A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)

Inclusion Criteria:

1. Able to comprehend and willing to sign the informed consent form (ICF), and willingto abide by the study restrictions.

2. Males and females aged between 18 (included) and 75 (included) years.

3. Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products.

4. Agree not to participate in other interventional clinical studies duringparticipation in this study.

5. Treated with standard of care for DPNP, either duloxetine or gabapentin orpregabalin as monotherapy or combination of 2.

6. Not current cannabis products users, that is, participants who were previouscannabis products users for any reason but have not used cannabis products within 3months of the screening visit, or participants who have never used cannabisproducts, that is, cannabis naïve participants.

7. A diagnosis of DPNP (at screening).

8. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.

9. Glycated hemoglobin (HbA1c) less than (<) 9% at screening.

10. Body mass index between 18 and 40 kilograms per square meter (kg/m^2), inclusive.

11. Have at least 5 out of 7 records of daily average pain intensity recordings in the 7days prior to randomization.

12. Agree not to drive or operate heavy machinery during the study treatment period.

13. Female participants must have a negative serum pregnancy test at screening and anegative urine pregnancy test prior to the administration of study treatment on Day 1or be of non-child-bearing potential as defined in the protocol.

14. Participants of reproductive potential who are sexually active must use effectivebirth control methods.

Exclusion Criteria:

1. Evidence of significant uncontrolled concomitant disease that could affectcompliance with the protocol at screening or randomization, ability to complete thestudy, or study assessments.

2. Presence of skin conditions in the affected dermatome at screening or randomizationthat could interfere with the evaluation of the neuropathic pain condition.

3. Presence of pain not associated with diabetic peripheral neuropathy (DPN) or otherneuropathies that may interfere with study assessments.

4. Known history of significant hypersensitivity, intolerance, adverse reaction orallergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.

5. Malignancies in the past 5 years prior to screening, except for cutaneous basal cellor squamous cell carcinoma resolved by excision.

6. Liver disease or liver injury as indicated by abnormal liver function tests atscreening.

7. History or presence of impaired renal function at screening

8. Presence of significant pulmonary disease at screening

9. Ongoing respiratory infection at screening.

10. History of acute coronary syndrome; unstable angina; congestive heart failure;cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or currentuncontrolled blood pressure.

11. Concomitant clinically significant cardiac arrhythmias, examples, sustainedventricular tachycardia, and second or third degree atrioventricular block without apacemaker, or any other relevant cardiac disease in the judgment of theinvestigator.

12. History of clinically significant electrocardiograms (ECG) abnormalities, or any ofthe following ECG abnormalities at screening or baseline:

• PR greater than (>) 200 milliseconds (msec)

• QRS complex >120 msec

• Fridericia QT correction formula (QTcF) greater than (>) 450 msec

• History of familial long QT syndrome or known family history of ventriculararrythmia.

• Acute ischemic changes.

13. History or presence of mental illness evidenced as defined in the protocol.

14. Abnormal neurological condition or abnormal neurological examination at screening injudgment of investigator.