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Trial registered on ANZCTR

Registration number

ACTRN12615000618550

Ethics application status

Approved

Date submitted

26/05/2015

Date registered

15/06/2015

Date last updated

10/12/2020

Date data sharing statement initially provided

19/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

COMPARE - An evaluation of two different treatments compared to usual speech pathology in people with problems communicating after stroke.

Scientific title

COMPARE - Constraint Induced or Multi-Modal aphasia rehabilitation versus usual care for stroke related chronic aphasia as measured by the change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1170-1136

Trial acronym

COMPARE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aphasia post stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Constraint Induced Aphasia Therapy (CIAT):
CIAT involves participants producing nouns, verbs, and functional phrases that they have not been able to produce prior to treatment, in response to pictured object and action cards, in a small social group setting. Physical visual barriers between participants discourage the use of gesture, drawing or writing as alternative means of communication when speech fails. Communication activities include requesting picture cards from group members (e.g., Do you have 'coffee'?), responding to requests from others (e.g., “Yes I have 'coffee'”), and rehearsal of functional communication routines (e.g., role playing being in a shop asking for coffee). Clinicians explicitly cue and shape the verbal responses such that, as performance improves, participant responses are shaped from simple, single word requests (e.g., “Coffee?”) through to more elaborate sentences (e.g., “John, I want a large, black coffee?”). CIAT Plus developed by CI Meinzer and colleagues also includes daily home practice (monitored via written log/carer report), which we will utilize in this study. There will be 30 hrs of treatment (3hrs/day, 5 days/week for 2 weeks), in a small group setting (2-3 participants per group) with one qualified speech pathologist.

Arm 2: Multi-Modality Aphasia Therapy (M-MAT):
M-MAT involves the same communication activities in the same setting as CIAT (socially inspired card based requesting and responding), but there are no visual barriers between participants. Clinicians explicitly cue and shape the verbal responses from participants with a series of structured multi-modal prompts that participants copy: associated gesture, written word, simple drawing, and verbal repetition. Daily home practice tasks are set and monitored via written log/carer report. There will be 30hrs of treatment (3hrs/day, 5 days/week for 2 weeks), in a small group setting (3 participants per group) with one qualified speech pathologist.

Optional Sub-Study for ARM 3 Usual Care
For ethical reasons, at the end of the 12 week follow up assessments participants randomised to ARM 3 Usual Care will be offered M-MAT or CIAT treatment equal in overall dose to that of the intervention participants. These participants will be re-randomised to either non-intense M-MAT or non-intense CIAT. Non-intense M-MAT and CIAT are equivalent in every respect to intense M-MAT and CIAT except that the treatment schedule is 2 hours per day, 3 days per week for 5 weeks duration (instead of 3 hours per day, 5 days per week for 2 weeks duration) in a small group setting (2-3 participants per group) with one qualified speech pathologist. This treatment data will be collected but not used in the primary or secondary statistical analysis of this trial. This data will be used in tertiary analyses to provide pre vs post views of treatment gains, where each participant is their own control, as well as a preliminary comparison of overall effect sizes from intense versus non-intense CIAT and M-MAT.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Arm 3: Usual Care control:
A usual care control group will undergo aphasia therapy at the type and frequency that is available to them at the time of their recruitment and randomization. For some participants this may comprise no direct intervention, while for others it may take the form of non-intense, individual, computerised or social/support group sessions (1 to 2 hours per week). All aphasia treatment related activity will be documented by the usual care therapists, and participants (or family members) will keep a diary of therapy activity for data triangulation. The UC group is assessed at the same 3 time points as the intervention groups.

Control group

Active

Outcomes

Primary outcome [1]

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline.

Timepoint [1]

Post-intervention - immediately after completion of intervention period.

Secondary outcome [1]

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score at 12 week follow up compared to baseline.

The WAB-AQ is calculated as a sum of subtests including measures of spontaneous speech (fluency and information), auditory comprehension, repetition and naming.

Timepoint [1]

12 weeks after completion of intervention period

Secondary outcome [2]

Change in Connected speech measures post-intervention and at 12 week follow up compared to baseline.

Connected speech measures will be collected and analysed using the SALT software. Samples include a picture description (from the WAB), picture description form the Nicholas and Brookshire procedure, a 5 minute monologue (stroke story; happy event) procedure and a 10-minute conversation between the participants and their nominated relative/friend or carer.

Timepoint [2]

Immediately after and 12 weeks after intervention.

Secondary outcome [3]

Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39g) post-intervention and at 12 week follow up compared to baseline.

SAQOL-39g is an interviewer administered self-report measure of subjective evaluation of functioning in 39 questions covering 3 domains: physical, psychosocial, and communication. It is specifically designed for people with aphasia with several modifications to improve accessibility (simple wording, large font, bolded text, visual rating scale).

Timepoint [3]

Immediately after and 12 weeks after intervention period.

Secondary outcome [4]

Change in Scenario Test post-intervention and at 12 week follow up compared to baseline.

The Scenario Test measures daily-life communication for people with moderate to severe aphasia. It examines verbal (speaking) and nonverbal (gesture, drawing, writing) communication in an interactive setting with pictorial supports to assist in message comprehension.

Timepoint [4]

Immediately after and 12 weeks after intervention period.

Secondary outcome [5]

Change in Communicative Effectiveness Index (CETI) post-intervention and at 12 week follow up compared to baseline.

The CETI is a 16-item spouse/carer rating scale of functional communication.

Timepoint [5]

Immediately after and 12 weeks after intervention period.

Secondary outcome [6]

Change in WAB-AQ at 12 week follow up as predicted by by scores on semantic processing (Pyramids and Palm Trees), phonological processing (Naming Battery Phonological errors), non-verbal reasoning (Raven’s Matrices), cognitive flexibility (Test of Everyday Attention: Visual Elevator) , auditory verbal memory (Picture Span Test) and attention (Test of Everyday Attention)

Timepoint [6]

12 weeks after intervention period

Secondary outcome [7]

Resource utilisation – economic analysis

Resource utilisation will be assessed through the use of a weekly participant diary, trial cost questionnaire and quality of life questionnaire.

Health-related quality of life (HRQoL) will be assessed using a standardised instrument, the EQ-5D-3L™. It is a cognitively simple questionnaire of five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.

Timepoint [7]

12 weeks after intervention period

Secondary outcome [8]

Optional sub-study outcome

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline.

Timepoint [8]

Immediately after sub-study intervention period.

Secondary outcome [9]

Optional sub-study outcome

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score at 12 week follow up compared to baseline.

Timepoint [9]

12 weeks after sub-study intervention period

Secondary outcome [10]

Optional sub-study outcome

Change in the WAB-AQ post-intervention main study compared to post-intervention sub-study

Timepoint [10]

Up to 20 weeks after main study intervention period.

Secondary outcome [11]

Relationship between lesion location and change in WAB-AQ score post-intervention and at 12 week follow-up

Timepoint [11]

Immediately after and 12 weeks after intervention period

Eligibility

Key inclusion criteria

Inclusion criteria
Participants will be included if they:
1. Have a documented stroke resulting in aphasia at least 6 months prior to assessment at the time of consent
2. Have aphasia of any type (<93.8 WAB-AQ)
3. Used English as their primary language prior to stroke
4. Are 18 years or older and able to give informed consent
5. Are independent in toileting
6. Are able and willing to attend/participate in baseline assessments, 2 week treatment period, post-intervention period and follow up period
7. Have a carer/significant other who is able and willing to participate in baseline, post-intervention and follow up assessments.

The sub-study is optional for participants randomized to the UC group and as such willingness to participate in the sub-study is not a limiting factor for inclusion into the study.

Carer/significant other as nominated by the participant will be included if they:
1. Are 18 years or older and able to give informed consent
2. Are able and willing to participate in baseline, post-intervention period and follow up assessments

A carer/significant other is nominated by the participant and is not a limiting factor for inclusion into the study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria
Participants will not be included if they:
1. Have had previous neurological event/diagnosis (head injury, neurosurgery, dementia, epilepsy, progressive neurological disorder) other than stroke
2. Have severe apraxia of speech or dysarthria on Apraxia Severity Rating Scale.
3. Have been diagnosed major clinical depression or other mental health condition that may affect involvement or adherence to the study protocol
4. Have uncorrected sensory loss (hearing/vision) preventing participation in communication assessments and treatments
5. Are unable to attend the 12 week follow-up assessments
6. Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the protocol.
7. Are participating in any other therapy (including alternative therapies and clinical trials) or taking medications (including herbal preparations) that are not considered to be standard care for people with aphasia.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligible participants will be randomised to one of three arms, namely:
1. Arm 1 – CIAT
2. Arm 2 – M-MAT
3. Arm 3 – Usual Care Control

Upon completion of all screening assessments and suitability checks, a participant eligibility checklist will be completed by the Blinded Assessor. This checklist will be sent to the Trial Manager who will initiate the randomisation process. The participant and the intervention therapist will be notified of the treatment assignment. This will not be disclosed to the Blinded Assessors.

Participants in the UC group will be re-randomised following the 12 week follow up visit to either CIAT or M-MAT and will participate in the option sub-study. The randomisation procedure will be the same as for the main-study.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be randomly assigned, stratified by WAB-AQ severity level (mild 93.7-62.6; moderate: 62.5-31.3; severe: 31.2-0) to treatment via a central allocation system. In this procedure, participants are randomly allocated, via computer-generated algorithm, to one of 3 conditions (CIAT, M-MAT, UC) and one of 3 severity levels (mild, moderate, severe).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Cohorts:
All patients who are randomised will be included in the analysis. All analyses will be performed on an intention-to-treat basis. Since this study is conducted on a medically stable population in a non-acute setting, loss to follow-up due to death and drop-out are expected to be minimal. However, if the loss to follow-up is found to exceed 10% at therapy completion and an additional 10% at the 12-week follow-up, the missing data will be handled through multiple imputation. In this case, a sensitivity analysis will be performed to assess differences in the estimated improvements with and without imputation.

Baseline Characteristics:
Baseline patient characteristics will be described using means and standard deviations. One-way ANOVA or the Kruskal-Wallis test and chi-square tests will be used to examine baseline data for differences in characteristics between groups.

Primary Outcome Analysis:
A linear mixed model (LMM) model will be developed to analyse between-group (CIAT vs UC and M-MAT vs UC) differences in improvement on the WAB-AQ, immediately post treatment [H1]. Baseline aphasia severity will be controlled for, by including it as a covariate in the model. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.

Secondary Endpoints:
The LMM model developed to assess the primary end-point will be extended to analyse between-group differences in improvement on WAB-AQ at the 12-week follow up [H2].
Between-group differences (CIAT vs UC and M-MAT vs UC) in improvements in accuracy and efficacy of connected speech [H3] will be analysed through (separate) LMM models for the number of correct information units (CIUs) and the rate at which correct information units are produced (CIUs/minute) respectively. Baseline aphasia severity will be controlled for in both models, by including it as a covariate. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor. In addition, the model for the number of CIUs will include time as an offset variable.
An analysis of covariance (ANCOVA) model will be developed to analyse between-group differences in quality of life outcomes, as measured by the Stroke and Aphasia Quality of Life (SAQoL-39g) scale [H4]. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.
LMM models will be developed to analyse between group differences (M-MAT vs UC and CIAT vs UC) in multimodal communication [H5] and functional communication [H6] at the 12-week follow-up. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.
An LMM model will be used to analyse differences in efficacy of M-MAT and CIAT for patients with mild, medium and severe aphasia at baseline; efficacy will be determined by improvement on the WAB-AQ at 12-week follow-up (compared to baseline) [H7]. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.
A two stage process will be used to inform the targeted delivery of aphasia treatment [H8]. First, a principal components analysis (PCA) will be used to extract the components that explain at least 80% of the variance in baseline scores on semantic processing (Pyramids and Palm Trees), phonological processing (Naming Battery Phonological errors), non-verbal reasoning (Raven’s Matrices), cognitive flexibility (Test of Everyday Attention: Visual Elevator), auditory verbal visual memory (Picture Span Test), and attention (Test of Everyday Attention). Second, a linear mixed model will be developed to analyse the effects of the extracted principal components on the improvement in WAB-AQ at 12 weeks. Baseline WAB-AQ will be controlled for in the model. In addition, treatment site and the clustering effect of performing treatment in groups will be included as random effects in the model.

Tertiary Endpoints:
A linear mixed model (LMM) will be developed to assess improvement on the WAB-AQ, immediately post intervention [H10]. Baseline aphasia severity and will be controlled for, by including them as covariates in the model. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.
An LMM model will be used to analyse differences in efficacy of non-intense M-MAT and non-intense CIAT for patients with mild, medium and severe aphasia at baseline; efficacy will be determined by improvement on the WAB-AQ immediately post treatment (compared to baseline) [H11]. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor.
An LMM model will be used to estimate differences in improvement on WAB-AQ between intense CIAT and non-intense CIAT, and intense M-MAT and non-intense MMAT [H12]. The clustering effect of performing treatment in groups will be controlled for, by including the cluster as a random factor. The intense and non-intense therapies will be considered equivalent if the 95% confidence interval of the estimate indicates that the estimated difference is clearly less than 5.

Economic Analysis
A standard protocol4 ensuring uniform data collection will be used to estimate resource use among all participants. The perspective of this evaluation is set as societal with a specific focus on the health sector, cost and individuals. Costs involved in the organisation and delivery of treatment and those associated with healthcare resources are included. In addition, other major cost drivers that may be influenced by the type of aphasia treatment received that occur beyond the health sector will also be included (such as time cost associated with informal care provided by family members and productivity gains/losses).

Sample Size
Randomisation in groups can have a clustering effect, with each triplet forming a mini-cluster. The outcomes of participants from within the same cluster may therefore be expected to be correlated. We anticipate a relatively small intraclass correlation coefficient (ICC) of 0.04. This is consistent with estimates of ICC used in other studies, where prior information on the size of the intraclass correlation was not available. Based on this intraclass correlation coefficient and a cluster size of 2 or 3, we calculate a maximum design effect of 1.08 (corresponding to a cluster size of 3). The naïve power analysis (without accounting for the clustering effect) indicated that we would require a sample size 198 to achieve 80% power at the 5% significance level. To adjust for the clustering effect, we multiplied this value by the design effect, and rounded off to a multiple of 3, to obtain balanced allocation across the three treatment groups. This yielded a required sample size of 216.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2016

Actual

22/06/2016

Date of last participant enrolment

Anticipated

31/12/2019

Actual

31/03/2020

Date of last data collection

Anticipated

31/03/2020

Actual

23/07/2020

Sample size

Target

216

Accrual to date

Final

216

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NH&MRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Bundoora, VIC, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Queensland

Address [1]

St Lucia QLD 4072

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Macquarie University

Address [2]

Sydney NSW 2109

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

University of Sydney

Address [3]

Sydney NSW 2006

Country [3]

Australia

Other collaborator category [4]

University

Name [4]

University of Technology Sydney

Address [4]

15 Broadway, Ultimo NSW 2007

Country [4]

Australia

Other collaborator category [5]

University

Name [5]

Edith Cowan University

Address [5]

2 Bradford Street, Mount Lawley WA 6050

Country [5]

Australia

Other collaborator category [6]

University

Name [6]

Monash University

Address [6]

Wellington Rd Clayton 3800 Victoria

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Research Ethics Committee

Ethics committee address [1]

Bundoora Vic 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/05/2015

Approval date [1]

22/07/2015

Ethics approval number [1]

Ethics committee name [2]

Edith Cowen University Human Research Ethics Committee

Ethics committee address [2]

Edith Cowan University
270 Joondalup Drive
JOONDALUP WA 6027

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/08/2016

Approval date [2]

26/08/2016

Ethics approval number [2]

Ethics committee name [3]

Gold Coast Hospital and Health Service human Research Ethics Committee

Ethics committee address [3]

Research and Ethics Communications
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard, Southport Qld 4215

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

10/11/2015

Approval date [3]

24/02/2016

Ethics approval number [3]

Ethics committee name [4]

Macquarie University Human Research Ethics Committee

Ethics committee address [4]

Research Office,   Level 3, C5C Building
Macquarie University, NSW 2109, Australia

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

02/08/2016

Approval date [4]

18/08/2016

Ethics approval number [4]

Ethics committee name [5]

Monash University Human Research Ethics Committee

Ethics committee address [5]

Monash University
Clayton, VIC, 3168

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

26/10/2015

Ethics approval number [5]

Ethics committee name [6]

The University of Queensland Human Research Ethics Committee

Ethics committee address [6]

St Lucia, QLD 4072

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

01/03/2016

Approval date [6]

07/04/2016

Ethics approval number [6]

Ethics committee name [7]

University of Auckland Human Participants Ethics Committee

Ethics committee address [7]

Level 10, 49 Symonds St, Auckland

Ethics committee country [7]

New Zealand

Date submitted for ethics approval [7]

23/03/2018

Approval date [7]

24/08/2018

Ethics approval number [7]

021001

Summary

Brief summary

The study will compare different treatments for people with aphasia. Participants will randomly assigned to one of three treatment groups CIAT, M-MAT or Usual Care. Participants will attend baseline assessments, a two week treatment period, assessment immediately after treatment and further follow up assessment 12 weeks after completing the treatment. 

Participants randomised to the Usual Care group will be offered additional treatment at the end of the 12 week follow up period as part of an optional sub-study. In this sub-study participants will be re-randomised to receive either CIAT or M-MAT. They will attend treatment visits over five weeks with follow up assessments immediately after the treatment period and again at 12 weeks after completing the treatment. 

Study Hypothesis: Compared to usual care, both the study treatments (CIAT and M-MAT) will result in reduced aphasia severity .

Trial website

www.latrobe.edu.au/compare

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Miranda Rose

Address

Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC 3086

Country

Australia

Phone

+61 3 9479 2088

Fax

[email protected]

Contact person for public queries

Name

Melanie Hurley

Address

Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC 3086

Country

Australia

Phone

+61 3 9479 2776

Fax

[email protected]

Contact person for scientific queries

Name

Miranda Rose

Address

Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora, VIC 3086

Country

Australia

Phone

+61 3 9479 2088

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Outcome data

When will data be available (start and end dates)?

Immediately after publication - end date to be determined

Available to whom?

Public

Available for what types of analyses?

Supporting future research

How or where can data be obtained?

Publications

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
837	Informed consent form	Aphasia Friendly Information (Aus)	368529-(Uploaded-19-12-2018-09-47-35)-Study-related document.pdf
838	Informed consent form	Carer / Close Other Information (Aus)	368529-(Uploaded-19-12-2018-09-48-06)-Study-related document.pdf
839	Informed consent form	For people with Aphasia (Aus)	368529-(Uploaded-19-12-2018-09-49-27)-Study-related document.pdf
840	Informed consent form	Aphasia Friendly Information (NZ)	368529-(Uploaded-19-12-2018-09-50-24)-Study-related document.pdf
841	Informed consent form	Carer / Close Other Information (NZ)	368529-(Uploaded-19-12-2018-09-50-54)-Study-related document.pdf
842	Informed consent form	Information for People with Aphasia	368529-(Uploaded-19-12-2018-09-51-23)-Study-related document.pdf
843	Ethical approval	La Trobe University Ethics approval	368529-(Uploaded-19-12-2018-09-54-17)-Study-related document.pdf
844	Ethical approval	New Zealand Ethics approval - The Auckland Univers... [More Details]	368529-(Uploaded-19-12-2018-09-55-12)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Constraint-induced or multi-modal personalized aphasia rehabilitation (COMPARE): A randomized controlled trial for stroke-related chronic aphasia.	2019	https://dx.doi.org/10.1177/1747493019870401
Embase	Statistical analysis plan for the COMPARE trial: a 3-arm randomised controlled trial comparing the effectiveness of Constraint-induced Aphasia Therapy Plus and Multi-modality Aphasia Therapy to usual care in chronic post-stroke aphasia (COMPARE).	2021	https://dx.doi.org/10.1186/s13063-021-05238-0
Embase	Acceptability, feasibility and preliminary efficacy of low-moderate intensity Constraint Induced Aphasia Therapy and Multi-Modality Aphasia Therapy in chronic aphasia after stroke.	2024	https://dx.doi.org/10.1080/10749357.2023.2196765

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically