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pdfTerms and Phrases Study Phase 2 Survey-Consumer-Last Update (1.20.2022)
HEADER / TITLE: FDA Terms and Phrases Study
OMB No. 0910-0895: Approval Expires 03/31/2024
FOOTER: If you have questions about the study, please contact the toll-free project hotline at 1-866-8607853
Screener
INTRO. Hello, we are recruiting people for a research study sponsored by the Food and Drug
Administration. The purpose of the study is to find out how people understand words and phrases that
are commonly used in prescription drug advertising.
RTI International, an independent, nonprofit research institute, will be conducting the survey with
consumers nationwide. The survey will take approximately 20 minutes. If you participate, you will
receive $20 in appreciation for your time. To see if you are eligible, please complete the brief survey
linked below.
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S1. How old were you on your last birthday?
_____
Over Age 18 ➔ CONTINUE
Under Age 18➔ TERMINATE
S2. Are you a medical or health professional?
Yes
➔ TERMINATE
No
➔ CONTINUE
S3. Have you ever worked for…?
Department of Health and
Human Services
➔ TERMINATE
U.S. Food and Drug
Administration
➔ TERMINATE
Market research firm
➔ TERMINATE
Pharmaceutical company
➔ TERMINATE
Itracks
➔ TERMINATE
RTI International
➔ TERMINATE
Burden Statement
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number.
1
[page break]
[IF NOT ELIGIBLE:
Thank and Terminate]
TERMINATE. We’re sorry, but you are not eligible for this study. There are many possible reasons people
are not eligible for this study. These reasons were decided earlier by the researchers. However, thank
you for your interest in this study and for taking the time to answer our questions today.
[END SURVEY – CODE INELIG.]
{page break}
[IF ELIGIBLE]
CONSENT.
Introduction and Purpose
You have been invited to take part in a research study. The purpose of the study is to find out how
people understand words and phrases that are commonly used in prescription drug advertising. RTI
International, a nonprofit research organization in North Carolina, is conducting this study sponsored by
the U.S. Food and Drug Administration (FDA).
Procedures
You are one of about 1,000 people from around the United States being asked to participate in this
study. If you agree to participate, you will take part in a web-based survey. The survey should take about
20 minutes.
Benefits
There is no direct benefit to you for participating. Your responses are very important because they will
help researchers find out how people understand information included in prescription drug advertising.
Risks
There are no known risks to participating in this study. We will not ask you any personal health
questions, but if any questions make you uncomfortable, you can refuse to answer. There is also a
potential risk of loss of confidentiality. Every effort will be made to protect your information, but this
cannot be guaranteed.
Confidentiality
The privacy and confidentiality of your information is of the highest importance, and we are committed
to maintaining a secure environment in which you can participate. All information you share in this
study will be kept confidential to the extent provided by law. The study team will not reveal your name
or any of your responses, and your personal information (name, address, phone number) will not be
2
linked to any of your responses. The information you share with us will be combined into a summary
report so that details of individual surveys cannot be linked to a specific participant. You will not be
recontacted about this research study in the future. However, once de-identified, your data may be
shared with other researchers or used by RTI/FDA for future research purposes.
Reimbursement
After the interview has been completed, you will receive a check by mail for $20 within 4 to 6 weeks in
appreciation for your time.
Right to Refuse or Withdraw
Your participation in this study is completely voluntary, and you can withdraw from the study for any
reason at any time without penalty.
Persons to Contact
If you have questions about the study, you can call the project director, Dr. Bridget Kelly, at 1-800-3348571, ext. 22098. She can be reached between 9:00 a.m. and 5:00 p.m. Eastern Time Monday to Friday.
If you have questions about your rights as a participant, you can call RTI’s Office of Research Protection
toll-free at 1-866-214-2043.
[CONSENT1.] If you have read this screen and agree to participate, please click the Yes button. If not, click
the No button.
1. Yes, I agree to participate. [Continue to SURVEY_INTRO]
2. No, I do not agree to participate. [Go on to CONSENT2]
[IF CONSENT1=NO OR SKIP]
[CONSENT2.] Are you sure you don't want to participate? Your opinions are important to us. Please select
the Yes button if you’d like to proceed to the survey. Select the No button to exit.
1. Yes, I agree to participate. [Continue to SURVEY_INTRO]
2. No, I do not agree to participate. [GO TO NOCONSENT]
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NOCONSENT: Thank you for your time.
[END SURVEY – CODE INELIG.]
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SURVEY_INTRO.
This survey focuses on words and phrases that are commonly used in prescription drug advertising.
Some questions include one or more example statements featuring the word or phrase we are asking
about. This survey will take about 20 minutes to complete. We ask you to complete the study in one
sitting (without taking any breaks) in order to avoid distractions.
Please answer the questions to the best of your ability.
Q1.
When you read each statement, which of the following come to mind about the drugs listed?
PLEASE CHECK ALL THAT APPLY.
It will be
easy to
take the
medicati
on as
intended
by my
doctor.
The drug
is a pill
(not a
shot).
The drug
does not
involve
measure
ment or
cutting
pills in
half.
The
instructi
ons are
clear.
The drug
does not
have to
be taken
at a
specific
time of
day.
The drug
does not
have to
be taken
with
food.
The drug
does not
require
trips to
the
doctor
for
blood
testing.
Other
This drug
is
“conveni
ent.”
This drug
is
“straight
forward
to use.”
This drug
is
“simple
to use.”
This drug
is “easy
to use.”
4
[IF Q1_A1=8] You selected “Other” for the statement: The drug is “convenient”
Please specify: [OPEN RESPONSE]
[IF Q1_A2=8] You selected “Other” for the statement: The drug is “straightforward to use”
Please specify: [OPEN RESPONSE]
[IF Q1_A3=8] You selected “Other” for the statement: The drug is “simple to use”
Please specify: [OPEN RESPONSE]
[IF Q1_A4=8] You selected “Other” for the statement: The drug is “easy to use”
Please specify: [OPEN RESPONSE]
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Q2.
How safe do you think each of the following drugs is compared to other drugs for the same
condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR BELIEFS.
Much
less
safe
Somewhat
less safe
Equally
as safe
Somewhat
safer
Much
safer
Safety
cannot be
compared
to other
drugs
This drug is “convenient.”
This drug is “straightforward to
use.”
This drug is “simple to use.”
This drug is “easy to use.”
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5
Q3.
How effective do you think each of the following drugs is compared to other drugs for the
same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
1
Much
less
effective
2
Somewhat
less
effective
3
Equally
as
effective
4
Somewhat
more
effective
5
Much
more
effective
6
Effectiveness
cannot be
compared to
other drugs
This drug is
“convenient.”
This drug is
“straightforward to
use.”
This drug is “simple
to use.”
This drug is “easy to
use.”
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6
Q4.
When you read each statement, how likely do you think it is that a patient taking each drug
would experience a severe asthma attack?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Not at
Somewhat
all likely likely
Neither
likely nor
unlikely
Somewhat likely Extremely
likely
This drug is shown to
“prevent” severe asthma
attacks.
This drug is shown to “help
prevent” severe asthma
attacks.
This drug is shown to
“reduce the risk” of severe
asthma attacks.
This drug is “proven to
help” prevent severe
asthma attacks.
This drug is “proven
effective” at preventing
severe asthma attacks.
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Q5.
When you read each statement, which of the following come to mind about the drugs listed?
PLEASE CHECK ALL THAT APPLY
There have
been studies
to show the
drug works as
it is supposed
to.
The drug would
need to be taken
with other drugs
in order to work.
The drug is
guaranteed to
be effective at
preventing
severe asthma
attacks.
Other
This drug is “proven to
help” prevent severe
asthma attacks.
This drug is “proven
effective” at preventing
severe asthma attacks.
7
[IF Q5_A1=4] You selected “Other” for the statement: This drug is “proven to help” prevent severe
asthma attacks.
Please specify: [OPEN RESPONSE]
[IF Q5_A2=4] You selected “Other” for the statement: This drug is “proven effective” at preventing
severe asthma attacks.
Please specify: [OPEN RESPONSE]
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Q6.
When you read each statement, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO
YOUR BELIEFS.
The drug
works
only on a
specific
cause of
the
migraine
and does
not affect
any other
parts of
the body.
The drug
works on a
specific
cause of the
migraine,
but may also
affect other
parts of the
body.
The drug
The
The
I
works
drug
drug is don’t
only at
works at applied know
the site or the site topically
location
or
(to the
of the
location
skin).
migraine
of the
and does migraine
not affect but may
any other
also
parts of
affect
the body.
other
parts of
the
body.
Other
This drug acts by
“targeting”
calcitonin gene
related peptide
(CGRP) receptors
to help address
migraines.
8
This drug “acts
locally” to help
address
migraines.
This drug has a
“targeted
mechanism of
action” to help
address
migraines.
[IF Q6_A1=7] You selected “Other” for the statement: This drug acts by “targeting” calcitonin gene
related peptide (CGRP) receptors to help address migraines.
Please specify: [OPEN RESPONSE]
[IF Q6_A2=7] You selected “Other” for the statement: This drug “acts locally” to help address migraines.
Please specify: [OPEN RESPONSE]
[IF Q6_A3=7] You selected “Other” for the statement: This drug has a “targeted mechanism of action”
to help address migraines.
Please specify: [OPEN RESPONSE]
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Q7.
When you read each statement, which of the following come to mind about the drugs listed?
PLEASE SELECT ALL THAT APPLY.
It is
strong.
It
works
better
than
other
drugs.
It has
longlasting
benefits.
It works
quickly.
It
might
have
more
side
effects
than
other
drugs.
It could be
addictive.
It might be
effective
on its own
(not
require
another
drug to be
taken with
it).
Other
9
This drug is
“powerful.”
This drug is
“potent.”
[IF Q7_A1=8] You selected “Other” for the statement: This drug is “powerful.”
Please specify: [OPEN RESPONSE]
[IF Q7_A2=8] You selected “Other” for the statement: This drug is “potent.”
Please specify: [OPEN RESPONSE]
{page break}
Q8.
How safe do you think each of the following drugs is compared to other drugs for the same
condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
1
Much
less
safe
2
Somewhat
less safe
3
Equally
as safe
4
Somewhat
safer
5
Much
safer
6
Safety
cannot be
compared
to other
drugs
This drug is shown to “prevent”…
This drug is shown to “help
prevent”…
This drug is shown to “reduce the
risk” of…
This drug is “proven to help”…
This drug is “proven effective”…
This drug is made from a “natural”
ingredient.
10
This drug works by “targeting”…
This drug “acts locally.”
This drug has a “targeted
mechanism of action.”
This drug is “powerful.”
This drug is “potent.”
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Q9.
How effective do you think each of the following drugs is compared to other drugs for the
same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
6
1
2
3
4
5
Effectiveness
Much
Somewhat Equally Somewhat
Much
cannot be
less
less
as
more
more
compared to
effective effective effective effective effective other drugs
This drug is shown to
“prevent”…
This drug is shown to
“help prevent”…
This drug is shown to
“reduce the risk” of…
This drug is “proven to
help”…
This drug is “proven
effective”…
This drug is made from a
“natural” ingredient.
This drug works by
“targeting”…
This drug “acts locally.”
This drug has a “targeted
mechanism of action.”
This drug is “powerful.”
This drug is “potent.”
11
{page break}
Q10.
How would knowing that a drug is the “#1 prescribed” drug affect your intention to ask your
doctor about it?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
Would it make you:
A lot less likely to ask my doctor
A little less likely to ask my doctor
Neither more nor less likely to ask my doctor
A little more likely to ask my doctor
A lot more likely to ask my doctor
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Q11.
How would knowing that a drug is the “#1 prescribed” drug affect other people’s intentions to
ask their doctors about it?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
Would it make them:
A lot less likely to ask their doctor
A little less likely to ask their doctor
Neither more nor less likely to ask their doctor
A little more likely to ask their doctor
A lot more likely to ask their doctor
{page break}
Q12.
What do you think about a drug when you read that it is the #1 prescribed” drug?
PLEASE CHECK ALL THAT APPLY.
It is the best available option.
It is safer than other drugs.
It is less expensive than other drugs.
It is more expensive than other drugs.
It is more likely to be covered by insurance than other drugs.
12
It is the most commonly prescribed.
It is more effective than other drugs.
It is more readily available than other drugs.
Other (please specify):__________________
{page break}
Q13.
How safe do you think each of the following drugs is compared to other drugs for the same
condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Much
less
safe
Some
what
less
safe
Equally
as safe
Some
what
safer
Much
safer
Safety
cannot
be
compar
ed to
other
drugs
This drug is “new.”
This drug “works differently.”
This drug is the “first and only” drug to…
This drug uses a “novel mechanism of
action.”
{page break}
13
Q14.
How effective do you think each of the following drugs is compared to other drugs for the
same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Much less
effective
Somewhat
less
effective
Equally as
effective
Somewha
t more
effective
Much more
effective
Effectiven
ess
cannot be
compare
d to other
brands
This drug is “new.”
This drug “works
differently.”
This drug is the “first
and only” drug to…
This drug uses a
“novel mechanism
of action.”
{page break}
Q15.
Which of the following come to mind when you read that a drug has been “FDA approved”?
PLEASE CHECK ALL THAT APPLY.
The drug must not have any serious side effects.
The drug has been evaluated for safety and effectiveness.
The drug offers benefits that are greater than the risks.
The drug is safer than other drugs.
The drug is as safe as other drugs.
Other (please specify):__________________
{page break}
14
Q16.
Which of the following come to mind when you read that a prescription drug is used “offlabel”?
PLEASE CHECK ALL THAT APPLY.
It does NOT have FDA approval for the specific medical condition for which it is being used.
It does NOT have FDA approval for any use.
It is used for an unapproved age group or dose.
It is used illegally.
It is a generic drug (not the brand name drug).
It is available over the counter.
Other (please specify):__________________
{page break}
Q17.
When you read that a drug “reverses” bone loss, what does that mean to you?
PLEASE CHOOSE THE ANSWER THAT COMES CLOSEST TO YOUR BELIEFS.
It will return bone density to normal.
It will build back bone that was lost.
It will stop bone density loss.
It will slow bone density loss.
Other (please specify):_________________
{page break}
Q18.
Which of the following come to mind when you read, “individual results may vary” in a
statement about a drug?
PLEASE SELECT ALL THAT APPLY.
The benefits will generally be the same for everyone.
The benefits will vary from person to person.
It will work for few people.
There is no guarantee it will work for you.
Other (please specify):__________________
{page break}
15
Q19.
What do you think about a drug when you read that the difference in effectiveness between it
and a placebo was “not statistically significant”?
PLEASE DESCRIBE IN YOUR OWN WORDS:
[OPEN-ENDED]
{page break}
Q20.
Please read the following four statements:
Statement 1: “This drug offers a manageable safety profile.”
Statement 2: “This drug offers an established safety profile.”
Statement 3: “This drug offers a well-studied safety profile.”
Statement 4: “This drug is well-tolerated.”
Do these four statements mean the same thing or do some of them mean something different to you?
They all mean the same thing.
They mean something different. Please specify the difference: ______________________
{page break}
Q21.
When you read each statement, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
The drug’s risks
and side effects
are well
understood.
The drug has
fewer risks
and side
effects than
other drugs
for the same
condition.
Health care
providers know
how to manage
the risks and side
effects.
Other
16
This drug offers a
“manageable safety
profile.”
This drug offers an
“established safety profile.”
This drug offers a “wellstudied safety profile.”
This drug is “well-tolerated.”
[IF Q21_A1=4] You selected “Other” for the statement: This drug offers a “manageable safety profile.”
Please specify: [OPEN RESPONSE]
[IF Q21_A2=4] You selected “Other” for the statement: This drug offers an “established safety profile.”
Please specify: [OPEN RESPONSE]
[IF Q21_A3=4] You selected “Other” for the statement: This drug offers a “well-studied safety profile.”
Please specify: [OPEN RESPONSE]
[IF Q21_A4=4] You selected “Other” for the statement: This drug is “well-tolerated.”
Please specify: [OPEN RESPONSE]
{page break}
Q22.
When you read each statement, what comes to mind about the following drugs?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
It will
return
vaginal
tissue to
its original
condition.
It will create
tissue that is
stronger or
better than the
original tissue.
It will
relieve
symptoms.
It involves
building new
tissue, but
may not
return tissue
to its original
state.
Other
17
This drug “restores”
vaginal tissue.
This drug “rebuilds”
vaginal tissue.
[IF Q22_A1=5] You selected “Other” for the statement: This drug “restores” vaginal tissue.
Please specify: [OPEN RESPONSE]
[IF Q22_A2=5] You selected “Other” for the statement: This drug “rebuilds” vaginal tissue.
Please specify: [OPEN RESPONSE]
{page break}
Q23.
How safe do you think each of the following drugs is compared to other drugs for the same
condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Much
less
safe
Somewhat
less safe
Equally
as safe
Somewhat safer
Much
safer
Safety
cannot be
compared
to other
drugs
This drug is the “#1
prescribed” drug.
This drug is “FDA
approved.”
This drug is used “off
label.”
This drug “reverses”…
18
For this drug,
“individual results may
vary.”
This drug “restores”…
This drug “rebuilds”…
{page break}
Q24.
How effective do you think each of the following drugs is compared to other drugs for the
same condition?
PLEASE SELECT THE RESPONSE FOR EACH UNDERLINED TERM THAT COMES CLOSEST TO YOUR
BELIEFS.
Much
less
effective
Somewhat
less
effective
Equally
as
effective
Somewhat
more
effective
Much
more
effective
Effectiveness
cannot be
compared to
other drugs
This drug is the “#1
prescribed” drug.
This drug is “FDA
approved.”
This drug is used “off
label.”
This drug “reverses”…
For this drug, “individual
results may vary.”
The difference in
effectiveness between
this drug and a placebo
was “not statistically
significant.”
This drug “restores”…
This drug “rebuilds”…
19
{page break}
Q25.
How many people out of 100 do you think of when you see each of the following? If you are
thinking of a range, please enter the midpoint of that range.
__________________________(enter a number from 0–100)
Many
__________________________(enter a number from 0–100)
A few
__________________________(enter a number from 0–100)
Some
The majority
__________________________(enter a number from 0–100)
__________________________(enter a number from 0–100)
Most
{page break}
Please read the following two statements:
“Pharmaceutical companies engage in prescription drug promotion to market their products.”
“Pharmaceutical companies engage in prescription drug advertising to market their products.”
Q26.
Do these statements mean the same thing to you or do they mean different things?
They mean the same thing to me.
They mean different things to me. Please specify the difference: ______________________
{page break}
20
Q27.
Which of the following do you think about when you read “prescription drug promotion” and
“prescription drug advertising”?
PLEASE CHECK ALL THAT APPLY.
Prescription drug
promotion
Prescription drug
advertising
Pharmaceutical representatives’
visits to doctors’ offices to discuss
prescription drugs
□
□
Drug information provided to
doctors at medical conferences
□
□
Print or web materials (e.g., ads in
medical journals) developed
specifically for health care providers
about a prescription drug
□
□
Television or radio ads about the
drug directed at consumers
□
□
Print ads in magazines or journals
directed at consumers
□
□
Website, web, or social media ads
about the drug directed at
consumers
□
□
A coupon, discount, or special offer
□
□
Other (please
specify):__________________
□
□
{page break}
Q28.
How safe do you think each of the following drugs is compared to other drugs for the same
condition?
Safety
cannot be
Much
compared
less Somewhat Equally Somewhat Much to other
safe
less safe
as safe
safer
safer
drugs
This drug can cause “reactions.”
This drug can cause “serious
reactions”
This drug can cause “severe, lifethreatening reactions.”
{page break}
21
Q29.
How effective do you think each of the following drugs is compared to other drugs for the
same condition?
Effectiveness
Much
Somewhat Equally Somewhat
Much
cannot be
less
less
as
more
more
compared to
effective effective effective effective effective other drugs
This drug can cause
“reactions.”
This drug can cause
“serious reactions.”
This drug can cause
“severe, life-threatening
reactions.”
{page break}
Q30. Please read the following statement: This drug’s effectiveness was based on clinical trial
endpoints.
In this statement, what does “endpoint” mean to you?
[Open-ended]
{page break}
Q31.
When you read each statement, which of the following come to mind about the following
drugs?
PLEASE CHECK ALL THAT APPLY.
It is all
natural.
The ingredients
are undiluted
or
unadulterated.
It does not
include any
artificial
ingredients.
It is
environmentally
friendly.
It is
regulated to
ensure its
purity.
Other
This drug is a
“pure” solution.
This drug
follows strict
“purity”
standards.
22
[IF Q31_A1=6] You selected “Other” for the statement: This drug is a “pure” solution.
Please specify: [OPEN RESPONSE]
[IF Q31_A2=6] You selected “Other” for the statement: This drug follows strict “purity” standards.
Please specify: [OPEN RESPONSE]
{page break}
DEMO_INTRO: Thank you for answering those questions. Now, we have just a few more questions
about you.
Q32.
What is your gender?
Q33.
Are you Hispanic or Latino?
Q34.
Male
Female
Prefer not to answer
Yes
No
What is your race? You may select one or more races.
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Prefer not to answer
{page break}
Q35.
What is the highest level of education you have attained?
Less than high school
High school graduate (or GED)
Some college or technical school (no degree)
College graduate (2- or 4-year degree)
Some graduate school
Graduate school degree
23
Q36.
Was your total household income in 2021?
Q37.
Less than $20,000
$20,000–$34,999
$35,000–$49,999
$50,000–$74,999
$75,000–$99,999
$100,000–$149,999
$150,000 or more
Prefer not to answer
How confident are you filling out medical forms by yourself?
Not at all confident
A little bit confident
Somewhat confident
Quite a bit confident
Extremely confident
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END. That concludes the survey. Thank you for your time. Your responses will help make prescription
drug information clearer. You will receive a check by mail for $20 within 4 to 6 weeks in appreciation for
your time.
Please click [SUBMIT] to submit your responses.
For any questions related to prescription drugs that might be relevant for you, please consult your
doctor.
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| File Type | application/pdf |
| Author | Snaauw, Roxanne |
| File Modified | 2022-01-20 |
| File Created | 2022-01-20 |