Continuation Protocol for Obstructive Sleep Apnea (OSA)

Primary outcomes

1. Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)

   Time frame: through study completion, an average of 1 year

   An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity.

2. Number of Participants With Vital Signs Abnormalities

   Time frame: through study completion, an average of 1 year

   Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.

3. Number of Participants With Concomitant Therapy (Medication or Devices)

   Time frame: through study completion, an average of 1 year

   Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.