Trial Outcomes & Findings for Study to Evaluate Multiple Doses in Patients With Nasal Polyposis (NCT NCT02734849)

Last Updated: 2021-01-25

Results Overview

NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

From Baseline (prior to the first dose) to Week 12 (Day 84)

Results posted on

2021-01-25

Participant Flow

Date First Patient First Visit 04 April 2016 Date Last Patient Last Visit 05 January 2018 Date Enrollment was Terminated 31 May 2017

Participant milestones

Participant milestones
Measure	25 mg AK001 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	250 mg AK001 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	Placebo Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
Overall Study STARTED	16	14	10
Overall Study COMPLETED	12	14	9
Overall Study NOT COMPLETED	4	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	25 mg AK001 n=15 Participants 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	250 mg AK001 n=14 Participants 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	Placebo n=10 Participants Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	Total n=39 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Region of Enrollment Europe	10 participants n=5 Participants	9 participants n=7 Participants	6 participants n=5 Participants	25 participants n=4 Participants
Total Polyp Score (TPS)	6.0 units on a scale n=5 Participants	6.0 units on a scale n=7 Participants	6.0 units on a scale n=5 Participants	6.0 units on a scale n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	48.0 Years n=5 Participants	46.5 Years n=7 Participants	45.0 Years n=5 Participants	45.0 Years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Baseline (prior to the first dose) to Week 12 (Day 84)

Population: Modified Intent-to-Treat (MITT) population included all randomized subjects who have taken at least one dose of the study drug and had both a baseline and at least one post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	25 mg AK001 n=15 Participants 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	250 mg AK001 n=14 Participants 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49	Placebo n=10 Participants Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
Change in Total Polys Score (TPS)	-0.5 score on a scale Interval -1.3 to 0.3	-0.3 score on a scale Interval -1.1 to 0.5	-0.2 score on a scale Interval -1.1 to 0.7

Adverse Events

25 mg AK001

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

250 mg AK001

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Henrik Rasmussen, MD, PhD, Chief Medical Officer

Allakos, Inc.

Phone: 1 6505975002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	25 mg AK001 n=15 participants at risk 25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	250 mg AK001 n=14 participants at risk 250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.	Placebo n=10 participants at risk Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Gastrointestinal disorders Toothache	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Vascular disorders Hypertension	13.3% 2/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
General disorders Facial pain	13.3% 2/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
General disorders Fatigue	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
General disorders Feeling hot	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
General disorders Pain	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
General disorders Pyrexia	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Psychiatric disorders Agitation	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Psychiatric disorders Insomnia	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Investigations Blood pressure increased	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Investigations Heart rate increased	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Investigations Weight increased	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Cardiac disorders Ventricular extrasystoles	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Blood and lymphatic system disorders Lymphadenopathy	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	14.3% 2/14 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	20.0% 2/10 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Nasal congestion	13.3% 2/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	14.3% 2/14 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Nasal discharge discolouration	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	20.0% 3/15 • Number of events 3 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.7% 1/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Respiratory, thoracic and mediastinal disorders Wheezing	13.3% 2/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Nervous system disorders Dizziness	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Nervous system disorders Headache	13.3% 2/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Nervous system disorders Memory impairment	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Nervous system disorders Migraine	13.3% 2/15 • Number of events 3 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Nervous system disorders Syncope	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Ear and labyrinth disorders Ear pain	6.7% 1/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	14.3% 2/14 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Acne	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Blister	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	7.1% 1/14 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Erythema	6.7% 1/15 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/10 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Generalised erythema	0.00% 0/15 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.
Skin and subcutaneous tissue disorders Pruritus	6.7% 1/15 • Number of events 2 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	0.00% 0/14 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.	10.0% 1/10 • Number of events 1 • The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study. If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.