Trial Outcomes & Findings for Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia (NCT NCT00857220)

NCT ID: NCT00857220

Last Updated: 2017-10-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 304 participants
• Primary outcome timeframe: 12 Months (from the 1st dose to the end of study)
• Results posted on: 2017-10-26

Participant Flow

The participant flow section includes all subjects randomized. The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. One subject did not receive study medication.

Participant milestones

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) Eszopiclone Overall
Overall Study STARTED	304
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	183

Reasons for withdrawal

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) Eszopiclone Overall
Overall Study Adverse Event	35
Overall Study Death	1
Overall Study Lack of Efficacy	11
Overall Study Lost to Follow-up	30
Overall Study Physician Decision	4
Overall Study Protocol Violation	16
Overall Study Withdrawal by Subject	67
Overall Study Clinical Hold	6
Overall Study Site Closed	5
Overall Study Miscellaneous	8

Baseline Characteristics

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

Baseline characteristics by cohort

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Age, Categorical <=18 years	303 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.2 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants
Region of Enrollment United States	303 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months (from the 1st dose to the end of study)

Population: The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Overall Incidence of Adverse Events Subjects with at least 1 TEAE	212 participants
Overall Incidence of Adverse Events Potentially-related TEAE	138 participants
Overall Incidence of Adverse Events Severe TEAE	10 participants
Overall Incidence of Adverse Events Serious TEAE	4 participants
Overall Incidence of Adverse Events Fatal TEAE	1 participants
Overall Incidence of Adverse Events Discontinued study due to TEAE	34 participants

SECONDARY outcome

Timeframe: 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Overall Incidence of Skin Reactions: Number of Events	17 Events

SECONDARY outcome

Timeframe: 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Overall Incidence of Skin Reactions: Number of Participant Affected	13 participants

SECONDARY outcome

Timeframe: 12 Months

Population: Intent to treat population

The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Any Suicidal Behavior	1 Subjects 0.3
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Completed Suicide	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Actual Attempt	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Interrupted Attempt	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Aborted Attempt	1 Subjects 0.3
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Preparatory Acts or Behavior	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Any Suicidal Ideation	4 Subjects 1.3
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Wish to be Dead	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Non-specific Active Suicidal Thoughts	3 Subjects 1.0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Active Suicidal Ideation without Intent to Act	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Active Suicidal Ideation w/ Some Intent to Act	0 Subjects 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Any Suicidality	4 Subjects 1.3
Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses Active Suicidal Ideation w/ Specific Plan	1 Subjects 0.3

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to Treat Population

These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12	1.1 score Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12 From Parent	2.6 units on a scale Standard Deviation 1.4
Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12 From Child	2.6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline at Month 12 in Subjective Sleep Latency (SL)	-18.1 Minutes Standard Deviation 87.3

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject's age group and gender from the raw score and then dividing this by the standard deviation for the subject's age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline in Child Behavior Checklist (CBCL) Activities scale standardized score	1.04 units on a scale Standard Deviation 13.83
Change From Baseline in Child Behavior Checklist (CBCL) Social scale standardized score	0.94 units on a scale Standard Deviation 14.29
Change From Baseline in Child Behavior Checklist (CBCL) School scale standardized score	0.02 units on a scale Standard Deviation 11.49
Change From Baseline in Child Behavior Checklist (CBCL) Total competence standardized score	1.02 units on a scale Standard Deviation 13.34
Change From Baseline in Child Behavior Checklist (CBCL) Internalizing problems standardized score	0.19 units on a scale Standard Deviation 15.13
Change From Baseline in Child Behavior Checklist (CBCL) Externalizing problems standardized score	0.29 units on a scale Standard Deviation 12.33
Change From Baseline in Child Behavior Checklist (CBCL) Total problems standardized score	0.19 units on a scale Standard Deviation 14.16

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to Treat Population

The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12	-3.9 units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners' CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d'), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Omissions % Percentile	10.285 percentage of score Standard Deviation 29.390
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Commissions % Percentile	-5.980 percentage of score Standard Deviation 29.332
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit RT Percentile	5.933 percentage of score Standard Deviation 27.606
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit RT Std Error Percentile	8.747 percentage of score Standard Deviation 30.776
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Variability Percentile	8.781 percentage of score Standard Deviation 32.543
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Detectability (d') Percentile	-3.614 percentage of score Standard Deviation 33.471
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Responsive Style (beta) Percentile	-3.614 percentage of score Standard Deviation 33.471
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Perseverations % Percentile	4.807 percentage of score Standard Deviation 25.389
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit RT Block Change Percentile	0.213 percentage of score Standard Deviation 33.614
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit SE Block Change Percentile	-2.919 percentage of score Standard Deviation 36.037
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit RT ISI Change Percentile	8.070 percentage of score Standard Deviation 30.364
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Hit SE ISI Change Percentile	8.270 percentage of score Standard Deviation 35.780
Change From Baseline in Conners' Continuous Performance Test II (CCPT II) Confidence Index	8.471 percentage of score Standard Deviation 23.889

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)	-22.7 Minutes Standard Deviation 70.5

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)	-0.8 Number of Awakenings Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject's sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).	45.3 Minutes Standard Deviation 119.8

SECONDARY outcome

Timeframe: Baseline and 12 Months (from the 1st dose to the end of study)

Population: Intent to treat population

The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.

Outcome measures

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 Participants Eszopiclone Overall
Change From Baseline in Pediatric Quality of Life Scale Physical Summary Score	-1.31 units on a scale Standard Deviation 11.15
Change From Baseline in Pediatric Quality of Life Scale Psychosocial Summary Score	2.14 units on a scale Standard Deviation 10.37

Adverse Events

2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)

Serious events: 4 serious events

Other events: 179 other events

Deaths: 0 deaths

Serious adverse events

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 participants at risk Eszopiclone Overall
General disorders Drowning	0.33% 1/303 • Number of events 1 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Viral Infection	0.33% 1/303 • Number of events 1 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Injury, poisoning and procedural complications Upper limb fracture	0.33% 1/303 • Number of events 1 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Psychiatric disorders Delirium	0.33% 1/303 • Number of events 1 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.

Other adverse events

Measure	2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs) n=303 participants at risk Eszopiclone Overall
Nervous system disorders Headache	21.5% 65/303 • Number of events 123 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Nervous system disorders Dysgeusia	13.9% 42/303 • Number of events 46 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Nervous system disorders Dizziness	9.9% 30/303 • Number of events 35 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Nervous system disorders Somnolence	5.0% 15/303 • Number of events 17 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Abdominal Pain Upper	6.3% 19/303 • Number of events 19 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Vomiting	5.0% 15/303 • Number of events 18 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Diarrhoea	4.3% 13/303 • Number of events 16 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Nausea	4.3% 13/303 • Number of events 14 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Toothache	3.0% 9/303 • Number of events 13 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Gastrointestinal disorders Abdominal discomfort	2.3% 7/303 • Number of events 7 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Nasopharyngitis	6.6% 20/303 • Number of events 27 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Upper respiratory infection	4.0% 12/303 • Number of events 16 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Respiratory, thoracic and mediastinal disorders Sinusitis	3.6% 11/303 • Number of events 14 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Influenza	3.3% 10/303 • Number of events 11 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Pharyngitis streptococcal	2.6% 8/303 • Number of events 8 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Infections and infestations Urinary tract infection	2.0% 6/303 • Number of events 7 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 16/303 • Number of events 18 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 13/303 • Number of events 18 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 12/303 • Number of events 14 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
General disorders Pyrexia	5.3% 16/303 • Number of events 20 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
General disorders Influenza like illness	2.0% 6/303 • Number of events 7 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Psychiatric disorders Insomnia	3.3% 10/303 • Number of events 10 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Psychiatric disorders Hallucination, visual	2.3% 7/303 • Number of events 8 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.
Injury, poisoning and procedural complications Contusion	2.0% 6/303 • Number of events 6 • 12 Months The intent-to-treat (ITT) population consisted of all randomized subjects who had taken any study medication. The ITT population was used for all safety analyses.

Additional Information

CNS Medical Director

Sunovion

Phone: 866-503-6357

Results disclosure agreements

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

Restriction type: OTHER