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This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
This first study will give valuable information on the feasibility of Previct Drugs function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of a medicinal product. It will also provide information on the usability of the device. Drug intake will in this first investigation be simulated by a controlled single application of commonly therapeutically used medicinal products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2), cannabinoids (D3), and opioids (D4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single application of phenethylamines (D1) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines. |
|
| Single application of benzodiazepines (D2) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines. |
|
| Single application of cannabinoids (D3) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids. |
|
| Single application of opioids (D4) | Experimental | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previct Drugs | Device | Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt". | Day 7 +/- 2 days (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku Hämäläinen, PhD | Kontigo Care AB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center (LUMC) Department of Anesthesiology | Leiden | 2333 ZA | Netherlands |
48 subjects were included in the Full Analysis Set (FAS), 12 subjects per medicinal product type.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers With Single Application of Phenethylamines (D1) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group. |
| FG001 | Healthy Volunteers With Single Application of Benzodiazepines (D2) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiazepines (D2) allocated to this specific group. |
| FG002 | Healthy Volunteers With Single Application of Cannabinoids (D3) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group. |
| FG003 | Healthy Volunteers With Single Application of Opioids (D4) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set (FAS)
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers With Single Application of Phenethylamines (D1) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4). | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt". | FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED). | Posted | Count of Units | Number of attempts | Day 7 +/- 2 days (Visit 2) | Number of attempts | Number of attempts |
From signed informed consent to study completion, an average of 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers With Single Application of Phenethylamines (D1) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepiness | Investigations | Systematic Assessment | Due to drug intake. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Markku Hämälainen, CSO | Kontigo Care AB | +46 (0)76 947 3132 | markku.hamalainen@kontigocare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2023 | Dec 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2023 | Dec 5, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
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|
| Day 7 +/- 2 days (Visit 2) |
| Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | Day 7 +/- 2 days (Visit 2) |
| Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "correlated" if the slope in a linear regression is significantly different from zero (p<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | Day 7 +/- 2 days (Visit 2) |
| Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and at 5 hours is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | Day 7 +/- 2 days (Visit 2) |
| Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table. | Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 1 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 2 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 4 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 5 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 7 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 8 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 9 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something: Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 10 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end. Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 11 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 12 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 13 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 15 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 16 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 18 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 20 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 21 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 23 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 24 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 26 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 27 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 29 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 31 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 33 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Usability Questionnaire - Question 34 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test? Response options:
| Day 7 +/- 2 days (Visit 2) |
| Healthy Volunteers With Single Application of Benzodiazepines (D2) |
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiazepines (D2) allocated to this specific group. |
| BG002 | Healthy Volunteers With Single Application of Cannabinoids (D3) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group. |
| BG003 | Healthy Volunteers With Single Application of Opioids (D4) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Eye color | Count of Participants | Participants |
|
| Audit questionnaire | The audit questionnaire is assessing current or recent history of alcohol misuse and consists of 10 questions that each, depending on answer, gives the responder a score between 0 and 4 where higher scores corresponds to alcohol misuse. In total, the person completing the audit questionnaire can get a score between 0 and 40. | Mean | Standard Deviation | Score on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Single Application of Phenethylamines (D1) | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines. |
| OG001 | Single Application of Benzodiazepines (D2) | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines. |
| OG002 | Single Application of Cannabinoids (D3) | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids. |
| OG003 | Single Application of Opioids (D4) | Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids. |
|
|
| Secondary | Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4). | For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt. | FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED). | Posted | Count of Units | Successful attempts | Day 7 +/- 2 days (Visit 2) | Successful attempts | Successful attempts |
|
|
|
| Secondary | Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms. | For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | FAS population. | Posted | Count of Units | Number of key features | Day 7 +/- 2 days (Visit 2) | Number of key features | Number of key features |
|
|
|
| Secondary | Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition. | For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "correlated" if the slope in a linear regression is significantly different from zero (p<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | FAS population. | Posted | Count of Units | Number of key features | Day 7 +/- 2 days (Visit 2) | Number of key features | Number of key features |
|
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| Secondary | Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms. | For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and at 5 hours is significant (p<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. | FAS population. | Posted | Count of Units | Number of Key features | Day 7 +/- 2 days (Visit 2) | Number of Key features | Number of Key features |
|
|
|
| Secondary | Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition. | For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table. | FAS population. Obtained measurement data included for all subjects where available. Data for 500 Lux Kay feature Dbase missing for one subject in group D4 (opioid group). Consequently, data from 11 subjects presented for this variable. | Posted | Number | Number of participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 1 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 2 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
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| Secondary | Usability Questionnaire - Question 4 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 5 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
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| Secondary | Usability Questionnaire - Question 7 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 8 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
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| Secondary | Usability Questionnaire - Question 9 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something: Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 10 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end. Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 11 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 12 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 13 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 15 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 16 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
|
|
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| Secondary | Usability Questionnaire - Question 18 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 20 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 21 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 23 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 24 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 26 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 27 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 29 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 31 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 33 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| Secondary | Usability Questionnaire - Question 34 | User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test? Response options:
| FAS | Posted | Count of Participants | Participants | Day 7 +/- 2 days (Visit 2) |
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| 0 |
| 48 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Healthy Volunteers With Single Application of Benzodiasepines (D2) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiasepines (D2) allocated to this specific group. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | Healthy Volunteers With Single Application of Cannabinoids (D3) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG003 | Healthy Volunteers With Single Application of Opioids (D4) | Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group. | 0 | 12 | 0 | 12 | 9 | 12 |
| Double vision | Eye disorders | Systematic Assessment |
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| Light headed, dizzy | Nervous system disorders | Systematic Assessment |
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| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Nervous system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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Not provided
| Male |
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| Eye color - grey |
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| Eye color - green |
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| Eye color - amber |
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| Eye color - brown |
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| Eye color - black |
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| Eye color - other |
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| Successful attempts |
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| Successful attempts - Horizontal nystagmus (NY) |
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| Successful attempts - Tremor (TR) |
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| Successful attempts - Pupillary light reflex (PLR) |
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| Successful attempts - Redness (RED) |
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| Number of key features |
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| 500 Lux |
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| Number of key features |
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| 500 LUX |
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| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | 5.98 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dcon at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0006 | Slope | 7.17 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Ctime at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | 4.75 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dend at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0002 | Slope | 5.95 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0285 | Slope | 6.92 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for D2m at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | 6.99 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dbase at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | 6.8 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dcon at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0001 | Slope | 5.94 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dend at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.012 | Slope | 5.85 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0174 | Slope | -9.62 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for NYmass at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.013 | Slope | -9.15 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for D1m at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -4.06 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for NCdiff at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0068 | Slope | 0.99 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dbase at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0485 | Slope | 1.12 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCV at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0031 | Slope | 2.08 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Ctime at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0036 | Slope | 1.18 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0089 | Slope | 1.05 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for RMCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -4.04 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for NCdiff at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0239 | Slope | 1.62 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM30 at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0435 | Slope | 0.93 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dcon at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0126 | Slope | 1.26 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Ctime at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0294 | Slope | -0.73 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for NCdiff at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0204 | Slope | 0.96 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for D1m at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0004 | Slope | 1.41 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for D2m at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0013 | Slope | -0.95 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCV at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0003 | Slope | -0.77 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -0.94 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for RMCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | 0.81 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Redness at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0096 | Slope | -0.87 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for NCdiff at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0003 | Slope | 0.36 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Redness at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0063 | Slope | 2.13 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM10 at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0018 | Slope | 2.30 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM30 at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0134 | Slope | 3.22 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Pa at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.48 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dbase at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -2.48 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCV at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.264 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dcon at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.47 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dend at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.64 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.63 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for RMCA at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0313 | Slope | 1.43 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for PESC at 50 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0481 | Slope | 1.92 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM5 at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0171 | Slope | 2.57 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM10 at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | 0.0007 | Slope | 3.84 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MM30 at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -2.15 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for dbase at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -2.20 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCV at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -2.44 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dcon at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -3.01 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for Dend at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.82 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for MCA at 500 lux is reported. |
| The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k * (plasma concentration) + m | Regression, Linear | <0.0001 | Slope | -1.83 | 2-Sided | Other | The hypothesis was that k = 0. If the hypothesis could be rejected (p<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition. Here the p-value for RMCA at 500 lux is reported. |
| Number of Key features |
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| 500 LUX |
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| At baseline number of false positive |
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| At baseline, missing key feature data |
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| At peak concentration number of true positive |
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| At peak concentration number of false negative |
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| At peak concentration, missing key feature data |
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The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported. |
| Regression, Logistic |
| <0.05 |
| probability |
| 0.00586 |
| 2-Sided |
| Other |
| The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported. | Regression, Logistic | <0.05 | probability | 0.0193 | 2-Sided | Other |
| The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported. | Regression, Logistic | <0.05 | probability | 0.000488 | 2-Sided | Other |
| The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported. | Regression, Logistic | <0.05 | probability | 0.1133 | 2-Sided | Other |
| Regression, Logistic | <0.05 | probability | 0.0107 | 2-Sided | Other |
| Could only understand some parts |
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| Could understand most parts |
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| Could understand almost every part |
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| Fully understandable |
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| No |
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| Easy to understand |
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| Nor easy or difficult to understand |
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| Difficult to understand |
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| Very difficult to understand |
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| No |
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| Easy to perform |
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| Nor easy or difficult to perform |
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| Difficult to perform |
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| Very difficult to perform |
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| No |
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| Several occasions |
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| Most occasions |
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| All occasions |
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| Missing |
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| 5-7 minutes |
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| > 7 minutes |
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| Most of the times |
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| I did not receive any notifications |
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| Yes |
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| No |
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| Several occasions |
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| Most occasions |
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| All occasions |
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| Missing |
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| Not applicable |
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| Easy |
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| Nor easy or difficult |
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| Difficult |
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| Very difficult |
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| Easy to perform |
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| Nor easy or difficult to perform |
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| Difficult to perform |
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| Very difficult to perform |
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| 1-2 minutes |
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| > 3 minutes |
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| One occasion |
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| Several occasions |
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| Most occasions |
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| All occasions |
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| Easy |
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| Nor easy or difficult |
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| Difficult |
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| Very difficult |
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| Easy to perform |
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| Nor easy or difficult to perform |
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| Difficult to perform |
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| 1-2 minutes |
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| > 3 minutes |
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| One occasion |
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| Several occasions |
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| Most occasions |
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| Easy to perform |
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| Nor easy or difficult to perform |
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| Difficult to perform |
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| Very difficult to perform |
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| Easy to perform |
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| Nor easy or difficult to perform |
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| Difficult to perform |
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| Very difficult to perform |
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| 1-2 minutes |
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| > 3 minutes |
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| One occasion |
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