Please select the eligibility criteria that correspond to the clinical trial below.
Title: A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)
Brief Summary: The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).


Options:
A: Inclusion Criteria:

* A history of house dust mite induced asthma
* Use of inhaled corticosteroids (ICS)
* Positive skin prick test to house dust mites
* Positive specific IgE to house dust mites

Exclusion Criteria:

* FEV1 lower than 70%
B: Inclusion Criteria:

* History of allergic rhinitis/rhinoconjunctivitis to house dust of 1 year duration or more (with or without asthma)
* If female of childbearing potential, has a negative urine pregnancy test at screening and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study.

Exclusion Criteria:

* Sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.)
* Sensitized and regularly exposed to seasonal allergens (i.e., birch or grass pollen)
* Immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms)
* History of chronic urticaria and/or angioedema within 2 years prior to screening
* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to screening
* Ongoing treatment with any specific immunotherapy
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen
* Unstable uncontrolled/partially controlled or severe asthma, or life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[SABA\]) within 3 months prior to screening
* Asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to screening
* Chronic sinusitis within 2 years prior to screening
* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps)
* Pregnant, breastfeeding or planning to become pregnant during the study
* Participation in a different investigational study at any site during the same time frame of this study
* Direct association with the administration of the study or a family member of the study staff
C: Inclusion Criteria:

1. Male or female outpatients aged 16 to 50 years (inclusive).
2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
3. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and \< 1,000 µg equivalent budesonide/day.

Exclusion Criteria:

1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
3. FEV1 \< 70% of predicted value at Visit 1.
4. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
5. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
D: Inclusion Criteria:

* History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
* If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
* Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

* Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
* History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
* Received an immunosuppressive treatment within 3 months prior to screening
* Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \[SABAs\]) at any time within 3 months prior to screening
* Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
* History of chronic urticaria and/or angioedema within 2 years prior to screening
* History of chronic sinusitis during 2 years prior to screening
* Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
* Previous exposure to MK-8237
* Receiving ongoing treatment with any specific immunotherapy at screening
* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
* Unable to meet medication washout requirements prior to screening
* Unable or unwilling to comply with the use of self-injectable epinephrine
* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
* Likely to travel for extended periods of time during the efficacy assessment period
* Participating in a different investigational study at any site during this study

Answer: D