6; 
• 
If the subject performed the DBPCFC at Visit S6: 14 days ±3 days after the last 
day of the DBPCFC. 
The site staff must go into IWRS to register the subject for completion. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 
PEF measurements (depending on the subject’s age and ability to perform these tests) 
will be obtained. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be collected. 
An EOS survey will be completed by the Investigator. 
7.2.5 Early Termination Visit 
The early termination visit is applicable for subjects withdrawing from the study 
prematurely. The site staff must go into IWRS to register the subject for early 
withdrawal. 
The following data will be collected from subjects who are withdrawn before completing 
the study: 
QoL questionnaire FAQLQ/FAIM forms (Appendix 14.3) will be completed by the 
subject (when applicable) and parent(s)/guardian(s) before any procedures at this visit 
are performed. The appropriate QoL questionnaire forms to complete depend on the 
age of the subject at the time of Visit 1. 
A physical examination, including a complete skin examination, will be performed. 
Vital signs (heart rate, systolic and diastolic blood pressure, and respiratory rate) for 
subjects in a sitting position will be measured. 

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Spirometry and PEF measurements (depending on the subject’s age and ability to 
perform these tests) will be obtained. 
SPT to cow’s milk will be performed. 
Blood samples for hematology and biochemistry laboratory tests, as well as 
immunological markers (IgE, IgG4) will be collected. 
A urine pregnancy test will be performed for female subjects with childbearing potential. 
Any AEs that have occurred since the previous visit will be documented and any 
changes in medications reported. 
Examination, grading, and photography of the area of the skin used for Viaskin patch 
application will be performed. 
Diary card will be collected. 
The treatment box from the previous visit is collected from the subject (when 
applicable) and drug accountability/compliance will be assessed. 
An EOS survey will be completed by the Investigator. 
 
7.3 
Efficacy and Safety Variables  
The timepoints of the planned study assessments are summarized in the Schedule of 
Assessments (Table 2 to Table 7). 
7.3.1 Efficacy Assessments 
Efficacy assessments will include the following variables: 
• 
Cumulative Reactive Dose (CRD) of cow’s milk proteins during the DBPCFC 
• 
Serum immunology: Levels of sIgE and allergen-specific IgE to cow’s milk, 
caseins, -lactalbumin, and -lactoglobulin, levels of specific IgG4 to total cow’s 
milk (not applicable after the switch to Viaskin Milk 300 µg), to caseins, -
lactalbumin, and -lactoglobulin. 
• 
Severity of symptoms elicited during the milk DBPCFC  
• 
SPT to cow’s milk 
• 
QoL assessments 
7.3.1.1 
Double-Blind Placebo-Controlled Food Challenge to Cow’s 
Milk (DBPCFC) 
A detailed Manual of Procedures for the preparation of the challenge formulas and for 
the conduct of the DBPCFC will be provided to the Investigators and their medical 
teams as well as to the site personnel that will be dedicated for the preparation of the 
challenge formulas. This could be dieticians, study nurses, pharmacists, pharmacy 
technicians, licensed medical assistants, or any other qualified site personnel, as 
delegated by the Investigator; only the site personnel dedicated to the preparation of 
the challenge formulas will be unblinded to the order of the formulas administered on 
the 2 days of the DBPCFCs. An outline of the procedures is specified in this section 
and the grading of each symptom will be made using the grading definition of the OFC 
symptom score sheets provided in Appendix 14.2. 

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The DBPCFC is the gold standard to diagnose and assess food allergy. The subject 
will be gradually fed with increasing amounts of cow’s milk proteins under medical 
observation. The challenge occurs over two days and must take place under direct 
medical supervision in a hospital/clinic setting with resuscitation equipment and 
emergency medications and staff immediately available. It is recommended to have an 
intravenous (i.v.) line in place prior to challenging the subjects; however, the final 
decision not to place this i.v. line can be made on a case-by-case basis at the 
discretion of the Investigator. A local anesthetic cream can be used for establishing this 
i.v. line, especially for children. If a site prefers to have the subjects come to the 
hospital the day before the conduct of the DBPCFC, to prepare them for the following 
day, this is allowed and will not be considered an SAE.  
Subjects must be off antihistamines 1 to 7 days (depending of the half-life, see 
Appendix 14.7) prior to any DBPCFC. Subjects will not be allowed to use long-acting 2 
agonists (eg, formoterol) within 36 hours prior to any DBPCFC. Subjects who received 
more than a 3-day course of systemic corticosteroids within 4 weeks of a DBPCFC 
should have the DBPCFC rescheduled to allow for 4 weeks of corticosteroids wash-
out. For subjects who require more than 1 day of systemic corticosteroids to treat 
reactions that occurred during the first day of the DBPCFC, the second day of the 
DBPCFC can be conducted only from the fourth day onwards. 
A DBPCFC will be performed at screening (Visits 2 and 3), at Month 12 (Visits 12 
and 13); a DBPCFC was planned at Month 24 (Visits 16 and 17) and for subjects who 
entered the study extension, at Month 36 (Visits 19 and 20) and Month 48 (Visits 22 
and 23), but these food challenges should no longer be performed while the subjects 
are still receiving Viaskin Milk 500 µg. A DBPCFC can be performed after 12 months 
(Visits S3 and S4) and/or 24 months (Visits S6 and S7) of treatment with Viaskin Milk 
300 µg, at the decision of the Investigator and the subject.  
No DBPCFC will be performed while the subjects are still receiving Viaskin Milk 
500 µg and until they reach 12 months of treatment with Viaskin Milk 300 µg.  
Each DBPCFC will comprise 2 visits: 1 visit for the Placebo Challenge and 1 visit for 
the Milk Challenge. The order of the 2 formulas is not known to the medical team until 
the end of the second day of the challenge. The second day of the food challenge 
should take place within 7 days (one week) after the first day of the food challenge. 
However, the second day may be scheduled up to a maximum of 14 days after the first 
food challenge and documented in the eCRF, if any of the following occurs: (1) the 
subject experiences reactions after the DBPCFC on the first day that require more than 
7 days to elapse before the next food challenge, or (2) any intercurrent disease 
preventing the second day of the challenge to be conducted safely as planned, such as 
a rhinitis, bronchitis or gastrointestinal infection; in this specific condition and for safety 
reasons, the timeframe between the 2 days of challenges might exceed 14 days and 
must be appropriately documented, or (3) the subject’s schedule or site logistics 
prevent the second day of food challenge to be performed within 7 days of the first day. 
The order of the food challenge (milk or placebo) will be blinded; it will be determined 
using a randomization table that will be distributed to site personnel dedicated to the 
preparation of the challenge formulas (see Section 8.4). After both days of a DBPCFC 
have been completed, the order of the food challenge (ie, actual visits that the milk and 
placebo challenges were administered) can be revealed for completion of the eCRF. 
The subject should have a light breakfast and may drink water at home at least 2 hours 
before starting the DBPCFC at the site. During the conduct of the challenge no other 
food (except for the food challenge formula) should be consumed by the subject. Water 
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during the challenge. After the last dose of the food challenge, the subject should wait 
at least 1 hour before ingesting any other food and/or drinking large volumes of water. 
The contents of the first meal after the food challenge should be light. 
All DBPCFCs will consist of administering cow’s milk proteins (or placebo) in gradually 
increasing doses at 20-minute intervals. The Investigator may use clinical judgment to 
increase the intervals between doses in case there is a suspicion that an objective 
reaction may be developing (see Section 7.3.1.1.3). 
Before implementation of Protocol Amendment 5, DBPCFCs to milk and to other 
allergens were strictly forbidden. After implementation of Protocol Amendment 5, 
DBPCFCs to milk (including baked milk, and outside of the one described in this 
protocol) will still be strictly forbidden as long as the subject is part of the study but 
performing DBPCFCs to any other food for the subject’s medical management will be 
permitted. Whether the subject’s medical condition is still compatible with their 
participation in the study should be assessed by the Investigator and the Sponsor’s 
medical monitor before the food challenge is performed. If not compatible, the Sponsor 
may decide to discontinue the subject from the study. Note that the initiation of other 
immunotherapy treatment remains prohibited during the participation of the subject in 
the MILES study (refer to Section 6.5.2). Viaskin Milk patches should not be applied 
on the day of a food challenge and until all procedures are completed. Information 
on food challenges to other allergens than cow’s milk will also be recorded in the 
eCRF. 
7.3.1.1.1 DBPCFC at Screening (Visits 2 and 3) 
During the screening DBPCFC, the doses of cow’s milk proteins to be ingested will be 
1 mg, 3 mg, 10 mg, 30 mg, 100 mg, and 300 mg administered at 20-minute intervals. 
The Investigator may use clinical judgment to increase the intervals between doses in 
case there is a suspicion that an objective reaction may be developing (see 
Section 7.3.1.1.3). Very occasionally, the Investigator may use clinical judgment to 
repeat the same dose (but only once) before administration of the next higher dose and 
only if there is a suspicion that an objective reaction may be developing (see 
Section 7.3.1.1.3). The dose and the time of administration of each dose (and of a 
repeated dose when applicable) will be recorded in the eCRF. The subjects will be kept 
under observation for an additional 3 hours after the ingestion of the last dose of the 
challenge formula. 
The subjects must react objectively (see Section 7.3.1.1.3) at or below the eliciting 
dose of 300 mg of cow’s milk proteins to be eligible for randomization to treatment. 
Hence, this screening DBPCFC will be stopped at or below the dose of 300 mg on 
either day of the challenge (milk or placebo), whether reactions have occurred or not. 
Subjects who have not reacted objectively at or below the eliciting dose of 300 mg of 
cow’s milk proteins will be considered ineligible for this study.  
All subjects should undergo procedures of the DBPCFC on both days. However, in 
exceptional cases, the DBPCFC on the second day of the challenge might not be 
performed if the subject had a severe anaphylactic reaction during the first day of the 
challenge, leaving no doubt about the nature of the formula administered, ie, cow’s 
milk. In this rare case and in this case only, the food challenge formula will be 
unblinded to confirm that the subject effectively received the milk formula. A severe 
anaphylactic reaction would involve a >20% drop of blood pressure, cyanosis or 
Sp02<92%, confusion, collapse, loss of consciousness, 3 doses of epinephrine or more 
(see Appendix 14.4).  

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At the end of the second day of the food challenge (Visit 3), the sequence of the 
2 formulas (milk or placebo) administered to the subject will be unblinded by the 
appropriate unblinded staff (eg, dieticians, study nurses, pharmacists, pharmacy 
technicians, licensed medical assistants, or any other qualified site personnel, as 
delegated by the Investigator) and revealed to the medical staff. The results of the 
challenge will then be established and recorded in the eCRF as follows: 
1. The subject had objective symptoms to the placebo formula at any dose leading 
to stopping the challenge. S/He cannot be randomized in the study. 
2. The subject had no objective symptoms during the 2 days of the DBPCFC, 
neither to the placebo nor to the milk formula, even at the highest dose of 
300 mg of cow’s milk proteins. S/He is considered not allergic enough to cow’s 
milk to participate in this study and cannot be randomized in the study. 
3. The subject had no objective symptom when receiving placebo but had an 
objective reaction (as defined in Section 7.3.1.1.3) at 1 of the doses of the milk 
formula consumed between 1 mg and 300 mg inclusive. S/He will be 
randomized in the study as s/he reacted to a dose of milk proteins lower than or 
equal to 300 mg (eliciting dose). 
7.3.1.1.2 DBPCFC at Month 12 (Visits 12 and 13), Month 24 (Visits 16 and 17), 
Month 36 (Visits 19 and 20), and Month 48 (Visits 22 and 23), and optional 
DBPCFC after 12 months (Visits S3 and S4) and 24 months (Visits S6 and 
S7) of treatment with Viaskin Milk 300 µg  
No patch should be applied on the day of the DBPCFC until all DBPCFC procedures 
have been completed. 
Following results of the 12-month blinded period, the DBPCFCs that were to be 
performed at Month 24, Month 36 and Month 48 should not be conducted while the 
subjects are still receiving Viaskin Milk 500 µg.  
After subjects switch to Viaskin Milk 300 µg, the DBPCFCs at 12 months and 24 
months will be optional and left at the Investigator’s and the subject’s decision. 
However, if a subject experienced a severe anaphylaxis to cow’s milk during the 
MILES study, whether or not occurring during the DBPCFC, no further DBPCFC 
should be conducted for this subject. 
All DBPCFCs at Month 12 and forward will be conducted using the same procedures 
that are described for the screening DBPCFC, with the exception that the dosing will 
continue beyond the 300 mg dose of cow’s milk proteins if there are no objective 
symptoms (see Section 7.3.1.1.3) at the 300 mg dose. The challenge must be 
continued up to the last dose of 3000 mg of cow’s milk proteins or until an objective 
reaction occurs (as defined in Section 7.3.1.1.3). 
For all DBPCFCs at Month 12 and forward, the doses of cow’s milk proteins will be 
1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 1000 mg, 2000 mg, and 3000 mg 
administered at 20-minute intervals. The Investigator may use clinical judgment to 
increase the intervals between doses in case there is a suspicion that an objective 
reaction may be developing (see Section 7.3.1.1.3). Very occasionally, the Investigator 
may use clinical judgment to repeat the same dose (only once) before administration of 
the next higher dose and only if there is a suspicion that an objective reaction may be 
developing (see Section 7.3.1.1.3). The dose and time of administration of each dose 
(and of a repeated dose when applicable) will be recorded in the eCRF. The subjects 

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Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
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will be kept under observation for an additional 3 hours after the ingestion of the last 
dose of the challenge formula. 
Subjects should undergo both days of the DBPCFC (milk and placebo). However, in 
exceptional cases, the DBPCFC on the second day of the challenge might not be 
performed if the subject had a severe anaphylactic reaction during the first day of the 
challenge, leaving no doubt about the nature of the formula administered, ie, cow’s 
milk. In this rare case and in this case only, the formula will be unblinded to confirm that 
the subject effectively received the milk formula. A severe anaphylactic reaction would 
involve a >20% drop of blood pressure, cyanosis or Sp02<92%, confusion, collapse, 
loss of consciousness, 3 doses of epinephrine or more (see Appendix 14.4). 
At the end of the second day of the food challenge, the sequence of the 2 formulas 
(milk or placebo) administered will be unblinded by the appropriate unblinded staff (eg, 
dieticians, study nurses, pharmacists, pharmacy technicians, licensed medical 
assistants, or any other qualified site personnel, as delegated by the Investigator) and 
revealed to the medical staff. The results of the challenge will then be established and 
recorded in the eCRF. 
7.3.1.1.3 Criteria for Stopping the DBPCFC 
The instructions for each of the DBPCFCs during the double-blind period (Screening, 
Month 12), the Viaskin Milk 500 µg open-label period (Month 24, Month 36 and Month 
48) and the Viaskin Milk 300 µg open-label period (12 and 24 months after the switch) 
are provided below. Further details are provided in the Manual of Procedures for the 
DBPCFC.  
Only clear-cut OBJECTIVE immediate-type symptom(s) requiring treatment will be 
considered a permissible reason to stop the DBPCFC and to determine the eliciting 
dose (highest dose given during the challenge) and the CRD of cow’s milk. For the 
open-label treatment period with Viaskin Milk 300 µg, abdominal complaints will also be 
considered as a criterion for stopping the challenge (see below). The main objective 
symptoms to expect are as follows (this list is not exhaustive; also refer to 
Appendix 14.2, OFC Symptom Score Sheets21, 22): local or generalized pruritus, 
flushing, local or generalized urticaria, hives, swollen lips, swollen tongue, throat 
tightness, vomiting, diarrhea, dyspnea, rhinorrhea, sneezing, wheezing, conjunctivitis, 
asthma, drop of the PEF, hypoxia, hypotension, hypotonia, decreased level of 
consciousness associated with collapse and/or incontinence or other life threatening 
symptoms. 
The stopping rules applying for DBPCFCs performed during the double-blind placebo-
controlled period and the open-label treatment period with Viaskin Milk 500 µg were the 
following: 
• 
There is a >1-point rise in an objective symptom from any category in the OFC 
Symptom Score Sheets, except only for pruritus, which requires >2-point rise 
• 
There is ≥1-point rise in an objective symptom from ≥2 categories in the OFC 
Symptom Score Sheets 
• 
There is a 1-point rise in an objective symptom from 1 category in the OFC 
Symptom Score Sheets, with the following exceptions: 
o Pruritus : 0 to 1 or 0 to 2 
o Urticaria: 0 to 1 

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o Rash: 0 to 1 
o Sneezing/Itching: 0 to 1 
o Nasal Congestion: 0 to 1 
o Rhinorrhea: 0 to 1 
o Laryngeal: 0 to 1 (if explained and not persistent) 
The stopping rules applying for DBPCFCs performed during the open-label treatment 
period with Viaskin Milk 300 µg are the following: 
Only 1 out of 5 categories has increased its grading symptom score 
 
≥ 1-point rise 
(i.e. mild, moderate or severe) 
OR 
≥ 2-point rise 
(i.e. moderate or severe) 
OR 
3-point rise 
(i.e. severe) 
o Wheezing 
o Objective Gastrointestinal** 
o Cardiovascular/neurological*** 
o 
Urticaria  
o 
Angioedema 
o 
Rash 
 
o Pruritus 
o Sneezing 
/Itching  
o Nasal 
Congestion  
o Rhinorrhea 
o Conjunctivitis 
o Abdominal 
complaints 
 
2 categories (or more) have increased their grading symptom scores 
 
≥ 1-point rise 
(i.e. mild, moderate or severe) 
AND 
≥ 2-point rise 
(i.e. moderate or severe) 
o 
Urticaria 
o 
Angioedema 
o 
Rash 
o 
Laryngeal* 
o 
Wheezing 
o 
Objective Gastrointestinal** 
o 
Cardiovascular/neurological*** 
o 
Pruritus 
o 
Sneezing/Itching 
o 
Nasal Congestion 
o 
Rhinorrhea 
o 
Conjunctivitis 
o 
Abdominal complaints 
 
* “Laryngeal” means symptoms due to laryngeal oedema and must be differentiated 
from another cause of cough like pharyngeal transient irritation or lower respiratory 
symptoms. Transient laryngeal irritation will not be considered as an objective OFC 
symptom and will not be considered in the stopping rules. 
**For emesis/vomiting, the symptoms may result from two different situations: 
vomiting/spitting-up during the feeding, resulting from subjective intolerance to the food 
formula or vomiting/emesis resulting from a gastrointestinal allergic reaction to the milk 
allergen, usually delayed from the feeding. Only the second situation will be considered 
as an objective OFC symptom and will be considered for the stopping rules. 
***Cardiovascular symptoms: hypotension or cardiovascular failure directly related to 
the systemic allergic reaction. They have to be differentiated from similar symptoms 
related to another cause, such as a dizziness induced by vomiting. 
In case of subjective symptoms, eg, mouth pruritus, throat pruritus, nausea, abdominal 
pain or any other subjective symptoms at a specific dose, deemed significant enough 
to question whether an objective symptom could occur, the Investigator can, under 
these conditions, extend the time between the previous dose and the next dose to see 
how the subject’s symptom(s) evolve(s). The same dose can be repeated only once, to 
check whether the subjective symptom(s) reappear(s) or not and with what intensity, 
and whether (an) objective symptom(s) now clearly appear(s). If (an) objective 

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Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 84 of 170 
The subjects must not take antihistamines for 1 to 7 days (depending on the half-life; 
see Appendix 14.7) prior to the test. Briefly, a skin lancet is pressed through a small 
drop of the commercial extract of cow’s milk and positive (histamine) and negative 
controls, into the epidermis of the volar surface of the forearm or back of the forearm. 
The area is measured for the average wheal diameter after 15 minutes. The average 
wheal diameter corresponds to the average of the size of the longest diameter and the 
longest perpendicular diameter. A tracing should be obtained by using a fine ballpoint 
pen. The tracing will be performed at the demarcation line for the wheal as the skin 
drops back to flush. Scotch or a clear transport tape should be used to lift the tracing 
and the tape tracing should be stuck in the subject’s dossier. 
The SPT should be performed by the same assessor at each visit, if possible, and the 
results will be recorded on the appropriate page(s) of the eCRF. 
7.3.1.4 
Quality of Life Questionnaire Forms 
The QoL questionnaire FAQLQ/FAIM forms23 was to be completed by the subjects 
(when applicable, depending on age) and parents/guardians at Screening Visit 1, at 
Month 12 and Month 24, and at Month 36 and Month 48 for subjects who entered the 
study extension (Table 2, Table 3, Table 4, and Table 5). The QoL questionnaire will be 
completed at the time of the switch and after 6, 12, 18 and 24 months of treatment with 
Viaskin Milk 300 µg (Table 6 and Table 7). At these visits, the QoL forms must be 
completed by the subjects (depending on the subject’s age at the time of Visit 1) and 
parents/guardians before any other study procedures are performed on that day. 
The appropriate QoL questionnaire forms to complete depend on the age of the subject 
at Visit 1, as follows:  
• 
Subjects 8 to 12 years old at the time of Visit 1 will complete the form 
FAQLQ-CF (Child Form) at Screening (Visit 1) and at Month 12 and Month 24, 
and at Month 36 and Month 48 for subjects who entered the study extension. 
Subjects who are 7 years old at the time of Visit 1 may also complete the form 
FAQLQ-CF at Screening (Visit 1), if their parent(s)/guardians(s) consider they 
are able to complete these questionnaires, so that when they turn 8 years old at 
Month 12, they will have a baseline questionnaire available. However, this is not 
mandatory. 
• 
Subjects 13 to 17 years old at the time of Visit 1 will complete the form 
FAQLQ-TF (Teenager Form) at Visit 1 and at Month 12 and Month 24, and at 
Month 36 and Month 48 for subjects who entered the study extension.  
• 
Parents/guardians of subjects 0 to 12 years old at the time of Visit 1 will 
complete the form FAQLQ-PF at Visit 1 and at Month 12 and Month 24, and at 
Month 36 and Month 48 for subjects who entered the study extension. 
• 
Parents/guardians of subjects 13 to 17 years old at the time of Visit 1 will 
complete the form FAQLQ-PFT at Visit 1 and at Months 12 and 24 and at 
Month 36 and Month 48 for subjects who entered the study extension.  
The FAIM is included as a part of the questionnaires listed above. The QoL 
questionnaire forms are included in Appendix 14.3. 
Data collected in the QoL forms must be entered on the appropriate pages of the 
eCRF. In order to maintain an unbiased assessment, the Investigator or study site 

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24 June 2019 
Confidential  
Page 85 of 170 
personnel must not influence the subject and/or parent(s)/guardian(s) while they are 
completing the forms. 
7.3.2 Safety Assessments 
Safety assessments will include the following: 
• 
AEs (including Viaskin Milk-induced local AEs and SAEs) 
• 
Vital Signs 
• 
Physical examinations (including complete skin examination) 
• 
Clinical laboratory data 
• 
Spirometry and PEF data 
7.3.2.1 
Adverse Events 
7.3.2.1.1 Definitions of an Adverse Event 
An AE is defined as any untoward medical occurrence in a clinical study subject 
administered a medicinal product and which does not necessarily have a causal 
relationship with this treatment. An AE can therefore be any unfavourable and 
unintended sign (including an abnormal laboratory finding or vital sign measurement), 
symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product.24 This 
includes an exacerbation of pre-existing conditions or events, intercurrent illnesses, 
drug interaction or the significant worsening of the indication under investigation that is 
not recorded elsewhere in the eCRF under specific efficacy assessments. Note: A 
procedure is not an AE, but the reason for the procedure may be an AE. 
It is the responsibility of the Investigators to document all AEs that occur during the 
study. AEs will be elicited by asking the subject or his/her parent(s)/guardian(s) a 
nonleading question, for example, “Are there any new or changed symptoms since we 
last asked or since your last visit?” AEs should be reported on the appropriate page of 
the eCRF.  
All AEs occurring after the first Viaskin patch application will be considered treatment-
emergent AEs (TEAEs). TEAEs will be defined as any AEs, regardless of relationship 
to Investigational product, which occur during or after the initial Viaskin patch 
application or any event already present that worsens in either intensity or frequency 
following exposure to the Viaskin patch. If relationship information is missing for a 
TEAE, it will be considered drug-related. AEs with missing or incomplete onset date will 
be treated as TEAEs and missing onset date will be imputed as date of initial Viaskin 
patch application unless there is evidence that the event occurred before the treatment 
period. 
Assessment of Severity 
Each AE will be assigned a category by the Investigator as follows: 
Mild 
An AE that is easily tolerated by the subject, causes minimal discomfort 
and does not interfere with everyday activities. 
Moderate 
An AE that is sufficiently discomforting to interfere with normal everyday 
activities; intervention may be needed. 

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24 June 2019 
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Severe 
An AE that prevents normal everyday activities; treatment or other 
intervention may be needed. 
If there is a change in severity of an AE, it must be recorded as a separate event. 
The severity of anaphylactic reactions, including those reported as part of medical 
history, will be assessed using the Anaphylaxis Staging System (Appendix 14.4). For 
anaphylactic reactions occurring during the DBPCFC, only those considered to be a 
SAE will be assessed for severity. 
Assessment of Causality 
The relationship between an AE and the investigational product will be determined by 
the Investigators on the basis of his/her clinical judgment and the following definitions: 
Unrelated 
Clinical event with an incompatible time relationship to the 
investigational product administration, and that could be explained by 
underlying disease or other drugs or chemicals or is incontrovertibly 
not related to the investigational product. 
Unlikely 
Clinical event whose time relationship to the investigational product 
administration makes a causal connection improbable, but that could 
plausibly be explained by underlying disease or other drugs or 
chemicals. 
Possible 
Clinical event with a reasonable time relationship to the 
investigational product administration, but that could also be 
explained by concurrent disease or other drugs or chemicals. 
Probable 
Clinical event with a reasonable time relationship to the 
investigational product administration, and is unlikely to be attributed 
to concurrent disease or other drugs or chemicals. 
Definite 
Clinical event with plausible time relationship to the investigational 
product administration, and that cannot be explained by concurrent 
disease or other drugs or chemicals. 
All SAEs assessed as “definitely related”, “probably related” and “possibly related” will 
be categorized as “related” for expedited reporting. 
Action Taken 
The Investigators will describe the action taken with the drug product in the appropriate 
section of the eCRF, as follows: 
• 
None: No change in the dose of the study product. 
• 
Discontinued permanently: The study product was permanently stopped. 
• 
Temporarily interrupted: Dosing of the study product was interrupted. 
• 
Other: Specify. 
Outcomes of Adverse Events 
The Investigators will describe the outcome of the AEs in the appropriate section of the 
eCRF, as follows: 

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• 
Recovered/Resolved: The subject fully recovered from the AE with no 
residual effect observed. 
• 
Recovered/Resolved with sequelae: The residual effects of the AE are still 
present and observable. 
• 
Ongoing: The AE itself is still present and observable. 
• 
Death. 
• 
Unknown/Lost to follow up. 
Treatment Required 
The Investigators will describe if the subject was treated for an AE in the appropriate 
section of the eCRF, as follows: 
• 
None: No treatment was required. 
• 
Medication required: Prescription and/or over-the-counter medication were 
required to treat the AE. 
• 
Hospitalization or prolongation of hospitalization required: Hospitalization 
was required or prolonged due to the AE, whether or not medication was 
required. 
• 
Other: Specify. 
More than one option can be recorded to report all treatments given for each AE. 
7.3.2.1.2 Reporting and Follow-up of Adverse Events 
AEs will be reported and documented in accordance with the procedures outlined in 
this section. AEs will be reported from the time of informed consent through to the EOS 
visit and documented on the appropriate AE pages of the eCRF. 
The Investigator will be responsible for ensuring that correct information concerning all 
AEs is included on the appropriate pages of the eCRF. 
The following data should be documented for each AE: 
Diagnosis of the event if available and description of the symptom event. 
Classification of ‘serious’ or ‘not serious.’ 
Severity. 
Date of first occurrence and date of resolution (if applicable). 
Action taken. 
Treatment required. 
Causal relationship. 
Outcome of event (recovered, recovered with sequelae, ongoing, death [with date and 
cause reported], unknown). 
All Investigators should follow up subjects with AEs until the event is resolved or until, 
in the opinion of the Investigator, the event is stabilized or determined to be chronic. 
Details of AE resolution must be documented in the eCRF. 
Based on the medical judgment of the Investigator, all non-serious AEs (including the 
abnormal laboratory values identified as AEs by the Investigator) will be followed until 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 88 of 170 
30 days after the removal of the last Viaskin patch. All unresolved, nonserious AEs 
beyond such date will be recorded as “ongoing” without further follow-up. 
7.3.2.2 
Serious Adverse Events 
7.3.2.2.1 Serious Adverse Event Definition 
An SAE is any untoward medical occurrence or effect that, at any dose: 
• Results in death. 
• Is life-threatening. This means that the subject is at risk of death at the time of the 
event; it does not mean that the event might hypothetically have caused death if 
it was more severe.  
Note: Whereas an anaphylactic reaction is generally considered to be 
potentially life-threatening, not all anaphylaxes put the subjects at immediate 
risk of death, if for example appropriate treatments lead to symptoms reduction 
or disappearance. As per the Anaphylaxis Staging System classification 
(Appendix 14.4), an anaphylaxis assessed as mild or moderate should not be 
classified as life-threatening. 
• Requires hospitalization (at least overnight stay or inpatient hospital admission) 
or prolongation of existing hospitalization  
Events associated with hospitalization for the following reasons will not be 
considered as a SAE: 
1. Evaluation or treatment of a pre-existing (before informed consent 
signature) and non-exacerbating condition: 
a. The condition existed prior to the subject’s entry into the study and has 
been recorded in the subject’s disease/medical history and the e-CRF 
AND  
b. The condition has not worsened in severity or frequency during the 
subject’s exposure to the investigational product AND  
c. It has not required a change in treatment management during the 
subject’s exposure to the investigational product; 
2. Hospitalization for a planned treatment of a pre-existing (before informed 
consent signature) and non-exacerbating condition; 
3. Hospitalization the day prior to or after the day of DBPCFC for practical 
reasons and without any AE fulfilling any other seriousness criterion. 
• Results in persistent or significant disability/incapacity (an AE is incapacitating or 
disabling if it results in a substantial and/or permanent disruption of the 
subject’s ability to carry out normal life functions). 
• Is a congenital anomaly/birth defect. 
• 
Is an “important medical event” that may not be immediately life-threatening or 
result in death or hospitalization but that may jeopardize the subject or require 
intervention to prevent one of the above outcomes. Examples of such events are 
intensive treatment in an emergency room or at home for allergic bronchospasm; 
blood dyscrasias or convulsions that do not result in hospitalization; or development 
of drug dependency or drug abuse.   
o An anaphylactic reaction classified as severe using the Anaphylaxis Staging 
System in Appendix 14.4 (i.e., anaphylactic reaction with cyanosis or SpO2 

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Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 90 of 170 
• 
Investigator name and site number 
• 
Event term 
• 
Event onset date 
• 
Serious criteria 
• 
Relationship to study drug 
Where applicable, information from relevant laboratory results, hospital case records 
and autopsy reports should be obtained. 
Instances of death, congenital abnormality or an event that is of such clinical concern 
as to influence the overall assessment of safety, if brought to the attention of the 
Investigator at any time after cessation of the investigational product administration and 
linked by the Investigator to this study should be reported to the study monitor. 
The sponsor and/or the CRO will promptly notify all relevant Investigators of findings 
that could adversely affect the safety of subjects, impact on the conduct of the study, or 
alter the IRB approval/favourable opinion of the study. In addition, the CRO, on behalf 
of the sponsor, will expedite the reporting to all concerned Investigators, to the DSMB 
and IRBs, where required, of all adverse reactions that are both serious and 
unexpected. The sponsor or designee will be responsible to notify the regulatory 
authorities of any adverse reactions as described above. 
Follow-up of all SAEs will be done until the outcome is resolved, has reached a stable 
condition in the Investigator’s opinion, or until the subject is lost to follow-up. 
7.3.2.3 
Unexpected Adverse Reactions 
7.3.2.3.1 Unexpected Adverse Reaction Definition 
An unexpected adverse reaction is any untoward and unintended response that is 
related to the administration of an investigational product at any dose that is not 
consistent with the applicable product information (eg, Investigator’s Brochure for an 
unauthorized investigational product). 
Serious adverse events that are both related (according to the Sponsor and/or the 
Investigator) to investigational medicinal product(s) and unexpected (according to the 
Sponsor based on the Reference Safety Information in use) will usually be assessed as 
reportable by the sponsor to Competent Authorities. 
Sponsor will directly or through contracted service providers submit expedited and 
periodic reports to Competent Authorities, Ethics Committees and Investigators per 
regulations and procedures in use, taking into account local specific requirements. 
All suspected unexpected serious adverse reactions (SUSARs) will be subject to 
expedited reporting. The CRO and/or the sponsor shall ensure that all relevant 
information about a SUSAR that is fatal or life-threatening is reported to the relevant 
competent authorities, Ethics Committees and Investigators within 7 calendar days 
after knowledge by the sponsor of such a case and that relevant follow-up information 
is communicated within an additional 8 calendar days. All other SUSARs will be 
reported to the relevant competent authorities, Ethics Committees and Investigators 
within 15 calendar days after knowledge by the sponsor of such a case. 

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CCI

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 92 of 170 
immediately and no later than 24 hours and reported to DBV GSP department using 
the same procedure as described for reporting SAEs (Section 7.3.2.2). If the pregnancy 
is to be terminated, the anticipated date of termination should be provided. 
Follow-up in the Event of a Pregnancy  
The sponsor will be informed of all pregnancies in study subjects. 
The subject will be asked to provide information on the outcome of the pregnancy, 
including premature termination should the case arise. Spontaneous miscarriages, 
ectopic pregnancies and congenital abnormalities will be reported as SAEs. Information 
on the status of the mother and child will be forwarded to DBV medical monitor and 
GSP. Generally, follow-up will be in accordance with regulatory guidance and at least 6 
to 8 weeks after the estimated delivery date. Any premature termination of the 
pregnancy will be reported. 
7.3.2.5 
Adverse Events of Special Interest to the Sponsor 
AEs of special interest (AESI) to the sponsor in this study will include: 
Local AESI:  
Any reaction at patch application site which could potentially lead to skin barrier 
disruption, such as but not limited to: blister, vesicle, ulcerative skin lesion, bleeding or 
any Grade 4 patch site reaction.  
 
Systemic AESI:  
Any acute systemic immediate allergic reactions (rapid onset) after exposure to known 
or suspected allergen, regardless of the causal relationship to the investigational 
product and occurring outside the DBPCFCs: 
1. Anaphylactic reaction: 
a. 
Any adverse event diagnosed by a physician as anaphylactic reaction, 
regardless of the severity and causal relationship to the investigational 
product. 
b. 
Anaphylactic reaction defined as the occurrence of the following allergic 
symptoms: 
i. 
Major acute allergic reaction (associated or not with other symptoms): acute 
hypotension (>20% drop in blood pressure) or associated cardiovascular 
symptoms (hypotonia, confusion, loss of consciousness, collapse, syncope, 
incontinence), 
ii. 
2 or more concomitant acute allergic symptoms from at least 2 different 
organ systems such as, but not limited to: 
• 
Upper airway or respiratory symptoms (dyspnea, wheeze-
bronchospasm, stridor, hypoxemia, decreased SaO2) 
• 
Acute and persistent gastro-intestinal symptoms (abdominal pain, 
cramps, vomiting) 
• 
Acute skin or mucosal tissue symptoms (angioedema, urticaria, 
pruritus, flush, swollen-lips-tongue, uvula) 
• 
Acute cardiovascular symptoms (hypotonia, reduced blood pressure) 
2. 
Any systemic hypersensitivity reaction leading to epinephrine use. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 93 of 170 
7.3.2.6 
Accidental Consumption of Cow’s Milk 
Any reaction triggered by accidental consumption of cow’s milk (in any form) during the 
conduct of the study. This event will be reported in a specific section of the eCRF. 
 
7.3.2.7 
Vital Signs 
Vital sign measurements will include heart rate, systolic and diastolic blood pressure, 
and respiratory rate. Measurements will be collected at each visit (see Table 2 to Table 
7), before the DBPCFC, and during the DBPCFC at the Investigator’s discretion, when 
applicable.  
Vital signs will be measured in a standardized manner, ie, after the subject has rested 
in the sitting position for 5 minutes and recorded in the eCRF. The criteria to determine 
clinically significant abnormalities in vital sign measurements are presented in 
Section 8.1.7.2. 
Weight and height measurements will also be collected for each subject at screening 
and at 6-month intervals during the study (Visits 10, 12, 15, and 16, and for the 
subjects who entered the study extension at Visits 18, 19, 21, and 22, and for the 
subjects who will switch to Viaskin Milk 300 µg, at Visits S1 to S7). 
7.3.2.8 
Physical Examination and Skin Reaction Grading 
Physical examination will include, but is not limited to, head, eyes, ears, nose, and 
throat (HEENT), as well as a complete examination of the skin, and will be performed 
at each visit (see Table 2 to Table 7), before the DBPCFC, and during the DBPCFC at 
the Investigator’s discretion, when applicable. 
Local skin reactions of the area of the skin used for application of the Viaskin patch on 
the arms (adolescents and former adolescents who become adults) or back (children) 
will be graded (Table 1) by the same Investigator at each visit if possible, according to 
the slightly modified recommendations of the EAACI/GA2LEN position paper.25 
Table 1: 
Skin Reaction Grading System 
Grade 
Skin Reaction 
Grade 0 
Negative 
Grade 1  
Only erythema, or erythema + infiltration 
Grade 2  
Erythema, few papules 
Grade 3  
Erythema, many or spreading papules 
Grade 4  
Erythema, vesicles 
 
Viaskin patches are transparent and the degree of local reactions can be easily seen 
through the patch. Grades of local skin reactions on the arms or the back will be 
recorded in the eCRF when subjects arrive at the site for a visit. 
If Grade 4 local skin reactions are observed, patch application should be transiently 
interrupted and the subject should visit the site for the next application (see 
Section 6.3.2). 
Photographic records will be taken of the site(s) of application of the Viaskin patch and 
filed in the subject’s medical records or source documents and provided to the CRO or 
sponsor as necessary upon request. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 94 of 170 
7.3.2.9 
Clinical Laboratory Evaluation 
Hematology, biochemistry, and any other laboratory tests will be analyzed at a central 
laboratory(ies) designated by the sponsor. Reference ranges will be supplied and used 
by the Investigator to assess the laboratory data for clinical significance and 
pathological changes. 
Blood samples will be collected from subjects at the timepoints listed in the Schedule of 
Assessments (Table 2 to Table 7). Instructions for blood sample collection, storage, 
and shipment will be provided in the laboratory manual. 
The following laboratory tests will be performed using collected samples: 
Hematology 
Hemoglobin, hematocrit, platelets, red blood cells (RBC), white blood cells (WBC), and 
differentials. 
Biochemistry 
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, total 
protein, blood urea nitrogen (BUN), and creatinine. 
Total Blood Volume Requirements 
The estimated maximum blood volume that will be collected from each subject during a 
visit will be approximately 15 mL for hematology and biochemistry laboratory tests and 
efficacy or exploratory assessments (serum immunology markers [Section 7.3.1.2], 
filaggrin mutations, and epigenetic analyses [Section 7.3.3]), up to Month 48, and 
approximately 12.5 mL during the treatment period with Viaskin Milk 300 µg. 
The estimated maximum total blood volume that will be collected from each subject up 
to Month 24 will be approximately 80 mL. For subjects who enter the study extension 
(Month 24 to 48), approximately 50 mL of additional blood will be collected. 
Consequently, the estimated maximum volume of total blood to be collected from each 
subject during the whole study (up to Month 48) was to be approximately 130 mL. For 
subjects who switch to Viaskin Milk 300 µg, up to 57.5 mL of additional blood will be 
collected within 24 months. The total blood volume requirement does not exceed the 
recommended sample blood volume of 3 mL/kg and up to 50 mL total within 8 weeks.26 
7.3.2.10 
Other Laboratory Variables 
For female subjects of childbearing potential, a urine sample will be collected to screen 
for pregnancy (urine β-HCG) at the visits listed in Table 2 to Table 7. 
7.3.2.11 
Spirometry and Peak Expiratory Flow 
Spirometry, measured as FEV1, will be performed for subjects ≥6 years old (unless 
they have documented inability to adequately perform spirometry) and the PEF will be 
assessed for subjects ≥5 years old at the timepoints listed in Table 2 to Table 7. PEF 
will not be collected for subject <5 years. Spirometry and/or PEF data (depending on 
the subject’s age and ability to perform these tests) will be documented on the 
appropriate pages of the eCRF. 
FEV1 will be measured on a standardized calibrated spirometer following the American 
Thoracic Society (ATS) guidelines. At least 3 acceptable maneuvers will be obtained 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 95 of 170 
and the highest values will be recorded in the eCRF. For subjects who are too young or 
who have documented inability to adequately perform the spirometry according to the 
ATS, only PEF values will be used. Again, at least 3 acceptable maneuvers will be 
obtained and the highest value will be recorded in the eCRF. 
7.3.2.12 
Subject Diary Cards 
Diary cards will be dispensed to the subjects at Visit 4 and as needed during the study. 
At each subsequent visit after Visit 4, the diary card will be reviewed by appropriate 
personnel at the site and the data in the card will be collected for entry into the eCRF or 
into the clinical database. 
Subjects or their parent(s)/guardian(s) will be instructed how to use the diary card from 
Visit 4 (Day 1) and to bring the card to the site at each subsequent visit. Subjects or 
their parent(s)/guardian(s) will be instructed to record on their diary cards any 
AEs/medical events and associated medications, the duration of application and 
reason for removal of the Viaskin patch, if the patch is removed before the 
recommended duration in addition to any information regarding cow’s milk consumption 
(including dairy products or any baked milk product) during their participation in the 
study. 
At the clinical site, upon review of the diary cards, the investigative staff will interview 
the subject to know whether the milk consumption was either accidental or voluntary. 
This will be useful for the Investigators to assess whether there has been any 
risk-taking behavior and collect as much information as possible about those cases. 
7.3.3 Exploratory Assessments 
Blood samples will be collected from subjects to assess levels of sIgE to peanut, egg, 
house dust mite and grass pollen at the timepoints listed in the Schedule of 
Assessments (Table 2 to Table 7).  Blood samples for serum immunology markers will 
be analyzed at a central laboratory designated by the sponsor. Instructions for blood 
sample collection, storage, and shipment will be provided in the laboratory manual. 
For the analysis of the mutations in the filaggrin gene, blood samples will be collected 
from subjects only after the genetic ICF/IAF are signed. Blood samples will be collected 
at the time of Visit 1. If not collected at Visit 1, blood samples for filaggrin analysis can 
be collected at any subsequent visit where blood is drawn (see Table 2, Table 3, 
Table 4, and Table 5), but only 1 sample collection for filaggrin is required during the 
study. No blood sample will be drawn for filaggrin analysis during the 24-month 
treatment period with Viaskin Milk 300 µg. The genetic screening of the mutations of 
the filaggrin gene will be performed at a central laboratory designated by the sponsor. 
For epigenetic analyses, blood samples will be collected from subjects only after the 
genetic ICF/IAF are signed. Blood samples will be collected at the visits specified in the 
Schedules of Assessments (Table 2 to Table 7). The sample will be stored and may be 
used to assess any epigenetic modifications such as DNA methylation in some allergy-
related genes that could play a role in the development of immune tolerance. These 
tests will be done at a central laboratory designated by the sponsor. 
Instructions for the collection, storage, and shipment of samples collected for the 
filaggrin and/or epigenetic analyses will be provided in the laboratory manual. 
An EOS survey will be completed by the Investigator for each individual subject when 
their participation in the study is terminated (see Table 2 to Table 7). This survey will 

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allow assessment of the planned management of the subject after termination of the 
study. 

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Table 2/Table 3/ Table 4/ Table 5: (Continued) Schedule of Assessments Legend 
1. 
Screening period, between V1 and V4 should be within 60 days. V2 (first day of food challenge) can be scheduled as soon as the laboratory results from V1 are available. 
2. 
End-of-Study Early Termination Visit is applicable only for subjects withdrawing from the study prematurely. 
3. 
Visit may be scheduled up to a maximum of 14 days after previous visit and documented in the eCRF. 
4. 
V4 is the first dosing visit. For subjects in Part A, procedures marked (4) should be performed at the site at the following timepoints: before the first Viaskin patch 
application, then 30 min, 1h, 2h; 3h and 6h after the first patch is applied. For subjects randomized in the Part B, the procedures should be performed at the same 
timepoints, except the 6h timepoint. 
5. 
V5 is applicable only for subjects randomized in Part A.  
6. 
Six (6) hours of observation for Part A subjects after the patch is applied at V4; 3h of observation for Part B subjects after the patch is applied at V4. At visits when a 
DBPCFC is performed, a minimum of 3h of observation after the last dose of the food challenge formula has been ingested. 
7. 
Genetic Informed Consent for filaggrin and epigenetic analyses is optional.  
8. 
Including history of cow’s milk allergy and any other types of allergy if applicable. 
9. 
Including date of birth, sex, ethnic origin, weight (kg) and height (cm). At V10, V12, V15, V16, and at V18, V19, V21, and V22 for subjects who entered in the study 
extension, only the subject’s weight and height will be collected. 
10. Eligibility criteria must be checked and confirmed at V4 (Day 1). 
11. Including, but not limited to, head, eyes, ears, nose, and throat (HEENT), and a complete examination of the skin. 
12. Physical examination and vital sign measurements must be performed before the DBPCFC and can be repeated anytime during the DBPCFC, as judged necessary by 
the Investigator. 
13. Vital signs measured in a sitting position include heart rate, systolic and diastolic blood pressure and respiratory rate. 
14. FAQLQ/FAIM: Quality of Life questionnaire forms to be completed must correspond to each subject’s age at V1. The questionnaires must be completed before any 
procedures at all visits when QoL forms are completed. 
15. Spirometry and/or peak expiratory flow measurements, depending upon the subject’s age and ability to perform these tests.  
16. Laboratory tests include Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells and differentials; Biochemistry: aspartate aminotransferase 
(AST), alanine aminotransferase (ALT), total bilirubin, total protein, blood urea nitrogen (BUN) and creatinine.  
17. Immunological markers include: sIgE and sIgG4 to whole cow’s milk proteins, caseins, α-lactalbumin, and β-lactoglobulin; and sIgE to peanut, egg, house dust mite, and 
grass pollen.  
18. Sample for the analysis of filaggrin mutations will be collected only once: this could be at V1 or at any of the visits mentioned. This is optional. Samples will be collected 
only after the genetic ICF/IAF is signed.  
19. This is optional. Samples will be collected only after the genetic ICF/IAF is signed. 
20. Only for female subjects of child-bearing potential. Additional pregnancy testing may be repeated during the study at the discretion of the Investigator. 
21. AEs are collected from the day of signing the ICF/IAF. 
22. The epinephrine auto-injector and the Anaphylaxis Emergency Action Plan are dispensed and their utilization explained at V4; epinephrine auto-injector training must be 
appropriately documented in the source documents. At subsequent study visits, utilization will be reviewed whenever necessary. Expiry date will be checked and a new 
auto-injector provided as necessary. 
23. IP Dispensation at V17 and beyond is applicable only to subjects who enter the study extension. 
24. Subjects will perform only one FU visit, 14 days after V16 or V17 for subjects ending at Month 24, or 14 days after V22 or V23 for subjects who were in the study 
extension up to Month 48. For subjects who do not consent to switch to Viaskin Milk 300 µg and who just reached V16, the EOS FU visit should take place within 14 days 
of V16. 
25. Signed Informed Consent/Assent to enter study extension will be obtained no later than at V17. 
26. Eligibility criteria will be assessed at V17 before subjects enter the study extension. 
27. Following results of the 12-month blinded period, the DBPCFCs that were to be performed at Month 24, Month 36 and Month 48 should not be conducted while the 
subjects are still receiving Viaskin Milk 500 µg. Visits V17, V20 and V23 are no longer applicable.  
28. Visits and phone contacts during the third and fourth years are applicable only to subjects who entered the study extension after V17. 

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Abbreviations: D=Day; DBPCFC=Double-Blind Placebo-Controlled Food Challenge; EOS=End-of-Study; ET=Early Termination; FAIM=Food Allergy Independent Measure; 
FAQLQ=Food Allergy Quality of Life Questionnaire; FEV1=Forced Expiratory Volume in 1 second; FU=Follow-up; Ig=Immunoglobulin; IP=Investigational Product; M=Month; 
Min=Minimum; NA=Not Applicable; PC=Phone Contact; V=Visit; W=Week. 
 
 

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Legend for Table 6 and Table 7: 
1. 
End-of-Study Early Termination Visit is applicable only for subjects withdrawing from the study prematurely. 
2. 
Visit may be scheduled up to a maximum of 14 days after previous visit and documented in the eCRF. 
3. 
At visits when a DBPCFC is performed, a minimum of 3h of observation after the last dose of the food challenge formula has been ingested. 
4. 
Including, but not limited to, head, eyes, ears, nose, and throat (HEENT), and a complete examination of the skin. 
5. 
Physical examination and vital sign measurements must be performed before the DBPCFC and can be repeated anytime during the DBPCFC, as judged necessary by 
the Investigator. 
6. 
Vital signs measured in a sitting position include heart rate, systolic and diastolic blood pressure and respiratory rate. 
7. 
FAQLQ/FAIM: Quality of Life questionnaire forms to be completed must correspond to each subject’s age at V1. The questionnaires must be completed before any 
procedures at all visits when QoL forms are completed. 
8. 
Spirometry and/or peak expiratory flow measurements, depending upon the subject’s age and ability to perform these tests.  
9. 
Laboratory tests include Hematology: hemoglobin, hematocrit, platelets, red blood cells, white blood cells and differentials; Biochemistry: aspartate aminotransferase 
(AST), alanine aminotransferase (ALT), total bilirubin, total protein, blood urea nitrogen (BUN) and creatinine.  
10. If performed within 1 month of VS1, the collection of blood for laboratory tests, immunological markers and epigenetic analyses is optional at VS1. 
11. Immunological markers include: sIgE to whole cow’s milk proteins, caseins, α-lactalbumin, and β-lactoglobulin; sIgG4 to caseins, α-lactalbumin, and β-lactoglobulin; sIgE 
to peanut, egg, house dust mite, and grass pollen.  
12. For subjects who signed the genetic ICF/IAF. 
13. Only for female subjects of child-bearing potential. Additional pregnancy testing may be repeated during the study at the discretion of the Investigator. 
14. DBPCFC is optional and left at the Investigator’s and the subject’s decision 
15. Review of utilization of the epinephrine auto-injector and the Anaphylaxis Emergency Action Plan whenever necessary. Expiry date will be checked, and a new auto-
injector provided as necessary. 
16. IP accountability will be performed at Visit S6 if the subject does not perform the DBPCFC at Visit S6. IP accountability will be performed at Visit S7 if the subject performs 
the DBPCFC at Visit S6. 
Abbreviations: D=Day; DBPCFC=Double-Blind Placebo-Controlled Food Challenge; EOS=End-of-Study; ET=Early Termination; FAIM=Food Allergy Independent Measure; 
FAQLQ=Food Allergy Quality of Life Questionnaire; FEV1=Forced Expiratory Volume in 1 second; FU=Follow-up; Ig=Immunoglobulin; IP=Investigational Product; M=Month; 
Min=Minimum; PC=Phone Contact; V=Visit; W=Week. 
 
 

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8 
Statistical Methods 
8.1 
Statistical and Analytical Plans 
A statistical analysis plan (SAP) will be prepared and finalized prior to database lock. 
The SAP will ensure that the study data listings, summary tables, and figures that will 
be produced, and the statistical methodologies that will be used, are complete and 
appropriate to allow valid conclusions regarding the study objectives. 
8.1.1 Datasets or Populations Analyzed 
The Safety Set (SS) will include all subjects who applied at least 1 Viaskin patch. 
Subjects will be analyzed according to treatment received. In case of wrong 
dispensation, the subject will be analyzed according to the treatment received the 
longest, or as it will be determined at the Blind Data Review Meeting (BDRM), on a 
case-by-case basis. The SS will be used for all safety analysis tables and listings. 
The Intent-to-Treat Set (ITT) will include all randomized subjects. Subjects will be 
analyzed according to randomized treatment. The ITT Set will be used for all analyses 
of efficacy endpoints.  
The Per Protocol Set (PPS) will include all subjects from the ITT population who do not 
have major protocol violations that may affect the primary endpoint. Major protocol 
deviations will be defined in the SAP.  
Protocol deviations will be categorized as either major or minor and discussed during 
the blinded data review meeting (BDRM). Decisions taken at the BDRM will be 
documented and approved by DBV prior to database lock and unblinding the study. 
The Open-label Sets (OLS) will include all subjects from the ITT who entered the 
open-label treatment period (ie, who applied at least one Viaskin Milk patch during the 
open-label treatment period) and will be described in the SAP.  
The Open-label Set 300 µg (OLS_300) will include all subjects who switched to Viaskin 
Milk 300 µg and will be described in the SAP.  
8.1.2 General Considerations 
There will be 2 age groups considered for the statistical analyses: 
• 
Children: 2 to 11 years of age at the time of Visit 1 
• 
Adolescents: 12 to 17 years of age at the time of Visit 1 
Data will be summarized by age group, dose level, and pooled placebo group for the 
randomized blinded treatment period (Months 0 to 12) as follows: 
Part A and Part B: Viaskin Milk 150 µg, 300 µg, 500 µg of cow’s milk proteins, and 
placebo. 
Part A and Part B subjects will be combined and pooled by dose level, as 
applicable, for the efficacy analyses at Month 12. 
In general, categorical data will be summarized using counts and percentages, and 
continuous variables will be summarized using the number of subjects with evaluable 

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data (n), mean, standard deviation, median, first and third quartiles (Q1, Q3), minimum 
and maximum. 
All hypothesis tests will be in scope of dose-response or longitudinal analyses. 
Listings of raw subject data will be sorted by dose level, randomization number and 
visit, as applicable, for all randomized subjects. For subjects in Part A, data from 
Cohorts 1, 2, and 3 will be presented separately in the listings. 
8.1.3 Subject Disposition 
The number and percentage of subjects in each analysis population (ITT, PPS, SS, 
OLS and OLS_300) will be summarized overall and by treatment group (dose 
level/placebo). 
Subject disposition will be summarized for all subjects in the ITT. The number and 
percentage of subject completed, discontinued, and the primary reason for early 
withdrawal from the study will be tabulated by dose level and placebo group. 
8.1.4 Demographic and Other Baseline Characteristics 
For continuous demographic variables and baseline characteristics (including age, 
height, weight, body mass index (BMI, kg/m²), body surface (m²), weight/height (kg/m), 
SPT mean wheal diameter, FEV1 percent predicted [spirometry], PEF percent 
predicted, CRD of cow’s milk, and milk sIgE), descriptive will be generated for each 
dose level and placebo group at Visit 1 for all subjects in the ITT. 
For categorical demographic variables and baseline characteristics (including sex, 
ethnic origin, and medical history), the number and percent of subjects in each 
category will be tabulated for each dose level and placebo group at Visit 1 for all 
subjects in the ITT. 
The same descriptive summaries will be repeated at the entry of the Open-Label period 
and at the entry of the switch to Viaskin Milk 300 µg. 
Individual subject demographic and baseline characteristics data will be listed. 
8.1.5 Concomitant Medications 
Concomitant medications will be coded using the World Health Organization Drug 
Dictionary (WHODrug). A summary of concomitant medications by the second level 
Anatomical Therapeutic Chemical (ATC) term and preferred term will be produced 
overall and by age group, for each dose level and placebo group on the ITT for the 
randomized blinded treatment period (Months 0 to 12).  
Concomitant medications during the open-label treatment periods after Month 12 will 
be described. Details will be provided in the SAP. 
 
8.1.6 Efficacy  
Missing data will not be imputed for the efficacy analyses except for the classification of 
treatment responders / non responders for the primary efficacy analysis. 

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8.1.6.1 
Primary Efficacy Endpoint and Analysis 
The primary efficacy endpoint will be the percentage (%) of subjects who are treatment 
responders after 12 months of EPIT treatment. 
A treatment responder is defined as a subject who meets at least one of the following 
criteria: 
• 
A ≥10-fold increase in the CRD of cow’s milk proteins at the Month 12 DBPCFC 
as compared to baseline value and reaching at least 144 mg of cow’s milk 
proteins (approximately 4.5 mL of milk). 
• 
A CRD of cow’s milk proteins ≥1444 mg (approximately 45 mL of milk) at the 
Month 12 DBPCFC. 
The CRD of cow’s milk proteins is entered directly in CRF by the sites and is calculated 
as the sum of all doses of cow’s milk proteins given during the challenge, including repeat 
doses if applicable, and exact quantity of the last dose given (if not given in totality). 
The percentage of subjects who are treatment responders after 12 months of EPIT 
treatment will be calculated on the ITT population using missing = failure imputation 
method (ie, subjects with missing observation at Month 12 will be considered as non-
responders). 
The number and percentage of responders will be summarized overall and by age 
group, for each pooled dose level (Part A and Part B) and placebo group, for the 
blinded treatment period (Months 0 to 12). 
Methods of exact logistic regression will be used to compare the proportion of 
treatment responders at Month 12 in each dose level to placebo, adjusting for age 
group, and including the treatment group as fixed effect, for subjects in the ITT 
population. P-values, odds ratios together with associated 95% Confidence Intervals 
(95% CI) will be presented.  
The primary efficacy endpoint of this study, together with additional exploratory 
analyses, will assess the dose-response relationship and aim to inform the dose 
selection for phase 3.  Model-based analytical approaches of exploratory dose 
finding (e.g., MCP-Mod) will be used to evaluate the dose-response relationship 
and estimate target dose(s).  
Further details of the statistical methodology and considerations for the approaches 
to be used in the analysis will be specified in the SAP.  
8.1.6.1.1 Sensitivity analyses on Primary efficacy criteria 
Sensitivity analyses will be performed in order to evaluate the impact of the primary 
efficacy criteria to the results and interpretation of study results. The analysis described 
above will be repeated for subjects in the ITT using observed data and in the PPS. A 
similar analysis will be performed on ITT population using multiple imputation instead of 
missing = failure imputation method. Multiple imputation method will be further 
described in the SAP.  
Other covariates of interest including baseline IgE (by levels) and country will be 
explored.  

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Finally, the primary efficacy analysis will be repeated for each age group as well as for 
each filaggrin mutation group (With filaggrin mutation / Without filaggrin mutation). 
Within subgroup, the treatment group comparisons will be conducted at a two-sided 
10% significance level. 
8.1.6.2 
Secondary Efficacy Endpoints and Analysis 
The secondary endpoints for the double-blind, placebo-controlled treatment period up 
to Month 12 are: 
• 
The mean and median CRD of cow’s milk proteins at Month 12 and change 
from baseline. 
• 
The change from baseline value in levels of sIgE and allergen-specific 
immunoglobulin G4 (sIgG4) to cow’s milk at all timepoints evaluated up to 
Month 12. 
• 
The change from baseline value in levels of sIgE and sIgG4 to caseins, α-
lactalbumin, and β-lactoglobulin at all timepoints evaluated up to Month 12.  
• 
The change from baseline in SPT wheal at all timepoints evaluated up to 
Month 12. 
• 
The change in the severity of symptoms elicited during the milk DBPCFC from 
baseline to Month 12.  
• 
The change from baseline in Quality of Life (QoL) assessments at Month 12. 
The endpoints after Month 12 for the open-label treatment periods with Viaskin Milk 
500 µg up to 48 months and Viaskin Milk 300 µg for 24 months are: 
• 
The percentage of subjects who are treatment responders over the course of 
open-label treatment with Viaskin Milk 500 µg and 300 µg.  
• 
The CRD of cow’s milk proteins over the course of open-label treatment with 
Viaskin Milk 500 µg and 300 µg. 
• 
The levels of sIgE to cow’s milk over the course of open-label treatment with 
Viaskin Milk 500 µg and 300 µg. 
• 
The levels of sIgG4 to cow’s milk proteins over the course of open-label 
treatment with Viaskin Milk 500 µg. 
• 
The levels of sIgE and sIgG4 to caseins, α-lactalbumin, and β-lactoglobulin over 
the course of open-label treatment with Viaskin Milk 500 µg and 300 µg.  
• 
The SPT wheal over the course of open-label treatment with Viaskin Milk 
500 µg and 300 µg. 
• 
The severity of symptoms elicited during the milk DBPCFC over the course of 
open-label treatment with Viaskin Milk 500 µg and 300 µg 
• 
The QoL assessments over the course of open-label treatment with Viaskin Milk 
500 µg and 300 µg. 
8.1.6.2.1 Treatment Responders  
Treatment responders during the open-label treatment periods after Month 12 will be 
explored. Details will be provided in the SAP. 
8.1.6.2.2 Cumulative Reactive Dose (CRD) of Cow’s Milk Proteins 
The CRD and changes from baseline will be summarized overall and by age group, 
dose level group (Part A and Part B pooled), and timepoint on the ITT for the 
randomized blinded treatment period (Months 0-12).  

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CRD during the open-label treatment periods after Month 12 will be explored. Details 
will be provided in the SAP.  
8.1.6.2.3 Immunological Markers  
All analyses will be carried out on the ITT population.   
Absolute values and changes from baseline for the immunological markers were to be 
summarized overall and by age group, dose level and placebo groups, and timepoint 
for the randomized blinded treatment period (Months 0 to 12). 
Longitudinal analyses will be explored for each of the following parameters:  
• 
cow’s milk sIgE and sIgG4 (cow’s milk sIgG4 will not be collected after the 
switch to Viaskin Milk 300 µg) 
• 
sIgE and sIgG4 to  
o caseins,  
o α-lactalbumin, and  
o β-lactoglobulin. 
Details will be provided in the SAP. 
Immunological markers during the open-label treatment periods after Month 12 will be 
explored. Details will be provided in the SAP. 
8.1.6.2.4 Skin Prick Test 
SPT at all timepoints evaluated will be summarized using descriptive statistics overall 
and by age group, dose level and placebo group on the ITT for the randomized blinded 
treatment period (Months 0 to 12).  
The change from baseline (Visit 1) will be assessed using the ratio of the average 
wheal diameter at each time point versus baseline, derived as improvement (if the ratio 
of the average wheal diameter ≤ 0.75) / no significant improvement (if the ratio of the 
average wheal diameter > 0.75) and will be compared between each dose level group 
and placebo, at each respective visit up to Month 12 using the chi-square test or exact 
logistic regression (same model as for the primary criteria) in case of low sample sizes 
(at least one theoretical frequency lower than 5).  
The number of subjects with a mean weal diameter equals to 0 will be presented. 
Longitudinal analyses will be explored for SPT average wheal diameter.  Details will be 
provided in the SAP. 
SPT during the open-label treatment periods after Month 12 will be explored. Details 
will be provided in the SAP. 

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8.1.6.2.5 Analysis of Severity During the Milk DBPCFC 
The change in the severity of symptoms elicited during the milk DBPCFC from baseline 
will be assessed at Month 12. Grading of symptoms will be done using the grading 
definition in the OFC Symptom Score Sheets., Each symptom (objective and subjective) 
will be graded 0, 1, 2 or 3. A total symptom score will be derived for objective symptoms. 
The total summary score (absolute and change from baseline) will be summarized 
overall and by age group, dose level and placebo group on the ITT for the randomized 
blinded treatment period (Months 0 to 12).  
A second severity score will be derived to assess the change from Baseline in the 
severity of symptoms elicited during the milk DBPCFC at comparable cow’s milk 
proteins dose. The calculation of this severity score at comparable cow’s milk proteins 
dose will be further described in the SAP. This score will be summarized overall and by 
age group, dose level and placebo group, and timepoint on the ITT for the randomized 
blinded treatment period (Months 0 to 12).  
Longitudinal analyses will be explored for severity score.  Details will be provided in the 
SAP. 
Time-to-first objective symptom at Month 12 will be summarized and Kaplan-Meier 
curves will be provided. Patients without any objective symptom during the DBPCFC 
will be censored at the time of discharge. 
Analysis of severity of symptoms during the open-label treatment periods after Month 12 
will be explored. Details will be provided in the SAP. 
8.1.6.2.6 Quality of Life Assessments 
FAQLQ QoL questionnaires will be completed by study subjects who are 8 years old 
and older (CF for age range 8 to 12 years old, TF for age range 13 to 17 years old). 
Subjects who are 7 years old at the time of Visit 1 may also complete the form 
FAQLQ-CF at Screening (Visit 1), if their parent(s)/guardians(s) consider they are able 
to complete these questionnaires, so that when they turn 8 years old at Month 12, they 
will have a baseline questionnaire available. However, this is not mandatory. Parents 
will also complete a FAQLQ for subjects 0 to 12 years old (PF) and for subjects 13 to 
17 years old (PFT). The same questionnaire will be completed throughout the study 
according to the subject’s age at Visit 1. 
Each questionnaire type will be summarized by dose level and placebo at each visit 
using absolute value and change from baseline on the ITT for the randomized blinded 
treatment period (Months 0 to 12). The summary scores presented will be those 
derived for the respective questionnaire. No attempt will be made to combine 
questionnaire types. 
Longitudinal analyses will be explored for QoL assessments.  Details will be provided in 
the SAP. 
QoL questionnaires during the open-label treatment periods after Month 12 will be 
explored. Details will be provided in the SAP. 
8.1.7 Safety Variables 
Safety endpoints will include the following: 

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• 
AEs and TEAEs by system organ class, preferred term, maximum severity, and 
relatedness to the investigational product. 
• 
SAEs and TESAEs by system organ class, preferred term, severity, and 
relatedness to the investigational product. 
• 
TEAEs leading to study discontinuation, and relatedness to the investigational 
product. 
• 
Incidence, duration, and maximum severity of local cutaneous reactions, as 
assessed by the subject. 
• 
Severity of local cutaneous reactions, as assessed by the Investigator. 
• 
AESI including systemic allergic symptoms and local AESI 
• 
Frequency and severity of symptoms elicited during the DBPCFC. 
• 
Vital signs, physical examinations, and laboratory data. 
• 
Spirometry and PEF data. 
In all safety presentations, imputation of missing data will take the option of the most 
conservative outcome, so that, for example, missing relatedness for a TEAE will be 
assumed to be related and missing severity will be assumed to be severe if the severity 
is missing for an AE starting on or after the date of initial Viaskin Milk patch application 
and mild if the severity is missing for an AE starting prior to the date of initial Viaskin 
Milk patch application. 
8.1.7.1 
Adverse Events 
For adverse events analyses, serious adverse events elicited during DBPCFC will not 
be considered, they will be described separately. 
All AEs and TEAEs will be listed and tabulated separately by Medical Dictionary for 
Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term. 
Incidence tables will be presented for all TEAEs and TESAEs for the reporting period 
as defined in Section 7.3.2.1. The following tabulations will be produced overall and by 
age group, dose level and pooled placebo group on the Safety Set (SS) for the 
randomized blinded treatment period (Months 0 to 12): 
• 
AEs and TEAEs overall and by system organ class and preferred term 
• 
AEs and TEAEs by maximum severity, overall and by system organ class and 
preferred term 
• 
TEAEs considered related to investigational product (IP), overall and by system 
organ class and preferred term 
• 
Number of TEAEs and number of TEAEs considered related to IP by severity  
• 
SAEs and TESAEs overall and by system organ class and preferred term 
• 
SAEs and TESAEs by maximum severity, overall and by system organ class 
and preferred term 
• 
TESAEs considered related to IP, overall and by system organ class and 
preferred term 

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• 
Viaskin Milk-induced local AEs overall and by system organ class and preferred 
term 
In order to give an indication of longer term safety, a summary of AEs will be produced 
for a subset of subjects who received the highest safe dose determined during the 
study from Months 0 to 48. A subject-year analysis will present the total number of 
subject-years, the number of subjects with a TEAE (and respectively, a TEAE 
considered related to IP) per subject-year, and the number of TEAEs (and respectively, 
TEAEs considered related to IP) per subject-year, for each dose level. 
Separate listings and tabulations will summarize: 
• 
Systemic AESI whatever the causal relationship with IP.  
• 
Local AESI. 
• 
Severity of symptoms elicited during the DBPCFC. 
• 
Discontinuations due to AEs will also be summarized. 
Local and systemic AESI will be identified using systematic retrieval strategies that will 
be detailed in the SAP. 
Adverse events occurring during the open-label treatment periods after Month 12 will 
be described. Details will be provided in the SAP. 
8.1.7.2 
Vital Signs 
Vital signs will include heart rate, systolic blood pressure, diastolic blood pressure, and 
respiratory rate. Observed vital sign values and changes from baseline will be 
summarized using descriptive statistics overall and by age group, visit, timepoint and 
dose level/placebo group on the SS for the randomized blinded treatment period 
(Months 0 to 12). Listings of values that are potentially clinically significant will be 
presented by subject and by test, where applicable. 
Vital signs of potential clinical significance for children and adolescents are defined as 
follows: 
Vital Sign 
Criteria for Clinically Significant Abnormalities 
Heart rate 
>120 beats per minute or an increase from pre-dosing of 
>20 beats per minute,  
or 
<50 beats per minute or a decrease from pre-dosing of 
>20 beats per minute 
Systolic blood 
pressure 
> 140 mmHg or an increase from pre-dosing of >40 mmHg, 
or 
< 90 mmHg or a decrease from pre-dosing of >30 mmHg 
Diastolic blood 
pressure 
> 90 mmHg or an increase from pre-dosing of > 30 mmHg,  
or 
< 50 mmHg or a decrease from pre-dosing of > 20 mmHg 
The Investigators will assess whether any of the abnormal values are clinically 
significant. Clinically significant abnormal values will be recorded as an AE. 
Vital signs measured during the open-label treatment periods after Month 12 will be 
described. Details will be provided in the SAP. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 116 of 170 
8.1.7.3 
Physical Examination and Patch Site Examination 
Physical examination results, including complete observation of the skin will be listed 
and summarized overall and by age group, visit, timepoint, and dose level/placebo 
group on the SS for the randomized blinded treatment period (Months 0 to 12).  
Physical examination during the open-label treatment periods after Month 12 will be 
described. Details will be provided in the SAP. 
In addition, examination of the skin at the site of Viaskin patch application will be 
graded from Grade 0 (negative) up to Grade 4 (erythema, vesicles). These results will 
be summarized using descriptive statistics and presented overall and by age group, 
visit, dose level and placebo group in the SS for the randomized blinded treatment 
period (Months 0 to 12). Worst grade reported by subject for blinded treatment period 
and open-label treatment period will also be tabulated. 
Examination of skin at patch site during the open-label treatment periods after Month 
12 will be described. Details will be provided in the SAP. 
8.1.7.4 
Clinical Laboratory Tests 
Clinical laboratory test results will be presented in Standard International (SI) units 
unless otherwise specified and will be summarized overall and by age group, dose 
level and placebo group, and timepoint for both absolute values and changes from 
baseline for the randomized blinded treatment period (Months 0 to 12).  
Shift tables will be generated to compare baseline values to the values collected at 
Month 12. Listed data values that are outside the reference range will be flagged. 
Clinical laboratory test results assessed during the open-label treatment periods after 
Month 12 will be described. Details will be provided in the SAP. 
Urine pregnancy test results will be listed. 
8.1.7.5 
Spirometry and Peak Expiratory Flow 
Spirometry (FEV1) and PEF results as % predicted values will be summarized overall 
and by age group, dose level and placebo group, and timepoint using descriptive 
statistics on the SS for the randomized blinded treatment period (Months 0 to 12). 
Spirometry and PEF results assessed during the open-label treatment periods after 
Month 12 will be described. Details will be provided in the SAP. 
Spirometry and PEF results will also be listed. 
8.1.7.6 
Subject Diary Card Data 
Diary card data will be listed. Data derived from the diaries (eg, number of days of 
itching, redness and swelling [with associated grades], worst grades of itching, redness 
and swelling documented by the subjects, compliance of treatment and duration of 
patch application) will be summarized. 
8.1.8 Exploratory Variables 
Exploratory endpoints include the change from baseline value in level of sIgE to 
peanut, egg, house dust mite, and grass pollen at all timepoints.  

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C

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 120 of 170 
All data that are not available in electronic format (eg, diary cards) will be 
double-entered into the data management system, if these data have to be entered by 
the CRO personnel. Following data verification (completion of second data entry and 
further verification of the entries), the audit trail will be switched on (ie, a computerized 
log of all subsequent changes to the data will be recorded). Automated checks will be 
made against the data to ensure completeness and consistency. The database and 
check programs will be validated before implementation. 
MedDRA will be used to code concomitant diseases and AEs and the WHODrug will be 
used for concomitant medications. 
Missing or inconsistent data will be queried in writing to the Investigator for clarification. 
Subsequent modifications to the database will be documented. 
The sites will enter data directly into the EDC system by completing the eCRF via a 
secure internet connection. The CRO will provide training on how to use the system to 
the Investigators at each site. Data entered into the eCRF must be verifiable against 
source documents at the site. Data to be recorded directly in the eCRF (without prior 
written or electronic record) will be identified and the eCRF will be considered the 
source document. Any changes to the data entered into the EDC system will be 
recorded in the audit trail and is FDA CFR 21 Part 11 compliant. 
Data entered into the eCRF will be validated as will be defined in the data validation 
specification. External data checks will be programmed where appropriate (eg for 
laboratory data) as well as for cross table checking between eCRF’s (eg AE and 
concomitant medication forms). 
10 Records and Supplies 
10.1 Drug Accountability 
On receipt of the investigational product (including placebo product, as applicable), the 
Investigator (or deputy) will conduct an inventory of the supplies and verify that the 
investigational product supplies are received intact and in the correct amounts before 
completing a supplies receipt. The Investigator will retain a copy of this receipt at the 
site and return the original receipt to the study monitor. The investigational product will 
be shipped by the depot to a designated person at the study site and must be stored in 
a locked and secured storage facility, accessible only to those individuals authorized by 
the Investigator. The inventory of supplies at each study site may be checked at any 
time during the study by the monitor. 
It is the responsibility of the study monitor to ensure that the Investigator (or deputy) 
has correctly documented the amount received, dispensed and returned of the 
investigational product on the dispensing log that will be provided. A full product 
accountability log will be maintained at the site at all times. The study monitor will 
arrange regular collection of unused investigational product that was returned by the 
subject. The study monitor will also perform an inventory of investigational product at 
the close-out visit to the study site. All discrepancies must be accounted for and 
documented. 
At the end of the study, the sites will be responsible for destroying unused 
investigational product and providing a corresponding certificate of destruction. 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 121 of 170 
10.2 Financing and Insurance 
Financing and insurance of this study will be outlined in a separate agreement between 
the CRO and the sponsor. 
 
 

Sponsor: DBV Technologies 
 
 
Amendment 6: MILES 
Final Version 6.0 
24 June 2019 
Confidential  
Page 122 of 170 
11 Ethics 
11.1 Institutional Review Board 
Before initiation of the study at each study site, the protocol, all protocol amendments, 
ICFs, IAFs, the subject information sheet and any other relevant study documentation 
will be submitted to the appropriate IRBs. Written approval of the study and all relevant 
study information must be obtained before the study sites can be initiated or the 
investigational product is released to the Investigators. Any necessary extensions or 
renewals of the IRB approval must be obtained, in particular, for changes to the study 
such as modification of the protocol, the ICFs, IAFs, the written information provided to 
subjects and/or parent(s)/guardian(s), and/or other procedures. 
The Investigator will report promptly to the IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit 
written summaries of the study status to the IRB annually, or more frequently if 
requested by the IRB. On completion of the study, the sponsor will notify the IRB that 
the study has ended. 
11.2 Ethical Conduct of the Study 
This study will be conducted in accordance with applicable laws and regulations 
including, but not limited to, the ICH guidelines for Good Clinical Practice (ICH E6)27, 
the ethical principles from the declaration of Helsinki28 (Appendix 14.7), and applicable 
local regulatory requirements. The IRB must review and approve the protocol and 
ICFs/IAFs before any subjects are enrolled into the study. Each subject and/or 
parent(s)/guardian(s) must sign and date the IRB-approved ICFs/IAFs, before any 
protocol-required procedures are performed. 
11.3 Subject Information and Consent 
The Investigator is responsible for ensuring that no subject undergoes any study-
related examination or activity before the subject’s parent(s)/guardian(s) has given 
written informed consent. Subjects ≥7 years old (or as per local or country specific 
guidelines or regulations) will be encouraged to sign the IAF to participate in the study. 
The written ICF/IAF must be given by the subject and/or his/her parent(s)/guardian(s), 
after detailed information about the study has been given by appropriate personnel at 
the site and in accordance with any national provisions on the protection of clinical 
study subjects. The verbal explanation will cover all the elements specified in the 
written information provided for the subject and/or parent(s)/guardian(s). 
The Investigator or designated personnel will inform the subject and/or 
parent(s)/guardian(s) of the objectives, methods, anticipated benefits and potential 
risks and inconveniences of the study. The subject and/or parent(s)/guardian(s) should 
be given every opportunity to ask for clarification of any points he/she does not 
understand and, if necessary, for more information. At the end of the interview, the 
subject and/or parent(s)/guardian(s) will be given time to consider the study, if needed, 
or if the subject and/or parent(s)/guardian(s) requests more time. Parent(s)/guardian(s) 
will be required to sign and date the ICF(s). After signatures are obtained, the 
ICF(s)/IAF(s) will be kept and archived by the Investigator in the Investigator’s study file 
for possible inspection by regulatory authorities, the IRB, and the CRO personnel. 
It should be emphasized to the subject and/or parent(s)/guardian(s) that he/she is at 
liberty to withdraw from the study at any time. Subjects and/or parent(s)/guardian(s) 

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Amendment 6: MILES 
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24 June 2019 
Confidential  
Page 123 of 170 
who refuse to give or who withdraw written informed consent should not be included or 
continue participation in the study. 
11.4 Subject Confidentiality 
All personal data collected and processed for the purposes of this study should be 
managed by the Investigator and his/her staff with adequate precautions to ensure 
confidentiality of those data, and in accordance with the Health Insurance Portability 
and Accountability Act29, applicable to national and/or local laws and regulations on 
personal data protection. 
Monitors, auditors, and other authorized agents of the sponsor and/or its designee, the 
ethics committees approving this research, and the FDA, as well as those of any other 
applicable agency, will be granted direct access to the study subjects’ original medical 
records for verification of clinical study procedures and/or data, without violating the 
confidentiality of the subjects to the extent permitted by the law and regulations. In any 
presentations of the results of this study or in publications, the subjects’ identity will 
remain confidential. 
 
 

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24 June 2019 
Confidential  
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13 References 
1 Wang J and Sampson HA. Food allergy. J Clin Invest. 2011; 121(3):827-835. 
2 Nowak-Węgrzyn A and Sampson HA. Future Therapies for Food Allergies. J Allergy 
Clin Immunol. 2011; 127(3):558-573. 
3 Høst A. Frequency of cow’s milk allergy in childhood. Ann Allergy Asthma Immunol. 
2002; 89(6suppl1):33-37 
4 Crisafulli G, Caminiti L and Pajno GB. Oral Desensitization for Immunoglobulin E-
Mediated Milk and Egg Allergies. Isr Med Assoc J. 2012; 14(1):53-56. 
5 Høst A and Halken S. A prospective study of cow milk allergy in Danish infants during 
the first 3 years of life. Clinical course in relation to clinical and immunological type of 
hypersensitivity reaction. Allergy. 1990; 45(8): 587-596 
6 Elizur A, Rajuan N, Goldberg MR, Leshno M, Cohen A and Katz Y. Natural Course 
and Risk Factors for Persistence of IgE-Mediated Cow’s Milk Allergy. J Pediatr. 2012, 
161(3):482-487 
7 Skripak JM, Matsui EC, Mudd K and Wood RA. The natural history of IgE-mediated 
cow’s milk allergy. J Allergy Clin Immunol. 2007; 120(5):1172-1177 
8 Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleisher DM, Henning AK, 
Mayer L, Burks W, Grishin A, Stablein D and Sampson HA. The natural history of 
milk allergy in an observational cohort. J Allergy Clin Immunol. 2013; 131(3):805-812 
9 Spergel JM. Natural history of cow’s milk allergy. Natural history of cow’s milk allergy. 
J Allergy Clin Immunol. 2013; 131(3):813-814. 
10 Savilahti EM and Savilahti E. Development of natural tolerance and induced 
desensitization in cow’s milk allergy. Pediatr Allergy Immunol. 2013; 24(2):114-121. 
11 Boyano-Martínez T, García-Ara C, Pedrosa M, Díaz-Pena JM and Quirce S. 
Accidental allergic reactions in children allergic to cow’s milk proteins. J Allergy Clin 
Immunol. 2009; 123(4):883-888 
12 Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, 
Burks AW and Wood RA. A randomized, double-blind, placebo-controlled study of 
milk oral immunotherapy for cow’s milk allergy. J Allergy Clin Immunol. 2008; 
122(6):1154-1160 
13 Keet CA, Frischmeyer-Guerrerio PA, Thyagarajan A, Schroeder JT, Hamilton RG, 
Boden S, Steele P, Driggers S, Burks AW and Wood RA. The safety and efficacy of 
sublingual and oral immunotherapy for milk allergy. J Allergy Clin Immunol. 2012; 
129(2):448-455 
14 Brożek JL, Terracciano L, Hsu J, Kreis J, Compalati E, Santesso N, Fiocchi A and 
Schünemann HJ. Oral immunotherapy for IgE-mediated cow’s milk allergy: a 
systematic review and meta-analysis. Clin Exp Allergy. 2012; 42(3):363-374 
15 Viaskin Milk (DBV135) Investigator’s Brochure (Edition 2, 2015). 
16 Dupont C, Kalach N, Soulaines P, Legoue-Morillon S, Piloquet H, Benhamou PH. 
Cow's milk epicutaneous immunotherapy in children: a pilot trial of safety, 
acceptability, and impact on allergic reactivity. J Allergy Clin Immunol 
2010;125(5):1165-1167 
17 Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, 
et al. Second symposium on the definition and management of anaphylaxis: 
 
                                               

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summary report – second National Institute of Allergy and Infectious Disease/Food 
Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol 2006; 117(2): 
391-397 
18 American Thoracic Society guidelines (2005); Available online at: 
http://www.thoracic.org/statements/resources/pft/PFT2.pdf. Accessed on 
13 Apr 2014. 
19 Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of 
Asthma - Summary Report 2007. Available online at: 
http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf. Accessed on 03 Apr 2014 
20 van der Velde JL, Flokstra-de Blok BM, Vlieg-Boerstra BJ, Elberink JN, Schouten JP, 
et al. Test–retest reliability of the Food Allergy Quality of Life Questionnaires 
(FAQLQ) for children, adolescents and adults. Qual Life Res 2009; 18:245–251 
21 Nowak-Wegrzyn A, Assa’ad AH, Bahna SL, Bock SA, Sicherer SH and Teuber SS. 
Work group report: oral food challenge testing. J Allergy Clin Immunol. 2009; 
123:S365-S383 
22 Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks 
WA, et al. Standardizing double-blind, placebo-controlled oral food challenges: 
American Academy of Allergy, Asthma & Immunology–European Academy of Allergy 
and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 
2012; 130(6):1260-1274 
23 Flokstra-de Blok BMJ, DunnGalvin A, Vlieg-Boerstra BJ, Oude Elberink JNG, 
Duiverman EJ, Hourihane JO, Dubois AEJ. Development and validation of the self-
administered Food Allergy Quality of Life Questionnaire for adolescents. J Allergy 
Clin Immunol 2008 Jul; 122(1):139-144. 
24 International Conference on Harmonisation, ICH E2A Guideline, Clinical Safety Data 
Management: Definitions and Standards or Expedited Reporting, October 1994 
25 Turjanmaa K, Darsow U, Niggemann B, et al. EAACI/GA2LEN position paper: 
present status of the atopy patch test. Allergy 2006; 61:1377-1384. 
26 Howie SRC. Blood sample volumes in child health research: review of safe limits. 
Bull World Health Organ 2011; 89:46–53 
27 International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. 
Good Clinical Practice. CPMP/ICH/135/35. 17 Jan 1997. 
28 World Medical Association, Declaration of Helsinki. Ethical Principles for Medical 
Research Involving Human Subjects. Last amended by the 64th WMA General 
Assembly, Brazil, Oct 2013 
29 US Department of Health and Human Services. The Health Insurance Portability and 
Accountability Act (HIPAA) of 1996 (P.L.104-191) [HIPAA]. 
http://aspe.hhs.gov/admnsimp/pl104191.htm. Effective 21 Aug 1996 

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14 Appendices 

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14.1 Investigator Signature Page 
Protocol Title: 
A Double-Blind, Placebo-Controlled Randomized Trial to Study 
the Viaskin MILk Efficacy and Safety for Treating IgE-Mediated 
Cow’s Milk Allergy in Children (MILES Study) 
 
Protocol Number: 
MILES 
Confidentiality and cGCP Compliance Statement 
I, the undersigned, have reviewed this protocol, including appendices, and I will 
conduct the study as described in compliance with this protocol, GCP, and relevant 
ICH guidelines. 
Once the protocol has been approved by the IRB, I will not modify this protocol without 
obtaining prior approval of DBV Technologies and of the IRB. I will submit the protocol 
modifications and/or any ICF/IAF modifications to DBV Technologies and the IRB, and 
approval will be obtained before any modifications are implemented. 
I understand that all information obtained during the conduct of the study related to the 
subjects’ state of health will be regarded as confidential. No subjects’ names will be 
disclosed. All subjects will be identified by assigned numbers on all eCRFs, laboratory 
samples or source documents forwarded to the sponsor. Clinical information may be 
reviewed by the sponsor or its agents or regulatory agencies. Agreement must be 
obtained from the subject before disclosure of subject information to a third party. 
Information developed in this clinical study may be disclosed by DBV Technologies, to 
other clinical Investigators, regulatory agencies, or other health authority or government 
agencies, as required. 
 
 
 
Investigator Signature 
 
Date 
 
 
 
Printed Name 
 
 
 
 
 
Institution 
 
 
 
 

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14.2 Oral Food Challenge Symptom Score Sheets 
I. SKIN 
 
Stopping rules: 
# of grade increase 
 
Alone 
Associated 
A. Pruritus 
+3 
+2 
0 = Absent 
 
 
1 = Mild: occasional scratching 
 
 
2 = Moderate: scratching continuously for >2 minutes at a time 
 
 
3 = Severe: hard continuous scratching excoriations 
 
 
B. Urticaria 
+2 
+1 
0 = Absent 
 
 
1 = Mild: ≤3 hives 
 
 
2 = Moderate: <10 hives but >3 
 
 
3 = Severe: generalized involvement 
 
 
C. Angioedema 
+2 
+1 
0 = Absent 
 
 
1 = Mild: mild lip edema 
 
 
2 = Moderate: significant lip or face edema 
 
 
3 = Severe: generalized involvement  
 
 
D. Erythematous Rash 
+2 
+1 
0 = Absent 
 
 
1 = Mild: few areas of faint erythema 
 
 
2 = Moderate: areas of erythema (>20% and <50%), macular and raised rash  
 
 
3 = Severe: generalized marked erythema (>50%), extensive raised lesions 
(>25%) 
 
 
Erythematous Rash % area involved (see below): 
/_____/____/% 
 
 
1-4 years old 
5-8 years old 
9-12 years old 
≥13 years old 
Head 
17% 
16% 
12% 
4.5% 
Neck 
2% 
2% 
2% 
1% 
Anterior trunk 
16% 
14% 
14% 
18% 
Posterior trunk 
16% 
18% 
18% 
18% 
Leg (1) 
15% 
15% 
17% 
18% 
Arm (1) 
9.5% 
10% 
10% 
9% 
Adapted from Lund CC, Browder NC (1944) The estimation of areas of burns. Surg Gynecol 
Obstet 79: 352–8 
 
 
 

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II. UPPER RESPIRATORY/OCCULAR 
 
Stopping rules: 
minimal # of grade 
increase 
 
Alone 
Associated 
A. Sneezing/Itching 
+3 
+2 
0 = Absent 
 
 
1 = Mild: rare bursts 
 
 
2 = Moderate: bursts <10, intermittent rubbing of nose / eyes / external ear 
canals 
 
 
3 = Severe: continuous rubbing of nose / eyes, periocular swelling and/or long 
 
 
bursts of sneezing 
 
 
B. Nasal Congestion 
+3 
+2 
0 = Absent 
 
 
1 = Mild: some hindrance to breathing 
 
 
2 = Moderate: nostrils feel blocked, breathing through mouth most of time 
 
 
3 = Severe: nostrils occluded 
 
 
 
 

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C. Rhinorrhea 
+3 
+2 
0 = Absent 
 
 
1 = Mild: occasional sniffling 
 
 
2 = Moderate: frequent sniffling, requires tissues 
 
 
3 = Severe: nose runs freely despite sniffling and tissues 
 
 
D. Laryngeal (only symptoms due to laryngeal edema) 
+2 
+1 
0 = Absent 
 
 
1 = Mild: throat clearing, occasional cough 
 
 
2 = Moderate: hoarseness, frequent dry cough 
 
 
3 = Severe: inspiratory stridor 
 
 
E. Conjunctivitis (see example below) 
 +3 
+2 
0 = Absent 
 
 
1 = Mild:  
 
 
2 = Moderate:  
 
 
3 = Severe:  
 
 
 
 
Grade 1 
Grade 2 
Grade 3 
 
III. LOWER RESPIRATORY 
 
Stopping rules: 
minimal # of grade 
increase 
 
Alone 
Associated 
A. Wheezing (including cough due to bronchospasm) 
+1 
+1 
0 = Absent 
 
 
1 = Mild: expiratory wheezing to auscultation 
 
 
2 = Moderate: dyspnea, inspiratory and expiratory wheezing 
 
 
3 = Severe: dyspnea, use of accessory muscles, audible wheezing 
 
 
 
IV. GASTROINTESTINAL 
 
Stopping rules: 
minimal # of grade 
increase 
 
Alone 
Associated 
A. Subjective Complaints 
+3 
+2 
0 = Absent 
 
 
1 = Mild: itchy mouth/throat, c/o nausea, abdominal pain, no change in activity 
 
 
2 = Moderate: frequent c/o nausea or abdominal pain, decreased activity 
 
 
3 = Severe: patient in bed; crying, notably distressed  
 
 
B. Objective Complaints 
+1 
+1 
0 = Absent 
 
 
1 = Mild: 1 episode of emesis* or diarrhea 
 
 
2 = Moderate: 2-3 episodes of emesis* or diarrhea or 1 of each 
 
 
3 = Severe: >3 episodes of emesis* or diarrhea or 2 of each 
 
 
* Emesis to be differentiated from “spitting-up” due to food intolerance while feeding. 
 
 

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V. CARDIOVASCULAR/NEUROLOGIC 
 
Stopping rules: 
minimal # of grade 
increase 
 
Alone 
Associated 
Cardiovascular/neurologic 
+1 
+1 
0 = Normal: heart rate or BP for age/baseline 
 
 
1 = Mild: color change, subjective response (weak, dizzy), or tachycardia, 
mental status change, mild hypotension (weak rapid pulse and/or 10-20% 
drop in blood pressure from baseline) 
 
 
2 = Moderate: drop in blood pressure >20% from baseline, significant change 
in mental status, light-headedness, feeling of “pending doom” 
 
 
3 = Severe: cardiovascular collapse, signs of impaired circulation, 
unconsciousness, bradycardia, cardiac arrest. 
 
 
 
 

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14.3 Quality of Life Questionnaire Forms 
14.3.1 Food Allergy Quality of Life Questionnaire-Child Form (FAQLQ-CF) 
 
 

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FAQLQ-CF 
Food Allergy Quality of Life Questionnaire –  
Child Form (8-12 years) 
 
 
 
 
 
To cite this questionnaire: 
Flokstra-de Blok BMJ, DunnGalvin A, Vlieg-Boerstra BJ, Oude Elberink JNG, Duiverman EJ, 
Hourihane JO, Dubois AEJ. Development and validation of a self-administered Food Allergy 
Quality of Life Questionnaire for children. Clin Exp Allergy 2009 Jan;39(1):127-137. 

Sponsor: DBV Technologies 
 
 
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The questions are about the influence of your food allergy on your quality of life. It is 
important that you fill in the answers yourself. You may ask your parents for help, but 
they are not allowed to tell you which answer to give. Answer every question by putting 
an ‘x’ in the proper box. You may choose from the following answers. 
 
 
 
 
 
 
 
not 
barely 
a little bit 
fairly 
quite 
very 
extremely 
 
 
How troublesome do you find it, because of your food 
allergy, that you … 
 
 
 
 
 
 
 
1 
must always watch what you eat? 
 
      
2 
can eat fewer things? 
 
      
3 
are limited in buying things you like? 
 
      
4 
have to read labels? 
 
      
5 
have to refuse food when you do things with others? 
 
      
6 
can less easily stay for a meal with someone? 
 
      
7 
can taste or try fewer things when eating out? 
 
      
8 
have to tell beforehand about what you are not allowed 
to eat when eating out? 
 
      
9 
have to check yourself whether you can eat something 
when eating out? 
 
      
10 hesitate eating certain foods when you don’t know if it 
is safe? 
 
      
11 must watch out when touching certain foods? 
 
      
12 don’t get anything when someone is giving treats at 
school? 
 
      
 
 
 

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not 
barely 
a little bit 
fairly 
quite 
very 
extremely 
 
 
How troublesome is it, because of your food allergy, … 
 
 
 
 
 
 
13 that the ingredients of a food change? 
       
14 that the label states: “May contain (traces of)….”? 
       
15 that you have to explain to people around you that you 
have a food allergy? 
       
16 that people around you forget that you have a food 
allergy? 
       
17 that others can eat the food you are allergic to when you 
do things with other people? 
       
18 that you don’t know how things taste which you can’t 
eat? 
       
 
How frightened are you because of your food allergy … 
 
 
 
 
 
 
19 of an allergic reaction? 
       
20 of eating the wrong food by accident? 
       
21 to eat something you have never eaten before? 
       
 
Answer the following questions: 
 
 
 
 
 
 
22 How concerned are you that you will never get rid of your 
food allergy? 
       
23 How disappointed are you when people don’t take your 
food allergy into account? 
       
24 How disappointed do you feel because you have a food 
allergy? 
       

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Amendment 6: MILES 
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Food Allergy Independent Measure – Child Form (8-12 years) 
The following four questions are about the chance that you think you have of 
something happening to you because of your food allergy. Choose one of the answers. 
This is followed by two more questions about your food allergy. Answer every question 
by putting an ‘x’ in the box next to the proper answer 
 
0 
1 
2 
3 
4 
5 
6 
never 
(0% chance) 
very small 
chance 
small 
chance 
fair 
chance 
big 
chance 
very big 
chance 
always 
(100% chance) 
 
How big do you think the chance is that you … 
0 
1  
2  
3  
4  
5 
6  
1 
will accidentally eat something to which you are allergic?  
 
 
 
 
 
 
2 
will have a severe reaction if you accidentally eat 
something to which you are allergic?  
 
 
 
 
 
 
 
3 
will die if you accidentally eat something to which you are 
allergic? 
 
 
 
 
 
 
 
4 
can not do the right things for your allergic reaction 
should you accidentally eat something to which you are 
allergic? 
 
 
 
 
 
 
 
 
5. How many foods are you unable to 
eat because of your food allergy? 
6. Everyone does things with other people, such as; 
- playing with friends,  
- going to a birthday party,  
- visiting,  
- staying over with someone for a meal or eating 
out. 
 
How much does your food allergy affect things you 
do with others? 
  almost none 
  very few 
  a few 
  some 
  many 
  very many 
  almost all 
  so little I don’t actually notice it 
  very little 
  little 
  moderately 
  a good deal 
  a great deal 
  a very great deal 

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Page 139 of 170 
 
14.3.2 Food Allergy Quality of Life Questionnaire-Teenager Form (FAQLQ-TF) 
 
 
 

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Page 140 of 170 
 
 
 
 
 
 
FAQLQ-TF 
Food Allergy Quality of Life Questionnaire –  
Teenager Form (13-17 years) 
 
 
 
 
 
To cite this questionnaire: 
Flokstra-de Blok BMJ, DunnGalvin A, Vlieg-Boerstra BJ, Oude Elberink JNG, Duiverman EJ, 
Hourihane JO, Dubois AEJ. Development and validation of the self-administered Food Allergy 
Quality of Life Questionnaire for adolescents. J Allergy Clin Immunol 2008 Jul;122(1):139-
144. 

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The following questions concern the influence your food allergy has on your quality of life. 
Answer every question by marking the appropriate box with an ‘x’. You may choose from one 
of the following answers. 
 
0 
1 
2 
3 
4 
5 
6 
not 
barely 
slightly 
moderately 
quite 
very 
extremely 

How troublesome do you find it, because of your food 
allergy, that you … 
0 
1 
2 
3 
4 
5 
6 
1 
must always be alert as to what you are eating? 
       
2 
are able to eat fewer products? 
       
3 
are limited as to the products you can buy? 
       
4 
must read labels? 
       
5 
have the feeling that you have less control of what you 
eat when eating out? 
       
6 
are less able to spontaneously accept an invitation to 
stay for a meal? 
       
7 
are less able to taste or try various products when eating 
out? 
       
8 
must check yourself whether you can eat something 
when eating out? 
       
9 
hesitate eating a product when you have doubts about 
it? 
       
10 must refuse treats at school or work? 
       
11 must be careful about touching certain foods? 
       
12 must carry an epinephrine auto injector 
 
? (If you don’t have an epinephrine 
auto injector mark an ‘x’ here  ) 
       



CCI

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0 
1 
2 
3 
4 
5 
6 
not 
barely 
slightly 
moderately 
quite 
very 
extremely 
 
How troublesome is it, because of your food allergy, … 
0 
1 
2 
3 
4 
5 
6 
13 that the ingredients of a food change? 
       
14 that the label states: “May contain (traces of)….”? 
       
15 that the labeling of the bulk packaging (for example box or 
bag) is different than the individual packages?  
       
16 that you have to explain to people around you that you 
have a food allergy? 
       
17 that during social activities others can eat the food to 
which you are allergic? 
       
18 that during social activities your food allergy is not taken 
into account enough? 
       
 
How frightened are you because of your food allergy … 
0 
1 
2 
3 
4 
5 
6 
19 of an allergic reaction? 
       
20 of accidentally eating the wrong food? 
       
21 to eat something you have never eaten before? 
       
 
Answer the following questions: 
0 
1 
2 
3 
4 
5 
6 
22 How discouraged do you feel during an allergic reaction?        
23 How disappointed are you when people don’t take your 
food allergy into account? 
       
 
 
 

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Page 143 of 170 
Food Allergy Independent Measure – Teenager Form (13-17 years) 
The following four questions are about the chance that you think you have of something 
happening to you because of your food allergy. Choose one of the answers. This is followed by 
two more questions about your food allergy. Answer every question by putting an ‘x’ in the 
box next to the proper answer. 
 
0 
1 
2 
3 
4 
5 
6 
never 
(0% chance) 
very small 
chance 
small 
chance 
fair 
chance 
great 
chance 
very great 
chance 
always 
(100% chance) 
 
How great do you think the chance is that you … 
0 
1  
2  
3  
4  
5 
6  
1 
will accidentally eat something to which you are 
allergic? 
 
 
 
 
 
 
 
2 
will have a severe reaction if you accidentally eat 
something to which you are allergic?  
 
 
 
 
 
 
 
3 
will die if you accidentally eat something to which you 
are allergic? 
 
 
 
 
 
 
 
4 
can not effectively deal with an allergic reaction should 
you accidentally eat something to which you are 
allergic? 
 
 
 
 
 
 
 
 
 
5.  How many products must you avoid because 
of your food allergy?  
6.  How great is the impact of your 
food allergy on your social life? 
 
  almost none 
  very few 
 
  negligibly small 
  very small 
  a few 
  small 
  some 
  moderate 
  many 
  great 
  very many 
  very great 
  almost all 
  extremely great 

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Page 144 of 170 
 
14.3.3 Food Allergy Quality of Life Questionnaire – Parent Form for Children 
(FAQLQ-PF) 
 
 

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Page 145 of 170 
 
 
 
 
FAQLQ-PF 
 
Food Allergy Quality of Life Questionnaire –  
Parent Form (0-12 years) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To cite this questionnaire: 
DunnGalvin A, Flokstra-de Blok BMJ, Burks AW, Dubois AEJ, Hourihane JO. Food allergy QoL 
questionnaire for children aged 0-12 years: content, construct, and cross-cultural validity. Clin Exp 
Allergy 2008 Jun;38(6):977-986. 

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Page 146 of 170 
 
 
Food Allergy Quality of Life Questionnaire-Parent 
Form 
(FAQoL-PF) 
Children aged 0-12 years 
 
 
 
 
Instructions to Parents 
 
• 
The following are scenarios that parents have told us affect children’s quality of life because 
of food allergy.  
 
• 
Please indicate how much of an impact each scenario has on 
your child’s quality of life by placing a tick  
or an x in one of the boxes numbered 0-6.   
 
 
 
 
 
 
All information given is completely confidential. 
This questionnaire will only be identified by a code number.  
Response Options 
0 = not at all 
1= a little bit 
2 = slightly 
3 = moderately 
4 = quite a bit 
5 = very much 
6 = extremely 

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Page 147 of 170 
 
• 
If your child is aged 0 to 3 years, please answer Section A. 
• 
If your child is aged 4 to 6 years, please answer Section A & Section B. 
• 
If your child is aged 7 years and over, please answer Section A, Section B & Section C. 
SECTION A 
Not at all 
Extremely 
Because of food allergy, my child feels… 
0 
1 
2 
3 
4 
5 
6 
1 
Anxious about food 
       
2 
Different from other children 
       
3 
Frustrated by dietary restrictions 
       
4 
Afraid to try unfamiliar foods 
       
5 
Concerned that I am worried that he/she will have a 
reaction to food 
       
 
Not at all 
Extremely 
Because of food allergy, my child… 
0 
1 
2 
3 
4 
5 
6 
6 
Experiences physical distress 
       
7 
Experiences emotional distress 
       
8 
Has a lack of variety in his/her diet 
       
 
Not at all 
Extremely 
Because of food allergy, my child has been negatively 
affected by… 
0 
1 
2 
3 
4 
5 
6 
9 
Receiving more attention more attention than other children 
of his/her age 
       
10 Having to grow up more quickly than other children of 
his/her age 
       
11 His/her environment being more restricted than other 
children of his/her age 
       
 
Not at all 
Extremely 
 
Not at all 
Extremely 
 
• If your child is aged 0 to 3 years, please now go to Section D. 
• If your child is aged 4 to 12 years, please now answer Section B. 
Because of food allergy, my child’s social environment 
is restricted because of limitations on… 
0 
1 
2 
3 
4 
5 
6 
12 Restaurants we can safely go to as a family 
       
13 Holiday destinations we can safely go to as a family 
       
Because of food allergy, my child’s ability to take part 
has been limited… 
0 
1 
2 
3 
4 
5 
6 
14 In social activities in other people’s houses ( sleepovers, 
parties, playtime)  
       

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SECTION B 
Not at all 
Extremely 
 
Not at all 
Extremely 
Because of food allergy, my child feels… 
0 
1 
2 
3 
4 
5 6 
16 Anxious when going to new places 
 
     
17 Concerned that he/she must always be cautious about food 
 
     
18 ‘Left out’ in activities involving food 
 
     
19 Upset that family social outings (eating out, celebrations, 
days out) have been limited by food allergy 
 
     
20 Anxious about accidentally eating an ingredient to which 
he/she is allergic 
 
     
21 Anxious when eating with unfamiliar adults/children 
 
     
22 Frustrated by social restrictions 
 
     
 
Not at all 
Extremely 
Because of food allergy, my child… 
0 
1 
2 
3 
4 
5 6 
23 Is more anxious in general than other children of his/her 
age 
 
     
24 Is more cautious in general than other children of his/her 
age 
 
     
25 Is not as confident as other children of his/her age in social 
situations  
 
     
26 Wishes his/her food allergy would go away 
 
     
 
 
• If your child is aged 6 years and under, please now go to Section D. 
• If your child is aged 7 years and older, please answer Section C. 
 
 
 
 
Because of food allergy, my child’s ability to take part 
has been limited… 
0 
1 
2 
3 
4 
5 
6 
15 In preschool/school events involving food (class 
parties/treats/lunchtime)  
       

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Page 149 of 170 
SECTION C 
Not at all 
Extremely 
Because of food allergy, my child feels… 
0 
1 
2 
3 
4 
5 6 
27 Worried about his/her future (opportunities, relationships) 
 
     
28 That many people do not understand the serious nature of 
food allergy 
 
     
29 Concerned  by poor labelling on food products 
 
     
30 That food allergy limits his/her life in general 
 
     
 
SECTION D 
 
 
 
Please answer the following questions with reference to the  
7-point scale on the right 
 
 
 
Q1. What chance do you think your child has of ….? 
 
 
Question 
7-point Scale 
0 1 2 3 4 5 6 
1 ……accidentally ingesting the food to which they are allergic? 
 
 
 
 
 
 
 
2 ……having a severe reaction if food is accidentally ingested? 
 
 
 
 
 
 
 
 
3 ……dying from his/her food allergy following ingestion in the 
future? 
 
 
 
 
 
 
 
4 ……effectively treating him/herself, or receiving effective 
treatment from others (including Epipen administration), if 
he/she accidentally ingests a food to which he/she is allergic? 
 
 
 
 
 
 
 
 
 
Q2. What chance does your child think he/she has of ……? 
 
 
Question 
7-point Scale 
0 1 2 3 4 5 6 
1 ……accidentally ingesting the food to which they are allergic? 
 
 
 
 
 
 
 
 
2 ……having a severe reaction if food is accidentally ingested? 
 
 
 
 
 
 
 
 
3 ……dying from his/her food allergy following ingestion in the 
future? 
 
 
 
 
 
 
 
 
4 ……effectively treating him/herself, or receiving effective 
treatment from others (including Epipen administration), if 
he/she accidentally ingests a food to which he/she is allergic? 
 
 
 
 
 
 
 
 
0 = extremely unlikely 
1 = very unlikely 
2 = somewhat unlikely 
3 = likely 
4 = quite likely 
5 = very likely 
6 = extremely likely 

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14.3.4 Food Allergy Quality of Life Questionnaire – Parent Form for Teenagers 
(FAQLQ-PFT) 
 
 

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Page 151 of 170 
 
 
 
 
 
 
FAQLQ-PFT 
Food Allergy Quality of Life Questionnaire – 
Parent Form – Adolescents aged 13-17 
 
 
To cite the original English questionnaire: 
Knibb et al., unpublished 
To cite the Dutch translated questionnaire: 
van der Velde JL, Flokstra-de Blok BMJ, Hamp A, Knibb RC, Duiverman EJ, Dubois AEJ. Adolescent-parent disagreement on 
quality of life of food allergic adolescents; Who makes the difference? Allergy. 2011  

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Please answer these questions with reference to the 7-point scale below. 
0 = extremely unlikely 
1 = very unlikely 
2 = somewhat unlikely 
3 = likely 
4 = quite likely 
5 = very likely 
6 = extremely likely 
 
 
Question 
7-point Scale 
0 
1 
2 
3 
4 
5 
6 
1. 
What chance do you think your teenager has of 
accidentally ingesting the food to which they are 
allergic? 
 
 
 
 
 
 
 
2. 
What chance do you think your teenager has of having 
a severe reaction if food is accidentally ingested? 
 
 
 
 
 
 
 
3. 
What chance do you think your teenager has of dying 
from his/her food allergy following ingestion in the 
future? 
 
 
 
 
 
 
 
4. 
What chance do you think your teenager has of 
effectively treating him/herself or receiving effective 
treatment 
from 
others 
(including 
Epipen 
administration) if he/she accidentally ingests a food to 
which he/she is allergic? 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14.4 Anaphylaxis Staging System 
Anaphylaxis is a generalized allergic reaction that is rapid in onset and may progress to 
death. The stages of severity for anaphylaxis reactions are presented below. 
Staging System of Severity of Anaphylaxis 
Stage 
Defined By 
1. Mild (skin and subcutaneous tissues, 
Gastrointestinal, and/or mild 
respiratory) 
Flushing, urticaria, periorbital or facial 
angioedema; mild dyspnea, wheeze or 
upper respiratory symptoms; mild 
abdominal pain and/or emesis. 
 
2. Moderate (mild symptoms + features 
suggesting moderate respiratory, 
cardiovascular or Gastrointestinal 
symptoms) 
Marked dysphagia, hoarseness, and/or 
stridor; shortness of breath, wheezing & 
retractions; crampy abdominal pain, 
recurrent vomiting and/or diarrhea; and/or 
mild dizziness. 
 
3. Severe (hypoxia, hypotension, or 
neurological compromise) 
Cyanosis or SpO2 <92% at any stage, 
hypotension, confusion, collapse, loss of 
consciousness; or incontinence. 
 
 
 

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14.5 Anaphylaxis Emergency Action Plan 
Example Form: ANAPHYLAXIS EMERGENCY ACTION PLAN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 

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14.8 Declaration of Helsinki 
 
 

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14.9 Reference Safety Information for the Cow’s Milk Food Challenge in the MILES 
study 
In the context of DBV135 (Viaskin Milk) clinical development, a formulated recipe of food 
challenge has been developed by DBV for the conduct of the Double-Blind Placebo-
Controlled Food Challenge (DBPCFC) procedure in clinical trials.  
The food challenge kits, containing the low and high dose of cow’s milk protein and 
placebo formulas, are provided to all sites participating in the Viaskin Milk clinical studies 
where DBPCFCs procedures are conducted according to a specific Manual of 
Procedure. 
The Food Challenge is a non-authorized product used to produce a physiological 
response that is relevant to the design of the clinical trial. 
All serious adverse events (SAE), including anaphylactic reactions and allergic 
symptoms, that occur during the Food Challenge procedures, are elicited events to either 
diagnose the food allergy or to assess the efficacy of the corresponding Investigational 
Medicinal Product (Viaskin Milk). Therefore, they are considered as expected by 
definition. 
Only death occurring within the context of the DBPCFC procedure or any SAE with the 
outcome “Death” related to Food Challenge will be considered as unexpected and 
considered as suspected unexpected serious adverse reaction for expedited reporting 
purpose.