Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants

May 9, 2018 updated by: Janssen Sciences Ireland UC

A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects

The primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, double-blind, randomized (participants taste the same groups of drugs [formulations] but in random order), single-center trial in healthy adult participants. The study will include 2 Sessions of 1 day, 1) Session 1, in which participants will receive 6 JNJ-53718678 oral solutions (1 reference and 5 different formulations) sequentially in a randomized order, Scoring of the taste will be done via a questionnaire designed for this purpose; 2) Session 2, within approximately a timeframe of 7 to 14 days after completion of Session 1, participants will taste 2 best scoring tastes coming out of Session 1. The study will consist of a screening phase of approximately 2 weeks, treatment phase of approximately 2 weeks and a post-treatment follow-up phase of 10 days after completion of the last Session. The total study duration for each participant will be approximately 6 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female participants of childbearing potential should have a urine pregnancy test at screening which should be negative
  • Participants must be non-smokers and/or have not used chewing tobacco for at least one month prior to screening
  • Participants must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
  • Participants must be able to taste and smell normally, to their own opinion, at all times throughout the study duration. Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or to continue to study
  • Participants must agree to use an adequate method of contraception

Exclusion Criteria:

  • Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease
  • Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
  • Participants with a history of clinically significant allergies, hypersensitivity, or intolerance to drugs such as, but not limited to, sulfonamides and penicillins, drug allergy witnessed in previous studies with experimental drugs, or to JNJ-53718678 or its excipients
  • Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
  • Participants having received an investigational drug (including investigational vaccines) or used an invasive investigational device within 3 months before the planned first dose of study drugs or is currently enrolled in an investigational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Session 1: Sequence 1
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 1: Sequence 2
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 1: Sequence 3
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 1: Sequence 4
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 1: Sequence 5
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 1: Sequence 6
Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation A
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation B
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation C
10 mg/mL oral solution containing 10 mg/mL sucralose.
Other Names:
  • JNJ-53718678
Drug: Formulation D
10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation E
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other Names:
  • JNJ-53718678
Drug: Formulation F
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 7
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 8
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 9
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 10
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 11
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Experimental: Session 2: Sequence 12
Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.
Drug: Formulation M1
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M2
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation M3
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N1
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N2
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678
Drug: Formulation N3
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other Names:
  • JNJ-53718678

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability Score
Time Frame: up to 12 hour post-administration of study drug
Formulations will be assessed using Acceptability Questionnaire, which evaluates sweetness, bitterness, aroma type, aroma strength, smell and overall acceptability using visual analogue scales (VAS) with range from 0 (super bad) to 100 (super good).
up to 12 hour post-administration of study drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Local and Systemic adverse Events
Time Frame: Screening up to end of Study (Week 6)
Screening up to end of Study (Week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Sciences Ireland UC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR106726
  • 53718678RSV1003 (Other Identifier: Janssen Sciences Ireland UC)
  • 2014-005157-39 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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