Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls
Brief Summary: Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD


Options:
A: Inclusion Criteria:

* Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

  1. Smoking history of at least 20 pack years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

     Exclusion Criteria:
* Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
* Patients who had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with a history of asthma.
* Patients with diabetes type I or uncontrolled diabetes type II.
* Any patient with lung cancer or a history of lung cancer.
* Patients with a history of certain cardiovascular co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.
B: Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

* a) Smoking history of at least 10 pack-years
* b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
C: Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

  * Smoking history of at least 20 pack years
  * Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value.
  * Post-bronchodilator FEV1/FVC \< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

* Pregnant or lactating females
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long term oxygen therapy (\> 15 h a day)
* Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
* Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
* Patients with a history of asthma (with further criteria)
* Patients with Type I or uncontrolled Type II diabetes
* Patients with contraindications for tiotropium
* Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patients with a history of long QT syndrome or whose QTc interval is prolonged
* Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
* Patients who have had treatment with the investigational drug (with further criteria)
* Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
* Patients with known history of non compliance to medication
* Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

* Signed and dated inform consent
* Out-patient, clinical diagnosis of COPD
* Men or women at the age of 40 or over

Exclusion Criteria:

* A history of asthma
* Seasonal allergic rhinitis before 40 years of age
* Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder

Answer: C