Table E1. List of inclusion and exclusion criteria (as defined in the study protocol).

Inclusion criteria
1	Positive history of grass pollen allergy, positive SPT response to grass pollen extract, grass pollen allergen–specific IgE and rPhl p 1/rPhl p 5–specific IgE (≥3.5 kUA/L) at the screening visit or within 12 months before the screening visit
2	Moderate-to-severe symptoms of grass pollen allergy during peak pollen season in the baseline period (exact definition of this criterion is specified in the study reference manual [SRM])
3	Age between 18 and 60 years (male/female)
4	Subjects must have standard health insurance
5	Subject must appear capable of understanding and complying with all relevant aspects of the study protocol
6	Subject must be available during the study period to complete all treatments and assessments
Exclusion criteria
1	Symptomatic perennial allergies or symptomatic seasonal coallergies during the GPS
2	Atopic dermatitis
3	Pregnancy or breast-feeding
4	Women with childbearing potential who are not using a medically accepted birth control method
5	Autoimmune diseases and immune defects, including immunosuppression and immune complex–induced immunopathies
6	Contraindication for adrenaline
7	Severe general maladies, malignant diseases
8	Patients undergoing long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers, or psychoactive drugs
9	Contraindications for SPTs, such as skin inflammation in the test area and urticaria facticia
10	Asthma not controlled by low-dose inhaled corticosteroids, meaning that patients with a history of concomitant asthma should have an FEV1 of greater than 70% at inclusion; patients without a history of asthma should have an FEV1 of grater then 70% or a peak expiratory flow of greater than 80% at inclusion
11	Chronic use of b-blockers
12	Participation in another clinical trial within 1 month before the study; however, participation during the previous month solely in the form of blood donation and/or without other interventions will be acceptable
13	Patients who participated in a pollen SIT trial or received marketed pollen SIT in 2 y before the study
14	Patients who had a previous grass pollen SIT or have participated in a clinical trial of grass pollen SIT
15	Risk of noncompliance with the study procedure and restrictions (eg with alcohol, drug, or medication abuse within the past year)
16	Use of prohibited medication before screening (visit 1) and throughout the study: Depot corticosteroids 12 weeks before visit 1 Oral corticosteroids 8 weeks before visit 1 High-dose inhaled corticosteroids 4 weeks before visit 1
17	Use of antihistamines 3 days before visits 1 or V2
18	Patients with nasal polyposis
19	Patients sensitized to Phl p 7 (specific IgE to Phl p 7 and/or Bet v 4 >0.35 kUA/L)

SIT, Specific immunotherapy.