Managing Mild Traumatic Brain Injury Related Headaches With Repetitive Transcranial Magnetic Stimulation
NCT03314584, Not applicable, Completed, VA Office of Research and Development; results first posted 2025-08-07
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Managing Mild Traumatic Brain Injury Related Headaches With Repetitive Transcranial Magnetic Stimulation | ClinicalTrials.gov |
| NCT number | NCT03314584 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 179 participants, actual | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Traumatic Brain Injury (TBI) | ClinicalTrials.gov |
| Interventions | Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation, Magnetic resonance imaging (MRI) | ClinicalTrials.gov |
| First posted | 2017-10-19 | ClinicalTrials.gov |
| Last updated | 2025-08-07 | ClinicalTrials.gov |
| Results first posted | 2025-08-07 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Headache Days Per Week | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Primary | Number of Days With Debilitating MTBI-headaches Per Week. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Primary | Duration of Debilitating MTBI-headaches (Hours). | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatments occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Primary | Average Interference (0-10) of Headaches in Daily Activities. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency, duration, and interference of MTBI-headaches (MTBI-HA). A score of 0 for interference would indicate no interference in daily activities while a score of 10 would indicate complete interference (e.g. the subject could not get out of bed and go to work due to their pain). Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Primary | Baseline vs Post-Treatment HIT-6 Scores (36-78). | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure is measuring headache impact on quality of life and will be quantified through the self-assessed Headache Impact Test (HIT-6). Each question ranges from 6-13 and the total score ranges from 36 to 78. The assessment indicates the effect that headaches have on normal daily life and ability to function with a higher score indicating more interference in daily life and function. | ClinicalTrials.gov |
| Primary | Change From Baseline to Post-Treatment HDRS-17 Scores | The measure will be assessed each visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be measuring depression scores and will be quantified through the administered Hamilton Scale for Depression. This contains 17 items to be rated (HDRS-17), but four other questions are not added to the total score and are used to provide additional clinical information. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. The total score ranges from 0 to 53 and is calculated from adding together the first 17 questions. A higher score indicated more severe depression. | ClinicalTrials.gov |
| Primary | Connors Continuous Performance Test Score. | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure quantified through the Connors continuous performance test will be sustained and selective attention. This is administered on a laptop and is automatically scored. Key performance indicators are reported as T-scores (mean of 50, SD = 10) and percentiles. T-scores are compared to the normative sample. Variability measure which looked at response speed consistency and indicated fluctuations in attention. A higher score indicated more fluctuations. | ClinicalTrials.gov |
| Primary | Brief Pain Inventory Global Score. | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome will measure global pain through the brief pain inventory assessment. Pain will be recorded at it's worst, it's best and on average over the previous 24 hours on a 0 to 10 scale These scores are reflected in questions 3-6 of the assessment and will be averaged together to give an overall average pain level score with a higher value reflecting more pain. Then the pain's impact on general activity, mood, walking ability, normal work, relationships, sleep and enjoyment of life will be measured on a 0 to 10 scale and averaged for an overall pain score. These scores are reflected in question 9a-g and will be averaged together to give an overall average pain interference level with a higher value indicating more interference in daily life. | ClinicalTrials.gov |
| Primary | Hopkins Verbal Learning Test (HVLT-R) Total Scores | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The Hopkins Verbal Learning Test (HVLT-R) will be used to measure memory. In this assessment, 12 words are taught and subjects are tasked to recall those words in three difference trials. When scoring the HVLT-R, the number of words recalled are summed to calculate a total recall score which ranges from 0-36 with higher values indicating more words being recalled. | ClinicalTrials.gov |
| Primary | Stroop Test Score | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The Stroop test was administered to assess cognitive functioning performance. In the test, the participant must demonstrate inhibition of cognitive interference by naming the color of the colored word instead of the word itself based on the observation that normal individuals can read words much faster than they can identify and name colors. This follows two other trials where the participant just reads the words aloud and another trial of the participant just identifying the color of a series of x's. Each trial, the participant was given 45 second to identify as many colors as they could. There is no maximum score for this assessment. This assessment is scored by the number of items they were able to correctly read out rather than on a T-score. A higher score indicated higher cognitive functioning. | ClinicalTrials.gov |
| Primary | Average Intensity of Persistent Headaches. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experienced. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Primary | Average Intensity of Debilitating Headaches. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA). Intensity was rated on a scale of 0-10 with 0 indicating no pain and 10 indicating the worst pain they have experience. Baseline data includes all logs from the start of the study until the start of treatment. Post-intervention data looked at the time between the 3-month follow-up and the previous visit. | ClinicalTrials.gov |
| Secondary | Significant T-Values for Connectivity Between Regions. | Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up. | Resting state functional magnetic imaging scans and subsequent processing using CONN Toolbox were used to determine T-values. ROIs (region of interest) where determined and compared to other ROIs to assess connectivity between regions. Value of "0" indicated no significant connectivity between regions (p\<0.01). The sign of the value indicated directionality of connectivity. Larger absolute values of the T-value indicated stronger connectivity. | ClinicalTrials.gov |
Outcomes 13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Number of Headache Days Per Week | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects are missing their 3-month follow up data due to it not being collected. | days/week | MEAN | ClinicalTrials.gov |
| PRIMARY | Number of Days With Debilitating MTBI-headaches Per Week. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | days/week | MEAN | ClinicalTrials.gov |
| PRIMARY | Duration of Debilitating MTBI-headaches (Hours). | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatments occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | hours | MEAN | ClinicalTrials.gov |
| PRIMARY | Average Interference (0-10) of Headaches in Daily Activities. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Baseline vs Post-Treatment HIT-6 Scores (36-78). | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Post-Treatment HDRS-17 Scores | The measure will be assessed each visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Connors Continuous Performance Test Score. | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | T-Score | MEAN | ClinicalTrials.gov |
| PRIMARY | Brief Pain Inventory Global Score. | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Hopkins Verbal Learning Test (HVLT-R) Total Scores | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Test Score | The measure will be assessed every visit from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | Number of words | MEAN | ClinicalTrials.gov |
| PRIMARY | Average Intensity of Persistent Headaches. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Average Intensity of Debilitating Headaches. | The measure will be assessed daily from baseline to the 3-month post-treatment follow up (treatment occurred for 2-5 weeks starting in week 3). | Some subjects were excluded from the pre-intervention or post-intervention data due to missing data. Subjects did not need both to be included in the analysis. The number analyzed below reflects that total subjects with valid data for that group and time point. | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Significant T-Values for Connectivity Between Regions. | Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up. | Some subjects were excluded due to not having a resting state MRI scan performed. | T-value | NUMBER | ClinicalTrials.gov |
Results by group 58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Number of Headache Days Per Week | Transcranial Magnetic Stimulation | Pre-intervention persistent headache frequency | 4.2 | Standard Deviation 2.9 | days/week | ClinicalTrials.gov |
| Number of Headache Days Per Week | Sham Transcranial Magnetic Stimulation | Pre-intervention persistent headache frequency | 4.6 | Standard Deviation 2.0 | days/week | ClinicalTrials.gov |
| Number of Headache Days Per Week | Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) persistent headache frequency | 3.1 | Standard Deviation 2.3 | days/week | ClinicalTrials.gov |
| Number of Headache Days Per Week | Sham Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) persistent headache frequency | 4.3 | Standard Deviation 1.9 | days/week | ClinicalTrials.gov |
| Number of Days With Debilitating MTBI-headaches Per Week. | Transcranial Magnetic Stimulation | Pre-intervention debilitating headache frequency | 2.1 | Standard Deviation 2.0 | days/week | ClinicalTrials.gov |
| Number of Days With Debilitating MTBI-headaches Per Week. | Sham Transcranial Magnetic Stimulation | Pre-intervention debilitating headache frequency | 2.1 | Standard Deviation 1.9 | days/week | ClinicalTrials.gov |
| Number of Days With Debilitating MTBI-headaches Per Week. | Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache frequency | 1.3 | Standard Deviation 1.8 | days/week | ClinicalTrials.gov |
| Number of Days With Debilitating MTBI-headaches Per Week. | Sham Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache frequency | 1.8 | Standard Deviation 1.7 | days/week | ClinicalTrials.gov |
| Duration of Debilitating MTBI-headaches (Hours). | Transcranial Magnetic Stimulation | Pre-intervention debilitating headache duration | 3.5 | Standard Deviation 1.6 | hours | ClinicalTrials.gov |
| Duration of Debilitating MTBI-headaches (Hours). | Sham Transcranial Magnetic Stimulation | Pre-intervention debilitating headache duration | 5.5 | Standard Deviation 4.6 | hours | ClinicalTrials.gov |
| Duration of Debilitating MTBI-headaches (Hours). | Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache duration | 4.3 | Standard Deviation 3.3 | hours | ClinicalTrials.gov |
| Duration of Debilitating MTBI-headaches (Hours). | Sham Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache duration | 5.0 | Standard Deviation 4.3 | hours | ClinicalTrials.gov |
| Average Interference (0-10) of Headaches in Daily Activities. | Transcranial Magnetic Stimulation | Pre-intervention debilitating headache interference | 6.9 | Standard Deviation 1.5 | score on a scale | ClinicalTrials.gov |
| Average Interference (0-10) of Headaches in Daily Activities. | Sham Transcranial Magnetic Stimulation | Pre-intervention debilitating headache interference | 6.6 | Standard Deviation 1.8 | score on a scale | ClinicalTrials.gov |
| Average Interference (0-10) of Headaches in Daily Activities. | Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache interference | 5.8 | Standard Deviation 2.1 | score on a scale | ClinicalTrials.gov |
| Average Interference (0-10) of Headaches in Daily Activities. | Sham Transcranial Magnetic Stimulation | Post-intervention (3-months after TX) debilitating headache interference | 5.7 | Standard Deviation 2.6 | score on a scale | ClinicalTrials.gov |
| Baseline vs Post-Treatment HIT-6 Scores (36-78). | Transcranial Magnetic Stimulation | Pre-intervention HIT-6 total score. | 65.2 | Standard Deviation 4.8 | score on a scale | ClinicalTrials.gov |
| Baseline vs Post-Treatment HIT-6 Scores (36-78). | Sham Transcranial Magnetic Stimulation | Pre-intervention HIT-6 total score. | 65.1 | Standard Deviation 6.5 | score on a scale | ClinicalTrials.gov |
| Baseline vs Post-Treatment HIT-6 Scores (36-78). | Transcranial Magnetic Stimulation | Post-intervention (3-months post TX) HIT-6 total score. | 60.7 | Standard Deviation 8.8 | score on a scale | ClinicalTrials.gov |
| Baseline vs Post-Treatment HIT-6 Scores (36-78). | Sham Transcranial Magnetic Stimulation | Post-intervention (3-months post TX) HIT-6 total score. | 60.3 | Standard Deviation 8.8 | score on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Transcranial Magnetic Stimulation | 38 | ClinicalTrials.gov | |
| Overall Study | STARTED | Sham Transcranial Magnetic Stimulation | 41 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Transcranial Magnetic Stimulation | 31 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Sham Transcranial Magnetic Stimulation | 38 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Transcranial Magnetic Stimulation | 7 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Sham Transcranial Magnetic Stimulation | 3 | ClinicalTrials.gov |
Adverse events 6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| serious | Vasovagal Response during study intervention | General disorders | Transcranial Magnetic Stimulation | 0 | 38 | 0 | ClinicalTrials.gov |
| serious | Vasovagal Response during study intervention | General disorders | Sham Transcranial Magnetic Stimulation | 1 | 41 | 1 | ClinicalTrials.gov |
| serious | Increased sensitivity to light w/ nausea | General disorders | Transcranial Magnetic Stimulation | 1 | 38 | 1 | ClinicalTrials.gov |
| serious | Increased sensitivity to light w/ nausea | General disorders | Sham Transcranial Magnetic Stimulation | 0 | 41 | 0 | ClinicalTrials.gov |
| serious | Breast Cancer | Reproductive system and breast disorders | Transcranial Magnetic Stimulation | 0 | 38 | 0 | ClinicalTrials.gov |
| serious | Breast Cancer | Reproductive system and breast disorders | Sham Transcranial Magnetic Stimulation | 1 | 41 | 1 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Transcranial Magnetic Stimulation | 0 | 38 | ClinicalTrials.gov |
| Total, all-cause mortality | Sham Transcranial Magnetic Stimulation | 0 | 41 | ClinicalTrials.gov |
| Total, other adverse events | Transcranial Magnetic Stimulation | 0 | 38 | ClinicalTrials.gov |
| Total, other adverse events | Sham Transcranial Magnetic Stimulation | 0 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Transcranial Magnetic Stimulation | 1 | 38 | ClinicalTrials.gov |
| Total, serious adverse events | Sham Transcranial Magnetic Stimulation | 2 | 41 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41109991 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: deaths from any cause | Trial comparisons |
| Transcranial Magnetic Stimulation vs Sham Transcranial Magnetic Stimulation: serious adverse events | Trial comparisons |
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)