Trial Outcomes & Findings for Testing Legally Feasible Options: Study 1 (NCT NCT04259749)

NCT ID: NCT04259749

Last Updated: 2023-10-30

Results Overview

Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

267 participants

Primary outcome timeframe

There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Results posted on

2023-10-30

Participant Flow

Participant milestones

Participant milestones
Measure
Status Quo
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Overall Study
STARTED
89
91
87
Overall Study
COMPLETED
89
91
87
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Legally Feasible Options: Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Status Quo
n=89 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=91 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=87 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Total
n=267 Participants
Total of all reporting groups
Age, Continuous
16.73 years
STANDARD_DEVIATION 3.23 • n=5 Participants
16.47 years
STANDARD_DEVIATION 3.26 • n=7 Participants
16.56 years
STANDARD_DEVIATION 3.11 • n=5 Participants
16.56 years
STANDARD_DEVIATION 3.11 • n=4 Participants
Sex/Gender, Customized
male
24 participants
n=5 Participants
28 participants
n=7 Participants
31 participants
n=5 Participants
83 participants
n=4 Participants
Sex/Gender, Customized
female
61 participants
n=5 Participants
62 participants
n=7 Participants
51 participants
n=5 Participants
174 participants
n=4 Participants
Sex/Gender, Customized
other/nonbinary
4 participants
n=5 Participants
1 participants
n=7 Participants
5 participants
n=5 Participants
10 participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
16 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
83 Participants
n=5 Participants
86 Participants
n=7 Participants
81 Participants
n=5 Participants
250 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
13 Participants
n=5 Participants
18 Participants
n=7 Participants
13 Participants
n=5 Participants
44 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
7 Participants
n=7 Participants
18 Participants
n=5 Participants
32 Participants
n=4 Participants
Race (NIH/OMB)
White
59 Participants
n=5 Participants
54 Participants
n=7 Participants
52 Participants
n=5 Participants
165 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
7 Participants
n=5 Participants
9 Participants
n=7 Participants
3 Participants
n=5 Participants
19 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
3 Participants
n=7 Participants
1 Participants
n=5 Participants
7 Participants
n=4 Participants
Region of Enrollment
United States
89 participants
n=5 Participants
91 participants
n=7 Participants
87 participants
n=5 Participants
267 participants
n=4 Participants

PRIMARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime soon?", "Do you think you will smoke an unflavored cigarette (unflavored = cigarettes without menthol or mint) anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarette (unflavored = cigarettes without menthol or mint), would you smoke it?". Responses to each item are made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed for a total scale score. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=73 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=74 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Non-flavored)
.18 proportion of participants
Interval 0.1 to 0.3
.23 proportion of participants
Interval 0.14 to 0.36
.33 proportion of participants
Interval 0.21 to 0.48

PRIMARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try a cigarette flavored with menthol or mint anytime soon?", "Do you think you will smoke a cigarette flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarette flavored with menthol or mint, would you smoke it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=75 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=72 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=76 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Smoking Cigarettes After Shopping in the StoreLab (Menthol)
.13 proportion of participants
Interval 0.06 to 0.23
.19 proportion of participants
Interval 0.1 to 0.32
.33 proportion of participants
Interval 0.21 to 0.48

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try an unflavored vaping product soon?", "Do you think you will use an unflavored vaping product anytime in the next year?"; and "If one of your best friends offered you an unflavored vaping product would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is number of participants susceptible to using ENDS after shopping in the StoreLab (non-flavored). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=71 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=75 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Non-flavored)
.17 proportion of participants
Interval 0.09 to 0.28
.23 proportion of participants
Interval 0.13 to 0.36
.34 proportion of participants
Interval 0.22 to 0.49

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor soon?", "Do you think you will use a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with fruit, candy, alcohol or non-alcohol drink, or some other sweet flavor, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scaled score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=74 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=75 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Sweet-flavored)
.34 proportion of participants
Interval 0.22 to 0.48
.35 proportion of participants
Interval 0.23 to 0.5
.42 proportion of participants
Interval 0.28 to 0.57

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try a vaping product flavored with menthol or mint soon?", "Do you think you will use a vaping product flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a vaping product flavored with menthol or mint, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=75 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=74 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=74 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Electronic Nicotine Delivery Device (ENDS) After Shopping in the StoreLab (Menthol-flavored)
.27 proportion of participants
Interval 0.16 to 0.41
.39 proportion of participants
Interval 0.25 to 0.54
.43 proportion of participants
Interval 0.29 to 0.58

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try an unflavored cigarillos/filtered cigar soon?", "Do you think you will use an unflavored cigarillos/filtered cigar anytime in the next year?"; and "If one of your best friends offered you an unflavored cigarillos/filtered cigar, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=73 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=74 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Non-flavored)
.09 proportion of participants
Interval 0.04 to 0.19
.10 proportion of participants
Interval 0.05 to 0.21
.17 proportion of participants
Interval 0.09 to 0.31

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor soon?", "Do you think you will use a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with fruit, candy, alcohol or some other sweet flavor would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=73 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=75 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Sweet-flavored)
.10 proportion of participants
Interval 0.05 to 0.19
.16 proportion of participants
Interval 0.08 to 0.28
.25 proportion of participants
Interval 0.14 to 0.39

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try a cigarillos/filtered cigar flavored with menthol or mint soon?", "Do you think you will use a cigarillos/filtered cigar flavored with menthol or mint anytime in the next year?"; and "If one of your best friends offered you a cigarillos/filtered cigar flavored with menthol or mint would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Outcome is proportion of participants susceptible to using LCCs after shopping in the StoreLab (number of susceptible over number in condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=74 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=74 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=75 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Little Cigar/Cigarillos (LCC) After Shopping in the StoreLab (Menthol-flavored)
.10 proportion of participants
Interval 0.05 to 0.2
.13 proportion of participants
Interval 0.07 to 0.25
.21 proportion of participants
Interval 0.11 to 0.35

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try unflavored smokeless tobacco soon?", "Do you think you will use unflavored smokeless tobacco anytime in the next year?"; and "If one of your best friends offered you unflavored smokeless tobacco, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=75 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=68 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=73 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Non-flavored)
.06 proportion of participants
Interval 0.03 to 0.15
.07 proportion of participants
Interval 0.03 to 0.17
.12 proportion of participants
Interval 0.06 to 0.24

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try smokeless tobacco flavored with fruit soon?", "Do you think you will use smokeless tobacco flavored with fruit anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with fruit, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=72 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=72 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=74 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Sweet-flavored)
.09 proportion of participants
Interval 0.04 to 0.19
.10 proportion of participants
Interval 0.04 to 0.2
.20 proportion of participants
Interval 0.11 to 0.33

SECONDARY outcome

Timeframe: There is one visit in this research: This variable is assessed at that visit, immediately after the experimental manipulation.

Population: The numbers of participants per condition differs from the baseline table because of missing data.

Self-report items: "Do you think you will try smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen soon?", "Do you think you will use smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen anytime in the next year?"; and "If one of your best friends offered you smokeless tobacco flavored with menthol, mint, spearmint, or wintergreen, would you use it?". Responses to each item were made on a 1 (Definitely Not) to 10 (Definitely Yes) scale and the three items were summed. The total scale score was dichotomized: those who scored a '3' were recoded as '0' (not susceptible) and any scores greater than '3' were coded as '1' (susceptible). Proportion of susceptible participants was the outcome (number susceptible over the total number of participants within condition).

Outcome measures

Outcome measures
Measure
Status Quo
n=75 Participants
The StoreLab power wall will display all tobacco products. All flavored and mentholated products available: No bans: All tobacco products are available
Flavors Banned
n=74 Participants
The StoreLab will display tobacco products without characterizing flavors, but will allow mint and menthol products to be displayed. Flavor Ban: Only flavored tobacco products are banned
Flavors and Menthol Banned
n=74 Participants
The StoreLab will display only tobacco products without characterizing flavors; mint and menthol will not be displayed. Flavor Ban: Only flavored tobacco products are banned Menthol Ban: Mentholated products are banned
Proportion of Participants Susceptible to Using Smokeless Tobacco After Shopping in the StoreLab (Menthol-flavored)
.27 proportion of participants
Interval 0.16 to 0.41
.39 proportion of participants
Interval 0.25 to 0.54
.43 proportion of participants
Interval 0.29 to 0.58

Adverse Events

Status Quo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Flavors Banned

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Flavors and Menthol Banned

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William G. Shadel

RAND

Phone: 412-683-2300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place