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SPECIFIC EXCLUSIONS FROM THIS STUDY

You may not take part in this study if:

• You have received a COVID-19 vaccine within 7 days before screening or admission, or you are to be vaccinated with a COVID-19 vaccine at any time during your stay at the PCRU.

• You are not a woman, in good health, breastfeeding or expressing breastmilk and having given birth at least 12 weeks ago.

• You are pregnant.

• You do not want to temporarily discontinue breastfeeding your child for a total period of 4.5 days, starting from evening of the day before the administration of the study drug (Day -1) up to the next day after you leave the PCRU (Day 5).

• You do not agree to using a breast pump regularly or to not giving that breastmilk to your child during this period.

• You have not chosen another feeding method for your child during the 4.5 days when he/she will not be able to take your breastmilk.

• You are not able to express at least 14 mL of breastmilk over a 2-hour interval prior to Day 1

• Your infant cannot be fed successfully from a bottle or other alternative methods (such as a cup, syringe, finger-feeder, etc.) prior to the start of the study.

• Your infant cannot tolerate infant formula for the scenario that there is not sufficient stored breastmilk to cover the duration of the study e.g. when nursing is restricted.

COMMON EXCLUSIONS TO MOST OF THE STUDIES

You may not take part in this study if:

• You are outside of the age limits (18-55 years) or weight limits (minimum of 50 kg), or you are outside of the limits of the Body Mass Index (minimum 17.5 kg/m2 ).

• You are regularly taking medications or you are suffering from a chronic illness.

• You have an illness or you have received treatment that may affect absorption of the medicines (for example a gastrectomy).

• You are suffering from asthma or from any allergy to a medicine.

• You are suffering from symptomatic or seasonal allergies (hay fever) and require treatment.

• You smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco / nicotine containing products.

• You have taken part in another clinical study involving investigational medicines within the last 30 days.

• You have given blood or constituent elements of blood (platelets) during the two months preceding the study or you intend to be a donor in the two months following the end of the study (Red Cross standard to guarantee blood cells regeneration). Giving plasma is allowed.

• You have taken or you are taking drugs.

• You think you are at risk of being infected with the AIDS virus, hepatitis B or C.

• You have a history of regular alcohol consumption exceeding 14 drinks/week (1 drink = 90 mL of wine or 240 mL of beer or 30 mL of spirit).