<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/NCT02239679</url>
  </required_header>
  <id_info>
    <org_study_id>CP0109</org_study_id>
    <nct_id>NCT02239679</nct_id>
  </id_info>
  <brief_title>Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy</brief_title>
  <official_title>A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DUSA Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DUSA Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and&#xD;
      effective in the treatment of actinic keratoses (AK) on the face, following treatment with&#xD;
      liquid nitrogen cryotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Number of AKs in Treatment Area</measure>
    <time_frame>Week 52</time_frame>
    <description>Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With 0 AKs</measure>
    <time_frame>Week 4</time_frame>
    <description>Normalized based on number of lesions present at Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction Score</measure>
    <time_frame>Week 52</time_frame>
    <description>Subject satisfaction score&#xD;
= Excellent (very satisfied)&#xD;
= Good (moderately satisfied)&#xD;
= Fair (slightly satisfied)&#xD;
= Poor (not satisfied at all) Unknown</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With 0 AKs</measure>
    <time_frame>Week 12</time_frame>
    <description>Normalized based on number of lesions present at Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With 0 AKs</measure>
    <time_frame>Week 24</time_frame>
    <description>Normalized based on number of lesions present at Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With 0 AKs</measure>
    <time_frame>Week 36</time_frame>
    <description>Normalized based on number of lesions present at Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Subjects With 0 AKs</measure>
    <time_frame>Week 52</time_frame>
    <description>Normalized based on number of lesions present at Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence Rate</measure>
    <time_frame>Week 52</time_frame>
    <description>Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>within 52 weeks after Baseline</time_frame>
    <description>Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>Screening</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>Baseline</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>24-48 hours after photodynamic therapy (PDT) #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>Screening</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>Baseline</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>Screening</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>Baseline</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>Screening</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>Baseline</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>24 weeks after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>Screening</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>Baseline</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>During PDT #1</time_frame>
    <description>Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.&#xD;
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>Screening</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>Baseline</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>Screening</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>Baseline</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>24-48 hours after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>24 Weeks after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>36 Weeks after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>52 Weeks after PDT #1</time_frame>
    <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>ALA X3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VEH</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALA X2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aminolevulinic Acid</intervention_name>
    <description>20% ALA applied to face for one hour prior to 10 J/cm2 blue light</description>
    <arm_group_label>ALA X2</arm_group_label>
    <arm_group_label>ALA X3</arm_group_label>
    <other_name>Levulan Kerastick</other_name>
    <other_name>ALA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Solution Vehicle</intervention_name>
    <description>Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light</description>
    <arm_group_label>VEH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BLU-U</intervention_name>
    <description>10 J/cm2 blue light delivered at 10 mW/cm2</description>
    <arm_group_label>ALA X2</arm_group_label>
    <arm_group_label>ALA X3</arm_group_label>
    <arm_group_label>VEH</arm_group_label>
    <other_name>BLU-U Blue Light Photodynamic Therapy Illuminator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryotherapy</intervention_name>
    <description>Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.</description>
    <arm_group_label>ALA X2</arm_group_label>
    <arm_group_label>ALA X3</arm_group_label>
    <arm_group_label>VEH</arm_group_label>
    <other_name>Liquid Nitrogen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Four to fifteen AKs on the face&#xD;
&#xD;
          -  histologically confirmed presence of abnormal architecture and satellite atypical&#xD;
             keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged&#xD;
             skin adjacent to AKs&#xD;
&#xD;
          -  at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck&#xD;
             area within the past five years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or&#xD;
             photodermatosis&#xD;
&#xD;
          -  lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated&#xD;
             skin cancers within the Treatment Area&#xD;
&#xD;
          -  skin pathology or condition which could interfere with the evaluation of the test&#xD;
             product or requires the use of interfering topical or systemic therapy&#xD;
&#xD;
          -  Subject is immunosuppressed&#xD;
&#xD;
          -  unsuccessful outcome from previous ALA-PDT therapy&#xD;
&#xD;
          -  currently enrolled in an investigational drug or device study&#xD;
&#xD;
          -  has received an investigational drug or been treated with an investigational device&#xD;
             within 30 days prior to the initiation of treatment&#xD;
&#xD;
          -  known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl&#xD;
             alcohol, laureth 4, polyethylene glycol)&#xD;
&#xD;
          -  has an active herpes simplex infection OR a history of 2 or more outbreaks within the&#xD;
             past 12 months, on the face&#xD;
&#xD;
          -  use of the following topical preparations on the extremity to be treated:&#xD;
&#xD;
               -  Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic&#xD;
                  acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within&#xD;
                  2 days&#xD;
&#xD;
               -  Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks&#xD;
&#xD;
               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels,&#xD;
                  5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical&#xD;
                  treatments for AK within 8 weeks&#xD;
&#xD;
          -  use of systemic retinoid therapy within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart Marcus, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>DUSA Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Dermatology</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutics Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altman Dermatology Associates</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shideler Clinical Research Center</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sadick Research Group</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suzanne Bruce and Associates, P.A.,The Center for Skin Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>August 16, 2017</results_first_submitted>
  <results_first_submitted_qc>September 19, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2017</results_first_posted>
  <last_update_submitted>July 27, 2018</last_update_submitted>
  <last_update_submitted_qc>July 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Actinic Keratosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminolevulinic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ALA X2</title>
          <description>Cryotherapy followed by 2 aminolevulinic acid + blue light (BLU-U) treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.</description>
        </group>
        <group group_id="P2">
          <title>ALA X3</title>
          <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="P3">
          <title>VEH-PDT</title>
          <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10 mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</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="59"/>
                <participants group_id="P3" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ALA X2</title>
          <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="B2">
          <title>ALA X3</title>
          <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="B3">
          <title>VEH-PDT</title>
          <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="B4">
          <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="59"/>
            <count group_id="B3" value="54"/>
            <count group_id="B4" value="166"/>
          </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="67.9" spread="9.65"/>
                    <measurement group_id="B2" value="66.7" spread="9.35"/>
                    <measurement group_id="B3" value="65.8" spread="9.5"/>
                    <measurement group_id="B4" value="66.8" spread="9.48"/>
                  </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="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="164"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Skin Type</title>
          <description>Fitzpatrick Skin Type staging:&#xD;
Skin Type I - Burns easily, never tans Skin Type II - Burns easily, tans minimally Skin Type III - Burns moderately, tans gradually Skin Type IV - Burns minimally, tans well Skin Type V - Rarely burns, tans profusely</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Skin Type I - Burns easily, never tans</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Skin Type II - Burns easily, tans minimally</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Skin Type III - Burns moderately, tans gradually</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Skin Type IV - Burns minimally, tans well</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Skin Type V - Rarely burns, tans profusely</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Number of AKs in Treatment Area</title>
        <description>Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.</description>
        <time_frame>Week 52</time_frame>
        <population>Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of AKs in Treatment Area</title>
          <description>Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.</description>
          <population>Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.</population>
          <units>lesions</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.91"/>
                    <measurement group_id="O2" value="2.1" spread="0.84"/>
                    <measurement group_id="O3" value="4.7" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0166</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With 0 AKs</title>
        <description>Normalized based on number of lesions present at Baseline</description>
        <time_frame>Week 4</time_frame>
        <population>Analysis population consisted of observed data; ie. subjects with data at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With 0 AKs</title>
          <description>Normalized based on number of lesions present at Baseline</description>
          <population>Analysis population consisted of observed data; ie. subjects with data at Week 4.</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction Score</title>
        <description>Subject satisfaction score&#xD;
= Excellent (very satisfied)&#xD;
= Good (moderately satisfied)&#xD;
= Fair (slightly satisfied)&#xD;
= Poor (not satisfied at all) Unknown</description>
        <time_frame>Week 52</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction Score</title>
          <description>Subject satisfaction score&#xD;
= Excellent (very satisfied)&#xD;
= Good (moderately satisfied)&#xD;
= Fair (slightly satisfied)&#xD;
= Poor (not satisfied at all) Unknown</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slightly Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With 0 AKs</title>
        <description>Normalized based on number of lesions present at Baseline</description>
        <time_frame>Week 12</time_frame>
        <population>Analysis population consisted of observed data; ie. subjects with data at Week 12.</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With 0 AKs</title>
          <description>Normalized based on number of lesions present at Baseline</description>
          <population>Analysis population consisted of observed data; ie. subjects with data at Week 12.</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With 0 AKs</title>
        <description>Normalized based on number of lesions present at Baseline</description>
        <time_frame>Week 24</time_frame>
        <population>Analysis population consisted of observed data only.</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With 0 AKs</title>
          <description>Normalized based on number of lesions present at Baseline</description>
          <population>Analysis population consisted of observed data only.</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With 0 AKs</title>
        <description>Normalized based on number of lesions present at Baseline</description>
        <time_frame>Week 36</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With 0 AKs</title>
          <description>Normalized based on number of lesions present at Baseline</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Subjects With 0 AKs</title>
        <description>Normalized based on number of lesions present at Baseline</description>
        <time_frame>Week 52</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With 0 AKs</title>
          <description>Normalized based on number of lesions present at Baseline</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0102</p_value>
            <p_value_desc>no adjustments for multiple comparisons</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>stratified by site</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0089</p_value>
            <p_value_desc>no adjustment for multiple comparisons</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>stratified by site</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Recurrence Rate</title>
        <description>Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).</description>
        <time_frame>Week 52</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Recurrence Rate</title>
          <description>Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).</description>
          <population>Analysis population consisted of observed data only</population>
          <units>number of lesions</units>
          <param>Count of Units</param>
          <units_analyzed>number of lesions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>number of lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="441"/>
                <count group_id="O2" value="525"/>
                <count group_id="O3" value="522"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <p_value_desc>no adjustments for multiple comparisons</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>stratified by site</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>no adjustment for multiple comparison</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>stratified by site</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response</title>
        <description>Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first</description>
        <time_frame>within 52 weeks after Baseline</time_frame>
        <population>Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first</description>
          <population>Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.</population>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="20.4"/>
                    <measurement group_id="O2" value="33.3" spread="19.7"/>
                    <measurement group_id="O3" value="25.9" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>24-48 hours after photodynamic therapy (PDT) #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hyperpigmentation</title>
        <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hyperpigmentation</title>
          <description>HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hypopigmentation</title>
        <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypopigmentation</title>
          <description>HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>5 minutes after PDT #1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Erythema</title>
        <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Erythema</title>
          <description>Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>5 minutes after PDT #1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>24 weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Edema</title>
        <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Edema</title>
          <description>EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.&#xD;
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>During PDT #1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.&#xD;
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>5 minutes after PDT #1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Stinging/Burning</title>
        <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Stinging/Burning</title>
          <description>STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Scaling &amp; Dryness</title>
        <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Scaling &amp; Dryness</title>
          <description>SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>Screening</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <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="59"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>24-48 hours after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>4 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>12 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>24 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="51"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>36 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Oozing/Vesiculation/Crusting</title>
        <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
        <time_frame>52 Weeks after PDT #1</time_frame>
        <population>Analysis population consisted of observed data only</population>
        <group_list>
          <group group_id="O1">
            <title>ALA X2</title>
            <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O2">
            <title>ALA X3</title>
            <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
          <group group_id="O3">
            <title>VEH-PDT</title>
            <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
          </group>
        </group_list>
        <measure>
          <title>Oozing/Vesiculation/Crusting</title>
          <description>OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above</description>
          <population>Analysis population consisted of observed data only</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="50"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ALA X2</title>
          <description>Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="E2">
          <title>ALA X3</title>
          <description>Cryotherapy followed by 3 aminolevulinic acid + BLU-U treatments&#xD;
Aminolevulinic Acid: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
        <group group_id="E3">
          <title>VEH-PDT</title>
          <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.&#xD;
Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light&#xD;
BLU-U: 10 J/cm2 blue light delivered at 10mW/cm2&#xD;
Cryotherapy: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable AK lesions at screening.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-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="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>duodenal neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Non-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="13" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="59"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="54"/>
              </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>First publication of results will be made by the Sponsor. If publication is not submitted within 12 months after the date of study final report, the PI may publish the results from the site individually, subject to compliance with the other terms of the clinical trial agreement, including a requirement that the PI provide a draft of the publication for the sponsor's review 30 days before submission for publication so that sponsor can review the publication for confidential information</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anna Houlihan</name_or_title>
      <organization>DUSA Pharmaceuticals Inc., a Sun Pharma Co.</organization>
      <phone>9147608796</phone>
      <email>Anna.Houlihan@sunpharma.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/NCT02239679
org study id: CP0109
nct id: NCT02239679
lead sponsor: 
has dmc: No
The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and
      effective in the treatment of actinic keratoses (AK) on the face, following treatment with
      liquid nitrogen cryotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Total Number of AKs in Treatment Area
time frame: Week 52
description: Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
measure: Proportion of Subjects With 0 AKs
time frame: Week 4
description: Normalized based on number of lesions present at Baseline
measure: Subject Satisfaction Score
time frame: Week 52
description: Subject satisfaction score
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all) Unknown
measure: Proportion of Subjects With 0 AKs
time frame: Week 12
description: Normalized based on number of lesions present at Baseline
measure: Proportion of Subjects With 0 AKs
time frame: Week 24
description: Normalized based on number of lesions present at Baseline
measure: Proportion of Subjects With 0 AKs
time frame: Week 36
description: Normalized based on number of lesions present at Baseline
measure: Proportion of Subjects With 0 AKs
time frame: Week 52
description: Normalized based on number of lesions present at Baseline
measure: Recurrence Rate
time frame: Week 52
description: Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
measure: Duration of Response
time frame: within 52 weeks after Baseline
description: Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first
measure: Hyperpigmentation
time frame: Screening
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: Baseline
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 24-48 hours after photodynamic therapy (PDT) #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 4 Weeks after PDT #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 12 Weeks after PDT #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 24 Weeks after PDT #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 36 Weeks after PDT #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hyperpigmentation
time frame: 52 Weeks after PDT #1
description: HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
measure: Hypopigmentation
time frame: Screening
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: Baseline
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 24-48 hours after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 4 Weeks after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 12 Weeks after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 24 Weeks after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 36 Weeks after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Hypopigmentation
time frame: 52 Weeks after PDT #1
description: HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
measure: Erythema
time frame: Screening
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: Baseline
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 5 minutes after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 24-48 hours after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 4 Weeks after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 12 Weeks after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 24 Weeks after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 36 Weeks after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Erythema
time frame: 52 Weeks after PDT #1
description: Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
measure: Edema
time frame: Screening
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: Baseline
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 5 minutes after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 24-48 hours after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 4 Weeks after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 12 Weeks after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 24 weeks after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 36 Weeks after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Edema
time frame: 52 Weeks after PDT #1
description: EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
measure: Stinging/Burning
time frame: Screening
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: Baseline
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: During PDT #1
description: Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 5 minutes after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 24-48 hours after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 4 Weeks after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 12 Weeks after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 24 Weeks after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 36 Weeks after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Stinging/Burning
time frame: 52 Weeks after PDT #1
description: STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
measure: Scaling & Dryness
time frame: Screening
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: Baseline
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 24-48 hours after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 4 Weeks after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 12 Weeks after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 24 Weeks after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 36 Weeks after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Scaling & Dryness
time frame: 52 Weeks after PDT #1
description: SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
measure: Oozing/Vesiculation/Crusting
time frame: Screening
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: Baseline
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 24-48 hours after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 4 Weeks after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 12 Weeks after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 24 Weeks after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 36 Weeks after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
measure: Oozing/Vesiculation/Crusting
time frame: 52 Weeks after PDT #1
description: OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
arm group label: ALA X3
arm group type: Experimental
description: Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
arm group label: VEH
arm group type: Placebo Comparator
description: Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group.
arm group label: ALA X2
arm group type: Experimental
description: Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
intervention type: Drug
intervention name: Aminolevulinic Acid
description: 20% ALA applied to face for one hour prior to 10 J/cm2 blue light
arm group label: ALA X2
arm group label: ALA X3
other name: Levulan Kerastick
other name: ALA
intervention type: Drug
intervention name: Topical Solution Vehicle
description: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
arm group label: VEH
intervention type: Device
intervention name: BLU-U
description: 10 J/cm2 blue light delivered at 10 mW/cm2
arm group label: ALA X2
arm group label: ALA X3
arm group label: VEH
other name: BLU-U Blue Light Photodynamic Therapy Illuminator
intervention type: Procedure
intervention name: Cryotherapy
description: Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
arm group label: ALA X2
arm group label: ALA X3
arm group label: VEH
other name: Liquid Nitrogen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stuart Marcus, MD, PhD
role: Study Director
affiliation: DUSA Pharmaceuticals, Inc.
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Aminolevulinic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 