Brief title

Brief title chosen by the research group, intended for the lay public (can be omitted if the researchers so wish)

Study number

Sponsoring organisation number and EUDRACT number

Trial registration date

The date of inclusion in the Database

Sponsor

Name of sponsoring organisation that took responsibility for conducting the study

Official scientific title

Official name of the study report provided by the principal investigator or sponsor; this title must include the name of intervention, the condition studied and the scope of the investigation

Condition

The medical condition (indication) being studied

Intervention

The generic name of Chiesi’s test product investigated, as well as the generic name of all other comparison/control products, where applicable.

Study type

Interventional/observational

Study design

Primary investigative techniques used in the study (type of allocation, type of masking, type of control and group assignment, duration)

Study phase

Phase of investigation: 1; 1-2; 2; 2-3; 3; 4 (post-marketing studies). Not applicable for observational trials

Brief summary

Short description of the primary purpose of the study intended for the lay public. Includes a brief statement of the study hypothesis

Primary outcome

The primary outcome that the study was designed to evaluate. Where applicable, description should include the time at which the outcome was measured

Key secondary outcomes

Key secondary outcomes specified in the protocol. Where applicable, description should include the time at which the outcome wasmeasured

Key inclusion and exclusion criteria

Key patients characteristics that determined eligibility for participation in the study

Gender

Male/Female

Age limits

Minimum and maximum age of participants

Number of subjects

The total number of subjects enrolled into the study

Start date

First patient enrolment date (first visit)

End date

Last patient enrolment date (last visit)

Facility Locations

Name and addresses of the organisations where the trial has beenconducted

Research ethics review

Has the study at the time of registration received appropriate ethics committee approval (Yes/No)?

Research contact person

CTI (Clinical Trial Investigator) name and e-mail

Main results

The key results of the study, focused on the primary and secondary outcomes reported in the Registry

Main adverse events

The drug-related adverse events most frequently reported during the study, likely to be included in the product prescribing information.

Link to publication

Full bibliographic citations to publications related to the protocol: background and/or results.