doi: 10.1038/nature08617 35 ZhaoSLinYXuWJiangWZhaZWangPet al
TsokoMBeauseigneurFGrestiJNiotIDemarquoyJBoichotJet al
Inspect the pen and ensure the solution is clear and colourless Prime the pen on first use until a drop appears Dial the required dose (clicks) Apply to clean skin (abdomen or thigh) Hold in place for 6 seconds Replace the cap and store properly 12 clicks = 5 mg Use once daily Typically used for up to 20 consecutive days Follow with a 2-week break before restarting Adjust under professional guidance Approximately 20 doses per pen (based on 5 mg daily use)
Use is restricted to trained professionals operating in laboratory or research settings, following appropriate safety and handling protocols.
After reconstitution, keep the vial refrigerated at 28 C, protected from light, and use within the bacteriostatic-water window (commonly cited as up to ~28 days)
"Further, while we acknowledge the corrective and preventive actions that your site has taken or plans to take, your written response is inadequate because it does not provide sufficient details about how you, as a clinical investigator, will ensure adequate oversight of the study procedures (for example, adherence to eligibility requirements)
