Tobacco DependenceEUREST-PLUSNCT02773836
European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
An observational study of Tobacco Dependence, run by European Network For Smoking and Tobacco Prevention at 1 site in Belgium.
Trial summary
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco Products Directive (TPD) within the context of FCTC ratification at an EU level. The investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate the psychosocial and behavioral impact of TPD… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Questionnaire
- How many people
- 6,036 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2016to 6 May 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort of 1,000 smokers recruited in each of 6 European Member States (n=6,000 in total), to be recruited at baseline.
Who may be able to join
- Must be 18 years of age or older.
- Must smoke at least monthly.
- Must have smoked 100 cigarettes in their lifetime.
- Must live in the household visited
Who cannot join
- Inability to complete the questionnaire due to health/mental incapability.
- Unable to provide consent to participate.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
European Network For Smoking and Tobacco Prevention
Brussels, 1050
About this study
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco Products Directive (TPD) within the context of FCTC ratification at an EU level. The investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany, Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.
EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation programme under grant agreement No 681109
Read the detailed description
Smoking and other forms of tobacco consumption are considered the single most important cause of preventable morbidity and premature mortality worldwide, with tobacco the major single cause for premature deaths in the European Union (EU).Efforts to reduce the devastation of tobacco-related deaths and illness in the EU consist of its newly adopted binding legislation, the Tobacco Products Directive (TPD), and the ongoing implementation of the WHO Framework Convention on Tobacco Control (FCTC).
Objective:
The main objective of EUREST-PLUS is to monitor and evaluate the psychosocial and behavioral impact of the TPD within the context of FCTC ratification at a European level, through the creation of a cohort study of adult smokers in 6 EU MS (Germany, Greece, Hungary, Poland, Romania, Spain; total n=6000) in a pre- vs. post-TPD study design. The baseline recruitment will take place in WP2 and the follow up in WP3.
Sampling frames:
- The sampling frame will be determined through a national probability sampling design within each country.
- Sample stratification will be geographic and comprise the major regions of each country (Nomenclature of Territorial Units for Statistics - NUTS) NUTS2 (Basic regions for the application of regional policies) will be used for all countries except Germany - where NUTS1 (Major socio-economic regions) will be used, as well as degrees of urbanization (city/town/rural.)
- Geographic areas excluded from the sampling design will be: In Greece, the islands in the Ionian Sea, the northern Aegean Sea and the southern Aegean Sea. In Spain the Canaries, Ceuta and Melilla
- Overall the design will be multistage within strata. The strata will be conceptually divided into clusters, each the size of an enumeration area, with the objective of sampling a total of 250 clusters - 4 adult smokers per cluster in every country.
- Clusters will be allocated based on population size and sampled via random sampling.
Sampling households within clusters:
- Interviewers will employ a random walk procedure within a particular cluster
- Once interviewers have arrived at an address, the household will be approached four times at different times of the day and week before being designated as "unable to be contacted."
- If an address corresponds to multiple households, a single household will be chosen at random.
- Households are approached until a total of 4 adult smokers have been reached within the cluster. A maximum of one male smoker and one female smoker will be selected for interview in each household.
- One male and one female from within the household that meet the criteria will be selected using the last birthday method
Respondents:
- The respondents for the Survey will be smokers aged 18 and older. The first part of the survey, which is the household screener, contains the questions that are used to determine whether the household has members that meet the criteria for inclusion.
- The household screener is asked of the most knowledgeable individual (MKI) within the household.
- One male and one female from within the household that meet the criteria will be selected using the last birthday method.
- The Individual screener follows the Household screener and confirms the information from the MKI is accurate. If the selected individual meets the eligibility criteria and consents to participate, they will be included in the sample
Survey (questionnaire):
The questionnaire will include questions not only about tobacco use, history of use, history of quitting, quit method(s) used, measures of dependence, and demographics (age, gender, education, income) but also extensive, theory-based measures of responsiveness to each policy domain of the FCTC. The survey questionnaire will consist of:
- multiple measures of policy-specific variables for each of the domains of the TPD and FCTC (e.g., health warnings, additives, e-cigarettes for TPD, illicit trade; additional domains of the FCTC, including smoke-free laws, tax/price policies, cessation services, additional product regulation domains);
- psychosocial mediators, identified by past research and theory to predict future health behaviours, including beliefs and attitudes, perceived risk, intentions to quit;
- moderators such as demographic variables (sex, gender), and other variables that will allow analyses of whether TPD and FCTC policies vary in their impact as a function of socioeconomical status.
- Conditions
- Tobacco Dependence
- Being tested
- Questionnaire
- Keywords
- tobacco use, e-cigarettes, public policy, ITC
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
| Study group | Role | What they receive |
|---|---|---|
| Greek cohort | Participants recruited from Greece will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire | |
| German cohort | Participants recruited from Germany will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire | |
| Romanian Cohort | Participants recruited from Romania will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire | |
| Spanish Cohort | Participants recruited from Spain will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire | |
| Hungarian Cohort | Participants recruited from Hungary will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire | |
| Polish cohort | Participants recruited from Poland will receive a questionnaire at pre- and post- intervention Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Think About the Harm of Smoking
In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses:
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Baseline Pre-TPD
Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
How soon after waking do you usually have your first smoke? responses:
- 5 min or less
- 6-30 min
- 31-60 min
- More than 60 min
Measured: Baseline Pre-TPD
Number of Participants Who Think About How Much They Enjoy Smoking by Frequency
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you . . .
Think about how much you enjoy smoking?
- Never
- Rarely
- Sometimes
- Often
- Very often
- Refused
- Don't know
Measured: Baseline Pre-TPD
Number of Participants Who Have Ever Tried to Quit Smoking
Have you ever tried to quit smoking?
- Yes
- No
8 Refused 9 Don't know
Measured: Baseline Pre-TPD
Number of Participants Who Plan to Quit Smoking
Are you planning to quit smoking . . .
- Within the next month
- Within the next 6 months
- Sometime in the future, beyond 6 months
- Or are you not planning to quit?
8 Refused 9 Don't know
Measured: Baseline Pre-TPD
Number of Participants Who Think About the Harm of Smoking
In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses:
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Post-TPD
Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
How soon after waking do you usually have your first smoke? responses:
- 5 min or less
- 6-30 min
- 31-60 min
- More than 60 min
Measured: Post-TPD
Number of Participants Who Have Ever Tried to Quit Smoking
Have you ever tried to quit smoking?
- Yes
- No
8 Refused 9 Don't know
Measured: Post-TPD
Number of Participants Who Plan to Quit Smoking
Are you planning to quit smoking . . .
- Within the next month
- Within the next 6 months
- Sometime in the future, beyond 6 months
- Or are you not planning to quit?
8 Refused 9 Don't know
Measured: Post-TPD
Secondary outcomes (4)
Number of Participants Who Think About The Money They Spend on Smoking
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the money you spend on smoking?
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Baseline Pre-TPD
Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the harm your smoking might be doing to other people?
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Baseline Pre-TPD
Number of Participants Who Think About The Money They Spend on Smoking
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the money you spend on smoking?
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Post-TPD
Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the harm your smoking might be doing to other people?
- Never
- Rarely
- Sometimes
- Often
- Very often
8 Refused 9 Don't know
Measured: Post-TPD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start15 Jun 2016
- Primary completion12 Sep 2016
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Network For Smoking and Tobacco Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, German Cancer Research Center, Maastricht University, University of Athens, AER PUR ROMANIA, European Respiratory Society, University of Waterloo, Institut Català d'Oncologia, DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY, PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA, University of Crete, TNS OPINION SA
- Responsible party
- Sponsor
- Investigators
- Constantine Vardavas, MD,RN,MPH,PHD, Principal investigator, European Network For Smoking and Tobacco Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773836
- Sponsor's protocol ID
- 681109
- Acronym
- EUREST-PLUS
- Status last verified
- Feb 2019
- First submitted
- 11 May 2016
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
- ClinicalTrials.gov ID
- NCT02773836
- Acronym / sponsor ID
- EUREST-PLUS / 681109
- Conditions
- Tobacco Dependence
- Keywords
- tobacco use, e-cigarettes, public policy, ITC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,036 participants (actual)
- Lead sponsor
- European Network For Smoking and Tobacco PreventionUniversity, hospital or other
- Collaborators
- King's College London, German Cancer Research Center, Maastricht University, University of Athens, AER PUR ROMANIA, European Respiratory Society, University of Waterloo, Institut Català d'Oncologia, DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY, PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA, University of Crete, TNS OPINION SA
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco Products Directive (TPD) within the context of FCTC ratification at an EU level. The investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany, Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.
EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation programme under grant agreement No 681109
Detailed description
Smoking and other forms of tobacco consumption are considered the single most important cause of preventable morbidity and premature mortality worldwide, with tobacco the major single cause for premature deaths in the European Union (EU).Efforts to reduce the devastation of tobacco-related deaths and illness in the EU consist of its newly adopted binding legislation, the Tobacco Products Directive (TPD), and the ongoing implementation of the WHO Framework Convention on Tobacco Control (FCTC).
Objective:
The main objective of EUREST-PLUS is to monitor and evaluate the psychosocial and behavioral impact of the TPD within the context of FCTC ratification at a European level, through the creation of a cohort study of adult smokers in 6 EU MS (Germany, Greece, Hungary, Poland, Romania, Spain; total n=6000) in a pre- vs. post-TPD study design. The baseline recruitment will take place in WP2 and the follow up in WP3.
Sampling frames:
- The sampling frame will be determined through a national probability sampling design within each country.
- Sample stratification will be geographic and comprise the major regions of each country (Nomenclature of Territorial Units for Statistics - NUTS) NUTS2 (Basic regions for the application of regional policies) will be used for all countries except Germany - where NUTS1 (Major socio-economic regions) will be used, as well as degrees of urbanization (city/town/rural.)
- Geographic areas excluded from the sampling design will be: In Greece, the islands in the Ionian Sea, the northern Aegean Sea and the southern Aegean Sea. In Spain the Canaries, Ceuta and Melilla
- Overall the design will be multistage within strata. The strata will be conceptually divided into clusters, each the size of an enumeration area, with the objective of sampling a total of 250 clusters - 4 adult smokers per cluster in every country.
- Clusters will be allocated based on population size and sampled via random sampling.
Sampling households within clusters:
- Interviewers will employ a random walk procedure within a particular cluster
- Once interviewers have arrived at an address, the household will be approached four times at different times of the day and week before being designated as "unable to be contacted."
- If an address corresponds to multiple households, a single household will be chosen at random.
- Households are approached until a total of 4 adult smokers have been reached within the cluster. A maximum of one male smoker and one female smoker will be selected for interview in each household.
- One male and one female from within the household that meet the criteria will be selected using the last birthday method
Respondents:
- The respondents for the Survey will be smokers aged 18 and older. The first part of the survey, which is the household screener, contains the questions that are used to determine whether the household has members that meet the criteria for inclusion.
- The household screener is asked of the most knowledgeable individual (MKI) within the household.
- One male and one female from within the household that meet the criteria will be selected using the last birthday method.
- The Individual screener follows the Household screener and confirms the information from the MKI is accurate. If the selected individual meets the eligibility criteria and consents to participate, they will be included in the sample
Survey (questionnaire):
The questionnaire will include questions not only about tobacco use, history of use, history of quitting, quit method(s) used, measures of dependence, and demographics (age, gender, education, income) but also extensive, theory-based measures of responsiveness to each policy domain of the FCTC. The survey questionnaire will consist of:
- multiple measures of policy-specific variables for each of the domains of the TPD and FCTC (e.g., health warnings, additives, e-cigarettes for TPD, illicit trade; additional domains of the FCTC, including smoke-free laws, tax/price policies, cessation services, additional product regulation domains);
- psychosocial mediators, identified by past research and theory to predict future health behaviours, including beliefs and attitudes, perceived risk, intentions to quit;
- moderators such as demographic variables (sex, gender), and other variables that will allow analyses of whether TPD and FCTC policies vary in their impact as a function of socioeconomical status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Greek cohort | – | Other: QuestionnaireParticipants recruited from Greece will receive a questionnaire at pre- and post- intervention |
| German cohort | – | Other: QuestionnaireParticipants recruited from Germany will receive a questionnaire at pre- and post- intervention |
| Romanian Cohort | – | Other: QuestionnaireParticipants recruited from Romania will receive a questionnaire at pre- and post- intervention |
| Spanish Cohort | – | Other: QuestionnaireParticipants recruited from Spain will receive a questionnaire at pre- and post- intervention |
| Hungarian Cohort | – | Other: QuestionnaireParticipants recruited from Hungary will receive a questionnaire at pre- and post- intervention |
| Polish cohort | – | Other: QuestionnaireParticipants recruited from Poland will receive a questionnaire at pre- and post- intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of 1,000 smokers recruited in each of 6 European Member States (n=6,000 in total), to be recruited at baseline.
Key inclusion criteria (4 listed)
- Must be 18 years of age or older.
- Must smoke at least monthly.
- Must have smoked 100 cigarettes in their lifetime.
- Must live in the household visited
Key exclusion criteria (2 listed)
- Inability to complete the questionnaire due to health/mental incapability.
- Unable to provide consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | Other | German cohort, Greek cohort, Hungarian Cohort, Polish cohort, Romanian Cohort, Spanish Cohort |
Primary outcome
Number of Participants Who Think About the Harm of Smoking
Time frame: Baseline Pre-TPD
In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses: 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 8 Refused 9 Don't know
Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
Time frame: Baseline Pre-TPD
How soon after waking do you usually have your first smoke? responses: 1. 5 min or less 2. 6-30 min 3. 31-60 min 4. More than 60 min
Number of Participants Who Think About How Much They Enjoy Smoking by Frequency
Time frame: Baseline Pre-TPD
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you . . . Think about how much you enjoy smoking? 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 6. Refused 7. Don't know
Number of Participants Who Have Ever Tried to Quit Smoking
Time frame: Baseline Pre-TPD
Have you ever tried to quit smoking? 1. Yes 2. No 8 Refused 9 Don't know
Number of Participants Who Plan to Quit Smoking
Time frame: Baseline Pre-TPD
Are you planning to quit smoking . . . 1. Within the next month 2. Within the next 6 months 3. Sometime in the future, beyond 6 months 4. Or are you not planning to quit? 8 Refused 9 Don't know
Number of Participants Who Think About the Harm of Smoking
Time frame: Post-TPD
In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses: 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 8 Refused 9 Don't know
Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
Time frame: Post-TPD
How soon after waking do you usually have your first smoke? responses: 1. 5 min or less 2. 6-30 min 3. 31-60 min 4. More than 60 min
Number of Participants Who Have Ever Tried to Quit Smoking
Time frame: Post-TPD
Have you ever tried to quit smoking? 1. Yes 2. No 8 Refused 9 Don't know
Number of Participants Who Plan to Quit Smoking
Time frame: Post-TPD
Are you planning to quit smoking . . . 1. Within the next month 2. Within the next 6 months 3. Sometime in the future, beyond 6 months 4. Or are you not planning to quit? 8 Refused 9 Don't know
4 secondary outcomes
Number of Participants Who Think About The Money They Spend on Smoking
Time frame: Baseline Pre-TPD
Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
Time frame: Baseline Pre-TPD
Number of Participants Who Think About The Money They Spend on Smoking
Time frame: Post-TPD
Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
Time frame: Post-TPD
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine Vardavas, MD,RN,MPH,PHD principal investigator
European Network For Smoking and Tobacco Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Dependence, run by European Network For Smoking and Tobacco Prevention at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Think About the Harm of Smoking (time frame: Baseline Pre-TPD). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.