Trial Outcomes & Findings for AAT-App Outpatient Trial (NCT NCT05120856)

NCT ID: NCT05120856

Last Updated: 2024-12-16

Results Overview

Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using a timeline follow-back assessment. Participants will select a number, ranging from 0-80, to estimate how many standard drinks they consumed on each day in that week. Past-week standard drinks will be calculated using the sum of values for each of the past 7 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Results posted on

2024-12-16

Participant Flow

Recruitment commenced on May 25, 2022 and ended on January 22, 2024. Recruitment was open to people receiving outpatient treatment for alcohol problems in the state of Victoria, Australia.

After providing informed consent to participate, participants (N=82) were sent a link to download the app. 3 participants who were enrolled did not download and install the app, hence the final sample assigned to groups comprised 79 participants.

Participant milestones

Participant milestones
Measure
Active AAT-App
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Overall Study
STARTED
39
40
Overall Study
Provided Week 4 Primary Outcome Data
29
32
Overall Study
Completed Week 4 Secondary Outcome Survey
27
31
Overall Study
Provided Week 8 Primary Outcome Data
27
30
Overall Study
Completed Week 8 Secondary Outcome Survey
26
30
Overall Study
Provided Week 16 Primary Outcome Data
20
27
Overall Study
COMPLETED
23
28
Overall Study
NOT COMPLETED
16
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AAT-App Outpatient Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active AAT-App
n=39 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Total
n=79 Participants
Total of all reporting groups
Age, Continuous
48.8 years
STANDARD_DEVIATION 9.5 • n=5 Participants
44.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
46.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
16 Participants
n=7 Participants
34 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
24 Participants
n=7 Participants
45 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · African
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · East Asian or Southeast Asian
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Latino / Latina
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · South Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · White / European
38 Participants
n=5 Participants
32 Participants
n=7 Participants
70 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Prefer not to say
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
Australia
39 participants
n=5 Participants
40 participants
n=7 Participants
79 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: The numbers describe how many participants were included in the linear mixed model (i.e., providing valid alcohol use data fro at least one time point). Numbers varied across time points (Baseline: 37 Active, 40 Minimal; Week 4: 29 Active, 32 Minimal; Week 8: 27 Active, 30 Minimal; Week 16: 20 Active, 27 Minimal), however, these were analysed using a single linear mixed-effects model which calculated estimated marginal means.

Participants will estimate the number of standard drinks of alcohol consumed on each day within the past week, using a timeline follow-back assessment. Participants will select a number, ranging from 0-80, to estimate how many standard drinks they consumed on each day in that week. Past-week standard drinks will be calculated using the sum of values for each of the past 7 days.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=38 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Number of Standard Drinks Consumed Per Week
Baseline
38.469 standard drinks (10 grams alcohol)
Standard Error 5.612
29.645 standard drinks (10 grams alcohol)
Standard Error 5.427
Number of Standard Drinks Consumed Per Week
Week 4
33.199 standard drinks (10 grams alcohol)
Standard Error 5.297
28.801 standard drinks (10 grams alcohol)
Standard Error 5.124
Number of Standard Drinks Consumed Per Week
Week 8
27.929 standard drinks (10 grams alcohol)
Standard Error 5.397
27.957 standard drinks (10 grams alcohol)
Standard Error 5.148
Number of Standard Drinks Consumed Per Week
Week 16
17.390 standard drinks (10 grams alcohol)
Standard Error 6.695
26.268 standard drinks (10 grams alcohol)
Standard Error 6.108

SECONDARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: All time points were analysed in a single linear mixed-effects model that included anyone who provided valid data for at least one time point. Estimated marginal means are shown below, along with numbers of participants providing data at each time point.

The Craving Experience Questionnaire frequency scale (CEQ-F) is a validated, 10-item scale, with each item rated on a scale of 0-10. Total scores are calculated based on the mean of individual items. Higher scores indicate more frequent craving experiences. Three subscale scored can also be calculated: "intensity" (3 items), "imagery" (4 items), and "intrusiveness" (3 items). Secondary analyses will be conducted for each of its 3 subscales.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=38 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
Baseline
4.103751 score on a scale
Standard Error 0.3370139
3.957517 score on a scale
Standard Error 0.3289793
Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
Week 4
3.773293 score on a scale
Standard Error 0.3136546
3.689666 score on a scale
Standard Error 0.3038462
Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
Week 8
3.442836 score on a scale
Standard Error 0.3188280
3.421814 score on a scale
Standard Error 0.3037450
Past-Week Frequency of Alcohol Cravings (as Measured by the Craving Experience Questionnaire Frequency Scale - CEQ-F)
Week 16
2.781920 score on a scale
Standard Error 0.4044861
2.886112 score on a scale
Standard Error 0.3737217

SECONDARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: A linear mixed model included all participants who provided valid data for at least one time point. Estimated marginal means and numbers providing data at each specific time point are reported below

The Severity of Dependence Scale (SDS) is a validated, 5-item scale, with each item scored 0-3. Total scores are calculated by summing individual item scores. Higher scores indicate more severe psychological dependence on the drug being enquired about (i.e., alcohol in this study)

Outcome measures

Outcome measures
Measure
Active AAT-App
n=39 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Severity of Dependence Scale (SDS) Scores
Baseline
7.989 score on a scale
Standard Error 0.564
8.752 score on a scale
Standard Error 0.551
Severity of Dependence Scale (SDS) Scores
Week 16
5.649 score on a scale
Standard Error 0.722
5.085 score on a scale
Standard Error 0.654
Severity of Dependence Scale (SDS) Scores
Week 4
7.404 score on a scale
Standard Error 0.505
7.836 score on a scale
Standard Error 0.490
Severity of Dependence Scale (SDS) Scores
Week 8
6.819 score on a scale
Standard Error 0.518
6.919 score on a scale
Standard Error 0.490

SECONDARY outcome

Timeframe: Baseline and 16 weeks after commencing app use

Population: A linear mixed model included all participants providing scores at baseline and/or follow-up. Estimates marginal means, and numbers of participants providing data at each time point, are provided below.

The Alcohol Use Disorders Identification Test (AUDIT) is a validated, 10-item scale, with each item scored 0-4. Total scores are calculated based on the sum of individual item scores. Given the AUDIT usually enquires about drinking and related problems in the past year, wording of instructions and questions was modified to ask participants to base answers on the past 3 months so that equivalent, non-overlapping periods were assessed at both baseline and the final follow-up.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=39 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)
Baseline
26.897 score on a scale
Standard Error 1.296
26.250 score on a scale
Standard Error 1.279
Total Scores on the Alcohol Use Disorders Identification Test (AUDIT)
Week 16
14.028 score on a scale
Standard Error 1.674
13.796 score on a scale
Standard Error 1.495

SECONDARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: All time points were analysed in a single linear mixed-effects model including all participants who provided valid data for at least one time point. Estimated marginal means and numbers of participants contributing data at each time point are reported below.

Participants estimated the number of standard drinks of alcohol consumed on each day within the past week. Any day when they estimate they consumed at least 5 standard drinks in a day was considered an HDD.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=38 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Past-week Heavy Drinking Days (HDDs)
Baseline
2.928 Heavy drinking days in a week
Standard Error 0.386
2.195 Heavy drinking days in a week
Standard Error 0.372
Past-week Heavy Drinking Days (HDDs)
Week 4
2.602 Heavy drinking days in a week
Standard Error 0.360
2.145 Heavy drinking days in a week
Standard Error 0.348
Past-week Heavy Drinking Days (HDDs)
Week 16
1.626 Heavy drinking days in a week
Standard Error 0.471
1.994 Heavy drinking days in a week
Standard Error 0.426
Past-week Heavy Drinking Days (HDDs)
Week 8
2.277 Heavy drinking days in a week
Standard Error 0.367
2.095 Heavy drinking days in a week
Standard Error 0.349

SECONDARY outcome

Timeframe: Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: A linear mixed-effects model analysing this outcome included all participants who provided data for at least one of the 3 time points at which it was measured. Numbers providing data at each time point, and predicted marginal means from the analysis, are reported below.

At baseline, participants will complete the past-week drinking assessment described above and also report number of drinking days in each of the 3 weeks preceding the past week. 1-month and 3-month follow-up assessments will be identical to the baseline assessment.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=37 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Past-Month Drinking Days
Baseline
14.209 number of days any alcohol was consumed
Standard Error 1.601
11.895 number of days any alcohol was consumed
Standard Error 1.569
Past-Month Drinking Days
Week 8
13.087 number of days any alcohol was consumed
Standard Error 1.518
11.245 number of days any alcohol was consumed
Standard Error 1.455
Past-Month Drinking Days
Week 16
11.966 number of days any alcohol was consumed
Standard Error 1.878
10.595 number of days any alcohol was consumed
Standard Error 1.701

SECONDARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: A mixed effects logistic regression model included all participants who provided data for at least 1 time point. Numbers providing data at each individual time point and predicted proportions produced by the model are reported below.

Past-week complete abstinence will be defined as zero days in the past week on which any alcohol was consumed. Predicted proportions from the linear mixed-effects model are entered using a measure type of "mean", as advised by the trial statistician, because the model produces predicted means from the data (after coding abstinence as 1 and non-abstinence as 0) after the model accounts for complexities in the data, such as the repeated measures of the data, imbalances in group sizes, and assumptions regarding error correlation, random effects, fixed effects.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=38 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Baseline
.256 proportion of participants abstinent
Interval 0.186 to 0.327
.322 proportion of participants abstinent
Interval 0.233 to 0.41
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Week 4
.273 proportion of participants abstinent
Interval 0.212 to 0.334
.325 proportion of participants abstinent
Interval 0.241 to 0.409
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Week 8
.291 proportion of participants abstinent
Interval 0.223 to 0.359
.328 proportion of participants abstinent
Interval 0.242 to 0.415
Proportion of Past-Week Complete Abstinence at Post-Intervention and Follow Up Assessments
Week 16
.334 proportion of participants abstinent
Interval 0.203 to 0.466
.335 proportion of participants abstinent
Interval 0.22 to 0.451

SECONDARY outcome

Timeframe: Baseline, 8 weeks after commencing app use, and 16 weeks after commencing app use

Population: The mixed effects logistic regression model included all participants who provided data for this outcome for at least one time point. Numbers providing data for each specific time point and predicted proportions who were past-month abstinent from the model are provided below.

Participants reporting zero drinking days in the past month will be classified as past-month abstinent. Predicted proportions from the linear mixed-effects model are entered using a measure type of "mean", as advised by the trial statistician, because the model produces predicted means from the data (after coding abstinence as 1 and non-abstinence as 0) after the model accounts for complexities in the data, such as the repeated measures of the data, imbalances in group sizes, and assumptions regarding error correlation, random effects, fixed effects.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=38 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Baseline
.160 proportion of participants abstinent
Interval 0.041 to 0.279
.224 proportion of participants abstinent
Interval 0.12 to 0.328
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Week 8
.232 proportion of participants abstinent
Interval 0.141 to 0.323
.256 proportion of participants abstinent
Interval 0.175 to 0.337
Proportion of Past-Month Complete Abstinence at Post-Intervention and Follow Up Assessments
Week 16
.303 proportion of participants abstinent
Interval 0.171 to 0.434
.288 proportion of participants abstinent
Interval 0.182 to 0.394

SECONDARY outcome

Timeframe: Baseline, 4 weeks after commencing app use, 8 weeks after commencing app use, 16 weeks after commencing app use.

Population: Linear mixed-effects models tested all time points in a single model for each of the 3 ATOP scores. These numbers reflect the number of participants who provided data for at least one time point. Predicted marginal means and numbers of participants providing data at each individual time point are presented below

3 items will be adapted from the Australian Treatment Outcomes Profile (ATOP) assessing psychological health, physical health, and overall quality of life over the past 28 days. Each item will be rated on a scale from zero to ten, where zero is poor and ten is good. Each rating will be treated as a separate variable in analyses (i.e., no composite score will be derived from the 3 separate items).

Outcome measures

Outcome measures
Measure
Active AAT-App
n=39 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=40 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 4 psychological wellbeing
4.920 units on a scale
Standard Error 0.277
4.926 units on a scale
Standard Error 0.269
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 4 physical wellbeing
5.341 units on a scale
Standard Error 0.304
4.969 units on a scale
Standard Error 0.296
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 8 physical wellbeing
5.382 units on a scale
Standard Error 0.311
5.124 units on a scale
Standard Error 0.296
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 16 physical wellbeing
5.464 units on a scale
Standard Error 0.416
5.435 units on a scale
Standard Error 0.379
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Baseline quality of life
5.708 units on a scale
Standard Error 0.329
5.227 units on a scale
Standard Error 0.322
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 4 quality of life
5.807 units on a scale
Standard Error 0.303
5.483 units on a scale
Standard Error 0.295
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 8 quality of life
5.905 units on a scale
Standard Error 0.310
5.739 units on a scale
Standard Error 0.296
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 16 quality of life
6.102 units on a scale
Standard Error 0.407
6.251 units on a scale
Standard Error 0.371
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Baseline psychological wellbeing
4.912 units on a scale
Standard Error 0.312
4.709 units on a scale
Standard Error 0.304
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 8 psychological wellbeing
4.928 units on a scale
Standard Error 0.284
5.144 units on a scale
Standard Error 0.268
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Week 16 psychological wellbeing
4.944 units on a scale
Standard Error 0.403
5.578 units on a scale
Standard Error 0.364
Scores for Quality of Life and Health Items on the Australian Treatment Outcomes Profile (ATOP)
Baseline physical wellbeing
5.300 units on a scale
Standard Error 0.333
4.814 units on a scale
Standard Error 0.325

SECONDARY outcome

Timeframe: Baseline and Post-Intervention (28 days after commencing app use)

Population: A linear mixed-effects model was used to analyse this outcome and included all participants who provided valid data for at least one time point. Numbers providing data at each individual time point, and predicted marginal means are provided below

Approach bias will be assessed within the app using an alcohol approach avoidance task. The approach avoidance task is a behavioural task designed to measure alcohol approach bias, which is the tendency to approach alcohol-related stimuli more quickly than avoiding them (relative to the same tendency for neutral stimuli). This is calculated from reaction time differences according to the formula: (RTalc-avoid - RTalc-approach) - (RTneu-avoid - RTneu-approach), where RTs are the mean reaction times for alcohol avoidance, alcohol approach, neutral stimulus avoidance, and neutral stimulus approach reactions, respectively. Thus, a positive approach bias score reflects a tendency to make an approach movement towards alcohol images more quickly than to make an avoidance, and for that tendency to be larger than the equivalent tendency for neutral images. Scores do not have specific minimum or maximum values.

Outcome measures

Outcome measures
Measure
Active AAT-App
n=33 Participants
Participants will receive the active AAT-App. AAT-App: Participants will receive the active AAT-App on their smartphone, which includes ApBM training, and prompted to engage with the app during the 28-day intervention period.
Minimal AAT-App
n=36 Participants
Participants will receive the minimal version of AAT-App. Minimal AAT-App: Participants will receive the minimal version of AAT-App, which does not include ApBM training, on their smartphone and prompted to engage with the app during the 28-day intervention period.
Approach Bias
Baseline
-69.67 units on a scale
Standard Error 21.17
-52.16 units on a scale
Standard Error 19.75
Approach Bias
Week 4
-47.01 units on a scale
Standard Error 22.45
-44.08 units on a scale
Standard Error 19.44

Adverse Events

Active AAT-App

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

Minimal AAT-App

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

Dr Joshua B. B. Garfield

Monash University

Phone: +61 3 8413 8711

Results disclosure agreements

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