Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: GlaxoSmithKline

 
 
 

 
 
  
CONFIDENTIAL  
  
GlaxoSmithKline group of companies  
  
WWEpi Project number:  
PASS information  
  
Title  
Drug Utilization of Pirinase Hayfever Relief for  
Adults 0.05% Nasal Spray for Allergic Rhinitis  
Symptoms in Adults  
Protocol version identifier  
3.0  
Date of last version of protocol  08 March 2016  
EU PAS (ENCEPP) register 
number  
EUPAS12436  
Active substance  
Fluticasone propionate   
Pharmacotherapeutic group: Intranasal Corticosteroids   
ATC Code: R01AD08  
Medicinal product  
  
Pirinase Hayfever Relief for Adults 0.05%  
Nasal Spray  
Product reference  
PL 00079/0688  
  
Procedure number  
N/A  
Marketing  
authorisation holder(s)  
  
Beecham Group Plc  
980 Great West Road  
Brentford  
Middlesex  
TW8 9GS  
Trading as  
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 
9GS, U.K.  
  
Joint PASS  
No  
  
2  
  

 
 
 
 

 
 
 

  
CONFIDENTIAL  
  
WWEpi Project number:  
  
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TABLE OF CONTENTS  
PAGE  
1. 
LIST OF ABBREVIATIONS ...................................................................................... 7  
2. 
ABSTRACT ............................................................................................................ 10  
3. 
AMENDMENTS AND UPDATES ............................................................................ 13  
4. 
MILESTONES ........................................................................................................ 13  
5. 
RATIONAL AND BACKGROUND .......................................................................... 13  
5.1. 
Background ................................................................................................ 13  
5.2. 
Rationale .................................................................................................... 13  
6. 
RESEARCH QUESTION AND OBJECTIVE(S) ...................................................... 14  
7. 
RESEARCH METHODS ............................... ERROR! BOOKMARK NOT 
DEFINED.  
7.1. 
Study Design .............................................................................................. 16  
8. 
SCHEDULE OF EVENTS ....................................................................................... 17  
8.1. 
Study Population and Setting ...................................................................... 17  
8.2. 
Variables..................................................................................................... 18  
8.2.1. 
Outcome definitions ..................................................................... 18  
8.3. 
Data sources .............................................................................................. 19  
8.4. 
Study size ................................................................................................... 19  
8.5. 
Data management ...................................................................................... 19  
8.5.1. 
Data handling conventions ........................................................... 
19  
8.5.2. 
Resourcing needs ........................................................................ 20  
8.6. 
Data analysis .............................................................................................. 20  
8.6.1. 
Essential analysis ........................................................................ 20  
8.6.2. 
Exploratory analysis ..................................................................... 
20  
8.7. 
Quality control and Quality Assurance ........................................................ 20  
8.8. 
Limitations of the research methods ........................................................... 21  
8.8.1. 
Limitations ................................................................................... 21  
8.8.2. 
Study closure/uninterpretability of results ..................................... 
22  
9. 
PROTECTION OF HUMAN SUBJECTS ................................................................ 23  
9.1. 
Ethical approval and subject consent .......................................................... 23  
9.2. 
Subject confidentiality ................................................................................. 23  
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE  
REACTIONS .......................................................................................................... 23  
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY  

  
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RESULTS .............................................................................................................. 23  
11.1. Target Audience ......................................................................................... 23  
11.2. Study reporting and publications ................................................................. 24  
12. REFERENCES ....................................................................................................... 24  
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS ...................................................... 
25 ANNEX 2. SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 
.......................... 26  
ANNEX 3. PRODUCT ARTWORK & LABELLING  ..................................................... 34  
  
 

  
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1.  
LIST OF ABBREVIATIONS  
  
AE  
Adverse Event  
CI  
Confidence Interval  
CRO  
Contract Research Organization  
EU-PAS   
European Union - Post-Authorisation Study  
GCP  
Good Clinical Practice  
GSKCH  
GlaxoSmithKline Consumer Healthcare  
GSL  
General Sale List  
HIV  
Human Immunodeficiency Virus  
ICH  
International Conference on Harmonization of  
Technical Requirements for Registration of  
Pharmaceuticals for Human Use  
MFC  
Product Formulation Code  
MHRA  
Medicines and Healthcare Products Regulatory Agency  
PII  
Personally Identifiable Information  
QR  
Quick Response  
SD  
Standard Deviation  
SPC  
Summary of Product Characteristics  
UK  
United Kingdom  
  
  

  
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SPONSOR INFORMATION PAGE  
WWEpi Project Identifier:  
Sponsor Legal Registered and Contact Address:  
GlaxoSmithKline Consumer Healthcare  
980 Great West Road  
Brentford  
Middlesex, TW8 9GS  
UK  
In some countries, the clinical trial sponsor may be the local GlaxoSmithKline affiliate 
company (or designee). Where applicable, the details of the Sponsor and contact person 
will be provided to the relevant regulatory authority as part of the clinical trial 
submission.  
 

  
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2.  
ABSTRACT  
Title  
Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray  
Rationale and background  
The Medicines and Healthcare products Regulatory Agency (MHRA) has required this 
study to evaluate consumer compliance with the product labelling of Pirinase Hayfever 
Relief for Adults 0.05% Nasal Spray over at least 2 allergy seasons for the treatment of 
seasonal allergic rhinitis including hayfever.  The purpose is to obtain real-world 
information on how consumers are complying with the product labelling. This study will 
coincide with the launch of Pirinase Hayfever Relief for Adults 0.05% Nasal Spray in the 
United Kingdom (UK).  
Research question and Objectives  
The primary objective of this study is to evaluate if consumers comply with key warnings 
and directions on the outer label for selection and use of the drug.    
Study Objective  
To evaluate if consumers comply with key warnings and directions on the outer label for 
selection and use of the drug  
Primary Objectives  
The five primary objectives are the following:  
1. To assess if consumers of the correct age use the product: Ages 18 and older  
2. To assess the correct frequency of use: No more than 2 sprays in each nostril per 
day  
3. To assess reduction of dose: If symptoms improve, 1 spray in each nostril per day  
4. To assess if a physician is consulted before use: if a woman is pregnant or 
breastfeeding  
5. To assess if a physician is consulted:  If symptoms have not improved after using 
for 7 days, a doctor is consulted  
Secondary Objectives  
The two secondary objectives are the following:  
1. To assess if consumers do not use if they are taking medications for Human 
Immunodeficiency Virus (HIV)  
2. To assess if a physician is consulted: Not used more than 1 month continuously 
without consulting a doctor  
  

  
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Study Design  
This will be an online survey.  Consumers who have purchased and used the product will 
opt into an online survey by scanning a QR code on the product package labelling or 
through an e-mailed invitation to those who have purchased the product at a Boots 
Pharmacy, which will also include a link to the survey. The anticipated study timeframe 
is approximately 2 calendar years so that data from at least 2 allergy seasons for the 
treatment of seasonal allergic rhinitis including hayfever are included.  The intention will 
be to recruit approximately half the subjects in each year.    
Population  
An all comers population (consumers who opt in at their own discretion) of 1,537 
consumers, will be included in this study.  No targeting or enrichment for age, gender, 
and social backgrounds will be conducted.  The demographics will be reported for those 
who choose to enter the online survey  
Variables  
Primary endpoints are comprised of the proportion of consumers who comply with each 
of the 5 endpoints listed below:  
1. Consumer is 18 years of age or older  
2. Consumer does not exceed 2 sprays/nostril per day  
3. Dose is reduced to 1 spray/nostril per day if symptoms improve  
4. Doctor is consulted before use if a woman is pregnant or breastfeeding  
5. Doctor is consulted if symptoms do not improve after 7 days of use  
Secondary endpoints are comprised of the proportion of consumers who comply with 
each of the specified endpoints below:  
1. Those taking HIV medications do not use the drug   
2. Doctor is consulted is medication is used more than 1 month continuously  
Demographics and Profiling Information  
Descriptive statistics will be used to report consumer demographics and additional 
profiling information.  Demographic information is comprised of age, race, education and 
household purchase information (primary purchaser or other).  The additional profiling 
information is comprised of the following:  
• 
How long they have had allergies  
• 
What type of allergies they have  
• 
Typical allergy symptoms  
• 
How often they see their doctor  
  

  
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Data Sources  
Endpoints will be assessed based on data from self-reported consumer responses to the 
online survey.  
Study Size  
1,537 consumers will complete the survey.  No targeting or enrichment for age, gender, 
and social backgrounds will be conducted.  The demographics will be reported for those 
who choose to enter the online survey.  For the threshold of 80% for success, this sample 
size of 1537 achieves at least 91% power with an assumed compliance rate of 83.3% for 
each of these five primary endpoints, and the significance level of 0.05 using a two-sided 
exact binomial test.    
Data Analysis  
Primary endpoints will be analyzed individually and no adjustment for multiple 
comparisons will be performed.  The compliance rate for each of the five primary 
endpoints will be reported and its two-sided 95% confidence limit will be computed 
using the exact method.  The endpoint will have met the threshold for success if the lower 
bound of the 2-sided 95% exact confidence interval (CI) is at least 80%.    
Secondary endpoints will be analyzed individually and no adjustment for multiple 
comparisons will be performed.  The compliance rate for each of the secondary endpoints 
will be reported and its two-sided 95% confidence limit will be computed using the exact 
method.  There are no success thresholds set for secondary endpoints.    
Milestones  
Milestones for this study include the following:  
1. Start of data collection  
February 2016  
2. Study progress report   
February 2017  
3. End of data collection   
March 2018  
4. Final report of study results June 2018  
3.  
AMENDMENTS AND UPDATES  
  
Amendment 
or update no  
Date  
Section of 
study 
protocol  
Amendment 
or update  
Reason  
1  
02MAR2016  8.8  
Added in 
limitations of 
the research 
methods  
MHRA 
request  

  
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2  
08MAR2016  8.8  
Added in 
additional 
limitation of 
the research 
methods  
MHRA 
request  
  
4.  
MILESTONES  
  
Milestone  
Planned date  
Start of data collection  
February 2016  
End of data collection  
March 2018  
Study progress report 1*  
February 2017  
Final report of study results  
June 2018  
* An enrolment update will be submitted to MHRA after approximately 1 year of enrolment.  No interim 
data analysis is planned.    
  
5.  
RATIONAL AND BACKGROUND  
5.1.  
Background  
The Medicines and Healthcare products Regulatory Agency (MHRA) has required a post-
approval commitment from GlaxoSmithKline Consumer Healthcare (GSKCH) for 
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray.  This spray will be marketed for 
General Sale (GSL) in the United Kingdom (UK).    
5.2.  
Rationale  
The post-approval commitment to MHRA is to provide observational data regarding the 
real-world use of Pirinase Hayfever Relief for Adults 0.05% Nasal Spray by consumers.  
Specifically, data about the consumer’s compliance with key warnings and directions will 
be collected.    
6.  
RESEARCH QUESTION AND OBJECTIVE(S)  
The primary objective of this study is to evaluate if consumers comply with key warnings 
and directions on the outer label for selection and use of the drug.    
The primary and secondary objectives and endpoints are listed below:  
 
Primary Objectives  
Primary Endpoints  

  
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•  To assess if consumers of the correct 
age use the product:  Ages 18 and 
older  
• Consumer is 18 years of age or older  
•  To assess the correct frequency of 
use:  No more than 2 sprays in each 
nostril per day  
• Consumer does not exceed 2 
sprays/nostril per day  
•  To assess reduction of dose: If 
symptoms improve, 1 spray in each 
nostril per day  
• Dose is reduced to 1 spray/nostril per day 
if symptoms improve  
•  To assess if a physician is consulted 
before use:  if a woman is pregnant 
or breastfeeding   
• Doctor is consulted before use if a 
woman is pregnant or breastfeeding  
•  To assess if a physician is consulted:  
If symptoms have not improved after  
using for 7 days, a doctor is 
consulted.  
• Doctor is consulted if symptoms do not 
improve after 7 days of use  
  
Secondary Objectives  
Secondary Endpoints  
•  
  
To assess if consumers do not use if 
they are taking medications for  
Human Immunodeficiency Virus 
(HIV)]  
• Those taking HIV medications do not use 
the drug  
•  To assess if a physician is consulted:  
Not used more than 1 month 
continuously without consulting a 
doctor  
• Doctor is consulted if medication is used 
more than 1 month continuously  
  
Demographic information that will be collected are listed below:  
1. Age  
2. Race  
3. Education  
4. Primary purchaser of medicines  
Additional profiling information that will be collected are listed below:  
1. How long they have had allergies  
2. What type of allergies they have  
3. Typical allergy symptoms  
4. How often they see their doctor  
 

  
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6.1.  
Study Design  
This is an online survey to evaluate consumer compliance with the product labelling for 
consumers who purchase Pirinase Hayfever Relief for Adults 0.05% Nasal Spray.  
Consumers will respond to screening criteria and if they qualify for the study, they will 
complete the online survey related to their use of the drug.  After completing the survey 
consumer participation will be considered complete.  Data collection will continue 
through at least 2 allergy seasons and until 1,537 surveys are completed.    
Consumers will access an online survey by scanning a QR code on the product package 
labelling or through an e-mailed invitation to those who have purchased the product at a 
Boots Pharmacy, which will also include a link to the survey.  The entire study will be 
conducted online; there will be no study visits.   
  
The specific tasks include the following:  
1) Consumers who have purchased the product will scan the QR code found on the 
product package labelling or by accessing the link in the e-mailed invitation.  
2) A Participation Agreement will be displayed.  The consumer will read and sign 
this Agreement electronically.  Anyone who does not sign the Participation 
Agreement will not be admitted to the survey.    
3) The online survey will begin with a set of brief screening questions related to the 
inclusion/exclusion criteria.    
4) If the consumer qualifies and is interested, he or she will then be invited to 
complete the online survey.  This process is voluntary for all participants.  
5) The online survey will consist of closed-ended questions related to the 
consumer’s use of the product.   
6) Demographics and profiling information will be collected.  
7) If a consumer has not used the product for at least a month when they initially 
complete the survey, a reminder message will be sent to them at a later time so 
that they can complete the question related to use after 1month.   
8) After completing the survey, consumer participation in the study will be 
considered complete.  
  
  
  
  
  
  
  

  
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7.  
SCHEDULE OF EVENTS  
Procedure / Assessment  
Initial   
Survey  
Response Day  
Subsequent  
Survey  
Response Day2  
Inclusion / Exclusion Criteria  
X  
  
Participation Agreement  
X  
  
Online compliance survey completion   
X  
  
Self-reported demographics   
X  
  
Self-reported allergy profiling information  
X  
  
Reminder message sent to consumers who have not 
used the product for at least 1 month at the initial 
response day1  
  
X  
Self-reported compliance with 1 month warning1  
X  
X  
Study conclusion  
X  
  
 1 
 Label Warning:  To assess the correct frequency of use (not used more than 1 month continuously without 
consulting a doctor).  
2 
 Subsequent Survey Response Day:  This is for consumers who had not used the product for at least 1 
month when they initially completed the survey.  This allows subject to complete the 1 month question on 
the survey.  
  
  
7.1.  
Study Population and Setting  
1,537 consumers in the UK who have purchased and used Pirinase Hayfever Relief for 
Adults 0.05% Nasal Spray for at least 7 days will be included in this study.  No targeting 
or enrichment for age, gender, and social backgrounds will be conducted.  The 
demographics will be reported for those who choose to enter the online survey.  
The anticipated timeframe is approximately 2 calendar years so that data from at least 2 
allergy seasons for the treatment of seasonal allergic rhinitis including hayfever are 
included.  The allergy season in the UK can range from April through September with 
June often having the highest pollen counts and allergy sales; however, allergy seasons 
vary. If the sample size is not met within the 2-year period the study may be extended.  

  
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This is an all comers study which means that consumers will opt into the survey 
themselves.  Consumers will access the online survey by scanning a QR code on the 
product package labelling or through an e-mailed invitation to those who have purchased 
the product at a Boots Pharmacy, which will also include a link to the survey. The 
population is expected to reflect a real-world population of consumers who will purchase 
and use the drug.  
Inclusion:  
A consumer will be eligible for inclusion in this study only if all of the following criteria 
apply:  
1. Consumers will be required to review, and electronically sign a Participation 
Agreement prior to completing the online survey.  
2. Consumers of any age may participate.  
3. Consumers who have purchased and used Pirinase Hayfever Relief for Adults 
0.05% Nasal Spray for at least 7 days and are willing to participate in the online 
survey.  
4. Consumers of either gender may participate  
Exclusion:  
A consumer will not be eligible for inclusion in this study if any of the following criteria 
apply:  
1. Anyone who is directly involved with medicines such as doctors, nurses, and 
pharmacists.  
2. Consumers who decline participation in the online survey  
  
7.2.  
Variables  
7.2.1.  
 Outcome definitions  
Primary Endpoints  
Primary endpoints are comprised of the proportion of consumers who comply with each 
of the 5 endpoints listed below:  
• Consumer is 18 years of age or older  
• Consumer does not exceed 2 sprays/nostril per day  
• Dose is reduced to 1 spray/nostril per day if symptoms improve  
• Doctor is consulted before use if a woman is pregnant or breastfeeding  
• Doctor is consulted if symptoms do not improve after 7 days of use  
  

  
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Secondary Endpoints  
Secondary endpoints are comprised of the proportion of consumers who comply with 
each of the specified endpoints listed below:  
• Those taking HIV medications do not use the drug  
• Doctor is consulted if medication is used more than 1 month continuously  
  
Demographics and Profiling Information  
Descriptive statistics will be used to report consumer demographics and additional 
profiling information.  Demographic information is comprised of age, race, education and 
household purchase information (primary purchaser or other).  The additional profiling 
information is comprised of the following:  
• 
How long they have had allergies  
• 
What type of allergies they have  
• 
Typical allergy symptoms  
• 
How often they see their doctor  
  
7.3.  
Data sources  
Endpoints will be assessed based on data from self-reported consumer responses to the 
online survey.  
7.4.  
*Study size  
1,537 consumers will complete the survey.  No targeting or enrichment for age, gender, 
and social backgrounds will be conducted.  The demographics will be reported for those 
who choose to enter the online survey.   For the threshold of 80% for success, this sample 
size of 1537 achieves at least 91% power with an assumed compliance rate of 83.3% for 
each of these five primary endpoints, and the significance level of 0.05 using a two-sided 
exact binomial test.    
7.5.  
Data management  
7.5.1.  
Data handling conventions  
The online survey will provide an audit trail so that data entry can be further reviewed or 
investigated, if needed.   Programmed edit checks will be generated automatically, as the 
data is being entered into the system (e.g. the consumer will be restricted from 
proceeding in the survey until the previous question is answered). The CRO will monitor 
the survey status on a monthly basis by reviewing percent completed, percent of primary 
endpoints answered and demographics of the study population.   

  
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The online survey will be programmed and tested using DatStat Illume 2016 v.6.0 and 
DatStat Discovery v 6.0.  There will be no formal query resolution for any missing data.  
Data will be locked after the planned sample size has been achieved or at such time as the 
sponsor concludes the data collection.  Data is stored in the DatStat co-location TierPoint 
data center. TierPoint is a SSAE16 SOC1 & SOC2, Type II certified data center.  
TierPoint provides the physical security, power, backups, and DatStat IT has full control 
over the servers housed in the DatStat racks.   
  
7.5.2.  
Resourcing needs  
This study is being managed by Concentrics Research.  FMD K&L will be involved in 
the data and analysis for this study  
7.6.  
Data analysis  
Detailed methodology for summary and statistical analyses of the data collected in this 
study, including the handling of missing data, will be documented in a Statistical 
Analysis Plan.  This document, which will be dated and maintained by the Sponsor or 
designee, may modify the plans outlined in the protocol; however, any major 
modifications of the primary endpoint definition and/or its analysis will also be reflected 
in a protocol amendment.  
  
7.6.1.  
Essential analysis  
Primary endpoints will be analyzed individually and no adjustment for multiple 
comparisons will be performed.  The compliance rate for each of the five primary 
endpoints will be reported and its two-sided 95% confidence limit will be computed 
using the exact method.  The endpoint will have met the threshold for success if the lower 
bound of the 2-sided 95% exact confidence interval (CI) is at least 80%.    
Secondary endpoints will be analyzed individually and no adjustment for multiple 
comparisons will be performed.  The compliance rate for each of the secondary endpoints 
will be reported and its two-sided 95% confidence limit will be computed using the exact 
method.  There are no success thresholds set for secondary endpoints.    
  
7.6.2.  
Exploratory analysis  
Demographic and baseline characteristics will be summarized for the analysis population 
using descriptive statistics.  Continuous demographic and baseline variables such as age 
will be reported using mean, standard deviation (SD), median, minimum and maximum. 
Categorical variables including sex, age group, and race will be summarized as number 
(percent) of consumers.    

  
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7.7.  
Quality control and Quality Assurance  
This is an observational study with data being collected from consumers using an online 
survey.  There is no plan for monitoring.   
To ensure compliance with GCP and all applicable regulatory requirements, GSKCH 
may conduct a quality assurance assessment and/or audit of the records, and the 
regulatory agencies may conduct a regulatory inspection at any time during or after 
completion of the study.   
In the event of an assessment, audit or inspection, the investigator (and institution) must 
agree to grant the advisor(s), auditor(s) and inspector(s) direct access to all relevant 
documents and to allocate their time and the time of their staff to discuss the conduct of 
the study, any findings/relevant issues and to implement any corrective and/or 
preventative actions to address any findings/issues identified.  
The sponsor will be available to help prepare for an inspection.  
Following closure of the study, the CRO will maintain all study records (except for those 
required by local regulations to be maintained elsewhere), in a safe and secure location.    
The records (study/ site master file) must be maintained to allow easy and timely 
retrieval, when needed (e.g., for a GSK audit or regulatory inspection) and must be 
available for review in conjunction with assessment of the facility, supporting systems, 
and relevant staff.  
Where permitted by local laws/regulations or institutional policy, some or all of these 
records can be maintained in a format other than hard copy (e.g., microfiche, scanned, 
electronic); however, caution needs to be exercised before such action is taken.   
The CRO is required to keep study data on file for at least 15 years after completion or 
discontinuation of the study. The minimum retention time will meet the strictest standard 
applicable to that site for the study, as dictated by any institutional requirements or local 
laws or regulations, GSK standards/procedures, and/or institutional requirements.    
No study document should be destroyed without a prior written agreement between 
GSKCH. The CRO must notify GSK of any changes in the archival arrangements, 
including, but not limited to, archival at an off-site facility or transfer of ownership of the 
records.  
7.8.  
Limitations of the research methods  
7.8.1.  
Limitations  
This study will be conducted as an online survey and will be limited to only those who 
have access to the internet. Since internet usage is correlated to various demographics, 

  
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the age and gender of those who enrol could be slightly different from the general 
population. Also due to only being an online survey, baseline characteristic of those who 
are able to enrol could potential be different from those who do not have internet access 
and cannot enrol.  This might limit the external validity of the study.    
Consumers who have not used the product for greater than 1 month will be able to 
complete all of the survey except the questions around the 1 month usage.  They will be 
invited back after they have had the opportunity to use the product for one month to 
complete the 1 month usage questions.  There is a possibility that some of these 
consumers will not re-enter the survey after 1 month to complete those questions.  Data 
for the secondary objective of doctor is consulted if medication is used more than 1 
month continuously may be limited.  
Given that there are approximately 100,000 HIV+ patients in the UK1 and the proposed 
sample size for this study of 1,537, it is unlikely that consumers on HIV medications will 
complete the survey.  Data for the secondary objective of those taking HIV medications 
do not use the drug may be limited.  
7.8.2.  
Study closure/uninterpretability of results  
GSKCH reserves the right to temporarily suspend or prematurely discontinue this study  
at any time for reasons including, but not limited to, safety or ethical issues or severe 
non-compliance.  
  
 

  
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8.  
PROTECTION OF HUMAN SUBJECTS  
8.1.  
Ethical approval and subject consent  
The study will be conducted in accordance with all applicable regulatory requirements, 
and with GSK policy.  
The study will also be conducted in accordance with applicable International Conference 
on Harmonization (ICH) Good Clinical Practice (GCP) and all applicable consumer 
privacy requirements.    
Prior to starting the online survey, each consumer will review and electronically sign a 
Participation Agreement.    
8.2.  
Subject confidentiality  
An online survey include all data collected for this study.  Each consumer will be 
assigned and identified by a subject number. Any reference made to an individual 
consumer within the study will be done by using the unique subject number.  In order to 
protect the privacy of consumers, limited Personally Identifiable Information (PII) will be 
collected in the survey.  In the event that a consumer needs to be contacted for 
verification or follow-up purposes, limited contact information consisting of the 
consumer’s name, e-mail address, and phone number will be collected in the survey.  
9.  
MANAGEMENT AND REPORTING OF ADVERSE  
EVENTS/ADVERSE REACTIONS  
While there is no intent to elicit Adverse Events (AEs) in this post-marketing survey, 
consumers taking part in the survey might spontaneously report an AE. If an AE is 
spontaneously reported during the survey, it will be reported as per any post marketed 
medicinal product. Reference to the Yellow Card Scheme for reporting of side effects 
will be included at the end of the survey.   
.  
10.  
PLANS FOR DISSEMINATING AND COMMUNICATING  
STUDY RESULTS  
10.1.  
Target Audience  
The target audience for this study is the Medicines and Healthcare products Regulatory 
Agency (MHRA) as well as GlaxoSmithKline stakeholders (Medical, Regulatory and 
Global Clinical Safety and Pharmacovigilance).  

  
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10.2.  
Study reporting and publications  
Progress reports and clinical study results will be posted into the EU-PAS Register within 
2 weeks of their finalization. Final study report will be reported within 12 months of the 
end of data collection. Final study results may be reported in a manuscript and submitted 
to a peer reviewed scientific or medical journal within 18 months of last participant 
surveyed if required. The final manuscript may be also transmitted to the Agency within 
2 weeks after acceptance of the publication.   
  
11.  
REFERENCES  
1.  Yin, Z., Brown, A., Hughes, G., Nardone, A., & Gill Noel O. and Delpech, V. (2014, 
November). Gov.UK. Retrieved from www.gov.uk: 
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/40 
1662/2014_PHE_HIV_annual_report_draft_Final_07-01-2015.pdf  
  
 

  
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ANNEX 1. LIST OF STAND-ALONE DOCUMENTS  
  
No.  Document Title  
Date  
1.   Summary of Product Characteristic 
(SmPC)  
17/12/2015  
2.  
Product Artwork & Labelling  
17/12/2015  
  
  
  
 

  
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ANNEX 2. Summary of Product Characteristics (SmPC)  
 

  
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* ANNEX 3. Product Artwork & Labelling 
  

  
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