Trial Outcomes & Findings for Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis (NCT NCT00674700)

Last Updated: 2016-05-19

Results Overview

The AAdSS is derived from the daily Rhinoconjunctivitis Total Symptom Scores (RTSS), based on the severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe). It ranges from 0 to 12, the higher the score the more severe the rhinitis.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

509 participants

Primary outcome timeframe

Last 3 months of Year 1

Results posted on

2016-05-19

Participant Flow

First Patient First Visit 12 OCT 2007, Last Patient Last Visit 01 FEB 2010

Participant milestones

Participant milestones
Measure	300 IR 300 IR house dust mites allergen extract tablet	500 IR 500 IR house dust mites allergen extract tablet	Placebo Placebo tablet
Year 1 STARTED	170	169	170
Year 1 COMPLETED	139	135	153
Year 1 NOT COMPLETED	31	34	17
Year 2 Follow-up Without Treatment STARTED	139	135	153
Year 2 Follow-up Without Treatment COMPLETED	133	123	141
Year 2 Follow-up Without Treatment NOT COMPLETED	6	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	300 IR 300 IR house dust mites allergen extract tablet	500 IR 500 IR house dust mites allergen extract tablet	Placebo Placebo tablet
Year 1 Adverse Event	17	20	5
Year 1 Withdrawal by Subject	7	7	6
Year 1 Any other reason not above-mentioned	7	7	6
Year 2 Follow-up Without Treatment Adverse Event	0	1	1
Year 2 Follow-up Without Treatment Withdrawal by Subject	1	1	4
Year 2 Follow-up Without Treatment Any other reason not above-mentioned	5	10	7

Baseline Characteristics

Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 IR n=153 Participants 300 IR house dust mites allergen extract tablet	500 IR n=150 Participants 500 IR house dust mites allergen extract tablet	Placebo n=163 Participants Placebo tablet	Total n=466 Participants Total of all reporting groups
Age, Continuous	29.0 years STANDARD_DEVIATION 8.52 • n=5 Participants	30.1 years STANDARD_DEVIATION 8.43 • n=7 Participants	30.0 years STANDARD_DEVIATION 8.96 • n=5 Participants	29.7 years STANDARD_DEVIATION 8.64 • n=4 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	77 Participants n=7 Participants	80 Participants n=5 Participants	242 Participants n=4 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	73 Participants n=7 Participants	83 Participants n=5 Participants	224 Participants n=4 Participants

PRIMARY outcome

Timeframe: Last 3 months of Year 1

Population: The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.

Outcome measures

Outcome measures
Measure	300 IR n=141 Participants 300 IR house dust mites allergen extract tablet	500 IR n=136 Participants 500 IR house dust mites allergen extract tablet	Placebo n=153 Participants Placebo tablet
Average Adjusted Symptom Score (AAdSS) During the Year 1 Primary Period	3.18 Units on a scale (range: 0 to 12) Standard Error 0.224	3.09 Units on a scale (range: 0 to 12) Standard Error 0.230	3.87 Units on a scale (range: 0 to 12) Standard Error 0.217

SECONDARY outcome

Timeframe: Last 3 months of Year 1

Population: The Full Analysis Set included all participants who received at least one dose of the investigational product and had at least one Adjusted Symptom Score evaluation in the year.

The Rhinitis Total Symptom Score (RTSS) evaluates the presence and severity of the 4 rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion (absence of symptom (0), mild symptom (1), moderate symptom (2), severe symptom (3)). It ranges from 0 to 12, the higher the score the more severe the rhinitis.

Outcome measures

Outcome measures
Measure	300 IR n=141 Participants 300 IR house dust mites allergen extract tablet	500 IR n=136 Participants 500 IR house dust mites allergen extract tablet	Placebo n=153 Participants Placebo tablet
Average Rhinitis Total Symptom Score (ARTSS)	2.74 Units on a scale (range: 0 to 12) Standard Error 0.178	2.72 Units on a scale (range: 0 to 12) Standard Error 0.183	3.32 Units on a scale (range: 0 to 12) Standard Error 0.173

Adverse Events

300 IR

Serious events: 6 serious events

Other events: 128 other events

Deaths: 0 deaths

500 IR

Serious events: 1 serious events

Other events: 123 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	300 IR n=170 participants at risk 300 IR house dust mites allergen extract tablet	500 IR n=169 participants at risk 500 IR house dust mites allergen extract tablet	Placebo n=170 participants at risk Placebo tablet
Reproductive system and breast disorders Metrorrhagia	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Reproductive system and breast disorders Vaginal laceration	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Pharyngeal Oedema	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Skin and subcutaneous tissue disorders Eczema	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Infections and infestations Tubo-ovarian abscess	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Injury, poisoning and procedural complications Injury	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Injury, poisoning and procedural complications Road traffic accident	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.

Other adverse events

Additional Information

Michel Roux, Medical Director

Stallergenes

Phone: +33 1 55 59 2970

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	300 IR n=170 participants at risk 300 IR house dust mites allergen extract tablet	500 IR n=169 participants at risk 500 IR house dust mites allergen extract tablet	Placebo n=170 participants at risk Placebo tablet
Gastrointestinal disorders Oral pruritus	30.0% 51/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	25.4% 43/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	4.7% 8/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Gastrointestinal disorders Oedema mouth	12.4% 21/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	16.6% 28/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Gastrointestinal disorders Tongue oedema	5.3% 9/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.9% 10/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Gastrointestinal disorders Lip oedema	7.1% 12/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	2.4% 4/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Infections and infestations Nasopharyngitis	16.5% 28/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	13.6% 23/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	22.9% 39/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Infections and infestations Influenza	8.8% 15/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	8.3% 14/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	9.4% 16/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Infections and infestations Pharyngitis	10.0% 17/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.9% 10/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	11.2% 19/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Infections and infestations Upper respiratory tract infection	6.5% 11/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	3.0% 5/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.3% 9/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Throat irritation	24.7% 42/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	21.3% 36/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	4.1% 7/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Cough	4.1% 7/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	9.5% 16/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	10.6% 18/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	3.5% 6/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	6.5% 11/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.00% 0/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Asthma	2.4% 4/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.9% 10/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.9% 10/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.5% 6/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	4.1% 7/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	7.1% 12/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 9/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	1.2% 2/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	3.5% 6/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Nervous system disorders Headache	13.5% 23/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	14.2% 24/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	19.4% 33/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Skin and subcutaneous tissue disorders Eczema	2.4% 4/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	1.8% 3/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.3% 9/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
Ear and labyrinth disorders Ear pruritus	2.4% 4/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	7.7% 13/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.
General disorders Pyrexia	2.4% 4/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	0.59% 1/169 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.	5.9% 10/170 • During the Year 1 with treatment and during the follow-up year without treatment. Results are provided here for the Year 1. Safety variables were adverse events (AEs) monitored throughout the study and data from physical examinations and clinical laboratory assessments.