Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.


Options:
A: Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
B: Inclusion Criteria:

* Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
* Current or previous smoker with a smoking history of 10 or more pack years
* Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
* Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
* Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
C: Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids.
* Any significant disease or disorder that may jeopardize the safety of the patient
D: Inclusion criteria:

* Established clinical history of moderate to severe COPD.
* Post bronchodilator FEV1 of \< 50% of predicted normal.
* FEV1 / FVC ratio \<70%.
* Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.
* Free from exacerbation in the 6 weeks prior to screening.
* Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria:

* Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.
* Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).
* Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.
* Has undergone lung transplantation and/or lung volume reduction.
* Female who is a nursing mother.
* Requires regular (daily) long-term oxygen therapy (LTOT).
* Is receiving beta-blockers (except eye drops).
* Has a serious, uncontrolled disease likely to interfere with the study.
* Has received any other investigational drugs within the 4 weeks prior to Visit 1.
* Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
* Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).

Answer: B