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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003112-31 | EudraCT Number |
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The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol Mebutate | Experimental | Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8 |
|
| Imiquimod | Active Comparator | Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol Mebutate Gel, 0.015% | Drug | Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SCC | Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC or censoring. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SCC and Other Neoplasia | Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring. | 3 years |
Not provided
Inclusion Criteria:
Signed Informed Consent Form (ICF) prior to any trial-related procedures
Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
Subject at least 18 years of age
Female subjects must be of either:
Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)
Exclusion Criteria:
Location of the selected treatment area:
Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
Organ transplant recipients
Immunosuppressed subjects (for example HIV patients)
Female subjects who are breastfeeding.
Subjects who are institutionalised by court order or by the local authority
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
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| Name | Affiliation | Role |
|---|---|---|
| Rolf-Markus Szeimies, Prof.Dr.med. | Klinik für Dermatologie und Allergologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers - Service de Dermatologie | Angers | 49933 | France | |||
| CHU Besançon - Hôpital Jean Minjoz |
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The clinical trial was performed at 44 sites in 3 countries: France, 11 sites; Germany, 15 sites; and United Kingdom, 18 sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Ingenol Mebutate | Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8> > Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2013 | Jul 20, 2020 |
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|
| Imiquimod Cream, 5% | Drug | Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs |
|
|
| Number of Participants With Complete Clearance of AK Lesions After Last Treatment | To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) | 8-16 weeks |
| Number of Participants With Partial Clearance of AK Lesions | To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) | 8-16 weeks |
| Number of Participants With Complete Clearance of AK Lesions at 12 Months | To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12. | 1 year |
| Besançon |
| 25030 |
| France |
| HOPITAL AVICENNE - Service de Dermatologie | Bobigny | 93009 | France |
| CHRU de Brest - Hôpital Morvan - Service de Dermatologie | Brest | 29609 | France |
| CHU Albert Michallon - Service de Dermatologie, Pôle Pluridisciplinaire de Médecine | Grenoble | 38043 | France |
| Hôpital Claude Huriez - CHRU de Lille - Clinique de Dermatologie | Lille | 59037 | France |
| Hôpital de la Timone - Service de Dermatologie Vénérologie | Marseille | 13385 | France |
| CHU de Nantes - Hôtel Dieu - Unité Fonctionnelle de Dermatologie Cancérologie | Nantes | 44093 | France |
| HOPITAL DE L ARCHET II - Service de Dermatologie-Vénérologie | Nice | 06202 | France |
| Hôpital Caremeau | Nîmes | 30029 | France |
| HOPITAL COCHIN TARNIER - Service de Dermatologie | Paris | 75006 | France |
| Hôpital Saint Louis - Service de Dermatologie | Paris | 75475 | France |
| CHU BORDEAUX - Hôpital Haut-Lévêque | Pessac | 33604 | France |
| CHU Poitiers - Service de Dermatologie | Poitiers | 86021 | France |
| C.H.U. de Saint-Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| Hôpital d'instruction des Armées Bégin - Clinique Dermatologique | Saint-Mandé | 94160 | France |
| Hautarztpraxis Simon | Berlin | 10827 | Germany |
| Hauttumorzentrum Bochum Universitätsklinikum der Ruhr-Universität-Bochum | Bochum | 44791 | Germany |
| Praxis Streit Bucholz | Buchholz | 21244 | Germany |
| Dermatologisches Zentrum, Am Krankenhaus 1 | Buxtehude | 21614 | Germany |
| Klinikum Dortmund - Hautklinik | Dortmund | 44137 | Germany |
| Mensingderma | Hamburg | 22391 | Germany |
| Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie | Leipzig | 04103 | Germany |
| Hautpraxis Dr. Ina Schulze | Markkleeberg | 04416 | Germany |
| Hauttumorzentrum Münster | Münster | 48149 | Germany |
| Klinik für Dermatologie und Allergologie, Klinikum Vest, Behandlungszentrum, Knappschaftskrankenhaus Recklinghausen, | Recklinghausen | 45657 | Germany |
| Universitätklinikum Regensburg | Regensburg | 93053 | Germany |
| Praxis Dr. Hoffmann | Witten | 58453 | Germany |
| Praxis Derma Hübinger | Wuppertal | 42105 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Ninewells Hospital | Dundee | Angus | United Kingdom |
| Cumberland Infirmary | Carlisle | Cumbria | United Kingdom |
| Heavitree Hospital | Exeter | Devon | United Kingdom |
| Brighton General Hospital | Brighton | East Sussex | United Kingdom |
| Manchester Royal Infirmary | Manchester | Greater Manchester | United Kingdom |
| Monklands Hospital | Airdrie | Lanarkshire | United Kingdom |
| Scunthorpe General Hospital | Scunthorpe | Lincolnshire | United Kingdom |
| Royal Gwent Hospital | Newport | Monmouthshire | United Kingdom |
| Harrogate District Hospital | Harrogate | North Yorkshire | United Kingdom |
| Scarborough Hospital | Scarborough | North Yorkshire | United Kingdom |
| Cannock Chase Hospital | Cannock | Staffordshire | United Kingdom |
| East Surrey Hospital | Redhill | Surrey | United Kingdom |
| Southlands Hospital | Shoreham-by-Sea | West Sussex | United Kingdom |
| St Luke's Hospital | Bradford | West Yorkshire | United Kingdom |
| Chapel Allerton Hospital | Leeds | West Yorkshire | United Kingdom |
| Hull Royal Infirmary | Hull | United Kingdom |
| FG001 | Imiquimod | Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8> > Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs |
| COMPLETED |
|
| NOT COMPLETED |
|
In total, 485 subjects were randomised (full analysis set), but 1 subject (randomised in United Kingdom) was not treated. To support the primary safety endpoints, all baseline and safety results are based on the 484 subjects. Efficacy analysis are based on all 485 randomized subjects due to the intention-to-treat principle.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ingenol Mebutate | Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8> > Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. |
| BG001 | Imiquimod | Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8> > Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of SCC | Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC or censoring. | Safety analysis set: all treated subjects | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of SCC and Other Neoplasia | Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring. | Safety analysis set: all treated subjects | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Clearance of AK Lesions After Last Treatment | To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) | Full analysis set: all randomised subjects | Posted | Count of Participants | Participants | 8-16 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Partial Clearance of AK Lesions | To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) | Full analysis set: all randomised subjects | Posted | Count of Participants | Participants | 8-16 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Complete Clearance of AK Lesions at 12 Months | To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12. | Full analysis set: all randomised subjects. | Posted | Count of Participants | Participants | 1 year |
|
From Day 1 and up to 3 years.
Adverse events (AEs) were reported differently before and after Week 20. Week 20 is the first week of the follow-up period. Before Week 20, all AEs and serious AEs were recorded; after Week 20, all AEs inside the treatment area but only BCC/SCC and related SAEs outside the treatment area, were recorded.
As per above rules, there were deaths occuring after Week 20 without an associated AE recorded. However, all deaths in the trial are included under "All-Cause Mortality"
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ingenol Mebutate Until Week 20 | Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8. Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. | 0 | 240 | 21 | 240 | 67 | 240 |
| EG001 | Imiquimod Until Week 20 | Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8 Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs | 1 | 244 | 14 | 244 | 70 | 244 |
| EG002 | Ingenol Mebutate After Week 20 | Ingenol mebutate Week 20 is the first week of the follow-up period. | 8 | 240 | 11 | 240 | 51 | 240 |
| EG003 | Imiquimod After Week 20 | Imiquimod Week 20 is the first week of the follow-up period. | 5 | 244 | 2 | 244 | 50 | 244 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment | Source data does not describe 'number of events', only 'number of subjects'. |
|
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Reversible ischaemic neurological deficit | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye swelling | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-centre publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Disclosure | LEO Pharma A/S | +45 44945888 | disclosure@leo-pharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2019 | Jul 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Germany |
|
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