<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01675882</url>
  </required_header>
  <id_info>
    <org_study_id>VIPES</org_study_id>
    <secondary_id>2011-002550-32</secondary_id>
    <nct_id>NCT01675882</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy</brief_title>
  <acronym>VIPES</acronym>
  <official_title>A Double-blind, Placebo-controlled, Randomized Trial to Study the Viaskin Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DBV Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DBV Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this dose-finding study for the treatment of peanut allergy are:&#xD;
&#xD;
        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg&#xD;
           peanut protein per patch) to significantly desensitize peanut-allergic subjects to&#xD;
           peanut after 12 months of treatment.&#xD;
&#xD;
        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peanut allergy is a common allergy in the United States, with a prevalence in the general&#xD;
      population as high as 1%. Peanut allergy management is based on strict peanut avoidance and&#xD;
      injectable epinephrine after the allergic systemic reactions have started. Specific&#xD;
      Immunotherapy methods currently available have shown some limitations in their use because of&#xD;
      safety issues. Hence, there is an important unmet medical need for efficient and safe&#xD;
      treatment of peanut allergy.&#xD;
&#xD;
      DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method&#xD;
      based on delivering precise quantity of the allergen on the upper layers of the skin.&#xD;
      Avoiding contact between the allergen and the bloodstream should confer to epicutaneous&#xD;
      immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented&#xD;
&#xD;
      The VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the&#xD;
      efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of&#xD;
      immediate hypersensitive reaction to peanut protein.&#xD;
&#xD;
      The trial will be conducted at sites with investigators and staff trained and experienced in&#xD;
      the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of&#xD;
      performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or&#xD;
      pediatric subjects. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be&#xD;
      evaluated for the study. Following the confirmation of peanut allergy at screening, subjects&#xD;
      will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg,&#xD;
      100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily&#xD;
      applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two&#xD;
      DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks&#xD;
      after completion of treatment and the last DBPCFC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Treatment Responders at Month 12; Analyzed in Overall Population</measure>
    <time_frame>At Month 12</time_frame>
    <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population</measure>
    <time_frame>At Month 12</time_frame>
    <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)</measure>
    <time_frame>At Month 12</time_frame>
    <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population</measure>
    <time_frame>At Month 12</time_frame>
    <description>The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population</measure>
    <time_frame>Baseline and Month 12</time_frame>
    <description>The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and &gt;0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as &lt;=0.5 or &gt;0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</measure>
    <time_frame>Baseline and Months 3, 6 and 12</time_frame>
    <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Viaskin Peanut 50 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Peanut 100 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Peanut 250 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Viaskin Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Peanut 50 mcg</intervention_name>
    <description>Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract</description>
    <arm_group_label>Viaskin Peanut 50 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Peanut 100 mcg</intervention_name>
    <description>Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract</description>
    <arm_group_label>Viaskin Peanut 100 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Peanut 250 mcg</intervention_name>
    <description>Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract</description>
    <arm_group_label>Viaskin Peanut 250 mcg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Viaskin Placebo</intervention_name>
    <description>Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation</description>
    <arm_group_label>Viaskin Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peanut-allergic subjects between 6 and 55 years of age, with a well-documented medical&#xD;
             history of systemic reactions after ingestion of peanut and currently following a&#xD;
             strict peanut-free diet.&#xD;
&#xD;
          -  Peanut-specific immunoglobulin E (IgE) level (Phadia CAP-system) &gt; 0.7 kU/L and a&#xD;
             positive skin prick test to peanut with a largest wheal diameter ≥ 8 mm&#xD;
&#xD;
          -  Positive double-blind placebo-controlled food challenge (DBPCFC) at ≤ 300 mg of peanut&#xD;
             proteins: the eliciting dose of peanut proteins during the DBPCFC is capped at 300 mg,&#xD;
             i.e. subjects must react to peanut before reaching or at the dose of 300 mg peanut&#xD;
             proteins.&#xD;
&#xD;
          -  Negative pregnancy test for women of childbearing potential. Females of childbearing&#xD;
             age must use effective methods of contraception to prevent pregnancy and agree to&#xD;
             continue to practice an acceptable method of contraception for the duration of&#xD;
             participation in the study. Sexual abstinence will be accepted as an effective method&#xD;
             of contraception for girls below 15 years of age.&#xD;
&#xD;
          -  Ability to perform spirometry maneuvers in accordance with the American Thoracic&#xD;
             Society guidelines (2005) for subjects 9 years of age and above Subjects below 9 years&#xD;
             of age can perform peak expiratory flow (PEF) instead.&#xD;
&#xD;
          -  Willing to comply with all study requirements during their participation in the study.&#xD;
&#xD;
          -  Provide signed informed consent and assent as appropriate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of severe anaphylaxis to peanut with the following symptoms:&#xD;
             hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or&#xD;
             incontinence).&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  FEV1 &lt;80% of the predicted value at screening for subjects 9 years of age and above.&#xD;
             PEF &lt; 80% of predicted for subjects below 9 years of age.&#xD;
&#xD;
          -  Subjects who did not react at or below the dose of 300 mg of peanut proteins during&#xD;
             the DBPCFC at screening.&#xD;
&#xD;
          -  Known allergy or known hypersensitivity to placebo excipients either of the Viaskin&#xD;
             patches or of the food challenge formulas.&#xD;
&#xD;
          -  Subjects reacting objectively to the placebo formula at screening.&#xD;
&#xD;
          -  Severe reaction during the screening food challenge, defined as need for intubation,&#xD;
             hypotension persisting after epinephrine administration, or the need for more than two&#xD;
             doses of epinephrine.&#xD;
&#xD;
          -  Inability to discontinue short-acting antihistamines for three days or long-acting&#xD;
             antihistamines for five to seven days (depending on half-life) prior to skin prick&#xD;
             testing or food challenges.&#xD;
&#xD;
          -  Subjects treated with systemic long-acting corticosteroids (depot corticosteroids)&#xD;
             within 12 weeks prior to the screening visit and/or systemic short-acting&#xD;
             corticosteroid within 4 weeks prior to the screening visit or any systemic&#xD;
             corticosteroid at screening.&#xD;
&#xD;
          -  Subjects with asthma defined as follows:&#xD;
&#xD;
               1. uncontrolled persistent asthma by National Asthma Education and Prevention&#xD;
                  Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or&#xD;
                  being treated with combination therapy of medium dose inhaled corticosteroid with&#xD;
                  a long acting inhaled β2-agonists;&#xD;
&#xD;
               2. at least two systemic corticosteroid courses for asthma in the past year or one&#xD;
                  oral corticosteroid course for asthma in the past three months;&#xD;
&#xD;
               3. prior intubation for asthma in the past two years.&#xD;
&#xD;
          -  Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors,&#xD;
             angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant&#xD;
             therapy.&#xD;
&#xD;
          -  Subjects undergoing any type of immunotherapy to any food within one year prior to the&#xD;
             screening visit.&#xD;
&#xD;
          -  Subjects presently on aeroallergen immunotherapy and unwilling or unable to&#xD;
             discontinue.&#xD;
&#xD;
          -  Subjects currently treated with anti-tumor necrosis factor drugs or anti-IgE drugs&#xD;
             (such as omalizumab) or any biologic immunomodulatory therapy within one year prior to&#xD;
             the screening visit.&#xD;
&#xD;
          -  Allergy or known history of reaction to Tegaderm®.&#xD;
&#xD;
          -  Subjects suffering from generalized dermatologic diseases (e.g. severe atopic&#xD;
             dermatitis, uncontrolled generalized eczema, keratosis pilaris, ichthyosis vulgaris)&#xD;
             with no intact skin zones to apply the patches.&#xD;
&#xD;
          -  Any disorder in which epinephrine is contraindicated such as coronary artery disease,&#xD;
             uncontrolled hypertension, or serious ventricular arrhythmias.&#xD;
&#xD;
          -  Participation in another clinical intervention study in the three months prior to the&#xD;
             screening visit.&#xD;
&#xD;
          -  Subjects on any experimental drugs or treatments.&#xD;
&#xD;
        Other inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Rady Childrens Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Childrens' Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASTHMA, Inc.</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheema Research Inc.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Allergy Asthma Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4V 1R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Appliquée en Asthme et Allergie de Québec</name>
      <address>
        <city>Sainte-Foy</city>
        <state>Quebec</state>
        <zip>G1V 4M6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Vincent de Paul</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCS des hôpitaux pédiatriques</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux De Brabois</name>
      <address>
        <city>Vandoeuvre-les-Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr2</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny UM</name>
      <address>
        <city>Łódź</city>
        <zip>92213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>September 28, 2021</results_first_submitted>
  <results_first_submitted_qc>September 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2021</results_first_posted>
  <disposition_first_submitted>September 28, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 28, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 19, 2015</disposition_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Food allergy</keyword>
  <keyword>Immediate hypersensitivity</keyword>
  <keyword>Whole peanut extract</keyword>
  <keyword>Allergenic product</keyword>
  <keyword>Specific Immunotherapy</keyword>
  <keyword>Epicutaneous Immunotherapy (EPIT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This Phase IIb, placebo-controlled study was conducted in participants aged 6 to 55 years old with peanut allergy at 22 study centers in 5 countries (Canada, France, Netherlands, Poland and USA) between 31 July 2012 and 31 July 2014. All participants who completed the VIPES study up to Visit 11 (inclusive) were eligible for participation in the follow-up study (OLFUS-VIPES).</recruitment_details>
      <pre_assignment_details>Study had a 4-week screening period, 52-week treatment period and 2-week follow-up period. A total of 221 participants were randomized in a 1:1:1:1 ratio into 4 treatment groups (50 micrograms [μg], 100 μg, 250 μg peanut proteins and placebo). Each participant underwent dose-escalating double-blind, placebo-controlled food challenge (DBPCFC) at screening and Month 12. At screening, a dose-escalating DBPCFC confirmed peanut allergy to an eliciting dose &lt;=300 milligrams (mg) peanut protein.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Viaskin Peanut 50 μg</title>
          <description>Participants applied 1 new Viaskin® Peanut (DBV712) 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="P2">
          <title>Viaskin Peanut 100 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="P3">
          <title>Viaskin Peanut 250 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant unwilling to continue</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Viaskin Peanut 50 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="B2">
          <title>Viaskin Peanut 100 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="B3">
          <title>Viaskin Peanut 250 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="56"/>
            <count group_id="B4" value="56"/>
            <count group_id="B5" value="221"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.3" spread="6.72"/>
                    <measurement group_id="B2" value="13.9" spread="6.66"/>
                    <measurement group_id="B3" value="13.6" spread="7.48"/>
                    <measurement group_id="B4" value="12.5" spread="6.84"/>
                    <measurement group_id="B5" value="13.1" spread="6.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Children (6-11 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adolescents (12-17 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adults (18-55 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>The ethnicity of the participants at French local sites was not collected as it was not applicable as per local law. As such, these participants are included in the category of 'Not applicable'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not applicable</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Treatment Responders at Month 12; Analyzed in Overall Population</title>
        <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Treatment Responders at Month 12; Analyzed in Overall Population</title>
          <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3" lower_limit="31.56" upper_limit="59.55"/>
                    <measurement group_id="O2" value="41.1" lower_limit="28.10" upper_limit="55.02"/>
                    <measurement group_id="O3" value="50.0" lower_limit="36.34" upper_limit="63.66"/>
                    <measurement group_id="O4" value="25.0" lower_limit="14.39" upper_limit="38.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p&lt;0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p&lt;0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0292</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>3.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p&lt;0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p&lt;0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1074</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>2.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p&lt;0.05.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0108</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.18</ci_lower_limit>
            <ci_upper_limit>3.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)</title>
        <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)</title>
          <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" lower_limit="37.18" upper_limit="75.54"/>
                    <measurement group_id="O2" value="46.2" lower_limit="26.59" upper_limit="66.63"/>
                    <measurement group_id="O3" value="53.6" lower_limit="33.87" upper_limit="72.49"/>
                    <measurement group_id="O4" value="19.4" lower_limit="7.45" upper_limit="37.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0035</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>2.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.34</ci_lower_limit>
            <ci_upper_limit>6.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0453</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>2.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>5.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0076</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>2.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.25</ci_lower_limit>
            <ci_upper_limit>6.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)</title>
        <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)</title>
          <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="13.34" upper_limit="59.01"/>
                    <measurement group_id="O2" value="10.5" lower_limit="1.30" upper_limit="33.14"/>
                    <measurement group_id="O3" value="38.9" lower_limit="17.30" upper_limit="64.25"/>
                    <measurement group_id="O4" value="22.2" lower_limit="6.41" upper_limit="47.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7112</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>4.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4048</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>2.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4705</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>4.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)</title>
        <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)</title>
          <description>A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a &gt;=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" lower_limit="3.67" upper_limit="70.96"/>
                    <measurement group_id="O2" value="81.8" lower_limit="48.22" upper_limit="97.72"/>
                    <measurement group_id="O3" value="60.0" lower_limit="26.24" upper_limit="87.84"/>
                    <measurement group_id="O4" value="57.1" lower_limit="18.41" upper_limit="90.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5921</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3260</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>2.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.0000</p_value>
            <method>Fisher Exact</method>
            <param_type>Relative risk</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>2.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population</title>
        <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population</title>
          <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="453.8" spread="608.16"/>
                    <measurement group_id="O2" value="539.7" spread="659.31"/>
                    <measurement group_id="O3" value="621.4" spread="715.03"/>
                    <measurement group_id="O4" value="283.7" spread="482.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0607</p_value>
            <p_value_desc>P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>70.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.41</ci_lower_limit>
            <ci_upper_limit>193.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0150</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>97.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.45</ci_lower_limit>
            <ci_upper_limit>237.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>242.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>100.03</ci_lower_limit>
            <ci_upper_limit>482.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)</title>
        <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)</title>
          <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="397.1" spread="510.13"/>
                    <measurement group_id="O2" value="441.2" spread="511.26"/>
                    <measurement group_id="O3" value="652.5" spread="766.93"/>
                    <measurement group_id="O4" value="160.5" spread="244.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0372</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>73.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.96</ci_lower_limit>
            <ci_upper_limit>225.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0143</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>96.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.92</ci_lower_limit>
            <ci_upper_limit>278.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>260.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>89.83</ci_lower_limit>
            <ci_upper_limit>625.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)</title>
        <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)</title>
          <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="501.7" spread="726.14"/>
                    <measurement group_id="O2" value="281.6" spread="472.47"/>
                    <measurement group_id="O3" value="573.9" spread="716.01"/>
                    <measurement group_id="O4" value="331.8" spread="511.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6596</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>26.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.58</ci_lower_limit>
            <ci_upper_limit>236.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8702</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>8.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-65.90</ci_lower_limit>
            <ci_upper_limit>189.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0630</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>158.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.50</ci_lower_limit>
            <ci_upper_limit>562.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)</title>
        <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)</title>
          <description>The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="557.1" spread="711.47"/>
                    <measurement group_id="O2" value="1218.5" spread="822.74"/>
                    <measurement group_id="O3" value="620.0" spread="619.68"/>
                    <measurement group_id="O4" value="705.7" spread="893.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6776</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>-80.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-237.22</ci_lower_limit>
            <ci_upper_limit>782.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5068</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>158.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-166.10</ci_lower_limit>
            <ci_upper_limit>1478.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7972</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>53.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-193.90</ci_lower_limit>
            <ci_upper_limit>1085.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population</title>
        <description>The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>At Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population</title>
          <description>The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="730.8" spread="1020.53"/>
                    <measurement group_id="O2" value="863.5" spread="1120.43"/>
                    <measurement group_id="O3" value="1010.6" spread="1223.85"/>
                    <measurement group_id="O4" value="451.4" spread="807.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0444</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>120.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.30</ci_lower_limit>
            <ci_upper_limit>321.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0175</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>147.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.67</ci_lower_limit>
            <ci_upper_limit>365.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>386.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>159.67</ci_lower_limit>
            <ci_upper_limit>771.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population</title>
        <description>The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
        <time_frame>Baseline and Month 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population</title>
          <description>The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="4.79"/>
                    <measurement group_id="O2" value="-0.9" spread="4.21"/>
                    <measurement group_id="O3" value="0.2" spread="4.65"/>
                    <measurement group_id="O4" value="-1.4" spread="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2510</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.55</ci_lower_limit>
            <ci_upper_limit>0.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6820</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.24</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2117</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>2.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and &gt;0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population</title>
        <description>The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as &lt;=0.5 or &gt;0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and &gt;0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population</title>
          <description>The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as &lt;=0.5 or &gt;0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: undiluted; &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: undiluted; &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="51"/>
                    <measurement group_id="O4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:10); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:10); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="48"/>
                    <measurement group_id="O4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:100); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:100); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:1000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:1000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:10000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: diluted (1:10000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: undiluted; &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: undiluted; &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:10); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:10); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:100); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:100); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:1000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:1000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:10000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6: diluted (1:10000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: undiluted; &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: undiluted; &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:10); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:10); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:100); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:100); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="43"/>
                    <measurement group_id="O4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:1000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:1000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="34"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:10000); &lt;= 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: diluted (1:10000); &gt; 0.5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>kilo units per liter (kU/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3" lower_limit="-375" upper_limit="676"/>
                    <measurement group_id="O2" value="29.9" lower_limit="-118" upper_limit="1243"/>
                    <measurement group_id="O3" value="50.7" lower_limit="-91" upper_limit="794"/>
                    <measurement group_id="O4" value="2.8" lower_limit="-117" upper_limit="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="-158" upper_limit="348"/>
                    <measurement group_id="O2" value="22.0" lower_limit="-65" upper_limit="1464"/>
                    <measurement group_id="O3" value="29.5" lower_limit="-93" upper_limit="747"/>
                    <measurement group_id="O4" value="-1.1" lower_limit="-363" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-211" upper_limit="305"/>
                    <measurement group_id="O2" value="4.9" lower_limit="-146" upper_limit="245"/>
                    <measurement group_id="O3" value="5.2" lower_limit="-382" upper_limit="598"/>
                    <measurement group_id="O4" value="-1.4" lower_limit="-327" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0337</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>17.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>38.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0020</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>26.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.38</ci_lower_limit>
            <ci_upper_limit>49.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0120</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>20.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.85</ci_lower_limit>
            <ci_upper_limit>40.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
          <units>kU/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="-375" upper_limit="676"/>
                    <measurement group_id="O2" value="63.1" lower_limit="-27" upper_limit="1243"/>
                    <measurement group_id="O3" value="50.7" lower_limit="-16" upper_limit="794"/>
                    <measurement group_id="O4" value="4.1" lower_limit="-117" upper_limit="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="-55" upper_limit="348"/>
                    <measurement group_id="O2" value="48.7" lower_limit="-9" upper_limit="1464"/>
                    <measurement group_id="O3" value="21.2" lower_limit="-70" upper_limit="291"/>
                    <measurement group_id="O4" value="-1.8" lower_limit="-363" upper_limit="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" lower_limit="-211" upper_limit="305"/>
                    <measurement group_id="O2" value="3.5" lower_limit="-146" upper_limit="150"/>
                    <measurement group_id="O3" value="1.0" lower_limit="-136" upper_limit="485"/>
                    <measurement group_id="O4" value="-12.0" lower_limit="-327" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
          <units>kU/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="-99" upper_limit="248"/>
                    <measurement group_id="O2" value="62.0" lower_limit="-118" upper_limit="303"/>
                    <measurement group_id="O3" value="135.5" lower_limit="0" upper_limit="552"/>
                    <measurement group_id="O4" value="4.8" lower_limit="-17" upper_limit="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="-158" upper_limit="170"/>
                    <measurement group_id="O2" value="24.2" lower_limit="-65" upper_limit="239"/>
                    <measurement group_id="O3" value="90.0" lower_limit="-10" upper_limit="440"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-43" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="-49" upper_limit="199"/>
                    <measurement group_id="O2" value="24.9" lower_limit="-98" upper_limit="163"/>
                    <measurement group_id="O3" value="39.4" lower_limit="-382" upper_limit="434"/>
                    <measurement group_id="O4" value="1.0" lower_limit="-31" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
          <units>kU/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3" lower_limit="-76" upper_limit="183"/>
                    <measurement group_id="O2" value="12.3" lower_limit="-1" upper_limit="169"/>
                    <measurement group_id="O3" value="3.1" lower_limit="-91" upper_limit="471"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-34" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" lower_limit="-0" upper_limit="214"/>
                    <measurement group_id="O2" value="3.6" lower_limit="-4" upper_limit="377"/>
                    <measurement group_id="O3" value="1.6" lower_limit="-93" upper_limit="747"/>
                    <measurement group_id="O4" value="-0.2" lower_limit="-42" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" lower_limit="-25" upper_limit="163"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-9" upper_limit="245"/>
                    <measurement group_id="O3" value="-2.0" lower_limit="-148" upper_limit="598"/>
                    <measurement group_id="O4" value="0.9" lower_limit="-107" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized.</population>
          <units>mg per liter (mg/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="-1" upper_limit="6"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-18" upper_limit="4"/>
                    <measurement group_id="O3" value="0.8" lower_limit="-1" upper_limit="14"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-3" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="-2" upper_limit="6"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-19" upper_limit="8"/>
                    <measurement group_id="O3" value="1.4" lower_limit="-6" upper_limit="19"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="-2" upper_limit="12"/>
                    <measurement group_id="O2" value="0.9" lower_limit="-9" upper_limit="10"/>
                    <measurement group_id="O3" value="1.6" lower_limit="-3" upper_limit="17"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-3" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Difference in LS mean</param_type>
            <param_value>2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.39</ci_lower_limit>
            <ci_upper_limit>3.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.</population>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="-1" upper_limit="6"/>
                    <measurement group_id="O2" value="0.4" lower_limit="-18" upper_limit="4"/>
                    <measurement group_id="O3" value="1.7" lower_limit="-1" upper_limit="14"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="-2" upper_limit="6"/>
                    <measurement group_id="O2" value="1.1" lower_limit="-19" upper_limit="8"/>
                    <measurement group_id="O3" value="4.4" lower_limit="0" upper_limit="19"/>
                    <measurement group_id="O4" value="-0.1" lower_limit="-1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="-2" upper_limit="12"/>
                    <measurement group_id="O2" value="1.6" lower_limit="-9" upper_limit="10"/>
                    <measurement group_id="O3" value="6.3" lower_limit="-1" upper_limit="17"/>
                    <measurement group_id="O4" value="-0.0" lower_limit="-2" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.</population>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0" upper_limit="2"/>
                    <measurement group_id="O2" value="0.6" lower_limit="-0" upper_limit="2"/>
                    <measurement group_id="O3" value="0.7" lower_limit="-0" upper_limit="4"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-3" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="-1" upper_limit="3"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O3" value="0.7" lower_limit="-6" upper_limit="6"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="-1" upper_limit="8"/>
                    <measurement group_id="O2" value="0.7" lower_limit="-1" upper_limit="3"/>
                    <measurement group_id="O3" value="0.9" lower_limit="-3" upper_limit="9"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-3" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</title>
        <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
        <time_frame>Baseline and Months 3, 6 and 12</time_frame>
        <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Viaskin Peanut 50 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O2">
            <title>Viaskin Peanut 100 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O3">
            <title>Viaskin Peanut 250 μg</title>
            <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)</title>
          <description>Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.</description>
          <population>The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.</population>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-0" upper_limit="2"/>
                    <measurement group_id="O3" value="0.4" lower_limit="-0" upper_limit="1"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="-0" upper_limit="3"/>
                    <measurement group_id="O2" value="0.5" lower_limit="-0" upper_limit="1"/>
                    <measurement group_id="O3" value="0.6" lower_limit="-0" upper_limit="6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="0.3" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O3" value="0.9" lower_limit="-0" upper_limit="8"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-0" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.</time_frame>
      <desc>The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Viaskin Peanut 50 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="E2">
          <title>Viaskin Peanut 100 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="E3">
          <title>Viaskin Peanut 250 μg</title>
          <description>Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Anaphylactic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="56" subjects_at_risk="56"/>
                <counts group_id="E4" subjects_affected="51" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="53" subjects_affected="39" subjects_at_risk="53"/>
                <counts group_id="E2" events="68" subjects_affected="33" subjects_at_risk="56"/>
                <counts group_id="E3" events="61" subjects_affected="32" subjects_at_risk="56"/>
                <counts group_id="E4" events="21" subjects_affected="14" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="23" subjects_affected="18" subjects_at_risk="53"/>
                <counts group_id="E2" events="52" subjects_affected="23" subjects_at_risk="56"/>
                <counts group_id="E3" events="38" subjects_affected="23" subjects_at_risk="56"/>
                <counts group_id="E4" events="15" subjects_affected="7" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site eczema</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E3" events="17" subjects_affected="10" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site swelling</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E3" events="15" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site papules</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site rash</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site urticaria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E2" events="22" subjects_affected="11" subjects_at_risk="56"/>
                <counts group_id="E3" events="11" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E4" events="14" subjects_affected="10" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="23" subjects_affected="14" subjects_at_risk="53"/>
                <counts group_id="E2" events="18" subjects_affected="11" subjects_at_risk="56"/>
                <counts group_id="E3" events="17" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E4" events="25" subjects_affected="12" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E2" events="17" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E3" events="15" subjects_affected="10" subjects_at_risk="56"/>
                <counts group_id="E4" events="30" subjects_affected="18" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="17" subjects_affected="11" subjects_at_risk="53"/>
                <counts group_id="E2" events="16" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E3" events="14" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E4" events="27" subjects_affected="13" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E4" events="15" subjects_affected="5" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E4" events="12" subjects_affected="6" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E4" events="10" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="9" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="16" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E4" events="18" subjects_affected="8" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>DBV Technologies</organization>
      <phone>33-1-55-42-78-78</phone>
      <email>clinicaltrials@dbv-technologies.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675882
org study id: VIPES
secondary id: 2011-002550-32
nct id: NCT01675882
lead sponsor: 
has dmc: Yes
The objectives of this dose-finding study for the treatment of peanut allergy are:

        -  To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg
           peanut protein per patch) to significantly desensitize peanut-allergic subjects to
           peanut after 12 months of treatment.

        -  To evaluate the safety of a long-term treatment with Viaskin Peanut.
Peanut allergy is a common allergy in the United States, with a prevalence in the general
      population as high as 1%. Peanut allergy management is based on strict peanut avoidance and
      injectable epinephrine after the allergic systemic reactions have started. Specific
      Immunotherapy methods currently available have shown some limitations in their use because of
      safety issues. Hence, there is an important unmet medical need for efficient and safe
      treatment of peanut allergy.

      DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method
      based on delivering precise quantity of the allergen on the upper layers of the skin.
      Avoiding contact between the allergen and the bloodstream should confer to epicutaneous
      immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented

      The VIPES study is a 12-month double-blind, placebo-controlled,randomized trial to study the
      efficacy and safety of Viaskin Peanut in subjects from 6 to 55 years old with a history of
      immediate hypersensitive reaction to peanut protein.

      The trial will be conducted at sites with investigators and staff trained and experienced in
      the diagnosis and the management of peanut allergy and anaphylaxis, and who are capable of
      performing a double-blind placebo-controlled food challenge (DBPCFC) in adult and/or
      pediatric subjects. Three doses of peanut proteins, i.e. 50 mcg, 100 mcg and 250 mcg will be
      evaluated for the study. Following the confirmation of peanut allergy at screening, subjects
      will be randomized in a 1:1:1:1 ratio into four different treatment groups, including 50 mcg,
      100 mcg and 250 mcg peanut protein or placebo. Treatment will be comprised of daily
      applications of Viaskin Peanut or placebo patch for 12 months. Each subject will undergo two
      DBPCFCs: one at screening and one at Month 12. A follow up visit will be performed 2 weeks
      after completion of treatment and the last DBPCFC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Treatment Responders at Month 12; Analyzed in Overall Population
time frame: At Month 12
description: A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
measure: Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)
time frame: At Month 12
description: A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)
time frame: At Month 12
description: A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)
time frame: At Month 12
description: A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a >=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population
time frame: At Month 12
description: The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)
time frame: At Month 12
description: The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)
time frame: At Month 12
description: The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)
time frame: At Month 12
description: The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population
time frame: At Month 12
description: The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population
time frame: Baseline and Month 12
description: The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
measure: Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
time frame: Baseline and Months 3, 6 and 12
description: The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as <=0.5 or >0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.
measure: Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
measure: Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
time frame: Baseline and Months 3, 6 and 12
description: Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
arm group label: Viaskin Peanut 50 mcg
arm group type: Experimental
arm group label: Viaskin Peanut 100 mcg
arm group type: Experimental
arm group label: Viaskin Peanut 250 mcg
arm group type: Experimental
arm group label: Viaskin Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: Viaskin Peanut 50 mcg
description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract
arm group label: Viaskin Peanut 50 mcg
intervention type: Biological
intervention name: Viaskin Peanut 100 mcg
description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract
arm group label: Viaskin Peanut 100 mcg
intervention type: Biological
intervention name: Viaskin Peanut 250 mcg
description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
arm group label: Viaskin Peanut 250 mcg
intervention type: Biological
intervention name: Viaskin Placebo
description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation
arm group label: Viaskin Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 55 Years
healthy volunteers: No
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country: Canada
country: France
country: Netherlands
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 