<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/NCT03004469</url>
  </required_header>
  <id_info>
    <org_study_id>PM1541</org_study_id>
    <nct_id>NCT03004469</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia</brief_title>
  <official_title>A Multicentre, Randomized, Double-blind, Parallel-group, Controlled Study, to Assess the Efficacy and Safety of P-3074 Cutaneous Spray, Solution, in the Treatment of Male Pattern Baldness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polichem S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polichem S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in&#xD;
      participants with androgenetic alopecia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2016</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24</measure>
    <time_frame>Baseline and Week 24</time_frame>
    <description>The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24</measure>
    <time_frame>Baseline, Week 12 and Week 24</time_frame>
    <description>The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24</measure>
    <time_frame>Week 12 and Week 24</time_frame>
    <description>Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24</measure>
    <time_frame>Baseline, Week 12 and Week 24</time_frame>
    <description>The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor</measure>
    <time_frame>Baseline, Week 12 and Week 24</time_frame>
    <description>An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24</measure>
    <time_frame>Weeks 4, 8, 12 and 24</time_frame>
    <description>The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than &quot;No evidence of irritation&quot; under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than &quot;No other effects&quot; under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs</measure>
    <time_frame>From the start of IMP up to 28 weeks</time_frame>
    <description>An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">458</enrollment>
  <condition>Alopecia, Androgenetic</condition>
  <arm_group>
    <arm_group_label>P-3074 + Finasteride Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>P-3074 Vehicle + Finasteride Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Finasteride + P-3074 Vehicle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P-3074</intervention_name>
    <arm_group_label>P-3074 + Finasteride Placebo</arm_group_label>
    <other_name>finasteride topical solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Finasteride</intervention_name>
    <arm_group_label>Oral Finasteride + P-3074 Vehicle</arm_group_label>
    <other_name>Propecia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P-3074 Vehicle</intervention_name>
    <arm_group_label>Oral Finasteride + P-3074 Vehicle</arm_group_label>
    <arm_group_label>P-3074 Vehicle + Finasteride Placebo</arm_group_label>
    <other_name>Vehicle of P-3074</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Finasteride Placebo</intervention_name>
    <arm_group_label>P-3074 + Finasteride Placebo</arm_group_label>
    <arm_group_label>P-3074 Vehicle + Finasteride Placebo</arm_group_label>
    <other_name>Placebo of Finasteride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent before starting any study related procedures;&#xD;
&#xD;
          -  Men 18 to 40 years of age;&#xD;
&#xD;
          -  Men with mild to moderate vertex male pattern hair loss according to a modified&#xD;
             Norwood/Hamilton classification scale (III vertex, IV or V);&#xD;
&#xD;
          -  Participants willing to have a tattoo in the target area;&#xD;
&#xD;
          -  Outpatients;&#xD;
&#xD;
          -  Ability to comprehend the full nature and purpose of the study, including possible&#xD;
             risks and side effects;&#xD;
&#xD;
          -  Ability to co-operate with the Investigator and to comply with the requirements of the&#xD;
             entire study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormal skin scalp findings which could interfere with the aim of&#xD;
             the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any&#xD;
             other abnormality;&#xD;
&#xD;
          -  Participants who had had hair transplant surgery or hair weaving;&#xD;
&#xD;
          -  Clinically relevant abnormal laboratory values indicative of physical illness;&#xD;
&#xD;
          -  Ascertained or presumptive hypersensitivity to the active principle and/or&#xD;
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in&#xD;
             general, which the Investigator considers may affect the outcome of the study;&#xD;
&#xD;
          -  History of local infections of skin and subcutaneous tissues of the head in the&#xD;
             3-months period before the trial inclusion;&#xD;
&#xD;
          -  Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,&#xD;
             skin, haematological, endocrine or neurological diseases, that may interfere with the&#xD;
             aim of the study;&#xD;
&#xD;
          -  Suspicion of malignancy, including prostate cancer;&#xD;
&#xD;
          -  History of infertility or difficulty fathering children;&#xD;
&#xD;
          -  Participants who wish to conceive children during the study or whose sexual partner(s)&#xD;
             is pregnant;&#xD;
&#xD;
          -  Participants with active seborrheic dermatitis;&#xD;
&#xD;
          -  History of varicocele;&#xD;
&#xD;
          -  Concurrent use of systemic corticosteroids, topical corticosteroids in the balding&#xD;
             area studied, anabolic steroids, or over-the-counter &quot;hair restorers&quot;;&#xD;
&#xD;
          -  Use of the following drugs with antiandrogenic properties within 6 months of study&#xD;
             entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine,&#xD;
             spironolactone or ketoconazole;&#xD;
&#xD;
          -  Participants who had been treated with any of the following drugs within the past&#xD;
             year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin,&#xD;
             systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen,&#xD;
             phenothiazines or cytotoxic agents;&#xD;
&#xD;
          -  Use of finasteride or dutasteride within previous 12 months;&#xD;
&#xD;
          -  Light or laser treatment of scalp within previous 3 months;&#xD;
&#xD;
          -  Participation in the evaluation of any drug for 3 months before this study, calculated&#xD;
             from the first day of the month following the last visit of the previous study;&#xD;
&#xD;
          -  History of drug, alcohol [&gt;2 drinks/day defined according to USDA Dietary Guidelines&#xD;
             2010], caffeine (&gt;5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Massana, MD</last_name>
    <role>Study Director</role>
    <affiliation>Almirall, S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site #103</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #104</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #102</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #101</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #211</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #202</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #212</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #216</name>
      <address>
        <city>Bochum</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #210</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #217</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #221</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #203</name>
      <address>
        <city>Dusseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #204</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #206</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #214</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #218</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #213</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #215</name>
      <address>
        <city>Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #220</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #208</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #219</name>
      <address>
        <city>Potsdam</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #209</name>
      <address>
        <city>Schwerin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #201</name>
      <address>
        <city>Wuppertal</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #303</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #309</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #302</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #308</name>
      <address>
        <city>Satoraljaujhely</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #301</name>
      <address>
        <city>Szolnok</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #307</name>
      <address>
        <city>Szombathely</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #401</name>
      <address>
        <city>Chelyabinsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #402</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #407</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #411</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #409</name>
      <address>
        <city>Rostov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #403</name>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #406</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #408</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #410</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #503</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #505</name>
      <address>
        <city>Barakaldo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #502</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #507</name>
      <address>
        <city>Cordoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #501</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #504</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #508</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site #506</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Russian Federation</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <results_first_submitted>February 27, 2019</results_first_submitted>
  <results_first_submitted_qc>March 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2019</results_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Finasteride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Protocol Version 4 dated 8 Mar 2017</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03004469/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Non-substantial amendment 1 dated 8 Mar 17</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03004469/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Statistical Analysis Plan dated 22 Jan 2018</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03004469/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Statistical Analysis Plan Amendment 1 dated 23 Mar 2018</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03004469/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted in 5 countries, in 52 sites and initiated on 02 Aug 2016 (First participant first visit) and the study got completed on 05 Mar 2018 (Last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 632 participants were screened, with 458 participants being randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>P-3074 + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1-milligram (mg) tablet orally once daily for 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>P-3074 Vehicle + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Oral Finasteride + P-3074 Vehicle</title>
          <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="189"/>
                <participants group_id="P2" count="184"/>
                <participants group_id="P3" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="135"/>
                <participants group_id="P3" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other unspecified reason</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The data presented here for the for all randomized participants in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>P-3074 + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks</description>
        </group>
        <group group_id="B2">
          <title>P-3074 Vehicle + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Oral Finasteride + P-3074 Vehicle</title>
          <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</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="189"/>
            <count group_id="B2" value="184"/>
            <count group_id="B3" value="85"/>
            <count group_id="B4" value="458"/>
          </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="31.7" spread="5.4"/>
                    <measurement group_id="B2" value="32.0" spread="4.8"/>
                    <measurement group_id="B3" value="31.9" spread="5.6"/>
                    <measurement group_id="B4" value="31.9" spread="5.2"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="184"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian/White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                    <measurement group_id="B2" value="181"/>
                    <measurement group_id="B3" value="83"/>
                    <measurement group_id="B4" value="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24</title>
        <description>The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
        <time_frame>Baseline and Week 24</time_frame>
        <population>Intent-to-Treat (ITT) Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24</title>
          <description>The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
          <population>Intent-to-Treat (ITT) Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>Hairs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="2.88"/>
                    <measurement group_id="O2" value="6.7" spread="3.01"/>
                    <measurement group_id="O3" value="21.1" spread="3.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>13.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.94</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.8</ci_lower_limit>
            <ci_upper_limit>21.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12</title>
        <description>The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12</title>
          <description>The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>Hairs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" spread="2.41"/>
                    <measurement group_id="O2" value="7.6" spread="2.46"/>
                    <measurement group_id="O3" value="22.5" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>12.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.5</ci_lower_limit>
            <ci_upper_limit>19.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24</title>
        <description>The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
        <time_frame>Baseline, Week 12 and Week 24</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24</title>
          <description>The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>Micrometer</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1231" spread="0.30653"/>
                    <measurement group_id="O2" value="-0.7207" spread="0.31033"/>
                    <measurement group_id="O3" value="-0.6938" spread="0.41951"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8052" spread="0.35151"/>
                    <measurement group_id="O2" value="-1.5289" spread="0.36691"/>
                    <measurement group_id="O3" value="0.7163" spread="0.46679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.322</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4024</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.40570</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2020</ci_lower_limit>
            <ci_upper_limit>0.3971</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.131</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.7237</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.47799</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2184</ci_lower_limit>
            <ci_upper_limit>1.6657</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24</title>
        <description>Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.</description>
        <time_frame>Week 12 and Week 24</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24</title>
          <description>Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.08"/>
                    <measurement group_id="O2" value="3.0" spread="0.09"/>
                    <measurement group_id="O3" value="2.8" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.09"/>
                    <measurement group_id="O2" value="3.0" spread="0.10"/>
                    <measurement group_id="O3" value="2.9" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.569</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.129</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24</title>
        <description>The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
        <time_frame>Baseline, Week 12 and Week 24</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24</title>
          <description>The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.10"/>
                    <measurement group_id="O2" value="0.4" spread="0.11"/>
                    <measurement group_id="O3" value="0.5" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.09"/>
                    <measurement group_id="O2" value="0.3" spread="0.09"/>
                    <measurement group_id="O3" value="0.7" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.708</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor</title>
        <description>An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
        <time_frame>Baseline, Week 12 and Week 24</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor</title>
          <description>An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.08"/>
                    <measurement group_id="O2" value="0.2" spread="0.08"/>
                    <measurement group_id="O3" value="0.2" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.09"/>
                    <measurement group_id="O2" value="0.1" spread="0.09"/>
                    <measurement group_id="O3" value="0.3" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.179</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.262</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24</title>
        <description>The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.</description>
        <time_frame>Weeks 4, 8, 12 and 24</time_frame>
        <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24</title>
          <description>The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.</description>
          <population>ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erectile Function Score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" spread="0.76"/>
                    <measurement group_id="O2" value="26.2" spread="0.79"/>
                    <measurement group_id="O3" value="23.5" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erectile Function Score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="0.80"/>
                    <measurement group_id="O2" value="24.9" spread="0.83"/>
                    <measurement group_id="O3" value="24.4" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erectile Function Score, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="0.73"/>
                    <measurement group_id="O2" value="25.5" spread="0.77"/>
                    <measurement group_id="O3" value="23.6" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erectile Function Score, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" spread="0.74"/>
                    <measurement group_id="O2" value="26.1" spread="0.79"/>
                    <measurement group_id="O3" value="24.9" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasmic Function Score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="0.21"/>
                    <measurement group_id="O2" value="9.0" spread="0.22"/>
                    <measurement group_id="O3" value="8.9" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasmic Function Score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="0.26"/>
                    <measurement group_id="O2" value="8.7" spread="0.27"/>
                    <measurement group_id="O3" value="9.1" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasmic Function Score, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="0.21"/>
                    <measurement group_id="O2" value="8.9" spread="0.22"/>
                    <measurement group_id="O3" value="9.0" spread="0.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orgasmic Function Score, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="0.25"/>
                    <measurement group_id="O2" value="9.1" spread="0.26"/>
                    <measurement group_id="O3" value="9.0" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Desire Score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="0.17"/>
                    <measurement group_id="O2" value="7.5" spread="0.17"/>
                    <measurement group_id="O3" value="7.1" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Desire Score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="0.16"/>
                    <measurement group_id="O2" value="7.4" spread="0.17"/>
                    <measurement group_id="O3" value="7.6" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Desire Score, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="0.15"/>
                    <measurement group_id="O2" value="8.0" spread="0.16"/>
                    <measurement group_id="O3" value="7.8" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sexual Desire Score, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="0.17"/>
                    <measurement group_id="O2" value="7.7" spread="0.18"/>
                    <measurement group_id="O3" value="7.8" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intercourse Satisfaction Score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="0.49"/>
                    <measurement group_id="O2" value="10.7" spread="0.51"/>
                    <measurement group_id="O3" value="8.5" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intercourse Satisfaction Score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="0.49"/>
                    <measurement group_id="O2" value="9.9" spread="0.51"/>
                    <measurement group_id="O3" value="9.0" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intercourse Satisfaction Score, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="0.49"/>
                    <measurement group_id="O2" value="10.2" spread="0.51"/>
                    <measurement group_id="O3" value="8.3" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intercourse Satisfaction Score, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="0.47"/>
                    <measurement group_id="O2" value="10.8" spread="0.50"/>
                    <measurement group_id="O3" value="8.9" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction Score, Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="0.22"/>
                    <measurement group_id="O2" value="8.0" spread="0.22"/>
                    <measurement group_id="O3" value="7.9" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction Score, Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="0.21"/>
                    <measurement group_id="O2" value="7.8" spread="0.22"/>
                    <measurement group_id="O3" value="7.8" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction Score, Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="0.22"/>
                    <measurement group_id="O2" value="8.1" spread="0.23"/>
                    <measurement group_id="O3" value="7.6" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Satisfaction Score, Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="0.22"/>
                    <measurement group_id="O2" value="8.1" spread="0.23"/>
                    <measurement group_id="O3" value="8.2" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Erectile Function Score, Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.103</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Erectile Function Score, Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.545</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Erectile Function Score, Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.842</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.0</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Erectile Function Score, Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.449</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.02</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Orgasmic Function Score, Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.272</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Orgasmic Function Score, Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.918</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Orgasmic Function Score, Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.078</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.078</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Orgasmic Function Score, Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.593</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Sexual Desire Score, Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.295</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Sexual Desire Score, Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.926</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Sexual Desire Score, Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.183</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Sexual Desire Score, Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.981</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.041</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.562</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.67</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.642</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.156</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.65</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.2</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.824</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.713</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.993</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.550</p_value>
            <method>Mixed linear model</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale</title>
        <description>Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than &quot;No evidence of irritation&quot; under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than &quot;No other effects&quot; under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years.</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>Safety Population includes all randomized participants who received at least one application of the IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale</title>
          <description>Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than &quot;No evidence of irritation&quot; under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than &quot;No other effects&quot; under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years.</description>
          <population>Safety Population includes all randomized participants who received at least one application of the IMP.</population>
          <units>Events per personal years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dermal Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.340"/>
                    <measurement group_id="O2" value="0.245"/>
                    <measurement group_id="O3" value="0.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Effects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.368"/>
                    <measurement group_id="O2" value="0.463"/>
                    <measurement group_id="O3" value="0.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs</title>
        <description>An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.</description>
        <time_frame>From the start of IMP up to 28 weeks</time_frame>
        <population>Safety Population includes all randomized participants who received at least one application of the IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>P-3074 + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>P-3074 Vehicle + Finasteride Placebo</title>
            <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Oral Finasteride + P-3074 Vehicle</title>
            <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs</title>
          <description>An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.</description>
          <population>Safety Population includes all randomized participants who received at least one application of the IMP.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="76"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the start of the IMP up to 28 weeks</time_frame>
      <desc>The data presented here for the safety population which includes all randomized participants who receive at least one application of the IMP.</desc>
      <group_list>
        <group group_id="E1">
          <title>P-3074 + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1mg tablet orally once daily for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>P-3074 Vehicle + Finasteride Placebo</title>
          <description>Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Oral Finasteride + P-3074 Vehicle</title>
          <description>Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</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="181"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Exposure via father</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skull fractured base</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="74" subjects_at_risk="181"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="181"/>
                <counts group_id="E3" subjects_affected="40" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Anal pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Inguinal hernia perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Dust allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Anorectal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Gastritis helminthic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="181"/>
                <counts group_id="E2" events="29" subjects_affected="24" subjects_at_risk="181"/>
                <counts group_id="E3" events="22" subjects_affected="15" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Testicular abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Blood bilirubin unconjugated increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Crystal urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Red blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Stress echocardiogram abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Cervicogenic headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="25" subjects_affected="17" subjects_at_risk="181"/>
                <counts group_id="E2" events="29" subjects_affected="20" subjects_at_risk="181"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Burnout syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Initial insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Loss of libido</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Sexual dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="181"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Sebaceous gland disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Skin plaque</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>High risk sexual behaviour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </event>
              <event>
                <sub_title>Stress at work</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="84"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Francesco Scarci</name_or_title>
      <organization>Polichem S.A.</organization>
      <phone>+41 091 9864 005</phone>
      <email>francesco.scarci@almirall.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/NCT03004469
org study id: PM1541
nct id: NCT03004469
lead sponsor: 
has dmc: No
The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in
      participants with androgenetic alopecia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
time frame: Baseline and Week 24
description: The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
measure: Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12
time frame: Baseline and Week 12
description: The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
measure: Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24
time frame: Baseline, Week 12 and Week 24
description: The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.
measure: Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24
time frame: Week 12 and Week 24
description: Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.
measure: Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24
time frame: Baseline, Week 12 and Week 24
description: The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
measure: Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
time frame: Baseline, Week 12 and Week 24
description: An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.
measure: Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24
time frame: Weeks 4, 8, 12 and 24
description: The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.
measure: Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
time frame: Baseline to Week 24
description: Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than "No evidence of irritation" under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than "No other effects" under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
time frame: From the start of IMP up to 28 weeks
description: An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.
arm group label: P-3074 + Finasteride Placebo
arm group type: Experimental
description: Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks.
arm group label: P-3074 Vehicle + Finasteride Placebo
arm group type: Placebo Comparator
description: Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
arm group label: Oral Finasteride + P-3074 Vehicle
arm group type: Active Comparator
description: Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
intervention type: Drug
intervention name: P-3074
arm group label: P-3074 + Finasteride Placebo
other name: finasteride topical solution
intervention type: Drug
intervention name: Finasteride
arm group label: Oral Finasteride + P-3074 Vehicle
other name: Propecia
intervention type: Drug
intervention name: P-3074 Vehicle
arm group label: Oral Finasteride + P-3074 Vehicle
arm group label: P-3074 Vehicle + Finasteride Placebo
other name: Vehicle of P-3074
intervention type: Drug
intervention name: Finasteride Placebo
arm group label: P-3074 + Finasteride Placebo
arm group label: P-3074 Vehicle + Finasteride Placebo
other name: Placebo of Finasteride
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Eric Massana, MD
role: Study Director
affiliation: Almirall, S.A.
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country: Belgium
country: Germany
country: Hungary
country: Russian Federation
country: Spain
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Finasteride
sharing ipd: No
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