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Trial registered on ANZCTR


Registration number
ACTRN12622001535763
Ethics application status
Approved
Date submitted
21/11/2022
Date registered
12/12/2022
Date last updated
9/10/2023
Date data sharing statement initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of the psychological, cognitive and physiological effects of Psychedelic Medicines (ASSESS)
Scientific title
A study of the psychological, cognitive and physiological effects of Psychedelic Medicines on healthy individuals (ASSESS)
Secondary ID [1] 308379 0
None
Universal Trial Number (UTN)
Trial acronym
ASSESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 328176 0
Condition category
Condition code
Mental Health 325230 325230 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a single drug exposure session with either psilocybin or Methylenedioxymethamphetamine (MDMA). This may occur individually or in small groups of 2-6 individuals within a session, all of whom will receive the same substance. The selection of group size will be based on participant and study staff availability. The selection of which substance each participant will receive will be based on participant preference. Since between substance comparisons are not primary aims, this non-random allocation will not pose any issue for the validity of the study. It will, however, improve participant tolerance of the substance, as receiving the substance of their preference is likely to lead to a more acceptable experience. Dosing sessions will be supported all times by two therapists (one male and one female) for the duration of the experience, in comfortable surroundings. The dosing session will last approximately 8 hours, during which time participants will sit in comfortable chairs with access to blindfolds and music if they would like. In the MDMA sessions, participants will be more likely to engage in a group discussion, while in the psilocybin session they will be more likely to use the blindfolds and listen to music. However, this will be up to participant preference. Prior to the dosing session, participants will undergo a preparatory session with one of the therapists who will supervise the dosing session, in order to orient participants to the experiences they will have in the session. This preparatory session will last between 45 minutes and 1.5 hours, and will involve a semi-structured conversation with considerable time for answering participant questions.

Some participants may return for a second series of sessions, where they will receive the drug they did not receive in the first session. For example, if they were administered MDMA initially, the second session will involve psilocybin. The selection of these participants will be based on participant choice and study staff and resource availability. This second session will take place at least 3 months following the first session.

For the psilocybin arm of the study, a single dose of 25 mg of psilocybin will be provided for a person weighing under 90 kg. A single dose of 30 mg of psilocybin will be provided for a person weighing between 90 kg and 115 kg. A single dose of 35 mg of psilocybin will be provided for a person weighing over 115 kg.

For the MDMA arm of the study, a single dose of 80 mg of MDMA will be provided, followed by an optional half-dose of 40 mg between 1 and 4 hours after the initial dose.

Both the MDMA and psilocybin will be orally administered in capsule form under the supervision of study personnel.
Intervention code [1] 324830 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333073 0
Depression rating scale score (measured by the Depression and Anxiety Stress Scale).
Timepoint [1] 333073 0
The primary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 3 months after the initial dosing session.
Primary outcome [2] 333074 0
The personality dimension of 'openness to experience' as measured by the IPIP-NEO-60.
Timepoint [2] 333074 0
The primary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 3 months after the initial dosing session.
Primary outcome [3] 333075 0
Trust in others, as measured by the The General Trust Scale
Timepoint [3] 333075 0
The primary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 3 months after the initial dosing session.
Secondary outcome [1] 415713 0
The first secondary outcome will be the electroencephalographic (EEG) measure known as the N100 (a negative voltage deflection occurring 100ms after stimulus presentation) in a latent inhibition task.
Timepoint [1] 415713 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 3 months after the initial dosing session.
Secondary outcome [2] 415714 0
Cognitive flexibility, as measured by accuracy at learning the new rule set in the Penn Conditional Exclusion Test.
Timepoint [2] 415714 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [3] 415715 0
Neural markers of working memory, as reflected by EEG measures of theta and gamma activity in the 3back task
Timepoint [3] 415715 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [4] 415716 0
Neural response to the presentation of negative emotional face expressions, as measured by the amplitude of the EEG measures N170 and P3 and theta activity following angry and fearful emotional faces.
Timepoint [4] 415716 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 3 months after the initial dosing session.
Secondary outcome [5] 415717 0
Tolerability, as measured by self-report measures designed for this study to assess side effects and the quality of the experience. We will also assess these measures in the context of the number of participants in the group, to determine whether group size affects feasibility.
Timepoint [5] 415717 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [6] 415950 0
Therapist competency questionnaire to assess whether exposure to the psychedelics increases self-reported feelings of competency to be a psychedelic assisted psychotherapist.
Timepoint [6] 415950 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [7] 415951 0
The mystical experiences questionnaire.
Timepoint [7] 415951 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [8] 415952 0
Feelings of connectedness to one's self and others, as measured by the The Watts Connectedness Scale.
Timepoint [8] 415952 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [9] 415953 0
Cognitive performance in the latent inhibition task
Timepoint [9] 415953 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [10] 415954 0
Cognitive performance in the Go Nogo task.
Timepoint [10] 415954 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [11] 415955 0
Reaction times in the Emotional Stroop task
Timepoint [11] 415955 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [12] 415956 0
Cognitive performance in the Penn Conditional Exclusion test
Timepoint [12] 415956 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [13] 415957 0
Cognitive performance in the 3back task
Timepoint [13] 415957 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.
Secondary outcome [14] 416366 0
Anxiety rating scale score (measured by the Depression and Anxiety Stress Scale).
Timepoint [14] 416366 0
The secondary timepoints will be a single baseline assessment within 5 to 16 days prior to the psychedelic exposure session, and a single post-psychedelic exposure assessment, within 5 to 16 days after the psychedelic exposure session. An exploratory analysis will also assess this measure at a follow-up timepoint, 3 months after the dosing session for all participants.

If participants take part in the cross-over component of the study, the same timepoints as with the initial dosing session will be assessed before and after the cross-over dosing session, which will take place a minimum of 6 months after the initial dosing session.

Eligibility
Key inclusion criteria
Participants will be healthy individuals who have undergone training in psychedelic assisted psychotherapy. Participants can be included if they are between the ages of 21 and 70, and voluntarily consent to participate after demonstrating competence to consent following discussion with one of the study researchers. Additional inclusion criteria will be:
- Participants must be able to swallow capsules.
- If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.
- Participants must have an identified support person and agree to be accompanied home by that person following dosing be in the presence of that person until the next day.
- Agree to not operate a vehicle for at least 48 hours after initial drug administration. Participants must have transportation available after the Experimental Session and through the following day. Participants will also be warned that the substances will be potentially detectable in roadside drug tests for a number of days after ingestion.
- Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable.
- Must agree to inform the investigator within 48 hours if any medical conditions occur or medical procedures are planned.
- Are proficient in speaking and reading English.
- Have completed a Certificate in Psychedelic-Assisted Therapies course.
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants who are not able to give adequate informed consent.
- Participants will be excluded if they are pregnant or lactating, have a history of neurological or mental illness or substance abuse or dependence. Participants will also be excluded if taking medication or drugs known to alter brain activity or have a history of seizures.
- Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition.
- Participants who are older than 40 years with a positive family history (in a first degree relative) of coronary heart disease and/or presenting substantive risk factors for cardiovascular disease as determined judged by a study doctor.
- Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Moderate to severe previous or current head injury/Traumatic Brain Injury (TBI).
- Have a history of stroke or Transient Ischemic Attack (TIA).
- Have moderate to severe hepatic impairment.
- Have epilepsy.
- Have insulin-dependent diabetes.
- Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period.
- Current or previous diagnosis of schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder.
- Or an immediate family member with a diagnosed psychotic disorder or meeting the DSM-5 criteria for any of these disorders.
- Current or previous diagnosis of alcohol or drug use disorder, or meeting the DSM-5 criteria for either of these disorders.
- History of serious suicide attempts requiring hospitalisation, or any participant presenting current serious suicide risk, as determined through meeting criteria on the Columbia Suicide Severity Rating Scale (C-SSRS) (participants will be excluded if they meet criteria on this scale).
- Significant history of mania.
- Any other psychiatric condition judged to be incompatible with safe exposure to psilocybin, e.g. borderline personality disorder.
- Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding. Any person with female reproductive organs and of childbearing potential will undertake a pregnancy test as part of the study prior to any dosing of MDMA or psilocybin.
- Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- Use of contraindicated medication (outlined further below).
- Previous experience with MDMA or psilocybin in the past three months.
- Current or previous diagnosis of antisocial personality disorder, or meeting the DSM-5 criteria for this disorder, or any other significant personality disorder as determined by the Standardized Assessment of Personality: Abbreviated Scale (SAPAS; Moran et al., 2003).
- Participants who weigh less than 48kg.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will either receive MDMA or psilocybin in groups of 2 to 6 participants. The study will compare outcomes from participants from each condition separately between baseline data (obtained prior to the psychedelic exposure) and a post-psychedelic exposure timepoint. Additionally, as a secondary follow-up timepoint, participants will complete all the same measures as at the post timepoint except for the EEG measures 3 months following the dosing session.

Some participants may choose to undergo the cross-over component of the study, where they will receive the drug that they did not receive in the initial dosing session. If they are involved in this cross-over component, they will complete all the same assessments as for the first dosing session.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
For the psychological variables, meta-analysis of the effects of psychedelic assisted therapy on depression within placebo-controlled trials show a Hedge’s g of 1.21 (Luoma, Chwyl, Bathje, Davis, & Lancelotta, 2020). However, these studies included multiple psychedelic sessions, along with psychotherapy, in individuals with diagnosed depression. Our sample will only undergo a single session of psychedelic exposure, without psychotherapy, and our participants are healthy, so any changes in psychological symptoms will be smaller (with less scope for change given their symptoms will be in the healthy range to begin with). Meta-analysis including only healthy individuals exposed to psilocybin provided a standardized mean difference effect size of 0.671 for improvement in depression symptoms (Galvão-Coelho et al., 2021). In addition to depressive symptoms, we are including measures such as personality and trust, which may be altered by exposure to psychedelics, but to a lesser extent than depressive symptoms. As such, assuming a conservative effect size provides a Cohen’s d of 0.45. Aiming for a p-value threshold of 0.5 with 80% power would require 41 participants, so recruiting 50 participants in each group will provide sufficient power to detect these moderate effects accounting for 10% attrition and any data collection issues (such as partial responses or outlying scores that require exclusion).

The self-report measures will be analysed as exploratory comparisons using robust repeated measures ANOVAs with the WRS2 package in R, which are as sensitive as traditional parametric t-tests, but robust against violations of the assumptions of traditional statistical methods (such as normality) (Mair & Wilcox, 2020) .

With regards to the EEG measures, while there is no directly comparable research available from which to extrapolate potential effect sizes, effect sizes in previous research that has examined the effects of acute exposure to psychedelics across a range of neural activity measures reported large effect sizes (Cohen’s d > 0.70) in measures obtained using some EEG tasks (Duerler et al., 2021; Muthukumaraswamy et al., 2013; Timmermann et al., 2018). Similarly large effect sizes have been obtained in clinical populations and in comparisons of healthy aging with measures of latent inhibition and 1/f metrics that assess excitation / inhibition balances (Kathmann, von Recum, Haag, & Engel, 2000; Schneider et al., 2018; Voytek et al., 2015). Additionally, effect sizes in cross-sectional studies comparing heavy MDMA users to healthy controls in EEG measures of the oddball task produce only medium effect sizes (d ~=0.6) (Croft, Klugman, Baldeweg, & Gruzelier, 2001; Tuchtenhagen et al., 2000). As such, we expect that non-acute effects of a single session psychedelic exposure are likely to be similarly medium sized for facial emotion processing, the Go Nogo task, and our other measures also. As such, we will power our core study to detect medium effect sizes (d = 0.6). Primary comparisons will be performed using paired samples t-test designs with two tailed statistical testing, comparing pre- to post MDMA exposure in a separate analysis to the pre- and post-psilocybin exposure. With this study design, recruiting 30 participants to the EEG component, and accounting for 10% attrition or technical issues in data collection (N = 27) provides sufficient statistical power to detect an effect size d = 0.57 with a power value of 0.80 at an alpha of 0.05.

EEG analyses will be performed automatically on the processed EEG data, time-locked to the stimuli presentation from each task, including all electrodes and time windows (without any specific electrode or time window selection that excludes any of the data), using randomisation statistics provided by the randomisation graphical user interface (RAGU) software (Habermann, Weusmann, Stein, & Koenig, 2018). This analysis approach applies randomisation statistics to robustly test for differences in the neural response strength using the global field potential, and for differences in the distribution of neural activity using global dissimilarity maps. This approach uses all electrodes and timepoints in its analysis, so prevents any potential experimenter bias from selection of electrodes or timepoints for analysis, while still robustly controlling for multiple comparisons using variations on traditional randomisation statistical approaches (the global duration statistic and global count statistic).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
26/09/2023
Date of last participant enrolment
Anticipated
12/01/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
100
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 38941 0
3127 - Surrey Hills

Funding & Sponsors
Funding source category [1] 312626 0
Commercial sector/Industry
Name [1] 312626 0
Monarch Mental Health Group
Country [1] 312626 0
Australia
Funding source category [2] 312628 0
University
Name [2] 312628 0
Australian National University
Country [2] 312628 0
Australia
Funding source category [3] 312629 0
Charities/Societies/Foundations
Name [3] 312629 0
Mind Medicine Australia
Country [3] 312629 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Monarch Mental Health Group
Address
Suite 701, Level 7, 225 Clarence Street, Sydney, NSW, 2000
Country
Australia
Secondary sponsor category [1] 314238 0
None
Name [1] 314238 0
Address [1] 314238 0
Country [1] 314238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311944 0
ACT Health
Ethics committee address [1] 311944 0
Ethics committee country [1] 311944 0
Australia
Date submitted for ethics approval [1] 311944 0
12/10/2022
Approval date [1] 311944 0
13/01/2023
Ethics approval number [1] 311944 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122926 0
Dr Neil Bailey
Address 122926 0
Monarch Mental Health Group, Shop 2, 629 Canterbury Road, Surrey Hills Vic 3127.
Country 122926 0
Australia
Phone 122926 0
+61 1300 867 888
Fax 122926 0
Email 122926 0
neil.bailey@anu.edu.au
Contact person for public queries
Name 122927 0
Samantha Webb
Address 122927 0
Monarch Mental Health Group, Shop 2, 629 Canterbury Road, Surrey Hills Vic 3127.
Country 122927 0
Australia
Phone 122927 0
+61 1300 867 888
Fax 122927 0
Email 122927 0
monarchri_psychedelics@mmhg.com.au
Contact person for scientific queries
Name 122928 0
Neil Bailey
Address 122928 0
Monarch Mental Health Group, Shop 2, 629 Canterbury Road, Surrey Hills Vic 3127.
Country 122928 0
Australia
Phone 122928 0
+61 1300 867 888
Fax 122928 0
Email 122928 0
monarchri_psychedelics@mmhg.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Both the EEG data and the self-report data, with all data de-identified prior to sharing.
When will data be available (start and end dates)?
Beginning 3 months following main results publication, with no end date determined.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via web address yet to be determined


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.