Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 6-month, Double-blind, Randomised, Multicenter, Multinational Trial to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With COPD. The ACROSS Trial
Brief Summary: The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.


Options:
A: Inclusion criteria:

* Patients with COPD and FEV1 \<60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio \<70%.
* Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion criteria:

* Diagnosis of other respiratory disorders (including asthma).
* Requirement for long term oxygen therapy.
B: Main Inclusion Criteria:

* FEV1/FVC ratio (post-bronchodilator) ≤70%
* FEV1 (post-bronchodilator) ≤50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as ≥16 hours/day
C: Inclusion Criteria:

* Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Any significant co-morbid disease
* Use of any maintenance therapy except short acting bronchodilators
D: Main Inclusion Criteria:

* Willingness to sign a written informed consent
* Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
* Chinese or Malay or Indian ethnicity
* History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
* Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) \< 70%
* Forced expiratory volume in the first second (FEV1) (post-bronchodilator) \< 50 % of predicted
* Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

* Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0
* Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
* History of asthma diagnosis in patients \< 40 years of age or relevant lung disease other than COPD
* Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
* Known alpha-1-antitrypsin deficiency

Answer: D