Adults 18 to 80, any sex, with Refractory Chronic Cough. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Awake Objective Cough Frequency on Log-transformed Scale - Cohort 1Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Awake Objective Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24-hour sound recordings were collected using a digital recording device.
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
0.56
0.43 – 0.72
Cohort 1 - Placebo for Gefapixant 50 mg
0.95
0.73 – 1.23
Cohort 1 - Gefapixant 100 mg
0.46
0.34 – 0.61
Cohort 1 - Placebo for Gefapixant 100 mg
0.95
0.71 – 1.28
Cohort 1 - Gefapixant 150 mg
0.48
0.35 – 0.65
Cohort 1 - Placebo for Gefapixant 150 mg
0.90
0.65 – 1.24
Cohort 1 - Gefapixant 200 mg
0.45
0.33 – 0.63
Cohort 1 - Placebo for Gefapixant 200 mg
1.06
0.75 – 1.48
Change in Awake Objective Cough Frequency on Log-transformed Scale - Cohort 2Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Awake Objective Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24-hour sound recordings were collected using a digital recording device.
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
0.80
0.66 – 0.96
Cohort 2 - Placebo for Gefapixant 7.5 mg
0.93
0.77 – 1.13
Cohort 2 - Gefapixant 15 mg
0.67
0.57 – 0.80
Cohort 2 - Placebo for Gefapixant 15 mg
0.90
0.75 – 1.08
Cohort 2 - Gefapixant 30 mg
0.53
0.40 – 0.69
Cohort 2 - Placebo for Gefapixant 30 mg
0.84
0.64 – 1.10
Cohort 2 - Gefapixant 50 mg
0.44
0.32 – 0.60
Cohort 2 - Placebo for Gefapixant 50 mg
1.00
0.72 – 1.38
Percent Change From Baseline in Awake Cough Frequency for Cohort 1Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Awake Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24-hour sound recordings were collected using a digital recording device. Percent Change in Awake Cough Frequency is the change from baseline in awake cough frequency x 100, divided by baseline awake cough frequency. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
-20.6
± 84.29
Cohort 1' - Placebo for Gefapixant 50 mg
-0.1
± 33.75
Cohort 1 - Gefapixant 100 mg
-31.7
± 70.27
Cohort 1 - Placebo for Gefapixant 100 mg
1.9
± 35.18
Cohort 1 - Gefapixant 150 mg
-22.0
± 82.84
Cohort 1 - Placebo for Gefapixant 150 mg
-0.1
± 39.55
Cohort 1 - Gefapixant 200 mg
-27.9
± 57.03
Cohort 1 - Placebo for Gefapixant 200 mg
15.1
± 48.38
Percent Change From Baseline in Awake Cough Frequency for Cohort 2Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Awake Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participant is awake. 24-hour sound recordings were collected using a digital recording device. Percent Change in Awake Cough Frequency is the change from baseline in awake cough frequency x 100, divided by baseline awake cough frequency. A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
5.0
± 125.05
Cohort 2 - Placebo for Gefapixant 7.5 mg
-3.8
± 36.13
Cohort 2 - Gefapixant 15 mg
-21.4
± 39.32
Cohort 2 - Placebo for Gefapixant 15 mg
-6.4
± 33.78
Cohort 2 - Gefapixant 30 mg
-26.3
± 61.01
Cohort 2 - Placebo for Gefapixant 30 mg
-1.1
± 64.38
Cohort 2 - Gefapixant 50 mg
-28.1
± 74.90
Cohort 2 - Placebo for Gefapixant 50 mg
23.1
± 92.60
Responder Analysis of Awake Cough Frequency for Cohort 1Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Participants were classified as responders based on the magnitude of the percent change from baseline in Awake Objective cough frequency: 1. ≥70% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤-70.0%; 0 Otherwise; 2. ≥50% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -50.0%; 0 Otherwise; 3. ≥30% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -30.0%; 0 Otherwise. These responder definitions were not mutually exclusive. A participant who achi
% Reduction ≥70
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
34.6
Cohort 1 - Placebo for Gefapixant 50 mg
0
Cohort 1 - Gefapixant 100 mg
33.3
Cohort 1 - Placebo for Gefapixant 100 mg
0
Cohort 1 - Gefapixant 150 mg
34.8
Cohort 1 - Placebo for Gefapixant 150 mg
4.5
Cohort 1 - Gefapixant 200 mg
32.0
Cohort 1 - Placebo for Gefapixant 200 mg
0
% Reduction ≥50
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
46.2
Cohort 1 - Placebo for Gefapixant 50 mg
0
Cohort 1 - Gefapixant 100 mg
50.0
Cohort 1 - Placebo for Gefapixant 100 mg
4.0
Cohort 1 - Gefapixant 150 mg
47.8
Cohort 1 - Placebo for Gefapixant 150 mg
4.5
Cohort 1 - Gefapixant 200 mg
44.0
Cohort 1 - Placebo for Gefapixant 200 mg
0
% Reduction ≥30
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
53.8
Cohort 1 - Placebo for Gefapixant 50 mg
12.0
Cohort 1 - Gefapixant 100 mg
66.7
Cohort 1 - Placebo for Gefapixant 100 mg
16.0
Cohort 1 - Gefapixant 150 mg
65.2
Cohort 1 - Placebo for Gefapixant 150 mg
22.7
Cohort 1 - Gefapixant 200 mg
56.0
Cohort 1 - Placebo for Gefapixant 200 mg
16.0
Responder Analysis of Awake Cough Frequency for Cohort 2Primary· Period 1 (while awake): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Participants were classified as responders based on the magnitude of the percent change from baseline in Awake Objective cough frequency: 1. ≥70% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤-70.0%; 0 Otherwise; 2. ≥50% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -50.0%; 0 Otherwise; 3. ≥30% Reduction=1 if Percent Change from Baseline in cough frequency at the end of the dosing interval ≤ -30.0%; 0 Otherwise. These responder definitions were not mutually exclusive. A participant who achi
% Reduction ≥70
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
3.4
Cohort 2 - Placebo for Gefapixant 7.5 mg
3.6
Cohort 2 - Gefapixant 15 mg
10.0
Cohort 2 - Placebo for Gefapixant 15 mg
0
Cohort 2 - Gefapixant 30 mg
20.7
Cohort 2 - Placebo for Gefapixant 30 mg
3.4
Cohort 2 - Gefapixant 50 mg
31.0
Cohort 2 - Placebo for Gefapixant 50 mg
3.7
% Reduction ≥50
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
13.8
Cohort 2 - Placebo for Gefapixant 7.5 mg
7.1
Cohort 2 - Gefapixant 15 mg
20.0
Cohort 2 - Placebo for Gefapixant 15 mg
6.9
Cohort 2 - Gefapixant 30 mg
31.0
Cohort 2 - Placebo for Gefapixant 30 mg
17.2
Cohort 2 - Gefapixant 50 mg
41.4
Cohort 2 - Placebo for Gefapixant 50 mg
11.1
% Reduction ≥30
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
37.9
Cohort 2 - Placebo for Gefapixant 7.5 mg
14.3
Cohort 2 - Gefapixant 15 mg
46.7
Cohort 2 - Placebo for Gefapixant 15 mg
20.7
Cohort 2 - Gefapixant 30 mg
62.1
Cohort 2 - Placebo for Gefapixant 30 mg
31.0
Cohort 2 - Gefapixant 50 mg
55.2
Cohort 2 - Placebo for Gefapixant 50 mg
22.2
Change From Baseline in Awake (0-8 Hours) Objective Cough Frequency for Cohort 1Secondary· Period 1 (while awake): baseline (Day 0) and 0-8 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 0-8 hours after Day 26, 30, 34 and 38 doses
Awake (0-8 hours) Objective Cough Frequency is the total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using a mixed
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
-24.5
-33.0 – -15.9
Cohort 1 - Placebo for Gefapixant 50 mg
-5.5
-14.2 – 3.3
Cohort 1 - Gefapixant 100 mg
-24.5
-33.1 – -15.8
Cohort 1 - Placebo for Gefapixant 100 mg
-0.1
-8.8 – 8.7
Cohort 1 - Gefapixant 150 mg
-26.5
-40.3 – -12.8
Cohort 1 - Placebo for Gefapixant 150 mg
2.7
-11.4 – 16.9
Cohort 1 - Gefapixant 200 mg
-27.5
-37.9 – -17.0
Cohort 1 - Placebo for Gefapixant 200 mg
2.2
-8.5 – 12.8
Change From Baseline in Awake (0-8 Hours) Objective Cough Frequency for Cohort 2Secondary· Period 1 (while awake): baseline (Day 0) and 0-8 hours after Day 4, 8, 12 & 16 doses; Period 2 (while awake): baseline (Day 22) and 0-8 hours after Day 26, 30, 34 and 38 doses
Awake (0-8 hours) Objective Cough Frequency is the total number of cough events during the monitoring period the participant was awake for the first 8 hours after the participant took their study medication divided by 8 or the total duration (in hours) for the monitoring period the participant was awake whichever is less. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using a mixed
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
-8.0
-17.9 – 1.9
Cohort 2 - Placebo for Gefapixant 7.5 mg
-1.1
-11.1 – 9.0
Cohort 2 - Gefapixant 15 mg
-15.2
-22.1 – -8.3
Cohort 2 - Placebo for Gefapixant 15 mg
-1.7
-8.8 – 5.3
Cohort 2 - Gefapixant 30 mg
-21.7
-31.9 – -11.5
Cohort 2 - Placebo for Gefapixant 30 mg
8.5
-1.8 – 18.8
Cohort 2 - Gefapixant 50 mg
-21.9
-32.8 – -11.0
Cohort 2 - Placebo for Gefapixant 50 mg
4.7
-6.5 – 16.0
Change From Baseline in Total (24 Hours) Cough Frequency - Cohort 1Secondary· Period 1: baseline (Day 0) and 0-24 hours after Day 4, 8, 12 & 16 doses; Period 2: baseline (Day 22) and 0-24 hours after Day 26, 30, 34 and 38 doses
Total (0-24 hours) Objective Cough Frequency is the total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
-16.6
-22.4 – -10.9
Cohort 1 - Placebo for Gefapixant 50 mg
-1.5
-7.5 – 4.5
Cohort 1 - Gefapixant 100 mg
-17.6
-24.1 – -11.0
Cohort 1 - Placebo for Gefapixant 100 mg
-0.9
-7.5 – 5.8
Cohort 1 - Gefapixant 150 mg
-18.0
-26.1 – -9.9
Cohort 1 - Placebo for Gefapixant 150 mg
1.5
-6.8 – 9.8
Cohort 1 - Gefapixant 200 mg
-17.4
-25.2 – -9.5
Cohort 1 - Placebo for Gefapixant 200 mg
3.1
-4.9 – 11.2
Change From Baseline in Total (24 Hours) Cough Frequency - Cohort 2Secondary· Period 1: baseline (Day 0) and 0-24 hours after Day 4, 8, 12 & 16 doses; Period 2: baseline (Day 22) and 0-24 hours after Day 26, 30, 34 and 38 doses
Total (0-24 hours) Objective Cough Frequency is the total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period. 24-hour sound recordings were collected using a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the repeated measures
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
-6.9
-12.6 – -1.1
Cohort 2 - Placebo for Gefapixant 7.5 mg
-2.7
-8.6 – 3.1
Cohort 2 - Gefapixant 15 mg
-11.0
-15.5 – -6.4
Cohort 2 - Placebo for Gefapixant 15 mg
-3.8
-8.4 – 0.9
Cohort 2 - Gefapixant 30 mg
-16.9
-23.3 – -10.4
Cohort 2 - Placebo for Gefapixant 30 mg
1.4
-5.2 – 7.9
Cohort 2 - Gefapixant 50 mg
-15.9
-21.0 – -9.9
Cohort 2 - Placebo for Gefapixant 50 mg
1.8
-4.4 – 7.9
Change From Baseline in Sleep Cough Frequency - Cohort 1Secondary· Period 1 (while asleep): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while asleep): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Sleep Objective Cough Frequency is the total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24-hour sound recording were collected with a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the rep
Group
Value
95% CI
Cohort 1 - Gefapixant 50 mg
-3.5
-7.0 – 0.1
Cohort 1 - Placebo for Gefapixant 50 mg
0.1
-3.5 – 3.7
Cohort 1 - Gefapixant 100 mg
-3.1
-6.8 – 0.6
Cohort 1 - Placebo for Gefapixant 100 mg
-0.7
-4.2 – 2.8
Cohort 1 - Gefapixant 150 mg
-2.0
-4.8 – 0.7
Cohort 1 - Placebo for Gefapixant 150 mg
-0.1
-2.8 – 2.6
Cohort 1 - Gefapixant 200 mg
-3.6
-7.0 – -0.1
Cohort 1 - Placebo for Gefapixant 200 mg
0.2
-3.2 – 3.6
Change From Baseline in Sleep Cough Frequency - Cohort 2Secondary· Period 1 (while asleep): baseline (Day 0) and 24 hours after Day 4, 8, 12 & 16 doses; Period 2 (while asleep): baseline (Day 22) and 24 hours after Day 26, 30, 34 and 38 doses
Sleep Objective Cough Frequency is the total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep. 24-hour sound recording were collected with a digital recording device. Results are change from baseline: a negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
Cough frequency was analyzed using MMRM to evaluate the results of the 2-period cross-over study. The derived change measured at each dose were the rep
Group
Value
95% CI
Cohort 2 - Gefapixant 7.5 mg
0.6
-2.7 – 3.9
Cohort 2 - Placebo for Gefapixant 7.5 mg
-0.6
-3.9 – 2.8
Cohort 2 - Gefapixant 15 mg
-3.1
-5.6 – -0.5
Cohort 2 - Placebo for Gefapixant 15 mg
-2.5
-5.1 – 0.2
Cohort 2 - Gefapixant 30 mg
-2.4
-4.7 – -0.2
Cohort 2 - Placebo for Gefapixant 30 mg
-1.6
-3.8 – 0.7
Cohort 2 - Gefapixant 50 mg
-3.0
-8.7 – 2.6
Cohort 2 - Placebo for Gefapixant 50 mg
2.1
-3.6 – 7.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data collection is up to 11 weeks All-cause mortality is up to 22 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: Gefapixant 50 mg
Serious: 0/28 (0%)
Deaths: 0/28
Cohort 1: Gefapixant 100 mg
Serious: 1/28 (4%)
Deaths: 0/28
Cohort 1 - Gefapixant 150 mg
Serious: 0/26 (0%)
Deaths: 0/26
Cohort 1: Gefapixant 200 mg
Serious: 0/26 (0%)
Deaths: 0/26
Cohort 1 - Placebo
Serious: 1/28 (4%)
Deaths: 0/28
Cohort 2 - Gefapixant 7.5 mg
Serious: 0/30 (0%)
Deaths: 0/30
Cohort 2 - Gefapixant 15 mg
Serious: 0/30 (0%)
Deaths: 0/30
Cohort 2 - Gefapixant 30 mg
Serious: 0/30 (0%)
Deaths: 0/30
Cohort 2 - Gefapixant 50 mg
Serious: 1/30 (3%)
Deaths: 0/30
Cohort 2- Placebo
Serious: 0/29 (0%)
Deaths: 0/29
Serious adverse events (5 terms)
Reaction
System
Cohort 1: Gefapixant 50 mg
Cohort 1: Gefapixant 100 mg
Cohort 1 - Gefapixant 150 mg
Cohort 1: Gefapixant 200 mg
Cohort 1 - Placebo
Cohort 2 - Gefapixant 7.5 mg
Cohort 2 - Gefapixant 15 mg
Cohort 2 - Gefapixant 30 mg
Cohort 2 - Gefapixant 50 mg
Cohort 2- Placebo
Blood creatinine increased
Investigations
—
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—
—
—
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
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Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A randomized, double-blind, placebo-controlled, crossover, dose escalation study to assess the efficacy and tolerability of gefapixant (AF-219; MK-7264) in participants with refractory chronic cough.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05813223 — Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
· EARLY_PHASE1
· recruiting
NCT04193202 — Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
· Phase 3
· completed
NCT04193176 — Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
· Phase 3
· completed
NCT03882801 — Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
· Phase 1
· completed
NCT03696108 — A Study of Gefapixant (MK-7264) in Japanese Adult Participants With Refractory or Unexplained Chronic Cough (MK-7264-038
· Phase 3
· completed
Other recruiting trials for Refractory Chronic Cough
NCT05600777 — A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
· Phase 3
· active not recruiting
NCT05599191 — A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
· Phase 3
· active not recruiting
Other Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
NCT02790840 — A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations
· Phase 1
· completed
NCT02612623 — An 8-Week Refractory Chronic Cough Study (MK-7264-021)
· Phase 2
· completed
NCT02612610 — A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)
· Phase 2
· completed
NCT02476890 — Effect of Gefapixant (MK-7264/AF-219) on Cough Reflex Sensitivity in Healthy and Chronic Cough Participants (MK-7264-014
· Phase 2
· completed
NCT02502097 — A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (M
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 22 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02349425.