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STUDY REPORT
These results concern only the samples tested in the laboratory which are defined here after.
The samples will be kept in our premises during 2 months from the date mentioned below.
The sample and the information regarding sample have been provided by the client. All information related to the sample are under liability of the client
and have not been checked by the Eurofins ATS company.
This report replaces and cancels the report N710506A01 dated 2 of September, 2015 which has to be
destroyed. The laboratory should not be hold as responsible in case of the previous report is used. The
present report modifies the study sponsor and deletes the quotation number according to sponsor request.
Study sponsor:
LABORATORIO BONIQUET
Study manager:
Marion HARO
Tested product:
Product 1
Name
Product code
ATS reference
Product 2
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
525668
525667
Brand
Product type
Study n:
Pretreatment gel
Whitening gel
145TUTE20V15
The copy of this report is only authorized by unabridged edition.
It is made of 33 pages.
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The study concerned by this report was carried out under my responsibility, according to
the experimental protocol, the quality plan of EUROFINS ATS laboratory, and in
accordance with the good clinical practices.
All observations and data taken during this study are reported in this report.
I certify the rereading of this report and I agree with its content,
Quality Assurance Reader, Sandrine GOBARD
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STUDY SUMMARY
ASSESSMENT OF THE ORAL TOLERANCE AND OF THE QUALITIES OF A
PRODUCT, APPLIED ONCE AT THE LABORATORY, IN NORMAL CONDITIONS OF
USE, BY 20 ADULT VOLUNTEERS: Use Test
Tested products:
Product 1
Name
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
Product code
Study sponsor:
Product 2
LABORATORIO BONIQUET
Objective:
The aim of the study is to assess the oral tolerance and the
qualities of the INSTANT SMILE product, applied once at the laboratory used in normal
conditions of use, by 20 adult volunteers.
Investigator:
Study dates:
Session 1: 05/08/2015
Session 2: 06/08/2015
Method:
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4. Apply a thin stripe of the gel Instant Smile inside the fluorescent bite. Cover the
whole internal face of the bite.
5. Fold the bite and put it inside your mouth by covering the teeth. Bite it directly and
close the lips for a better fluorescent effect.
6. Leave it for 15 minutes.
Assessment methods:
Oral tolerance: clinical observations are made by the Dentist to assess the oral intolerance
reactions (assessment of the functional and clinical signs) at the beginning and at the end
of the study.
Bleaching efficacy: The Dentist assessed the teeth whiteness thanks to the R-20
Bleaching shade guide at the beginning (T0) and after the use (Timm).
Acceptability: assessment of the qualities and performances of the product is made by the
volunteers, using a suitable questionnaire.
Panel:
22 healthy female and male adult volunteers with yellowed teeth aged from 19 to 70 years
old.
The assessment of the oral tolerance was made on 22 volunteers.
The bleaching efficacy was assessed in 22 volunteers.
The product acceptability was evaluated by the 22 volunteers.
Results:
- Assessment of the bleaching efficacy by clinical scoring
After a single use, the teeth whiteness increased for 22 volunteers (100% of the panel).
The average bleaching efficacy is equivalent to a benefit of 5.4 shades (2.7 grades) in the
22 volunteers. These results allow highlighting a bleaching efficacy of the product after a
single use.
- Assessment of the oral tolerance
Assessment of the oral tolerance by the Dentist (clinical signs):
No clinical manifestation was noticed, by the Dentist, after a single use, on the 22
volunteers.
Discomfort manifestations (functional signs):
No discomfort manifestation was reported to the dentist by any of the 22 volunteers.
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Added % of totally
agree and agree
91%
55%
3. During the use, the whitening kit gives a pleasant freshness feeling
91%
77%
100%
95%
100%
91%
73%
10. At the end of the study, you would like to keep using the product
68%
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Conclusion:
To conclude, the INSTANT SMILE product, referenced 59991732 - PRETREATMENT
and referenced 59991733 - WHITENING GEL, used in normal conditions of use, a
single use at the laboratory, by 22 healthy female and male adult volunteers, with
yellowed teeth, is considered as well tolerated regarding the oral tolerance.
The INSTANT SMILE product, led to a bleaching teeth improvement in 100% of the
volunteers with a mean benefit of 5.4 shades (i.e. 2.7 grades).
The performances and the qualities of the product were globally very well
appreciated by the 22 volunteers who participated in the study, with a satisfaction
rate of 82% and a purchase intention of 64%.
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TABLE OF CONTENT
AUTHENTICITY OF THE STUDY REPORT .................................................................. 2
STUDY SUMMARY ........................................................................................................ 3
TABLE OF CONTENT ................................................................................................... 7
1
OBJECTIVE............................................................................................................. 8
METHODOLOGY .................................................................................................... 8
3
ETHIC AND REGULATORY CONSIDERATIONS CONCERNING PROTECTION
OF PERSONS .................................................................................................................. 9
3.1 Legislative and regulatory references ................................................................... 9
3.2 Ethic considerations .............................................................................................. 9
3.3 Confidentiality ..................................................................................................... 10
3.4 Archiving ............................................................................................................. 10
4
7.1
7.2
7.3
7.4
RESULTS .............................................................................................................. 18
8.1 Description of the panel ...................................................................................... 18
8.2 Study exits .......................................................................................................... 18
8.3 Results analysis .................................................................................................. 19
APPENDIX I ................................................................................................................. 21
Individual results of the clinical scoring by the Dentist ................................... 22
APPENDIX II ................................................................................................................ 23
Assessment of the oral tolerance after a single application in the laboratory
(functional and clinical signs) ................................................................................... 24
APPENDIX III ............................................................................................................... 26
Global satisfaction and purchase intention graphs .......................................... 27
Acceptability table ............................................................................................... 28
Acceptability histogram ...................................................................................... 29
APPENDIX IV ............................................................................................................... 30
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OBJECTIVE
The aim of the study is to assess the oral tolerance and the qualities of the INSTANT
SMILE product, used in normal conditions of use, applied once at the laboratory, by 20
healthy volunteers, presenting with yellowed teeth, aged from 18 to 70 years old.
METHODOLOGY
Clinical observations are made by the Dentist at the beginning of the study to confirm
the inclusion criteria and to examine the area that will be put in contact with the tested
product.
The product is applied by the volunteers at the laboratory, according to the normal
conditions of use.
The oral tolerance (clinical signs) is assessed by the Investigator, by clinical
examination after the single application at the laboratory.
The subjective tolerance (functional signs) is assessed by the volunteers from
predefined criteria (teeth or gums sensitive to cold/hot, mouth ulcer, cracks, bleeding,
itching, bad breath) in presence of the Dentist, after the single application at the
laboratory.
The qualities of the product are assessed by the volunteers using a suitable
questionnaire, developed with the study sponsor, before the beginning of the study.
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3.1
The French law relative to the Public Health n 2004-806 of August 9, 2004 (articles 88 to
97) applied by the French Decree n 2006-477 of April 26, 2006 for the research integrates
the dispositions regarding the biomedical researches and replaces the French law of
December 20, 1988 relative to the protection of persons who take part in biomedical
researches called Law Huriet-Serusclat". All tests carried out within EUROFINS ATS,
even if they are not submitted to this law, are carried out according to this law.
The studies are carried out according to the most recent recommendations of the World
Medical Association (Helsinki Declaration 1964, in its current version), and to the
AFSSAPS recommendations relative to the biomedical researches on cosmetic products
entering in the application field of the French law relative to the Public Health n 2004-806
of August 9, 2004 (Version of September 7, 2006).
However, no information is sent to the national folder of people who takes part in
biomedical research and the opinion of the Committee of Persons Protection is not
asked.
The studies follow the Guidelines for the Assessment of Skin Tolerance of Potentially
Irritant Cosmetic Ingredients, COLIPA, Edition of 1997.
3.2
Ethic considerations
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3.3
Confidentiality
The complete data regarding the health of the volunteers, collected during their final
admittance in the volunteers database of EUROFINS ATS and necessary when recruiting
and selecting them for the studies, are strictly confidential and submitted to the medical
secret according to the article 378 of the Penal Code and to the article 4 of the Medical
Ethics Code (R-4127-1 to R-4127-112 of the Public Health Code of December 14,
2006). The anonymity of the volunteers is respected within all studies carried out in our
laboratories. However, each volunteer can be easily identified by the Investigator, the
doctors and all the persons in charge of the study, thanks to its personal volunteers code.
According to the article R. 5121-13 of the Public Health Code, the product type studied,
the trials, the volunteers, and the results are strictly confidential and the secret is
respected by the Doctors and all the persons working with them.
EUROFINS ATS ensures not to divulge all the data and results collected during a study.
Treatment of personal data is declared to CNIL.
3.4
Archiving
All data related to the study will be stored in the archives of EUROFINS ATS (Ple
dactivits dAix les Milles - ACTIMART 4 alle des Informaticiens, 1140 rue Andr
Ampre 13851 AIX EN PROVENCE) and at a service providers, Socit Gnrale
dArchives (ZI Les Estroublans - 49 boulevard de lEurope 13127 VITROLLES), for 10
years.
At the end of this period, the study sponsor will have to specify whether the data related to
the study should be thrown away or restored to him. Eurofins ATS can also consider
extending the storage period of these documents, at the study sponsors expenses.
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In order to meet client expectations and legal and regulatory requirements, EUROFINS
ATS established all necessary resources for the management of its structural
organizations and methods. With a constant client satisfaction policy, EUROFINS ATS
chooses to follow the ISO 9001 requirements in order to establish the company
organisation.
In this direction, this study was carried out in accordance with the procedures defined in
the quality system. In order to insure results reliability, quality auto-controls are made all
through the process.
Thus, during this study, all the documents, materials, environment and raw data were
checked in order to avoid deviations from the protocol.
In the same way, under quality policy, the clinical tests laboratory is audited every year in
order to assess that the procedures and instructions are well applied and to check their
conformity with our internal requirements and process efficiency.
5
5.1
STUDIED PANEL
Number of volunteers
The product was tested by 22 volunteers. The test was carried out in open.
5.2
All volunteers recruited in this study come from the volunteers data base of EUROFINS
ATS, and answer the inclusion and non inclusion criteria presented in the paragraphs
below.
Their final admittance was determined by the study manager from the answers given in a
pre-study questionnaire and after a preliminary interview. During this interview, the
following information is explained to the volunteers: title, objective, protocol, planning of
the study, payment methods, as well as the possible effects expected and the study
constraints. The admittance of the volunteers is validated by the signature of the
Information Note and a free and informed consent, by the investigator and the volunteers.
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5.3
Inclusion criteria
5.5
Non-inclusion criteria
Volunteers not answering the previous inclusion criteria,
Volunteers which used a whitening kit at home,
Volunteers within an exclusion period between two tests,
Minors or majors protected by the law and people admitted in a sanitary or social
institution for other purpose than research (French law : Public Health Code article
L1121-7),
Persons deprive of liberty by legal or administrative decision, patients in emergency
situation (French law : Public Health Code article L1121-6),
Pregnant or breastfeed women (French law : Public Health Code article L1121-5)
Volunteers presenting an evolutive oral pathology or a known contact allergy to one of
the ingredients of the tested product,
Volunteers who refused to give their free and informed consent,
Volunteers under antihistaminic, corticoids, desensitizing treatment and/or under any
treatment which could interfere with the oral metabolism.
Banning and restrictions
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5.6
Volunteers withdrawal
Volunteers may be excluded from the study for the following reasons:
They no longer follow the requirements and constraints of the study, explained during
the signing of the consent,
They suffer from an illness developed during the study which may interfere with the
objectives of the study,
They no longer wish to participate in the study.
TESTED PRODUCTS
Product 1
Product name
Reference
ATS reference
Presentation (galenic,
colour)
Packaging
Number of samples
received
Use by date
Storage conditions
Product 2
INSTANT SMILE
59991732 59991733 - WHITENING
PRETREATMENT
GEL
525668
525667
Blue liquid
Transparent gel
Plastic tube
Plastic tube
25
>30 months
A sample of the tested product is kept in EUROFINS ATS laboratory, during 2 months
after the end of the study. After this date and except contrary order from the study
sponsor, the product will be destroyed.
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7
7.1
CLINICAL STUDY
Applying
The applications are made by the volunteer, at the laboratory, according to the following
recommendations (developed with the study sponsor).
7.2
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Clinical assessments
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The results obtained are collected, analysed and interpreted by the study manager
according to the normal conditions of use and of the effects investigated by the study
manager.
Assessment of the oral tolerance by the Dentist:
Depending on the percentage of volunteers that showed clinical signs or reported
functional signs, the product global tolerance is determined according to the scale found in
table 1. For each conclusion line, only one criterion has to be reached to lead to the
corresponding conclusion. If the conclusion given by the percentage of volunteers that
showed clinical signs is different from the conclusion given by the percentage of volunteers
that reported functional signs, the global tolerance will be determined by the worst result.
For example, if 10% of the volunteers showed clinical signs of slight or moderated intensity
(good tolerance) and 50% of the volunteers reported functional signs of slight or moderate
intensity (moderate tolerance), the conclusion on the product global tolerance will be of
moderate tolerance.
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Global
tolerance
Slight or moderate
Intense
Slight or moderate
Intense
Very well
0%
0%
0%
0%
Well
]0%-10%]
0%
]0%-30%]
0%
Moderate
]10%-20%]
]0%-10%]
]30%-50%]
]0%-30%]
Bad
>20%
>10%
>50%
>30%
Global satisfaction
[80%-100%]
[60%-80%[
[40%-60%[
[20%-40%[
[0%-20%[
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RESULTS
8.1
This study was carried out on 05/08/2015 and on 06/08/2015 and includes 22 healthy
female and male adult volunteers, whom characteristics are presented in table 3:
Table 3: Volunteers characteristics and events occurred during the study
VOL
VOL CODE
Gender
Age (years)
Yellowed teeth
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
GEODA
MALEL
MOCLA
BLAMI
BLAMA3
PASFA1
EL TA
FANMI
ZANCA
GIAMI1
VIDJO
CARLA11
RIBST
SERVA1
MAGNA
ALTAN
DELCL
BOUME1
BOUZO
BOUAI1
CANJU
LESCO
F
F
F
F
F
M
M
F
F
F
F
F
F
F
F
F
F
F
F
M
F
F
70
58
48
19
48
43
62
65
25
65
64
47
35
45
53
53
65
37
42
51
19
41
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Average
48
None of the volunteers selected took a treatment contraindicated with the study.
8.2
Study exits
The 22 volunteers who participated in this study gave their opinion regarding the tested
product through the acceptability questionnaire.
The oral tolerance assessment was made on 22 volunteers.
The bleaching efficacy was assessed on 22 volunteers.
The product acceptability was evaluated by the 22 volunteers.
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8.3
Results analysis
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The qualities of the products were assessed by the volunteers through an acceptability
questionnaire. The positive answers are presented in table 4:
Table 4: Acceptability
USE TEST PARAMETERS
1. The whitening kit is easy to use
Added % of totally
agree and agree
91%
55%
3. During the use, the whitening kit gives a pleasant freshness feeling
91%
77%
100%
95%
100%
91%
73%
10. At the end of the study, you would like to keep using the product
68%
Appendix III presents the graphs of global satisfaction, the purchase intention and the
acceptability graph and table.
Conclusion:
To conclude, the INSTANT SMILE product, referenced 59991732 - PRETREATMENT
and referenced 59991733 - WHITENING GEL, used in normal conditions of use, a
single use at the laboratory, by 22 healthy female and male adult volunteers, with
yellowed teeth, is considered as well tolerated regarding the oral tolerance.
The INSTANT SMILE product, led to a bleaching teeth improvement in 100% of the
volunteers with a mean benefit of 5.4 shades (i.e. 2.7 grades).
The performances and the qualities of the product were globally very well
appreciated by the 22 volunteers who participated in the study, with a satisfaction
rate of 82% and a purchase intention of 64%.
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
TEL +33 (0)4.42.39.78.08 - FAX +33 (0)4.42.39.77.81
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APPENDIX I
Individual results of the clinical scoring by the Dentist
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
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APPENDIX I
Starting date :
05/08/2015
End date :
06/08/2015
WHITENING EFFICACY
INCLUSION
NUMBER
VOLUNTEER
CODE
Whiteness onT0
Whiteness on Ti
Ti-T0
GEODA
28
22
-6
MALEL
28
24
-4
MOCLA
22
16
-6
BLAMI
14
12
-2
BLAMA3
32
26
-6
PASFA1
26
16
-10
EL TA
26
18
-8
FANMI
30
26
-4
ZANCA
16
12
-4
10
GIAMI1
30
24
-6
11
VIDJO
28
16
-12
12
CARLA11
16
12
-4
13
RIBST
22
16
-6
14
SERVA1
24
22
-2
15
MAGNA
24
22
-2
16
ALTAN
26
24
-2
17
DELCL
32
26
-6
18
BOUME1
26
16
-10
19
BOUZO
26
22
-4
20
BOUAI1
32
28
-4
21
CANJU
14
10
-4
22
LESCO
26
22
-4
Average
-5,40
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APPENDIX II
Assessment of the oral tolerance after a single application in the laboratory
(functional and clinical signs)
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
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APPENDIX II
Number of volunteers :
22
Product imputability
D0Ti
D0T0
CLINICAL SIGNS
inflammation
dema
mouth ulcer
bleeding
D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0 D0T0 D0Ti D0Ti - D0
INCLUSION
NUMBER
VOLUNTEER
CODE
GEODA
MALEL
MOCLA
BLAMI
BLAMA3
PASFA1
EL TA
FANMI
ZANCA
10
GIAMI1
11
VIDJO
12
CARLA11
13
RIBST
14
SERVA1
15
MAGNA
16
ALTAN
-1
-1
17
DELCL
18
BOUME1
19
BOUZO
20
BOUAI1
-1
-1
21
CANJU
22
LESCO
crack
D0T0 D0Ti D0Ti - D0
other
D0T0 D0Ti D0Ti - D0
18
20
20
22
22
22
22
22
22
18
20
20
22
22
22
22
22
22
No reaction
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ASSESSMENT OF THE ORAL TOLERANCE: evaluation of the clinical signs by the Dentist
Location
D0T0
D0Ti
comments
D0Ti
710506A01v2.xlsx
APPENDIX II
Number of volunteers :
22
other
D0T0 D0Ti D0Ti - D0
GEODA
-1
-2
-2
-1
MALEL
MOCLA
BLAMI
-1
-1
BLAMA3
PASFA1
-1
-1
-1
EL TA
EL TA
FANMI
10
GIAMI1
-1
-1
11
VIDJO
12
CARLA11
-1
13
RIBST
-1
14
SERVA1
-1
-1
-1
15
MAGNA
-1
-1
16
ALTAN
-2
-1
17
DELCL
18
BOUME1
19
BOUZO
-1
20
BOUAI1
21
CANJU
22
LESCO
-1
18
0
0
0
16
1
0
0
22
0
0
0
16
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
17
1
0
0
22
0
0
0
17
0
0
0
20
1
0
0
22
0
0
0
20
0
0
0
18
1
0
0
22
0
0
0
18
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
22
1
0
0
22
0
0
0
22
0
0
0
21
22
21
18
22
Number of slight reactions
1
0
0
1
0
Number of moderate reactions 0
0
0
0
0
Number of intense reactions
0
0
0
0
0
* scale from 0 to 3 : 0 = no, 1 = slight, 2 = moderated, 3 = intense
No reaction
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ASSESSMENT OF THE ORAL TOLERANCE: functional signs reported to the Dentist by the volunteers
Location
D0T0
Duration
D0Ti
D0T0
Frequency
D0Ti
D0T0
comments
D0Ti
D0T0
D0Ti
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APPENDIX III
Global satisfaction and purchase intention graphs
Acceptability table
Acceptability histogram
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
TEL +33 (0)4.42.39.78.08 - FAX +33 (0)4.42.39.77.81
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APPENDIX III
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Unsatisfied
18%
Satisfied
82%
PURCHASE INTENTION
NO
36%
YES
64%
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APPENDIX III
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Acceptability table
Totally agree
Agree
Disagree
Totally disagree
55%
36%
9%
0%
45%
9%
27%
18%
3. During the use, the whitening kit gives a pleasant freshness feeling
55%
36%
9%
0%
36%
41%
23%
0%
77%
23%
0%
0%
59%
36%
5%
0%
41%
59%
0%
0%
41%
50%
9%
0%
27%
45%
27%
0%
10. At the end of the study, you would like to keep using the product
41%
27%
23%
9%
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APPENDIX III
Acceptability histogram
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100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
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APPENDIX IV
Answers to open questions
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
TEL +33 (0)4.42.39.78.08 - FAX +33 (0)4.42.39.77.81
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APPENDIX V
List of the personnel who participated in the study
Main investigator:
Name:
Frederic BIANCHI, M.D Dentist
Address:
ACTIMART
4 alle des Informaticiens
1140 rue Andr Ampre
13851 AIX EN PROVENCE cedex 3
Phone:
04 42 39 30 92
Study Manager:
Name:
Marion HARO
Address:
ACTIMART
4 alle des Informaticiens
1140 rue Andr Ampre
13851 AIX EN PROVENCE cedex 3
Phone:
04 42 37 16 21
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
TEL +33 (0)4.42.39.78.08 - FAX +33 (0)4.42.39.77.81
N SIRET : 33761796300083 Code APE : 7120B
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APPENDIX VI
Results authenticity
Eurofins ATS -Ple d'activit d'Aix-en-Provence - Actimart - 1140, Rue Ampre - 13851 Aix-en-Provence Cedex 3 - France
TEL +33 (0)4.42.39.78.08 - FAX +33 (0)4.42.39.77.81
N SIRET : 33761796300083 Code APE : 7120B
710506A01
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